Ceftriaxone Biopharma

PACKAGE LEAFLET: Information for the patient

CEFTRIAXONE BIOPHARMA 1 g / 3.5 ml

Powder and solvent for injectable solution for intramuscular use
Ceftriaxone (as ceftriaxone sodium)
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 could be harmful.
• 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 BIOPHARMA is and what it is used for
2. What you need to know before being administered CEFTRIAXONE BIOPHARMA
3. How CEFTRIAXONE BIOPHARMA is administered
4. Possible side effects
5. How to store CEFTRIAXONE BIOPHARMA
6. Contents of the pack and other information

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

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

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

It may also be administered:

• to treat specific sexually transmitted infections (gonorrhoea and syphilis).
• to treat patients with low levels of white blood cells (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 BIOPHARMA

Do not receive CEFTRIAXONE BIOPHARMA 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, chest pain, and a severe rash that develops rapidly.
• you are allergic to lidocaine and CEFTRIAXONE BIOPHARMA is to be administered by intramuscular injection.

CEFTRIAXONE BIOPHARMA 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 must receive a product containing calcium through a vein.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before you are given
CEFTRIAXONE BIOPHARMA 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 (see section 4).
• 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 and lead to weakness or breathlessness).
• 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 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”).

If you are due to have blood or urine tests
If you are given CEFTRIAXONE BIOPHARMA for a prolonged period, you may
need to have regular blood tests. CEFTRIAXONE BIOPHARMA 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 BIOPHARMA.
Children
Talk to your doctor, pharmacist, or nurse before CEFTRIAXONE
BIOPHARMA is given 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 BIOPHARMA
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, ask your doctor for advice before taking this
medicine.
Your doctor will assess the benefits that treatment with CEFTRIAXONE BIOPHARMA would provide you and the potential risks to the unborn or breastfeeding child.

Driving and using machines
CEFTRIAXONE BIOPHARMA may cause dizziness. If you feel dizzy, do not drive and do not use tools or machinery. Contact your doctor if you experience these symptoms.
CEFTRIAXONE BIOPHARMA contains sodium
This medicine contains approximately 83 mg of sodium (a main component of cooking salt)
per vial.
This is equivalent to 4% of the maximum daily recommended dietary intake for an adult.

3. How CEFTRIAXONE BIOPHARMA is administered

CEFTRIAXONE BIOPHARMA is generally administered by a doctor or nurse as an injection directly into a muscle. CEFTRIAXONE BIOPHARMA 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 BIOPHARMA 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 extent of your kidney and liver function. The number of days or weeks during which you will receive CEFTRIAXONE BIOPHARMA will depend on the type of infection you have.

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

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

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

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

Newborns (0–14 days of life):

• 20–50 mg of CEFTRIAXONE BIOPHARMA 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 BIOPHARMA you need and will closely monitor you, depending on the severity of your liver or kidney disease.

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

If you forget to take CEFTRIAXONE BIOPHARMA
If you miss an injection, you should receive it as soon as possible. However, if it is almost time for your next scheduled dose, 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 BIOPHARMA
Do not stop taking CEFTRIAXONE BIOPHARMA unless your doctor tells you to. If you have any doubts about using this medicine, consult your doctor or nurse.

4. Possible side effects

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

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

• Sudden swelling of the face, throat, lips or mouth. This may make breathing or swallowing difficult.
• Sudden swelling of the hands, feet and ankles.
• Chest pain in the context of allergic reactions, which may be a symptom of a heart attack triggered by an allergy (Kounis syndrome).

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 (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 Biopharma 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 indicating liver function.
• Rash.

Uncommon (may affect up to 1 in 100 people)

• Fungal infections (e.g. thrush).
• Decreased number of white blood cells (granulocytopenia).
• Reduced number of red blood cells (anaemia).
• Blood clotting problems. Signs include easy bruising, joint pain and swelling.
• Headache.
• Dizziness.
• Nausea or vomiting.
• Itching.
• Pain or burning sensation along the vein where CEFTRIAXONE BIOPHARMA 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 raised red areas (urticaria), which may cover large areas of the body, associated with itching and swelling.
• Blood or sugar in the urine.
• Oedema (fluid accumulation).
• Chills.
• Treatment with ceftriaxone, especially in elderly patients with severe renal impairment or neurological disorders, may rarely cause reduced consciousness, abnormal movements, agitation and seizures.

