Ceftriaxone P-Care

Patient Information Leaflet

CEFTRIAXONE P-CARE

500 mg / 2 ml powder and solvent for injectable solution for intramuscular use
CEFTRIAXONE (as ceftriaxone sodium)
Generic medicine
Please read this leaflet carefully before this medicine is administered to you, as it
contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Never give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Ceftriaxone P-Care is and what it is used for
2. What you need to know before you are given Ceftriaxone P-Care
3. How Ceftriaxone P-Care is administered
4. Possible side effects
5. How to store Ceftriaxone P-Care
6. Package contents and other information

1. What Ceftriaxone P-Care is and what it is used for

Ceftriaxone P-Care contains the active substance ceftriaxone, which is an antibiotic administered to adults and children (including newborns). It works by killing the bacteria that cause infections. It belongs to a group of medicines called cephalosporins.
Ceftriaxone P-Care is used to treat infections:

• of the brain (meningitis).
• of the lungs.
• of the middle ear.
• of the abdomen and abdominal wall (peritonitis).
• of the urinary tract and kidneys.
• of the bones and joints.
• of the skin or soft tissues.
• of the blood.
• of the heart.

It may be administered:

• to treat specific sexually transmitted infections (gonorrhoea and syphilis).
• to treat patients with a low white blood cell count (neutropenia) who have fever due to bacterial infection.
• to treat chest infections in adults with chronic bronchitis.

1/35

• to treat Lyme disease (caused by tick bites) in adults and children, including newborns from 15 days of age.
• to prevent infections during surgery.

2. What you need to know before being given Ceftriaxone P-Care

Do not be given Ceftriaxone P-Care if:

• you are allergic to ceftriaxone or to any of the other ingredients of this medicine (listed in section 6).
• you have had a sudden or severe allergic reaction to penicillin or to similar antibiotics (such as cephalosporins, penicillins, monobactams, and carbapenems). Possible signs include sudden swelling of the throat or face, which may make it difficult to breathe or swallow, sudden swelling of hands, feet and ankles, and a severe rash that develops rapidly.
• you are allergic to lidocaine and Ceftriaxone P-Care needs to be administered by intramuscular injection.

Ceftriaxone P-Care must not be given to children in the following cases:

• the child is premature.
• the child is a newborn (up to 28 days of life) and has certain blood disorders or jaundice (yellowing of the skin or whites of the eyes), or needs to receive a product containing calcium through a vein.

Warnings and precautions

• Talk to your doctor, pharmacist, or nurse before being given Ceftriaxone P-Care if: you are experiencing or have previously experienced any combination of the following symptoms: rash, skin redness, blistering of lips, eyes and mouth, skin peeling, high fever, flu-like symptoms, increased levels of liver enzymes detectable in blood tests, increase in a type of white blood cells (eosinophilia), and swollen lymph nodes (signs of serious skin reactions, see also section 4 “Possible side effects”).
• you have recently received or are about to receive products containing calcium.
• you have recently had diarrhoea after taking an antibiotic. You have had intestinal problems, particularly colitis (inflammation of the intestine).
• you have liver or kidney problems (see section 4).
• you have gallstones or kidney stones.
• you have other diseases, for example haemolytic anaemia (a reduction in red blood cells that may cause pale yellow skin and lead to weakness or breathlessness).
• you are on a low-sodium diet.

If you are due to have a blood or urine test
If you are given Ceftriaxone P-Care for a prolonged period, you may need to have regular blood tests. Ceftriaxone P-Care may affect the results of urine tests for sugar and a blood test known as the Coombs test. If you are due to have tests:

• inform the person taking your sample that you have been given Ceftriaxone P-Care. 2/35

Children
Talk to your doctor, pharmacist, or nurse before giving Ceftriaxone P-Care to a child if:

• the child has recently received or is about to receive a product containing calcium through a vein.

Other medicines and Ceftriaxone P-Care
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. In particular, inform your doctor or pharmacist if you are taking one of the following medicines:

• an antibiotic called an aminoglycoside.
• an antibiotic called chloramphenicol (used in the treatment of infections, particularly eye infections).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine.
Your doctor will weigh the benefits that treatment with Ceftriaxone P-Care would provide you against the possible risks to the unborn or breastfed child.

Driving and using machines
Ceftriaxone P-Care may cause dizziness. If you feel dizzy, do not drive or use tools or machinery. Contact your doctor if you experience these symptoms.

3. How Ceftriaxone P-Care is administered

Ceftriaxone P-Care is generally administered by a doctor or a nurse via an injection given directly into a muscle. Ceftriaxone P-Care will be prepared by a doctor, pharmacist, or nurse and will not be mixed or administered simultaneously with calcium-containing injections.
Usual dose
Your doctor will determine the correct dose of Ceftriaxone P-Care for you. The dose will depend on the severity and type of infection, any concomitant treatment with other antibiotics, your body weight and age, and the functioning of your kidneys and liver. The number of days or weeks during which you will receive Ceftriaxone P-Care will depend on the type of infection you have.
Adults, elderly patients, and children aged 12 years or older with a body weight of 50 kilograms (kg) or more:

• 1 to 2 g once daily, depending on the severity and type of infection. If you have a severe infection, your doctor will administer a higher dose (up to 4 g per day). If your daily dose exceeds 2 g, it may be given as a single daily dose or divided into two separate doses.

Newborns, infants, and children from 15 days to 12 years of age with a body weight below 50 kg:

• 50–80 mg of Ceftriaxone P-Care once daily per kg of the child's body weight, depending on the severity and type of infection. If you have a severe infection, your doctor will prescribe a higher dose starting from 100 mg per kg of body weight, up to a maximum of 4 g per day.
  If your daily dose exceeds 2 g, it may be given as a single daily dose or divided into two separate doses.

• Children with a body weight of 50 kg or more should receive the usual adult dose.

Newborns (0–14 days of life)

• 20–50 mg of Ceftriaxone P-Care once daily per kg of the newborn's body weight, depending on the severity and type of infection.
• The maximum daily dose must not exceed 50 mg per kg of the newborn's body weight.

Patients with liver or kidney problems
You may be given a different dose than the usual one. Your doctor will decide the amount of Ceftriaxone P-Care you need and will closely monitor you, depending on the severity of your liver or kidney disease.
If you take more Ceftriaxone P-Care than you should
If you are accidentally given more Ceftriaxone P-Care than prescribed, contact your doctor or go to the nearest hospital immediately.
If you forget to take Ceftriaxone P-Care
If you miss an injection, you should receive it as soon as possible. However, if it is almost time for your next scheduled injection, skip the missed dose. Do not take a double dose (two injections together) to make up for a forgotten dose.
If you stop treatment with Ceftriaxone P-Care
Do not stop taking Ceftriaxone P-Care unless your doctor tells you to. If you have any doubts about using this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
With this medicine, you may experience the following side effects:

Severe allergic reactions (not known, frequency cannot be estimated from the available data)
If you have a severe allergic reaction, seek medical advice immediately.
Signs may include:

• sudden swelling of the face, throat, lips or mouth. This may make breathing or swallowing difficult.
• sudden swelling of the hands, feet and ankles.

Severe skin reactions (not known, frequency cannot be estimated from the available data)
If you develop a severe skin reaction, inform a doctor immediately.

