Ceftriaxone Sandoz

Package leaflet: Information for the patient

Ceftriaxone Sandoz 1 g/10 ml powder and solvent for injectable solution for intravenous use
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 their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Ceftriaxone Sandoz is and what it is used for

Ceftriaxone Sandoz contains the active substance ceftriaxone, which is an antibiotic given 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 Sandoz 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 also 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.
• 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 Sandoz

Do not be given Ceftriaxone Sandoz 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 Sandoz is to be administered by intramuscular injection.

Ceftriaxone Sandoz 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 calcium-containing product intravenously.

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

• you have recently received or are about to receive calcium-containing products.
• you have recently had diarrhoea after taking an antibiotic. You have had intestinal problems, particularly colitis (inflammation of the intestine).
• 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, weakness or shortness of breath).
• you are on a low-sodium diet.
• 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 liver or kidney problems (see section 4).

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

• inform the person taking your sample that you have been given Ceftriaxone Sandoz.

If you are diabetic or require monitoring of blood glucose levels, do not use certain blood glucose monitoring systems which may measure blood glucose incorrectly during treatment with ceftriaxone. If such systems are used, check the instructions for use and inform your doctor, pharmacist or nurse. Alternative analytical methods should be used if necessary.
Children
Talk to your doctor, pharmacist or nurse before giving Ceftriaxone Sandoz to a child if:

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

Other medicines and Ceftriaxone Sandoz
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, breast-feeding and fertility
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breast-feeding, ask your doctor for advice before taking this medicine.
Your doctor will weigh the benefits of treatment with Ceftriaxone Sandoz for you against the possible risks to your baby.
Driving and using machines
Ceftriaxone Sandoz may cause dizziness. If you feel dizzy, do not drive or use tools or machines. Contact your doctor if you experience these symptoms.
Ceftriaxone Sandoz contains sodium
Ceftriaxone Sandoz 1 g/10 ml contains 82.93 mg of sodium per vial. This is equivalent to 4.15% of the maximum recommended daily dietary intake of sodium for an adult.

3. How Ceftriaxone Sandoz is administered

Ceftriaxone Sandoz is usually administered by a doctor or nurse through an intravenous infusion (IV infusion) or via an injection directly into a vein. Ceftriaxone Sandoz will be prepared by a doctor, pharmacist, or nurse and must not be mixed or administered simultaneously with calcium-containing injections.

Usual dose
Your doctor will determine the appropriate dose of Ceftriaxone Sandoz for you. The dose depends on the severity and type of infection, whether you are receiving other antibiotics at the same time, 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 Sandoz depends on the type of infection you have.

Adults, elderly patients, and children aged 12 years and 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.

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

• 50–80 mg of Ceftriaxone Sandoz 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 of 50 kg or more should receive the usual adult dose.

Neonates (0–14 days of life):

• 20–50 mg of Ceftriaxone Sandoz once daily per kg of the neonate’s body weight, depending on the severity and type of infection.
• The maximum daily dose must not exceed 50 mg per kg of the neonate’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 Sandoz you need and will monitor you closely, depending on the severity of your liver or kidney disease.

If you receive more Ceftriaxone Sandoz than you should
If you are accidentally given more Ceftriaxone Sandoz than prescribed, contact your doctor or the nearest hospital immediately.

If you miss a dose of Ceftriaxone Sandoz
If you miss an injection, it should be given 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 Sandoz
Do not stop taking Ceftriaxone Sandoz unless your doctor tells you to do so. 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 experience a severe skin reaction, seek medical advice immediately.
Signs may include:

• a severe rash that develops rapidly, with blistering or peeling of the skin and possibly 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, which usually resolves spontaneously. These symptoms occur shortly after starting treatment with Ceftriaxone Sandoz for spirochete infections such as Lyme disease.

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 for liver function.
• Rash.