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 blood test to detect blood-related problems).
• False positive test for galactosaemia (an abnormal accumulation of the sugar galactose).
• CEFTRIAXONE BIOPHARMA may interfere with certain types of blood glucose tests; please check with your doctor.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet,
please inform 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 BIOPHARMA

This medicinal product does not require any special storage conditions.
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 medicinal product after reconstitution has been demonstrated for 24 hours
between +2°C and +8°C and for 6 hours for the product stored at temperatures below 25°C.
Do not use this medicinal product after the expiry date stated on the packaging. The expiry date refers to the product in its original, unopened packaging stored correctly.
The expiry date refers to the last day of that month.
Keep this medicinal product out of the sight and reach of children.
Do not dispose of any medicinal product via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What CEFTRIAXONE BIOPHARMA contains
CEFTRIAXONE BIOPHARMA 1 g / 3.5 ml powder and solvent for injectable solution
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 BIOPHARMA and contents of the pack
CEFTRIAXONE BIOPHARMA 1 g / 3.5 ml powder and solvent for injectable solution for intramuscular use
One carton contains: 1 vial of powder and 1 solvent ampoule of 3.5 ml.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Biopharma S.r.l. – Via Paolo Mercuri, 8 - 00193 Rome - Italy
Responsible manufacturer for batch release:
Biopharma S.r.l. – Via delle Gerbere, 22/30 - 00134 S. Palomba (RM) - Italy

PATIENT INFORMATION LEAFLET: information for the patient

CEFTRIAXONE BIOPHARMA 1g / 10 ml

powder and solvent for injectable solution for intravenous use
Ceftriaxone (as ceftriaxone sodium)
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 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 BIOPHARMA is and what it is used for
2. What you need to know before being administered CEFTRIAXONE BIOPHARMA
3. How CEFTRIAXONE BIOPHARMA is administered
4. Possible side effects
5. How to store CEFTRIAXONE BIOPHARMA
6. Package contents and other information

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

CEFTRIAXONE BIOPHARMA 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 BIOPHARMA 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 a 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 BIOPHARMA

Do not be given CEFTRIAXONE BIOPHARMA 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, chest pain, and a severe rash that develops rapidly.
• you are allergic to lidocaine and CEFTRIAXONE BIOPHARMA is to be administered by intramuscular injection.

CEFTRIAXONE BIOPHARMA 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 BIOPHARMA 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 (see section 4).
• 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 breathlessness).
• 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 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”).

If you are due to have a blood or urine test
If you are given CEFTRIAXONE BIOPHARMA for a prolonged period, you may need to have regular blood tests. CEFTRIAXONE BIOPHARMA 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 BIOPHARMA.

Children
Talk to your doctor, pharmacist or nurse before giving CEFTRIAXONE BIOPHARMA 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 BIOPHARMA
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, breast-feeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breast-feeding, ask your doctor for advice before taking this medicine.
Your doctor will assess the benefits that treatment with CEFTRIAXONE BIOPHARMA would provide you against any possible risks to your baby.

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

CEFTRIAXONE BIOPHARMA contains sodium
This medicine contains approximately 83 mg of sodium (the main component of table salt) per vial.
This corresponds to 4% of the maximum recommended daily dietary intake of sodium for an adult.

3. How CEFTRIAXONE BIOPHARMA is administered

CEFTRIAXONE BIOPHARMA is generally administered by a doctor or nurse through an intravenous infusion (IV infusion) or via an injection directly into a vein. CEFTRIAXONE BIOPHARMA will be prepared by a doctor, pharmacist, or nurse and will not be mixed or simultaneously administered with injections containing calcium.
Usual dose
Your doctor will determine the correct dose of CEFTRIAXONE BIOPHARMA 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 extent of your kidney and liver function. The number of days or weeks during which you will receive CEFTRIAXONE BIOPHARMA 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 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 BIOPHARMA once daily per kg of the child's body weight, depending on the severity and type of infection. If the child has a severe infection, the doctor may prescribe a higher dose, starting from 100 mg per kg of body weight, up to a maximum of 4 g per day. If the daily dose exceeds 2 g, it may be administered 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 BIOPHARMA 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 BIOPHARMA you will need and will closely monitor you, depending on the severity of your liver or kidney disease.
If you receive more CEFTRIAXONE BIOPHARMA than you should
If you are accidentally given more CEFTRIAXONE BIOPHARMA than prescribed, contact your doctor or the nearest hospital immediately.
If you miss a dose of CEFTRIAXONE BIOPHARMA
If you miss an injection, you should receive it as soon as possible. However, if it is almost time for your next scheduled injection, skip the missed dose. Do not take a double dose (two injections together) to make up for the missed dose.
If you stop treatment with CEFTRIAXONE BIOPHARMA
Do not stop taking CEFTRIAXONE BIOPHARMA unless your doctor tells you to. If you have any doubts about using this medicine, consult your doctor or nurse.

4. Possible side effects

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

Severe allergic reactions (not known, frequency cannot be estimated from the available data)
If you have a severe allergic reaction, seek medical 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.
• Chest pain occurring in the context of allergic reactions, which may be a symptom of a heart attack triggered by an allergy (Kounis syndrome).