• Signs may include:

4/35

• Severe rash developing rapidly, with blistering or peeling of the skin and possible blistering in the mouth (Stevens-Johnson syndrome and toxic epidermal necrolysis, also known as SJS and TEN).
• Any combination of the following symptoms: widespread rash, high body temperature, increased liver enzymes, abnormalities in blood tests (eosinophilia), swollen lymph nodes and involvement of other organs in the body (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome).
• Jarisch-Herxheimer reaction, which may cause fever, chills, headache, muscle pain and rash, which generally tends to resolve spontaneously. These symptoms occur shortly after starting treatment with Ceftriaxone P-Care for spirochete infections such as Lyme disease.

Treatment with ceftriaxone, particularly in elderly patients with severe renal impairment or neurological disorders, may rarely cause reduced level of consciousness, abnormal movements, agitation and seizures.

Other possible side effects:

Common (may affect up to 1 in 10 people)

• Abnormalities in white blood cells (such as reduced leukocytes and increased eosinophils) and platelets (reduced thrombocytes).
• Soft stools or diarrhoea.
• Changes in blood test results indicating liver function abnormalities.
• Rash.

Uncommon (may affect up to 1 in 100 people)

• Fungal infections (e.g. thrush).
• Decreased number of white blood cells (granulocytopenia).
• Reduced number of red blood cells (anaemia).
• Blood clotting problems. Signs include easy bruising, joint pain and swelling.
• Headache.
• Dizziness.
• Nausea or vomiting.
• Itching.
• Pain or burning sensation along the vein where Ceftriaxone P-Care was administered. Pain at the injection site.
• Fever.
• Abnormal kidney function tests (increased blood creatinine).

Rare (may affect up to 1 in 1,000 people)

• Inflammation of the large intestine (colon). Signs include diarrhoea, often with blood and mucus, stomach pain and fever.
• Difficulty breathing (bronchospasm).

5/35

• Rash with raised red patches (urticaria), which may cover large areas of the body, associated with itching and swelling.
• Blood or sugar in the urine.
• Oedema (fluid retention).
• Chills.

Not known (frequency cannot be estimated from the available data)

• Secondary infections that may not respond to the prescribed antibiotic.
• A form of anaemia characterised by destruction of red blood cells (haemolytic anaemia).
• Severe decrease in the number of white blood cells (agranulocytosis).
• Seizures.
• Dizziness.
• Inflammation of the pancreas (pancreatitis). Signs include severe stomach pain radiating to the back.
• Inflammation of the mouth lining (stomatitis).
• Inflammation of the tongue (glossitis). Signs include swelling, redness and irritation of the tongue.
• Problems with the gallbladder and/or liver, which may cause pain, nausea and vomiting, yellowing of the skin, itching, unusually dark urine and clay-coloured stools.
• A neurological condition that may develop in newborns with severe jaundice (kernicterus).
• Kidney problems caused by calcium-ceftriaxone deposits. You may experience pain when urinating, or your urine output may decrease.
• False positive Coombs test (a blood test to detect blood problems).
• False positive test for galactosaemia (an abnormal accumulation of the sugar galactose).
• Ceftriaxone P-Care may interfere with certain types of blood glucose tests; please check with your doctor.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ceftriaxone P-Care

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month. The expiry date applies to the product stored in its original, unopened packaging and kept under the recommended storage conditions.
From a microbiological standpoint, the product should be used immediately after reconstitution. If not used immediately, the conditions and duration of storage prior to use are the responsibility of the user. The chemical and physical stability of the medicinal product after reconstitution has been demonstrated for 24 hours at +2°C to +8°C and for 6 hours when stored below 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

1. 6. Pack contents and other information What Ceftriaxone P-Care contains CEFTRIAXONE P-CARE 500 mg / 2 ml powder and solvent for injectable solution for intramuscular use One vial of powder contains: active substance: ceftriaxone disodium 3,5 H2O 596,5 mg equivalent to ceftriaxone 500 mg; one ampoule of solvent contains: aqueous solution of lidocaine 1%.

Description of the appearance of Ceftriaxone P-Care and pack contents
CEFTRIAXONE P-CARE 500 mg / 2 ml powder and solvent for injectable solution for intramuscular use: 1 vial of powder + 1 ampoule of solvent (2 ml).
Marketing Authorization Holder
Pharmacare srl – Via Marghera, 29 – 20149 Milano – Italy
Manufacturer
MITIM S.r.l. – Via Cacciamali 34-36-38 – 25125 Brescia
CT Srl Pharmaceutical Laboratory - Via Dante Alighieri, 71 – 18038 Sanremo (IM)
7/35

Patient Information Leaflet: information for the patient

CEFTRIAXONE P-CARE 500 mg / 5 ml powder and solvent for injectable solution for

intravenous use
CEFTRIAXONE (as ceftriaxone sodium)
Generic medicine
Please read this leaflet carefully before this medicine is administered to you because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Never give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What Ceftriaxone P-Care is and what it is used for
2. What you need to know before Ceftriaxone P-Care is administered
3. How Ceftriaxone P-Care is administered
4. Possible side effects
5. How to store Ceftriaxone P-Care
6. Package contents and other information

1. What Ceftriaxone P-Care is and what it is used for

Ceftriaxone P-Care contains the active substance ceftriaxone, which is an antibiotic administered to adults and children (including newborns). It works by killing the bacteria that cause infections. It belongs to a group of medicines called cephalosporins.
Ceftriaxone P-Care is used to treat infections of:

• the brain (meningitis).
• the lungs.
• the middle ear.
• the abdomen and abdominal wall (peritonitis).
• the urinary tract and kidneys.
• the bones and joints.
• the skin or soft tissues.
• the blood.
• the heart.

It may be administered:

• to treat specific sexually transmitted infections (gonorrhoea and syphilis).
• to treat patients with a low white blood cell count (neutropenia) who have fever due to bacterial infection. 8/35
• to treat chest infections in adults with chronic bronchitis.
• to treat Lyme disease (caused by tick bites) in adults and children, including newborns from 15 days of age.
• to prevent infections during surgery.

2. What you need to know before you are given Ceftriaxone P-Care

Do not be given Ceftriaxone P-Care if:

• you are allergic to ceftriaxone or to any of the other ingredients of this medicine (listed in section 6).
• you have previously had a sudden or severe allergic reaction to penicillin or to similar antibiotics (such as cephalosporins, penicillins, monobactams, and carbapenems). Possible signs include sudden swelling of the throat or face, which may make breathing or swallowing difficult, sudden swelling of the hands, feet, and ankles, or a severe rash that develops rapidly.
• you are allergic to lidocaine and Ceftriaxone P-Care is to be administered by intramuscular injection.

Ceftriaxone P-Care must not be given to children in the following cases:

• the child is premature.
• the child is a newborn (up to 28 days of age) and has certain blood disorders or jaundice (yellowing of the skin or whites of the eyes), or needs to receive a product containing calcium through a vein.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before you are given Ceftriaxone P-Care if:

• you are experiencing or have previously experienced any combination of the following symptoms: rash, skin redness, blistering on lips, eyes, or mouth, skin peeling, high fever, flu-like symptoms, increased liver enzymes detectable in blood tests, increased levels of a type of white blood cells (eosinophilia), and swollen lymph nodes (signs of serious skin reactions, see also section 4 “Possible side effects”).
• you have recently received or are about to receive products containing calcium.
• you have recently had diarrhoea after taking an antibiotic. You have had intestinal problems, particularly colitis (inflammation of the intestine).
• you have liver or kidney problems (see section 4).
• you have gallstones or kidney stones.
• you have other diseases, for example haemolytic anaemia (a reduction in red blood cells that may cause pale yellow skin, weakness, or shortness of breath).
• you are on a low-sodium diet.

