Ceftriaxone PensA

Package leaflet: Information for the patient

CEFTRIAXONE PENSA 500 mg / 2 ml powder and solvent for injectable solution for

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

1. What CEFTRIAXONE PENSA is and what it is used for

CEFTRIAXONE PENSA 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 PENSA 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 should know before being given CEFTRIAXONE PENSA

Do not be given CEFTRIAXONE PENSA 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 PENSA is to be administered by intramuscular injection.

CEFTRIAXONE PENSA 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 being given CEFTRIAXONE PENSA if:

• 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.
• you have gallstones or kidney stones.
• you have other diseases, for example 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.

If you are due to have a blood or urine test
If you are given CEFTRIAXONE PENSA for a prolonged period, you may need to have regular blood tests. CEFTRIAXONE PENSA 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 taking your sample that you have been given CEFTRIAXONE PENSA.

Children
Talk to your doctor, pharmacist or nurse before giving CEFTRIAXONE PENSA to a child if:

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

Other medicines and CEFTRIAXONE PENSA
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 may be pregnant or are planning to become pregnant, or if you are breastfeeding, consult your doctor before taking this medicine.
Your doctor will assess the benefits that treatment with CEFTRIAXONE PENSA would provide you against any possible risks to the baby.

Driving and using machines
CEFTRIAXONE PENSA 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 PENSA is administered

CEFTRIAXONE PENSA is generally administered by a doctor or a nurse via an injection given directly into a muscle. CEFTRIAXONE PENSA will be prepared by a doctor, pharmacist, or nurse and must not be mixed or co-administered with calcium-containing injections.
Standard dose
Your doctor will determine the appropriate dose of CEFTRIAXONE PENSA 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 functioning of your kidneys and liver. The number of days or weeks during which you will receive CEFTRIAXONE PENSA depends 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.

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

• 50–80 mg of CEFTRIAXONE PENSA 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 PENSA 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 standard one. Your doctor will decide the amount of CEFTRIAXONE PENSA you need and will monitor you closely, depending on the severity of your liver or kidney disease.
If you are given more CEFTRIAXONE PENSA than you should
If you are accidentally given more CEFTRIAXONE PENSA than prescribed, contact your doctor or go to the nearest hospital immediately.
If you miss a dose of CEFTRIAXONE PENSA
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 PENSA
Do not stop taking CEFTRIAXONE PENSA 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 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 rashes (not known, frequency cannot be estimated from the available data)
If you develop a severe skin rash, 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.

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.
• Skin 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).
• 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 PENSA 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.
• Breathing difficulties (bronchospasm).
• Skin rash with raised red lumps (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 spreading to the back.
• Inflammation of the mouth lining (stomatitis).
• Inflammation of the tongue (glossitis). Signs include swelling, redness and irritation of the tongue.
• Gallbladder problems that may cause pain, nausea and vomiting.
• 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 blood test to detect blood-related problems).
• False positive test for galactosaemia (an abnormal accumulation of the sugar galactose).
• CEFTRIAXONE PENSA may interfere with certain types of blood glucose tests; please consult 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 www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CEFTRIAXONE PENSA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is 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.
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 the product is stored at a temperature 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. Contents of the pack and other information

One vial of powder contains:
active substance: ceftriaxone sodium salt 3.5 H₂O 596.5 mg equivalent to ceftriaxone 500 mg;
one solvent vial contains: 1% lidocaine aqueous solution.
Description of the appearance of CEFTRIAXONE PENSA and contents of the pack
CEFTRIAXONE PENSA 500 mg/2 ml powder and solvent for injectable solution for intramuscular use: 1 vial of powder + 1 solvent vial of 2 ml.

Disposal of syringes/sharp objects
The following list of points must be strictly observed regarding the use and disposal of syringes and other sharp medical devices:

• Needles and syringes must never be reused.
• Place all used needles and syringes into a dedicated sharps container (single-use, puncture-resistant container).
• Keep the container out of reach of children.
• Used sharps containers must not be disposed of in domestic waste.
• Dispose of the full container according to local regulations or as instructed by your physician.

Disposal of expired/unwanted medicines
Release of medicines into the environment must be minimized. Medicines must not be disposed of via wastewater or household waste. Use designated collection systems, if available.

Marketing Authorization Holder
Pensa Pharma S.p.A. - Via Ippolito Rosellini, 12 - 20124 Milan, Italy

Manufacturer
Laboratorio Farmaceutico CT S.r.l. - Via Dante Alighieri, 71 - 18038 Sanremo (IM), Italy

Patient information leaflet

CEFTRIAXONE PENSA 1 g / 3.5 ml powder and solvent for injectable solution for use

intramuscularly
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 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 PENSA is and what it is used for
2. What you need to know before you are given CEFTRIAXONE PENSA
3. How CEFTRIAXONE PENSA is administered
4. Possible side effects
5. How to store CEFTRIAXONE PENSA
6. Contents of the pack and other information

1. What CEFTRIAXONE PENSA is and what it is used for

CEFTRIAXONE PENSA 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 PENSA 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.
• 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 surgical procedures.