Uncommon (may affect up to 1 in 100 people)

• Fungal infections (e.g. thrush).
• Decrease in the number of white blood cells (granulocytopenia).
• Reduction in the number of red blood cells (anaemia).
• Problems with blood clotting. Signs include easy bruising, joint pain and swelling.
• Headache.
• Dizziness.
• Nausea or vomiting.
• Itching.
• Pain or burning sensation along the vein where Ceftriaxone Sandoz 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).
• 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.
• Vertigo.
• 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, vomiting, yellowing of the skin, itching, unusually dark urine and clay-coloured stools.
• A neurological condition that may develop in newborns with severe jaundice (nuclear jaundice).
• 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-related problems).
• False positive result for galactosaemia (an abnormal accumulation of the sugar galactose).
• Ceftriaxone Sandoz may interfere with certain types of blood glucose tests; please consult your doctor.

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.

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 Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial after Exp.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 Sandoz contains
Ceftriaxone Sandoz 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 vial contains: water for injections.
Description of the appearance of Ceftriaxone Sandoz and package contents
Ceftriaxone Sandoz 1 g/10 ml powder and solvent for injectable solution for intravenous use: 1
powder vial + 1 solvent vial of 10 ml.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
SANDOZ Spa – Largo U. Boccioni, 1 – 21040 Origgio (VA)
Manufacturer
Laboratorio Farmaceutico C.T. S.r.l. – Via D. Alighieri, 71 – Sanremo (IM)

Package leaflet: information for the patient

Ceftriaxone Sandoz 2 g powder for solution for infusion

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 they have the same symptoms as you, because it could be dangerous.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Ceftriaxone Sandoz is and what it is used for

Ceftriaxone Sandoz 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 Sandoz 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.
• 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 Sandoz

Do not receive Ceftriaxone Sandoz 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, or a severe rash that develops rapidly.
• you are allergic to lidocaine and Ceftriaxone Sandoz is to be administered by intramuscular injection.

Ceftriaxone Sandoz 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 calcium-containing product intravenously.

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

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

If you are undergoing blood or urine tests
If you are receiving Ceftriaxone Sandoz for a prolonged period, you may need to have regular blood tests. Ceftriaxone Sandoz may affect the results of urine glucose tests 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 administered Ceftriaxone Sandoz.

If you are diabetic or require monitoring of blood glucose levels, do not use certain blood glucose monitoring systems that may inaccurately measure blood glucose during treatment with ceftriaxone. If such systems are used, check the instructions for use and inform your doctor, pharmacist, or nurse. Alternative analytical methods should be used if necessary.

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

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

Other medicines and Ceftriaxone Sandoz
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 any of the following medicines:

• an antibiotic called an aminoglycoside.
• an antibiotic called chloramphenicol (used to treat 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 of treatment with Ceftriaxone Sandoz for you and the potential risks to the unborn or breastfed child.

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

Ceftriaxone Sandoz contains sodium
Ceftriaxone Sandoz 2 g contains 165.87 mg of sodium per vial. This corresponds to 8.29% of the maximum daily recommended dietary intake of sodium for an adult.

3. How Ceftriaxone Sandoz is administered

Ceftriaxone Sandoz is generally administered by a doctor or nurse via intravenous infusion (IV infusion). Ceftriaxone Sandoz will be prepared by a doctor, pharmacist, or nurse and will not be mixed or co-administered with calcium-containing injections.
Standard dose
Your doctor will determine the correct dose of Ceftriaxone Sandoz for you. The dose will depend on the severity and type of infection, whether you are receiving other antibiotics at the same time, 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 Sandoz 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 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.

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

• 50–80 mg of Ceftriaxone Sandoz 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, 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 the 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 standard adult dose.
  Neonates (0–14 days of life)

• 20–50 mg of Ceftriaxone Sandoz once daily per kg of the neonate's body weight, depending on the severity and type of infection.

• The maximum daily dose must not exceed 50 mg per kg of the neonate'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 Sandoz you will need and will monitor you closely, depending on the severity of your liver or kidney disease.
If you are given more Ceftriaxone Sandoz than you should
If you are accidentally given more Ceftriaxone Sandoz than prescribed, contact your doctor or the nearest hospital immediately.
If you miss a dose of Ceftriaxone Sandoz
If you miss an injection, it should be administered 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 Sandoz
Do not stop taking Ceftriaxone Sandoz 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 will experience 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 immediate medical advice.
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 experience a severe skin reaction, seek immediate medical advice.
Signs may include:

• a severe rash that develops rapidly, with blistering or peeling of the skin and possibly 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, which generally resolves spontaneously. These symptoms occur shortly after starting treatment with Ceftriaxone Sandoz for spirochete infections such as Lyme disease.