If you are undergoing blood or urine tests
If you are given Ceftriaxone P-Care for a prolonged period, you may need to have regular blood tests. Ceftriaxone P-Care may affect the results of urine sugar tests and a blood test known as the Coombs test. If you are about to undergo testing:

• inform the person collecting your sample that you have been administered Ceftriaxone P-Care.

Children
Talk to your doctor, pharmacist, or nurse before administering Ceftriaxone P-Care to a child if:

• the child has recently received or is about to receive a product containing calcium through a vein.

Other medicines and Ceftriaxone P-Care
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. In particular, inform your doctor or pharmacist if you are taking one of the following medicines:

• an antibiotic called an aminoglycoside.
• an antibiotic called chloramphenicol (used in the treatment of infections, particularly eye infections).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine.
Your doctor will evaluate the benefits of treatment with Ceftriaxone P-Care for you and the potential risks to the unborn or breastfed child.

Driving and using machines
Ceftriaxone P-Care may cause dizziness. If you feel dizzy, do not drive and do not operate tools or machinery. Contact your doctor if you experience these symptoms.

3. How Ceftriaxone P-Care is administered

Ceftriaxone P-Care is generally administered by a doctor or nurse via intravenous infusion (IV infusion) or by injection directly into a vein.
Ceftriaxone P-Care will be prepared by a doctor, pharmacist, or nurse and will not be mixed or administered simultaneously with calcium-containing injections.
Usual dose
Your doctor will determine the appropriate dose of Ceftriaxone P-Care for you. The dose will depend on the severity and type of infection, whether you are receiving concomitant treatment with other antibiotics, your body weight and age, and the function of your kidneys and liver. The number of days or weeks during which you will receive Ceftriaxone P-Care will depend on the type of infection you have.
Adults, elderly patients, and children aged 12 years and older with a body weight equal to or greater than 50 kilograms (kg):

• 1 to 2 g once daily, depending on the severity and type of infection. If you have a severe infection, your doctor may administer a higher dose (up to 4 g per day). If your daily dose exceeds 2 g, it may be given as a single daily dose or as two separate doses.

10/35
Newborns, infants, and children from 15 days to 12 years of age with a body weight below 50 kg:

• 50–80 mg of Ceftriaxone P-Care once daily per kg of the child’s body weight, depending on the severity and type of infection. If the child has a severe infection, the doctor may prescribe a higher dose starting from 100 mg per kg of body weight, up to a maximum of 4 g per day. If the daily dose exceeds 2 g, it may be administered as a single daily dose or as two separate doses.
• Children with a body weight equal to or greater than 50 kg should receive the usual adult dose.

Newborns (0–14 days of life):

• 20–50 mg of Ceftriaxone P-Care once daily per kg of the newborn’s body weight, depending on the severity and type of infection.
• The maximum daily dose must not exceed 50 mg per kg of the newborn’s body weight.

Patients with liver or kidney problems
You may be given a different dose than the usual one. Your doctor will decide how much Ceftriaxone P-Care you need and will monitor you closely, depending on the severity of your liver or kidney disease.
If you are given more Ceftriaxone P-Care than you should
If you are accidentally given more Ceftriaxone P-Care than prescribed, contact your doctor or go to the nearest hospital immediately.
If you miss a dose of Ceftriaxone P-Care
If you miss an injection, you should receive it as soon as possible. However, if it is almost time for your next scheduled injection, skip the missed dose. Do not take a double dose (two injections together) to make up for the missed dose.
If you stop treatment with Ceftriaxone P-Care
Do not stop taking Ceftriaxone P-Care unless your doctor tells you to. If you have any doubts about using this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
With this medicine, you may experience the following side effects:

Severe allergic reactions (not known, frequency cannot be estimated from the available data)
If you have a severe allergic reaction, seek medical advice immediately.
Signs may include:

• Sudden swelling of the face, throat, lips or mouth. This may make breathing or swallowing difficult.
• Sudden swelling of the hands, feet and ankles.

Severe skin reactions (not known, frequency cannot be estimated from the available data)
11/35
If you develop a severe skin reaction, inform a doctor immediately.

• Signs may include:
• Severe rash that develops rapidly, with blistering or peeling of the skin and possible blistering in the mouth (Stevens-Johnson syndrome and toxic epidermal necrolysis, also known as SJS and TEN).
• Any combination of the following symptoms: widespread rash, high body temperature, increased liver enzymes, abnormalities in blood tests (eosinophilia), swollen lymph nodes and involvement of other organs in the body (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome).
• Jarisch-Herxheimer reaction, which may cause fever, chills, headache, muscle pain and rash, which usually resolves spontaneously. These symptoms occur shortly after starting treatment with Ceftriaxone P-Care for spirochete infections such as Lyme disease.

Treatment with ceftriaxone, particularly in elderly patients with severe renal impairment or neurological disorders, may rarely cause reduced consciousness, abnormal movements, agitation and seizures.

Other possible side effects:

Common (may affect up to 1 in 10 people)

• Abnormalities in white blood cells (such as reduced white blood cells and increased eosinophils) and platelets (reduced thrombocytes).
• Soft stools or diarrhoea.
• Changes in blood test results for liver function.
• Rash.

Uncommon (may affect up to 1 in 100 people)

• Fungal infections (e.g. thrush).
• Decreased number of white blood cells (granulocytopenia).
• Reduced number of red blood cells (anaemia).
• Blood clotting problems. Signs include easy bruising, joint pain and swelling.
• Headache.
• Dizziness.
• Nausea or vomiting.
• Itching.
• Pain or burning sensation along the vein where Ceftriaxone P-Care was administered. Pain at the injection site.
• Fever.
• Abnormal kidney function tests (increased blood creatinine).

Rare (may affect up to 1 in 1,000 people)

• Inflammation of the large intestine (colon). Signs include diarrhoea, often with blood and mucus, stomach pain and fever.
• Difficulty breathing (bronchospasm). 12/35
• Rash with hives (urticaria), which may cover a large area of the body, associated with itching and swelling.
• Blood or sugar in the urine.
• Oedema (fluid accumulation).
• Chills.