2. What you should know before being given CEFTRIAXONE PENSA

CEFTRIAXONE PENSA must not be administered to you 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 PENSA is to be administered by intramuscular injection.

CEFTRIAXONE PENSA 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 PENSA if:

• you have recently received or are about to receive products containing calcium.
• you have recently experienced diarrhoea after taking an antibiotic. You have had intestinal problems, particularly colitis (inflammation of the intestine).
• you suffer from liver or kidney problems.
• 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 need to undergo blood or urine tests
If you are given CEFTRIAXONE PENSA for a prolonged period, you may need to have regular blood tests. CEFTRIAXONE PENSA 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 collecting your sample that you have been administered CEFTRIAXONE PENSA.

Children
Talk to your doctor, pharmacist, or nurse before administering CEFTRIAXONE PENSA 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 PENSA
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 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 that treatment with CEFTRIAXONE PENSA may provide you and the potential risks to the baby.

Driving and using machines
CEFTRIAXONE PENSA 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 PENSA is administered

CEFTRIAXONE PENSA is generally administered by a doctor or a nurse via
an injection given directly into a muscle. CEFTRIAXONE PENSA 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 PENSA for you. The dose depends 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 PENSA depends 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 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 PENSA once daily per kg of the child's 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 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 PENSA 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 PENSA you need and will monitor you closely, depending on the severity of your liver or kidney disease.
If you receive more CEFTRIAXONE PENSA than you should
If you are accidentally given more CEFTRIAXONE PENSA than prescribed, contact your doctor or go to the nearest hospital immediately.
If you miss a dose of CEFTRIAXONE PENSA
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 PENSA
Do not stop taking CEFTRIAXONE PENSA 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 (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 rashes (not known, frequency cannot be estimated from the available data)
If you develop a severe skin rash, seek immediate medical advice.

• Signs may include a severe rash that develops rapidly, with blistering or peeling of the skin and possibly blistering in the mouth.

Other possible side effects:
Common (may affect up to 1 in 10 people)

• Abnormal 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. oral 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 PENSA 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.
• Breathing difficulties (bronchospasm).
• Skin rash with raised lumps (urticaria), possibly affecting 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.
• 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.
• Gallbladder problems which may cause pain, nausea and vomiting.
• 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.
• A false positive Coombs test (a blood test to detect blood disorders).
• A false positive test for galactosaemia (an abnormal accumulation of the sugar galactose).
• CEFTRIAXONE PENSA may interfere with certain types of blood glucose tests; 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 www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CEFTRIAXONE PENSA

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.
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 no longer in use. This will help protect the environment.

6. Package contents and other information

One vial of powder contains:
active substance: ceftriaxone disodium 3.5 H₂O 1.193 g equivalent to ceftriaxone 1 g;
one vial of solvent contains: 1% aqueous lidocaine solution.

Description of the appearance of CEFTRIAXONE PENSA and contents of the pack
CEFTRIAXONE PENSA 1 g / 3.5 ml, powder and solvent for injectable solution for intramuscular use: 1 vial of powder + 1 vial of solvent (3.5 ml).

Disposal of syringes/sharp objects
The following list of points must be strictly observed regarding the use and disposal of syringes and other sharp medical devices:

• Needles and syringes must never be reused.
• Place all used needles and syringes into a dedicated sharps container (single-use, puncture-resistant container).
• Keep the container out of reach of children.
• Used sharps containers must not be disposed of in domestic waste.
• Dispose of the full container in accordance with local requirements or as instructed by your physician.

Disposal of expired/unwanted medicines
Release of medicines into the environment must be minimized as much as possible. Medicines must not be disposed of via wastewater or household waste. Use designated collection systems, if available.

Marketing Authorization Holder
Pensa Pharma S.p.A. - Via Ippolito Rosellini, 12 - 20124 Milan, Italy

Manufacturer
Laboratorio Farmaceutico CT S.r.l. - Via Dante Alighieri, 71 - 18038 Sanremo (IM), Italy

Patient Information Leaflet: Information for the patient

CEFTRIAXONE PENSA 1 g / 3.5 ml powder and solvent for injectable solution for

intramuscular use
Ceftriaxone
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 effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What CEFTRIAXONE PENSA is and what it is used for

CEFTRIAXONE PENSA 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 PENSA is used to treat the following 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 surgical procedures.