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 for liver function.
• Rash.

Uncommon (may affect up to 1 in 100 people)

• Fungal infections (e.g. oral thrush).
• Decreased number of white blood cells (granulocytopenia).
• Reduced number of red blood cells (anaemia).
• Problems with blood clotting. Signs include easy bruising, joint pain and swelling.
• Headache.
• Dizziness.
• Nausea or vomiting.
• Itching.
• Pain or burning sensation along the vein where Ceftriaxone Sandoz was administered. Pain at the injection site.
• Fever.
• Abnormal kidney function test results (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).
• Rash with raised red areas (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.
• Vertigo.
• 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, 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 Sandoz may interfere with certain types of tests to measure blood glucose; please check with your doctor.

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.

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 Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial after Exp.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Sandoz contains
Ceftriaxone Sandoz 2 g powder for solution for infusion
Each vial contains:
Active substance: ceftriaxone disodium 3.5 H₂O 2.386 g, equivalent to ceftriaxone 2 g.
Description of the appearance of Ceftriaxone Sandoz and contents of the pack
Ceftriaxone Sandoz 2 g powder for solution for infusion: 1 vial.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
SANDOZ Spa – Largo U. Boccioni, 1 – 21040 Origgio (VA)
Manufacturer
Laboratorio Farmaceutico C.T. S.r.l. – Via D. Alighieri, 71 – Sanremo (IM)

Patient information leaflet

Ceftriaxone Sandoz 250 mg/2 ml powder and solvent for injectable solution for

intramuscular use
Ceftriaxone Sandoz 500 mg/2 ml powder and solvent for injectable solution for
intramuscular use
Ceftriaxone Sandoz 1 g/3.5 ml powder and solvent for injectable solution for intramuscular use
Ceftriaxone (as ceftriaxone disodium)
Lidocaine (as lidocaine hydrochloride)
Equivalent 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 effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Ceftriaxone Sandoz is and what it is used for

Ceftriaxone Sandoz 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 Sandoz 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.
• 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 Sandoz

Do not be given Ceftriaxone Sandoz 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 it difficult to breathe or swallow, sudden swelling of the hands, feet, and ankles, or a severe rash that develops rapidly.
• you are allergic to lidocaine and Ceftriaxone Sandoz is to be administered by intramuscular injection.

Ceftriaxone Sandoz 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 if the child is to receive a calcium-containing product intravenously.

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

• you have recently received or are about to receive calcium-containing products.
• you have recently had diarrhoea after taking an antibiotic, or have had intestinal problems, particularly colitis (inflammation of the intestine).
• 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, weakness, or shortness of breath).
• you are on a low-sodium diet.
• you are experiencing or have previously experienced any combination of the following symptoms: skin rash, skin redness, blistering on lips, eyes, or 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 cell (eosinophilia), and swollen lymph nodes (signs of serious skin reactions; see also section 4 “Possible side effects”).
• you have liver or kidney problems (see section 4).

If you are undergoing blood or urine tests
If you are given Ceftriaxone Sandoz for a prolonged period, you may need regular blood tests. Ceftriaxone Sandoz may affect the results of urine sugar tests and a blood test known as the Coombs test. If you are scheduled for tests:

• inform the person taking your sample that you have been administered Ceftriaxone Sandoz.

If you are diabetic or require monitoring of blood glucose levels, do not use certain blood glucose monitoring systems that may inaccurately measure blood glucose during treatment with ceftriaxone. If such systems are used, check the instructions for use and inform your doctor, pharmacist, or nurse. Alternative testing methods should be used if necessary.

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

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

Other medicines and Ceftriaxone Sandoz
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 any 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, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
Your doctor will assess the benefits of treatment with Ceftriaxone Sandoz for you and the potential risks for your baby.

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

Ceftriaxone Sandoz contains sodium
Ceftriaxone Sandoz 250 mg/2 ml contains 20.73 mg of sodium per vial. This corresponds to 1.04% of the maximum daily recommended dietary intake for an adult.
Ceftriaxone Sandoz 500 mg/2 ml contains 41.47 mg of sodium per vial. This corresponds to 2.07% of the maximum daily recommended dietary intake for an adult.
Ceftriaxone Sandoz 1 g/3.5 ml contains 82.93 mg of sodium per vial. This corresponds to 4.15% of the maximum daily recommended dietary intake for an adult.