Not known (frequency cannot be estimated from the available data)

• Secondary infections that may not respond to the prescribed antibiotic.
• A form of anaemia characterised by destruction of red blood cells (haemolytic anaemia).
• Severe decrease in the number of white blood cells (agranulocytosis).
• Seizures.
• Dizziness.
• Inflammation of the pancreas (pancreatitis). Signs include severe stomach pain spreading to the back.
• Inflammation of the mouth lining (stomatitis).
• Inflammation of the tongue (glossitis). Signs include swelling, redness and irritation of the tongue.
• Problems with the gallbladder and/or liver, which may cause pain, nausea and vomiting, yellowing of the skin, itching, unusually dark urine and pale stools.
• A neurological condition that may develop in newborns with severe jaundice (kernicterus).
• Kidney problems caused by calcium-ceftriaxone deposits. You may experience pain when urinating, or your urine output may decrease.
• False positive Coombs test (a test to detect blood problems).
• False positive test for galactosaemia (an abnormal accumulation of the sugar galactose).
• Ceftriaxone P-Care may interfere with certain types of tests to measure blood glucose; please check with your doctor.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ceftriaxone P-Care

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the
last day of that month. The expiry date applies to the product in its original, unopened packaging and
stored correctly.
From a microbiological point of view, the product must be used immediately after reconstitution. If
not used immediately, the conditions and duration of storage prior to use are the responsibility of the
user. Chemical and physical stability of the medicine after reconstitution has been demonstrated for
24 hours at +2°C to +8°C and for 6 hours when stored below 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Ceftriaxone P-Care contains
CEFTRIAXONE P-CARE 500 mg / 5 ml powder and solvent for injectable solution for intravenous use
One vial of powder contains:
active substance: ceftriaxone disodium 3.5 H2O 596.5 mg equivalent to ceftriaxone 500 mg;
one solvent vial contains: water for injections
Description of the appearance of Ceftriaxone P-Care and contents
CEFTRIAXONE P-CARE 500 mg / 5 ml powder and solvent for injectable solution for intravenous use: 1 powder vial + 1 solvent vial of 5 ml.
Marketing Authorization Holder
Pharmacare srl – Via Marghera, 29 – 20149 Milan – Italy
Manufacturer
MITIM S.r.l. – Via Cacciamali 34-36-38 – 25125 Brescia
CT Srl Pharmaceutical Laboratory - Via Dante Alighieri, 71 – 18038 Sanremo (IM)
14/35

Patient Information Leaflet

CEFTRIAXONE P-CARE 1 g / 3.5 ml powder and solvent for injectable solution for use

intramuscularly
CEFTRIAXONE (as sodium ceftriaxone)
Generic medicine
Please read this leaflet carefully before you are given this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Never give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Ceftriaxone P-Care is and what it is used for
2. What you need to know before you are given Ceftriaxone P-Care
3. How Ceftriaxone P-Care is administered
4. Possible side effects
5. How to store Ceftriaxone P-Care
6. Package contents and other information

1. What Ceftriaxone P-Care is and what it is used for

Ceftriaxone P-Care contains the active substance ceftriaxone, which is an antibiotic administered to adults and children (including newborns). It works by killing the bacteria that cause infections. It belongs to a group of medicines called cephalosporins.
Ceftriaxone P-Care is used to treat infections:

• of the brain (meningitis).
• of the lungs.
• of the middle ear.
• of the abdomen and abdominal wall (peritonitis).
• of the urinary tract and kidneys.
• of bones and joints.
• of the skin or soft tissues.
• of the blood.
• of the heart.

It may be administered:

• to treat specific sexually transmitted infections (gonorrhoea and syphilis).
• to treat patients with a low number of white blood cells in the blood (neutropenia) who have fever due to bacterial infection. 15/35
• to treat chest infections in adults with chronic bronchitis.
• to treat Lyme disease (caused by tick bites) in adults and children, including newborns from 15 days of age.
• to prevent infections during surgery.

2. What you need to know before you are given Ceftriaxone P-Care

Do not be given Ceftriaxone P-Care if:

• you are allergic to ceftriaxone or to any of the other ingredients of this medicine (listed in section 6).
• you have had a sudden or severe allergic reaction to penicillin or to similar antibiotics (such as cephalosporins, penicillins, monobactams and carbapenems). Possible signs include sudden swelling of the throat or face, which may make it difficult to breathe or swallow, sudden swelling of the hands, feet and ankles, and a severe skin rash that develops rapidly.
• you are allergic to lidocaine and Ceftriaxone P-Care is to be administered by intramuscular injection.

Ceftriaxone P-Care must not be given to children in the following cases:

• the child is premature.
• the child is a newborn (up to 28 days of age) and has certain blood disorders or jaundice (yellowing of the skin or whites of the eyes), or is to receive a product containing calcium through a vein.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given Ceftriaxone P-Care if:

• you are experiencing or have previously experienced any combination of the following symptoms: skin rash, skin redness, blistering on lips, eyes and mouth, skin peeling, high fever, flu-like symptoms, increased levels of liver enzymes detectable in blood tests, increase in a type of white blood cells (eosinophilia), and swollen lymph nodes (signs of serious skin reactions, see also section 4 “Possible side effects”).
• you have recently received or are about to receive products containing calcium.
• you have recently had diarrhoea after taking an antibiotic. You have had intestinal problems, particularly colitis (inflammation of the intestine).
• you have liver or kidney problems (see section 4).
• you have gallstones or kidney stones.
• you have other diseases, such as haemolytic anaemia (a reduction in red blood cells that may cause pale yellow skin and lead to weakness or shortness of breath).
• you are on a low-sodium diet.

If you are to undergo blood or urine tests
If you are given Ceftriaxone P-Care for a prolonged period, you may need to have regular blood tests. Ceftriaxone P-Care may affect the results of urine sugar tests and a blood test known as the Coombs test. If you are about to undergo testing:

• inform the person collecting the sample that you have been administered Ceftriaxone P-Care.

Children
Talk to your doctor, pharmacist or nurse before Ceftriaxone P-Care is administered to a child if:

• the child has recently received or is about to receive, via intravenous route, a product containing calcium.

Other medicines and Ceftriaxone P-Care
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor or pharmacist if you are taking one of the following medicines:

• an antibiotic called an aminoglycoside.
• an antibiotic called chloramphenicol (used in the treatment of infections, particularly eye infections).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Your doctor will evaluate the benefits of treatment with Ceftriaxone P-Care for you and the possible risks for the unborn or breastfed child.

Driving and using machines
Ceftriaxone P-Care may cause dizziness. If you feel dizzy, do not drive and do not use tools or machinery. Contact your doctor if you experience these symptoms.

3. How Ceftriaxone P-Care is administered

Ceftriaxone P-Care is generally administered by a doctor or nurse as an injection directly into a muscle.
Ceftriaxone P-Care will be prepared by a doctor, pharmacist, or nurse and will not be mixed or administered simultaneously with calcium-containing injections.
Recommended dose
Your doctor will determine the correct dose of Ceftriaxone P-Care for you. The dose will depend on the severity and type of infection, any concomitant treatment with other antibiotics, your body weight and age, and the function of your kidneys and liver. The number of days or weeks during which you will receive Ceftriaxone P-Care will depend on the type of infection you have.
Adults, elderly patients, and children aged 12 years or older with a body weight of 50 kilograms (kg) or more:

• 1 to 2 g once daily, depending on the severity and type of infection. If you have a severe infection, your doctor may administer a higher dose (up to 4 g per day). If your daily dose exceeds 2 g, it may be given as a single daily dose or divided into two separate doses.

17/35
Neonates, infants, and children from 15 days to 12 years of age with a body weight below 50 kg:

• 50–80 mg of Ceftriaxone P-Care once daily per kg of body weight, depending on the severity and type of infection. If the infection is severe, your doctor may prescribe a higher dose, starting from 100 mg per kg of body weight, up to a maximum of 4 g per day. If your daily dose exceeds 2 g, it may be given as a single daily dose or divided into two separate doses.
• Children with a body weight of 50 kg or more should receive the adult dose.