2. What you should know before being given CEFTRIAXONE PENSA

Do not be given CEFTRIAXONE PENSA 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 hands, feet, and ankles, and a severe rash that develops rapidly.
• you are allergic to lidocaine and CEFTRIAXONE PENSA is to be administered by intramuscular injection.

CEFTRIAXONE PENSA 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 being given CEFTRIAXONE PENSA if:

• you have recently received or are about to receive products containing calcium.
• you have recently experienced diarrhoea after taking an antibiotic. You have had intestinal problems, particularly colitis (inflammation of the intestine).
• you have liver or kidney problems.
• 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.

If you need to have blood or urine tests
If you are given CEFTRIAXONE PENSA for a prolonged period, you may need to have regular blood tests. CEFTRIAXONE PENSA 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 taking your sample that you have been given CEFTRIAXONE PENSA.

Children
Talk to your doctor, pharmacist, or nurse before giving CEFTRIAXONE PENSA to a child if:

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

Other medicines and CEFTRIAXONE PENSA
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 may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Your doctor will weigh the benefits of treatment with CEFTRIAXONE PENSA for you against the possible risks to your baby.

Driving and using machines
CEFTRIAXONE PENSA 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 PENSA is administered

CEFTRIAXONE PENSA is generally administered by a doctor or nurse via an injection given directly into a muscle. CEFTRIAXONE PENSA will be prepared by a doctor, pharmacist, or nurse and must not be mixed or co-administered with injections containing calcium.

Usual dose
Your doctor will determine the correct dose of CEFTRIAXONE PENSA 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 degree of function of your kidneys and liver. The number of days or weeks during which you will receive CEFTRIAXONE PENSA 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.

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

• 50–80 mg of CEFTRIAXONE PENSA 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 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 administered 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 PENSA 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 the amount of CEFTRIAXONE PENSA you will need and will monitor you closely, depending on the severity of your liver or kidney disease.

If you are given more CEFTRIAXONE PENSA than you should
If you are accidentally given more CEFTRIAXONE PENSA than prescribed, contact your doctor or go to the nearest hospital immediately.

If you miss a dose of CEFTRIAXONE PENSA
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 PENSA
Do not stop taking CEFTRIAXONE PENSA 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 get 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 rashes (not known, frequency cannot be estimated from the available data)
If you develop a severe skin rash, 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.

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 indicating liver function abnormalities.
• Skin rash.

Uncommon (may affect up to 1 in 100 people)

• Fungal infections (e.g. thrush).
• Decrease in white blood cell count (granulocytopenia).
• Reduction in 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 PENSA was administered. Pain at the injection site.
• Fever.
• Abnormal kidney function test results (increased creatinine in 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.
• Breathing difficulties (bronchospasm).
• Skin rash with raised red itchy lumps (urticaria), possibly affecting 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 type of anaemia characterised by destruction of red blood cells (haemolytic anaemia).
• Severe decrease in white blood cell count (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.
• Gallbladder problems which may cause pain, nausea and vomiting.
• 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 blood test to detect blood-related problems).
• False positive test for galactosaemia (an abnormal accumulation of the sugar galactose).
• CEFTRIAXONE PENSA may interfere with certain types of tests to measure glucose in the blood; please check with your doctor.

Reporting of side effects
If you get any side effects, including ones 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 www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CEFTRIAXONE PENSA

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.
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 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. Contents of the pack and other information

One vial of powder contains:
active substance: ceftriaxone sodium 3.5 H₂O 1.193 g equivalent to ceftriaxone 1 g;
one solvent vial contains: 1% aqueous lidocaine solution.
Description of the appearance of CEFTRIAXONE PENSA and contents of the pack
CEFTRIAXONE PENSA 1 g / 3.5 ml powder and solvent for injectable solution for intramuscular use: 1 vial of powder + 1 solvent vial of 3.5 ml.

Disposal of syringes/sharp objects
The following list of points must be strictly observed regarding the use and disposal of syringes and other sharp medical devices:

• Needles and syringes must never be reused.
• Place all used needles and syringes into a dedicated sharps container (single-use, puncture-resistant container).
• Keep the container out of reach of children.
• Used sharps containers must not be disposed of in household waste.
• Dispose of the full container according to local requirements or as instructed by your physician.

Disposal of expired/unwanted medicines
Release of medicines into the environment must be minimized. Medicines must not be disposed of via wastewater or in household waste. Use designated collection systems, if available.