3. How Ceftriaxone Sandoz is administered

Ceftriaxone Sandoz is generally administered by a doctor or nurse via an injection given directly into a muscle. Ceftriaxone Sandoz 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 Sandoz 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 Sandoz will depend on the type of infection you have.
Adults, elderly patients, and children aged 12 years and 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 either as a single daily dose or as 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 Sandoz 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 either as a single daily dose or as 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 Sandoz 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 the amount of Ceftriaxone Sandoz you need and will monitor you closely, depending on the severity of your liver or kidney disease.
If you are given more Ceftriaxone Sandoz than you should
If you are accidentally given more Ceftriaxone Sandoz than prescribed, contact your doctor or the nearest hospital immediately.
If you miss a dose of Ceftriaxone Sandoz
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 Sandoz
Do not stop taking Ceftriaxone Sandoz 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 everyone 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)
If you experience a severe skin reaction, seek medical attention immediately.
Signs may include:

• a severe rash that develops rapidly, with blistering or peeling of the skin and possibly 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, which usually resolves spontaneously. These symptoms occur shortly after starting treatment with Ceftriaxone Sandoz for spirochete infections such as Lyme disease.

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 for liver function.
• Rash.

Uncommon (may affect up to 1 in 100 people)

• Fungal infections (e.g. thrush).
• Decrease in the number of white blood cells (granulocytopenia).
• Reduction in the number of red blood cells (anaemia).
• Problems with blood clotting. Signs include easy bruising, joint pain and swelling.
• Headache.
• Dizziness.
• Nausea or vomiting.
• Itching.
• Pain or burning sensation along the vein where Ceftriaxone Sandoz was administered. Pain at the injection site.
• Fever.
• Abnormal results in 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.
• 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.

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.
• Vertigo.
• 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, vomiting, yellowing of the skin, itching, unusually dark urine and clay-coloured stools.
• A neurological condition that may develop in newborns with severe jaundice (nuclear jaundice).
• Kidney problems caused by calcium-ceftriaxone deposits. You may experience pain when urinating, or your urine output may decrease.
• A false positive Coombs test (a test to detect blood problems).
• A false positive test for galactosaemia (an abnormal accumulation of the sugar galactose).
• Ceftriaxone Sandoz may interfere with certain types of tests to measure glucose in the blood; please check with your doctor. Treatment with ceftriaxone, especially in elderly patients with severe renal impairment or neurological disorders, may rarely lead to reduced level of consciousness, abnormal movements, agitation and seizures.

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 Sandoz

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial after Exp.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 Sandoz contains
Ceftriaxone Sandoz 250 mg/2 ml powder and solvent for injectable solution for intramuscular use
one vial of powder contains:
active substance: ceftriaxone disodium 3.5 H₂O 298.2 mg equivalent to ceftriaxone 250 mg;
one solvent ampoule contains: aqueous solution of 1% lidocaine.

Ceftriaxone Sandoz 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 596.4 mg equivalent to ceftriaxone 500 mg;
one solvent ampoule contains: aqueous solution of 1% lidocaine.

Ceftriaxone Sandoz 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 solvent ampoule contains: aqueous solution of 1% lidocaine.

Description of the appearance of Ceftriaxone Sandoz and package contents
Ceftriaxone Sandoz 250 mg/2 ml powder and solvent for injectable solution for intramuscular use: 1 vial of powder + 1 solvent ampoule of 2 ml.
Ceftriaxone Sandoz 500 mg/2 ml powder and solvent for injectable solution for intramuscular use: 1 vial of powder + 1 solvent ampoule of 2 ml.
Ceftriaxone Sandoz 1 g/3.5 ml powder and solvent for injectable solution for intramuscular use: 1 vial of powder + 1 solvent ampoule of 3.5 ml.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
SANDOZ S.p.A. – Largo U. Boccioni, 1 – 21040 Origgio (VA)
Manufacturer
Laboratorio Farmaceutico C.T. S.r.l. – Via D. Alighieri, 71 – Sanremo (IM)