Neonates (0–14 days of life)

• 20–50 mg of Ceftriaxone P-Care once daily per kg of body weight, depending on the severity and type of infection.
• The maximum daily dose must not exceed 50 mg per kg of body weight.

Patients with liver or kidney problems
You may be given a different dose than the usual one. Your doctor will decide how much Ceftriaxone P-Care you need and will closely monitor you, depending on the severity of your liver or kidney disease.
If you are given more Ceftriaxone P-Care than you should
If you are accidentally given more Ceftriaxone P-Care than prescribed, contact your doctor or the nearest hospital immediately.
If you miss a dose of Ceftriaxone P-Care
If you miss an injection, you should receive it as soon as possible. However, if it is almost time for your next scheduled injection, skip the missed dose. Do not take a double dose (two injections together) to make up for a missed dose.
If you stop treatment with Ceftriaxone P-Care
Do not stop taking Ceftriaxone P-Care unless instructed by your doctor. If you have any doubts about using this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
With this medicine, you may experience the following side effects:

Severe allergic reactions (not known, frequency cannot be estimated from the available data)
If you have a severe allergic reaction, seek medical attention immediately.
Signs may include:

• sudden swelling of the face, throat, lips or mouth. This may make breathing or swallowing difficult.
• sudden swelling of the hands, feet and ankles.

18/35

Severe skin reactions (not known, frequency cannot be estimated from the available data)
If you develop a severe skin reaction, inform a doctor immediately.

• Signs may include:
• Severe rash that develops rapidly, with blistering or peeling of the skin and possible blisters in the mouth (Stevens-Johnson syndrome and toxic epidermal necrolysis, also known as SJS and TEN).
• Any combination of the following symptoms: widespread rash, high body temperature, increased liver enzymes, abnormalities in blood tests (eosinophilia), swollen lymph nodes and involvement of other organs in the body (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome).
• Jarisch-Herxheimer reaction, which may cause fever, chills, headache, muscle pain and rash, usually resolving spontaneously. These symptoms occur shortly after starting treatment with Ceftriaxone P-Care for spirochete infections such as Lyme disease.

Treatment with ceftriaxone, especially in elderly patients with severe renal impairment or neurological disorders, may rarely cause reduced level of consciousness, abnormal movements, agitation and seizures.

Other possible side effects:

Common (may affect up to 1 in 10 people)

• Abnormal white blood cells (such as reduced leukocytes and increased eosinophils) and platelets (reduced thrombocytes).
• Soft stools or diarrhoea.
• Changes in blood test results for liver function.
• Rash.

Uncommon (may affect up to 1 in 100 people)

• Fungal infections (e.g. thrush).
• Decreased number of white blood cells (granulocytopenia).
• Reduced number of red blood cells (anaemia).
• Blood clotting problems. Signs include easy bruising, joint pain and swelling.
• Headache.
• Dizziness.
• Nausea or vomiting.
• Itching.
• Pain or burning sensation along the vein where Ceftriaxone P-Care was administered. Pain at the injection site.
• Fever.
• Abnormal kidney function tests (increased blood creatinine).

Rare (may affect up to 1 in 1,000 people)
19/35

• Inflammation of the large intestine (colon). Signs include diarrhoea, often with blood and mucus, stomach pain and fever.
• Difficulty breathing (bronchospasm).
• Rash with raised red patches (urticaria), which may affect large areas of the body, associated with itching and swelling.
• Blood or sugar in the urine.
• Oedema (fluid accumulation).
• Chills.

Not known (frequency cannot be estimated from the available data)

• Secondary infections that may not respond to the prescribed antibiotic.
• A form of anaemia characterised by destruction of red blood cells (haemolytic anaemia).
• Severe decrease in the number of white blood cells (agranulocytosis).
• Seizures.
• Dizziness.
• Inflammation of the pancreas (pancreatitis). Signs include severe stomach pain spreading to the back.
• Inflammation of the mouth lining (stomatitis).
• Inflammation of the tongue (glossitis). Signs include swelling, redness and irritation of the tongue.
• Problems with the gallbladder and/or liver, which may cause pain, nausea and vomiting, yellowing of the skin, itching, unusually dark urine and pale stools.
• A neurological condition that may develop in newborns with severe jaundice (kernicterus).
• Kidney problems caused by calcium-ceftriaxone deposits. You may experience pain when urinating, or a reduced amount of urine produced.
• False positive Coombs test (a test to detect blood problems).
• False positive test for galactosaemia (an abnormal accumulation of the sugar galactose).
• Ceftriaxone P-Care may interfere with certain types of blood glucose tests; please check with your doctor.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ceftriaxone P-Care

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month. The expiry date applies to the product in its original, undamaged packaging, stored correctly.
20/35
From a microbiological standpoint, the product should be used immediately after reconstitution. If not used immediately, the conditions and duration of storage prior to use are the responsibility of the user. Chemical and physical stability of the medicine after reconstitution has been demonstrated for 24 hours between +2°C and +8°C, and for 6 hours when stored at temperatures below 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Ceftriaxone P-Care contains
CEFTRIAXONE P-CARE 1 g / 3.5 ml powder and solvent for injectable solution for intramuscular use
One vial of powder contains:
active substance: ceftriaxone disodium 3.5 H2O 1.193 g equivalent to ceftriaxone 1 g;
one ampoule of solvent contains: aqueous solution of 1% lidocaine.
Description of the appearance of Ceftriaxone P-Care and contents
CEFTRIAXONE P-CARE 1 g / 3.5 ml powder and solvent for injectable solution for intramuscular use: 1 powder vial + 1 solvent ampoule of 3.5 ml.
Marketing Authorization Holder
Pharmacare srl – Via Marghera, 29 – 20149 Milan – Italy
Manufacturer
MITIM S.r.l. – Via Cacciamali 34-36-38 – 25125 Brescia
CT Srl Pharmaceutical Laboratory - Via Dante Alighieri, 71 – 18038 Sanremo (IM)
21/35

Patient Information Leaflet

CEFTRIAXONE P-CARE 1 g / 10 ml powder and solvent for injectable solution for intravenous use

CEFTRIAXONE (as ceftriaxone sodium)
Generic medicine
Please read this leaflet carefully before this medicine is administered to you because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Never give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Ceftriaxone P-Care is and what it is used for
2. What you need to know before being administered Ceftriaxone P-Care
3. How Ceftriaxone P-Care is administered
4. Possible side effects
5. How to store Ceftriaxone P-Care
6. Package contents and other information

1. What Ceftriaxone P-Care is and what it is used for

Ceftriaxone P-Care contains the active substance ceftriaxone, which is an antibiotic administered to adults and children (including newborns). It works by killing bacteria that cause infections. It belongs to a group of medicines called cephalosporins.
Ceftriaxone P-Care is used to treat infections of:

• the brain (meningitis).
• the lungs.
• the middle ear.
• the abdomen and abdominal wall (peritonitis).
• the urinary tract and kidneys.
• the bones and joints.
• the skin or soft tissues.
• the blood.
• the heart.

It may also be administered:

• to treat specific sexually transmitted infections (gonorrhoea and syphilis).
• to treat patients with a low white blood cell count (neutropenia) who have fever due to a bacterial infection. 22/35
• to treat chest infections in adults with chronic bronchitis.
• to treat Lyme disease (caused by tick bites) in adults and children, including newborns from 15 days of age.
• to prevent infections during surgery.