Marketing Authorization Holder
Pensa Pharma S.p.A. - Via Ippolito Rosellini, 12 - 20124 Milano
Manufacturer
Laboratorio Farmaceutico CT S.r.l. - Via Dante Alighieri, 71 - 18038 Sanremo (IM)

Package leaflet: information for the patient

CEFTRIAXONE PENSA 2 g powder for solution for infusion

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

1. What CEFTRIAXONE PENSA is and what it is used for

CEFTRIAXONE PENSA 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 PENSA is used to treat the following 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 PENSA

Do not be given CEFTRIAXONE PENSA 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.

CEFTRIAXONE PENSA 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 PENSA if:

• you have recently received or are about to receive products containing calcium.
• you have recently experienced diarrhoea after taking an antibiotic, or have intestinal problems, particularly colitis (inflammation of the intestine).
• you have liver or kidney problems.
• 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.

If you need to undergo blood or urine tests
If you are given CEFTRIAXONE PENSA for a prolonged period, you may need to have regular blood tests. CEFTRIAXONE PENSA 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 taking your sample that you have been given CEFTRIAXONE PENSA.

Children
Talk to your doctor, pharmacist, or nurse before administering CEFTRIAXONE PENSA to a child if:

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

Other medicines and CEFTRIAXONE PENSA
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 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 PENSA for you and the potential risks for the unborn or breastfed baby.

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

3. How CEFTRIAXONE PENSA is administered

CEFTRIAXONE PENSA is generally administered by a doctor or nurse via
intravenous infusion (IV infusion) or by direct injection into a vein.
CEFTRIAXONE PENSA will be prepared by a doctor, pharmacist, or nurse and must not be mixed with,
nor administered simultaneously with, calcium-containing injections.
Usual dose
Your doctor will determine the correct dose of CEFTRIAXONE PENSA for you. The dose depends on
the severity and type of infection, whether you are receiving concomitant treatment with other antibiotics, your body weight and age, and the extent of your kidney and liver function. The number of days or weeks during which you will receive CEFTRIAXONE PENSA depends 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.

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

• 50–80 mg of CEFTRIAXONE PENSA 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 usual adult dose.

Newborns (0–14 days of life)

• 20–50 mg of CEFTRIAXONE PENSA 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 PENSA you need and will closely monitor you, depending on the severity of your liver or kidney disease.
If you are given more CEFTRIAXONE PENSA than you should
If you are accidentally given more CEFTRIAXONE PENSA than prescribed, contact your doctor or go to the nearest hospital immediately.
If you miss a dose of CEFTRIAXONE PENSA
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 PENSA
Do not stop taking CEFTRIAXONE PENSA unless instructed by your doctor. If you have any doubts about how to use 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 immediate medical attention.
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 rashes (not known, frequency cannot be estimated from the available data)
If you develop a severe skin rash, seek immediate medical attention.

• Signs may include a severe rash that develops rapidly, with blistering or peeling of the skin and possibly blisters in the mouth.

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.
• Skin rash.

Uncommon (may affect up to 1 in 100 people)

• Fungal infections (e.g. candidiasis).
• Decrease in the number of white blood cells (granulocytopenia).
• Reduction in the 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 PENSA 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.
• Breathing difficulties (bronchospasm).
• Skin rash with wheals (urticaria), possibly affecting 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.
• 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.
• Gallbladder problems that may cause pain, nausea and vomiting.
• 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 result (a test to detect blood problems).
• False positive result for galactosaemia (an abnormal accumulation of the sugar galactose).
• CEFTRIAXONE PENSA may interfere with certain types of tests to measure glucose in the blood; please consult your doctor.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CEFTRIAXONE PENSA

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 requires no special 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 medicine after reconstitution has been demonstrated for 24 hours between +2°C and +8°C, and for 6 hours when the product is stored below 25°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

One vial contains:
Active substance: ceftriaxone disodium 3.5 H₂O 2.386 g equivalent to ceftriaxone 2 g.
Description of the appearance of CEFTRIAXONE PENSA and pack contents
CEFTRIAXONE PENSA 2 g powder for solution for infusion: 1 vial of powder.
Disposal of syringes/sharp objects
The following list of points must be strictly observed regarding the use and
disposal of syringes and other sharp medical devices:

• Needles and syringes must never be reused.
• Place all used needles and syringes into a dedicated sharps container (single-use, puncture-resistant container).
• Keep the container out of reach of children.
• Used sharps containers must not be disposed of in household waste.
• Dispose of the full container in accordance with local requirements or as instructed by the physician.

Disposal of expired/unwanted medicines
Release of medicines into the environment should be minimized. Medicines must not be
disposed of via wastewater or in household waste. Use designated collection systems, if available.
Marketing Authorization Holder
Pensa Pharma S.p.A. - Via Ippolito Rosellini, 12 - 20124 Milano
Manufacturer
Laboratorio Farmaceutico CT S.r.l. - Via Dante Alighieri, 71 - 18038 Sanremo (IM)