2. What you need to know before you are given Ceftriaxone P-Care

Do not be given Ceftriaxone P-Care if:

• you are allergic to ceftriaxone or to any of the other ingredients of this medicine (listed in section 6).
• you have had a sudden or severe allergic reaction to penicillin or to similar antibiotics (such as cephalosporins, penicillins, monobactams, and carbapenems). Possible signs include sudden swelling of the throat or face, which may make breathing or swallowing difficult, sudden swelling of hands, feet and ankles, and a severe rash that develops rapidly.
• you are allergic to lidocaine and Ceftriaxone P-Care is to be administered by intramuscular injection.

Ceftriaxone P-Care must not be given to children in the following cases:

• the child is premature.
• the child is a newborn (up to 28 days of age) and has certain blood disorders or jaundice (yellowing of the skin or whites of the eyes), or needs to receive a product containing calcium through a vein.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before you are given Ceftriaxone P-Care if:

• you are experiencing or have previously experienced any combination of the following symptoms: rash, skin redness, blistering of the lips, eyes and mouth, skin peeling, high fever, flu-like symptoms, increased levels of liver enzymes detectable in blood tests, increased levels of a type of white blood cells (eosinophilia), and swollen lymph nodes (signs of serious skin reactions, see also section 4 “Possible side effects”).
• you have recently received or are about to receive products containing calcium.
• you have recently had diarrhoea after taking an antibiotic. You have had intestinal problems, particularly colitis (inflammation of the intestine).
• you have liver or kidney problems (see section 4).
• you have gallstones or kidney stones.
• you have other illnesses, such as haemolytic anaemia (a reduction in red blood cells that may cause pale yellow skin and lead to weakness or shortness of breath).
• you are on a low-sodium diet.

If you need to have blood or urine tests
If you are given Ceftriaxone P-Care for a prolonged period, you may need to have regular blood tests. Ceftriaxone P-Care may affect the results of urine sugar tests and a blood test known as the Coombs test. If you are due to have tests:

• inform the person collecting your sample that you have been given Ceftriaxone P-Care.

Children
Talk to your doctor, pharmacist, or nurse before administering Ceftriaxone P-Care to a child if:

• the child has recently received or is about to receive a product containing calcium through a vein.

Other medicines and Ceftriaxone P-Care
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. In particular, inform your doctor or pharmacist if you are taking one of the following medicines:

• an antibiotic called an aminoglycoside.
• an antibiotic called chloramphenicol (used in the treatment of infections, particularly eye infections).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine.
Your doctor will assess the benefits that treatment with Ceftriaxone P-Care would provide you and the possible risks to the unborn or breastfed child.

Driving and using machines
Ceftriaxone P-Care may cause dizziness. If you feel dizzy, do not drive and do not use tools or machinery. Contact your doctor if you experience these symptoms.

3. How Ceftriaxone P-Care is administered

Ceftriaxone P-Care is generally administered by a doctor or nurse through an intravenous infusion (IV infusion) or by direct injection into a vein.
Ceftriaxone P-Care will be prepared by a doctor, pharmacist, or nurse and will not be mixed or administered simultaneously with calcium-containing injections.

Standard dose
Your doctor will determine the correct dose of Ceftriaxone P-Care for you. The dose will depend on the severity and type of infection, any concomitant treatment with other antibiotics, your body weight and age, and the functioning of your kidneys and liver. The number of days or weeks during which you will receive Ceftriaxone P-Care will depend on the type of infection you have.

Adults, elderly patients, and children aged 12 years or older with a body weight equal to or greater than 50 kilograms (kg):

• 1 to 2 g once daily, depending on the severity and type of infection. If you have a severe infection, your doctor may administer a higher dose (up to 4 g per day). If your daily dose exceeds 2 g, it may be given as a single daily dose or as two separate doses.

24/35
Newborns, infants, and children from 15 days to 12 years of age with a body weight below 50 kg:

• 50–80 mg of Ceftriaxone P-Care once daily per kg of the child's body weight, depending on the severity and type of infection. If you have a severe infection, your doctor may prescribe a higher dose, starting from 100 mg per kg of body weight, up to a maximum of 4 g per day. If your daily dose exceeds 2 g, it may be given as a single daily dose or as two separate doses.
• Children with a body weight equal to or greater than 50 kg should receive the standard adult dose.

Newborns (0–14 days of life):

• 20–50 mg of Ceftriaxone P-Care once daily per kg of the newborn's body weight, depending on the severity and type of infection.
• The maximum daily dose must not exceed 50 mg per kg of the newborn's body weight.

Patients with liver or kidney problems
You may be given a different dose from the standard one. Your doctor will decide how much Ceftriaxone P-Care you need and will closely monitor you, depending on the severity of your liver or kidney disease.

If you are given more Ceftriaxone P-Care than you should
If you are accidentally given more Ceftriaxone P-Care than prescribed, contact your doctor or go to the nearest hospital immediately.

If you miss a dose of Ceftriaxone P-Care
If you miss an injection, you should receive it as soon as possible. However, if it is almost time for your next scheduled injection, skip the missed dose. Do not take a double dose (two injections together) to make up for the missed dose.

If you stop treatment with Ceftriaxone P-Care
Do not stop taking Ceftriaxone P-Care unless instructed by your doctor. If you have any doubts about using this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You may experience the following side effects with this medicine:

Severe allergic reactions (frequency not known, cannot be estimated from the available data)
If you have a severe allergic reaction, seek medical attention immediately.
Signs may include:

• sudden swelling of the face, throat, lips or mouth. This may make breathing or swallowing difficult.
• sudden swelling of the hands, feet and ankles.

25/35
Severe skin reactions (frequency not known, cannot be estimated from the available data)
If you develop a severe skin reaction, inform a doctor immediately.

• Signs may include:
• Severe rash developing rapidly, with blistering or peeling of the skin and possible mouth blisters (Stevens-Johnson syndrome and toxic epidermal necrolysis, also known as SJS and TEN).
• Any combination of the following symptoms: widespread rash, high body temperature, increased liver enzymes, abnormalities in blood tests (eosinophilia), swollen lymph nodes and involvement of other organs in the body (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome).
• Jarisch-Herxheimer reaction, which may cause fever, chills, headache, muscle pain and rash, which usually resolves spontaneously. These symptoms may occur shortly after starting treatment with Ceftriaxone P-Care for spirochete infections such as Lyme disease.

Treatment with ceftriaxone, especially in elderly patients with severe renal insufficiency or neurological disorders, may rarely cause reduced consciousness, abnormal movements, agitation and seizures.
Other possible side effects:
Common (may affect up to 1 in 10 people)

• Abnormalities in white blood cells (such as reduced leucocytes and increased eosinophils) and platelets (reduced thrombocytes).
• Soft stools or diarrhoea.
• Changes in blood test results for liver function.
• Rash.

Uncommon (may affect up to 1 in 100 people)

• Fungal infections (e.g. thrush).
• Decreased number of white blood cells (granulocytopenia).
• Reduced number of red blood cells (anaemia).
• Blood clotting problems. Signs include easy bruising, joint pain and swelling.
• Headache.
• Dizziness.
• Nausea or vomiting.
• Itching.
• Pain or burning sensation along the vein where Ceftriaxone P-Care was administered. Pain at the injection site.
• Fever.
• Abnormal kidney function tests (increased blood creatinine).

Rare (may affect up to 1 in 1,000 people)
26/35

• Inflammation of the large intestine (colon). Signs include diarrhoea, often with blood and mucus, stomach pain and fever.
• Difficulty breathing (bronchospasm).
• Rash with raised red patches (urticaria), which may cover a large area of the body, associated with itching and swelling.
• Blood or sugar in the urine.
• Oedema (fluid accumulation).
• Chills.

Frequency not known (cannot be estimated from the available data)

• Secondary infections that may not respond to the prescribed antibiotic.
• A form of anaemia characterised by destruction of red blood cells (haemolytic anaemia).
• Severe decrease in the number of white blood cells (agranulocytosis).
• Seizures.
• Dizziness.
• Inflammation of the pancreas (pancreatitis). Signs include severe stomach pain spreading to the back.
• Inflammation of the mouth lining (stomatitis).
• Inflammation of the tongue (glossitis). Signs include swelling, redness and irritation of the tongue.
• Problems with the gallbladder and/or liver, which may cause pain, nausea and vomiting, yellowing of the skin, itching, unusually dark urine and clay-coloured stools.
• A neurological condition that may develop in newborns with severe jaundice (kernicterus).
• Kidney problems caused by calcium-ceftriaxone deposits. You may experience pain when urinating, or your urine output may decrease.
• False positive Coombs test (a test to detect blood problems).
• False positive result for galactosaemia (an abnormal accumulation of the sugar galactose).
• Ceftriaxone P-Care may interfere with certain types of tests to measure blood glucose; please consult your doctor.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ceftriaxone P-Care

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the
last day of that month. The expiry date applies to the product in its original, undamaged packaging,
correctly stored.
27/35
From a microbiological standpoint, the product should be used immediately after reconstitution. If
not used immediately, the conditions and duration of storage prior to use are the responsibility of the
user. Chemical and physical stability of the medicine after reconstitution has been demonstrated for 24
hours between +2°C and +8°C and for 6 hours when stored below 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ceftriaxone P-Care contains
CEFTRIAXONE P-CARE 1 g / 10 ml powder and solvent for injectable solution for intravenous use
One vial of powder contains:
active substance: ceftriaxone disodium 3.5 H2O 1.193 g equivalent to ceftriaxone 1 g;
one solvent ampoule contains: water for injection
Description of the appearance of Ceftriaxone P-Care and package contents
CEFTRIAXONE P-CARE 1 g / 10 ml powder and solvent for injectable solution for intravenous use:
1 vial of powder + 1 ampoule of 10 ml solvent.
Marketing Authorization Holder
Pharmacare srl – Via Marghera, 29 – 20149 Milan – Italy
Manufacturer
MITIM S.r.l. – Via Cacciamali 34-36-38 – 25125 Brescia
CT Srl Pharmaceutical Laboratory - Via Dante Alighieri, 71 – 18038 Sanremo (IM)
28/35

Patient Information Leaflet

CEFTRIAXONE P-CARE 2 g powder and solution for infusion

CEFTRIAXONE (as ceftriaxone sodium)
Equivalent medicine
Please read this leaflet carefully before this medicine is administered to you because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Never give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Ceftriaxone P-Care is and what it is used for
2. What you need to know before being administered Ceftriaxone P-Care
3. How Ceftriaxone P-Care is administered
4. Possible side effects
5. How to store Ceftriaxone P-Care
6. Contents of the pack and other information

1. What Ceftriaxone P-Care is and what it is used for

Ceftriaxone P-Care contains the active substance ceftriaxone, which is an antibiotic administered to adults and children (including newborns). It works by killing bacteria that cause infections. It belongs to a group of medicines called cephalosporins.
Ceftriaxone P-Care is used to treat infections:

• of the brain (meningitis).
• of the lungs.
• of the middle ear.
• of the abdomen and abdominal wall (peritonitis).
• of the urinary tract and kidneys.
• of bones and joints.
• of the skin or soft tissues.
• of the blood.
• of the heart.

It may be administered:

• to treat specific sexually transmitted infections (gonorrhoea and syphilis).
• to treat patients with a low white blood cell count (neutropenia) who have fever due to bacterial infection.
• to treat chest infections in adults with chronic bronchitis.

29/35

• to treat Lyme disease (caused by tick bites) in adults and children, including newborns from 15 days of age.
• to prevent infections during surgery.

2. What you need to know before you are given Ceftriaxone P-Care

Do not be given Ceftriaxone P-Care if:

• you are allergic to ceftriaxone or to any of the other ingredients of this medicine (listed in section 6).
• you have had a sudden or severe allergic reaction to penicillin or to similar antibiotics (such as cephalosporins, penicillins, monobactams and carbapenems). Possible signs include sudden swelling of the throat or face, which may make breathing or swallowing difficult, sudden swelling of hands, feet and ankles, and a severe rash that develops rapidly.
• you are allergic to lidocaine and Ceftriaxone P-Care is to be administered by intramuscular injection.

Ceftriaxone P-Care must not be given to children in the following cases:

• the child is premature.
• the child is a newborn (up to 28 days of age) and has certain blood disorders or jaundice (yellowing of the skin or whites of the eyes), or is to receive a product containing calcium through a vein.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given Ceftriaxone P-Care if:

• you are experiencing or have previously experienced any combination of the following symptoms: rash, skin redness, blistering of the lips, eyes and mouth, skin peeling, high fever, flu-like symptoms, increased levels of liver enzymes detectable in blood tests, increase in a type of white blood cells (eosinophilia), and swollen lymph nodes (signs of serious skin reactions, see also section 4 “Possible side effects”).
• you have recently received or are about to receive products containing calcium.
• you have recently had diarrhoea after taking an antibiotic. You have had intestinal problems, particularly colitis (inflammation of the intestine).
• you have liver or kidney problems (see section 4).
• you have gallstones or kidney stones.
• you have other diseases, such as haemolytic anaemia (a reduction in red blood cells which may cause pale yellow skin and lead to weakness or shortness of breath).
• you are on a low-sodium diet.

If you are to undergo blood or urine tests
If you are given Ceftriaxone P-Care for a prolonged period, you may need to have regular blood tests. Ceftriaxone P-Care may affect the results of urine sugar tests and a blood test known as the Coombs test. If you are about to undergo tests:

• inform the person taking your sample that you have been given Ceftriaxone P-Care.

Children
Talk to your doctor, pharmacist or nurse before giving Ceftriaxone P-Care to a child if:

• the child has recently received or is about to receive a product containing calcium through a vein.

Other medicines and Ceftriaxone P-Care
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor or pharmacist if you are taking one of the following medicines:

• an antibiotic called an aminoglycoside.
• an antibiotic called chloramphenicol (used in the treatment of infections, particularly eye infections).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Your doctor will assess the benefits that treatment with Ceftriaxone P-Care would provide you and the potential risks to the unborn or breastfed child.

Driving and using machines
Ceftriaxone P-Care may cause dizziness. If you feel dizzy, do not drive and do not use tools or machinery. Contact your doctor if you experience these symptoms.

3. How Ceftriaxone P-Care is administered

Ceftriaxone P-Care is usually administered by a doctor or nurse via
intravenous infusion (IV infusion) or by injection directly into a vein.
Ceftriaxone P-Care will be prepared by a doctor, pharmacist, or nurse and will not be mixed
with, nor administered simultaneously to, injections containing calcium.
Usual dose
Your doctor will determine the correct dose of Ceftriaxone P-Care for you. The dose will depend on the severity
and type of infection, whether you are receiving concomitant treatment with other antibiotics, your body weight and
age, and the function of your kidneys and liver. The number of days or
weeks during which you will receive Ceftriaxone P-Care will depend on the type of infection you
have.
Adults, elderly patients, and children aged 12 years or older with a body weight equal to or greater than 50 kilograms (kg):

• 1 to 2 g once daily, depending on the severity and type of infection. If you have a severe infection, your doctor may administer a higher dose (up to 4 g per day). If your daily dose exceeds 2 g, it may be given as a single daily dose or divided into two separate doses.

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Newborns, infants, and children from 15 days to 12 years of age with a body weight below 50 kg:

• 50–80 mg of Ceftriaxone P-Care once daily per kg of the child's body weight, depending on the severity and type of infection. If you have a severe infection, your doctor may prescribe a higher dose starting from 100 mg per kg of body weight, up to a maximum of 4 g per day. If your daily dose exceeds 2 g, it may be given as a single daily dose or divided into two separate doses.
• Children with a body weight equal to or greater than 50 kg should receive the usual adult dose.

Newborns (0–14 days of life)

• 20–50 mg of Ceftriaxone P-Care once daily per kg of the newborn's body weight, depending on the severity and type of infection.
• The maximum daily dose must not exceed 50 mg per kg of the newborn's body weight.

Patients with liver or kidney problems
You may be given a different dose from the usual one. Your doctor will decide how much Ceftriaxone P-Care you need and will monitor you closely, depending on the severity of your liver or kidney disease.
If you are given more Ceftriaxone P-Care than you should
If you are accidentally given more Ceftriaxone P-Care than prescribed, contact your doctor or go to the nearest hospital immediately.
If you miss a dose of Ceftriaxone P-Care
If you miss an injection, you should receive it as soon as possible. However, if it is almost time for your next scheduled injection, skip the missed dose. Do not take a double dose (two injections together) to make up for a missed dose.
If you stop Ceftriaxone P-Care treatment
Do not stop taking Ceftriaxone P-Care unless your doctor tells you to. If you have any doubts about using this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You may experience the following side effects with this medicine:

Severe allergic reactions (not known, frequency cannot be estimated from the available data)
If you have a severe allergic reaction, seek medical attention immediately.
Signs may include:

• sudden swelling of the face, throat, lips or mouth. This may make breathing or swallowing difficult.
• sudden swelling of the hands, feet and ankles.

Severe skin reactions (not known, frequency cannot be estimated from the available data)
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If you develop a severe skin reaction, inform a doctor immediately.

• Signs may include:
• Severe rash that develops rapidly, with blistering or peeling of the skin and possible blistering in the mouth (Stevens-Johnson syndrome and toxic epidermal necrolysis, also known as SJS and TEN).
• Any combination of the following symptoms: widespread rash, high body temperature, elevated liver enzymes, abnormalities in blood tests (eosinophilia), swollen lymph nodes and involvement of other organs in the body (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome).
• Jarisch-Herxheimer reaction, which may cause fever, chills, headache, muscle pain and rash, which usually resolves spontaneously. These symptoms occur shortly after starting treatment with Ceftriaxone P-Care for spirochete infections such as Lyme disease.

Treatment with ceftriaxone, especially in elderly patients with severe renal insufficiency or neurological disorders, may rarely cause reduced consciousness, abnormal movements, agitation and seizures.
Other possible side effects:
Common (may affect up to 1 in 10 people)

• Abnormalities in white blood cells (such as reduced white blood cell count and increased eosinophils) and platelets (reduced thrombocytes).
• Soft stools or diarrhoea.
• Changes in blood test results for liver function.
• Rash.

Uncommon (may affect up to 1 in 100 people)

• Fungal infections (e.g. thrush).
• Decreased number of white blood cells (granulocytopenia).
• Reduced number of red blood cells (anaemia).
• Blood clotting problems. Signs include easy bruising, joint pain and swelling.
• Headache.
• Dizziness.
• Nausea or vomiting.
• Itching.
• Pain or burning sensation along the vein where Ceftriaxone P-Care was administered. Pain at the injection site.
• Fever.
• Abnormal kidney function tests (increased creatinine in the blood).

Rare (may affect up to 1 in 1,000 people)

• Inflammation of the large intestine (colon). Signs include diarrhoea, often with blood and mucus, stomach pain and fever. 33/35
• Difficulty breathing (bronchospasm).
• Skin rash with wheals (urticaria), which may cover a large area of the body, associated with itching and swelling.
• Blood or sugar in the urine.
• Oedema (fluid accumulation).
• Chills.

Not known (frequency cannot be estimated from the available data)

• Secondary infections that may not respond to the prescribed antibiotic.
• A form of anaemia characterised by destruction of red blood cells (haemolytic anaemia).
• Severe decrease in the number of white blood cells (agranulocytosis).
• Seizures.
• Dizziness.
• Inflammation of the pancreas (pancreatitis). Signs include severe stomach pain spreading to the back.
• Inflammation of the mouth lining (stomatitis).
• Inflammation of the tongue (glossitis). Signs include swelling, redness and irritation of the tongue.
• Problems with the gallbladder and/or liver, which may cause pain, nausea and vomiting, yellowing of the skin, itching, unusually dark urine and clay-coloured stools.
• A neurological condition that may develop in newborns with severe jaundice (kernicterus).
• Kidney problems caused by calcium-ceftriaxone deposits. You may experience pain when urinating, or your urine output may decrease.
• False positive Coombs test (a test to detect blood problems).
• False positive test for galactosaemia (an abnormal accumulation of the sugar galactose).
• Ceftriaxone P-Care may interfere with certain types of blood glucose tests; please check with your doctor.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ceftriaxone P-Care

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month. The expiry date applies to the product in its original packaging, stored correctly.
From a microbiological standpoint, the product should be used immediately after reconstitution. If not used immediately, the conditions and duration of storage prior to use are the responsibility of the user. The chemical and physical stability of the medicine after reconstitution has been demonstrated for 24 hours between +2°C and +8°C, and for 6 hours when stored below 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ceftriaxone P-Care contains
CEFTRIAXONE P-CARE 2 g powder and solution for infusion
One vial of powder contains:
active substance: ceftriaxone disodium 3.5 H2O 2.386 g equivalent to ceftriaxone 2 g;
one solvent ampoule contains: aqueous solution of 1% lidocaine.
Description of the appearance of Ceftriaxone P-Care and contents
CEFTRIAXONE P-CARE 2 g ml powder and solvent for infusion: 1 vial.
Marketing Authorization Holder
Pharmacare srl – Via Marghera, 29 – 20149 Milan – Italy
Manufacturer
MITIM S.r.l. – Via Cacciamali 34-36-38 – 25125 Brescia
CT Srl Pharmaceutical Laboratory - Via Dante Alighieri, 71 – 18038 Sanremo (IM)
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