Severe skin reactions (not known, frequency cannot be estimated from the available data)
If you develop 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, elevated liver enzymes, abnormalities in blood tests (eosinophilia), swollen lymph nodes, and involvement of other organs (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 skin rash, usually resolving spontaneously. These symptoms may occur shortly after starting Ceftriaxone Biopharma treatment 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 diarrhea.
• Changes in blood test results indicating 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 (anemia).
• 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 BIOPHARMA 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 diarrhea, often with blood and mucus, stomach pain, and fever.
• Difficulty breathing (bronchospasm).
• Skin rash with raised wheals (urticaria), which may cover large areas of the body, associated with itching and swelling.
• Blood or sugar in the urine.
• Edema (fluid retention).
• Chills.
• Treatment with ceftriaxone, especially in elderly patients with severe renal impairment or neurological disorders, may rarely cause reduced consciousness, abnormal movements, agitation, and seizures.

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

• Secondary infections that may not respond to the prescribed antibiotic.
• A form of anemia characterized by destruction of red blood cells (hemolytic anemia).
• 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.
• Problems with the gallbladder and/or liver, which may cause pain, nausea, vomiting, yellowing of the skin, itching, dark-colored urine, and clay-colored stools.
• A neurological condition that may develop in newborns with severe jaundice (kernicterus).
• Kidney problems caused by calcium-ceftriaxone deposits. You may experience pain when urinating, or a reduced amount of urine produced.
• False positive Coombs test (a blood test to detect blood-related problems).
• False positive test for galactosemia (an abnormal accumulation of the sugar galactose). CEFTRIAXONE BIOPHARMA may interfere with certain types of tests used to measure blood glucose; please consult your doctor.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet,
please contact 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 BIOPHARMA

This medicinal product does not require any special storage conditions.
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 medicinal product 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 use this medicinal product after the expiry date stated on the carton. The expiry date refers to the product in its original, unopened packaging stored under recommended conditions.
The expiry date refers to the last day of that month.
Keep this medicinal product out of the sight and reach of children.
Do not dispose of any medicinal product 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

What CEFTRIAXONE BIOPHARMA contains
CEFTRIAXONE BIOPHARMA 1 g / 10 ml powder and solvent for injectable solution
One vial of powder contains:
Active substance: ceftriaxone disodium 3.5 H₂O 1.193 g equivalent to ceftriaxone 1 g;
One ampoule of solvent contains: water for injection.

Description of the appearance of CEFTRIAXONE BIOPHARMA and contents of the pack
CEFTRIAXONE BIOPHARMA 1 g / 10 ml powder and solvent for injectable solution for intravenous use.
One carton contains: 1 vial of powder and 1 10 ml ampoule of solvent.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Biopharma S.r.l. – Via Paolo Mercuri, 8 - 00193 Rome - Italy
Responsible manufacturer for batch release:
Biopharma S.r.l. – Via delle Gerbere, 22/30 - 00134 S. Palomba (RM) - Italy

PATIENT INFORMATION LEAFLET: information for the patient

CEFTRIAXONE BIOPHARMA 2g powder for solution for infusion

Ceftriaxone (as sodium ceftriaxone)
Please read this leaflet carefully before you are given this medicine
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 others, 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, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

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

CEFTRIAXONE BIOPHARMA 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 BIOPHARMA 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 a 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 need to know before you are given CEFTRIAXONE BIOPHARMA

Do not receive CEFTRIAXONE BIOPHARMA 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, chest pain, and a severe rash that develops rapidly.
• you are allergic to lidocaine and CEFTRIAXONE BIOPHARMA is to be administered by intramuscular injection.

CEFTRIAXONE BIOPHARMA must not be given to children in the following cases:

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

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given CEFTRIAXONE BIOPHARMA 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 (see section 4).
• 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 and lead to weakness or breathlessness).
• 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 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”).

If you need to have blood or urine tests
If you are given CEFTRIAXONE BIOPHARMA for a prolonged period, you may need to have regular blood tests. CEFTRIAXONE BIOPHARMA 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 BIOPHARMA.

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

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

Other medicines and CEFTRIAXONE BIOPHARMA
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 assess the benefits that treatment with CEFTRIAXONE BIOPHARMA may provide you and the possible risks to the baby.

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

CEFTRIAXONE BIOPHARMA contains sodium
This medicine contains approximately 166 mg of sodium (a main component of cooking salt) per vial.
This is equivalent to 8% of the maximum daily intake recommended in an adult's diet.

3. How CEFTRIAXONE BIOPHARMA is administered

CEFTRIAXONE BIOPHARMA is generally administered by a doctor or nurse via intravenous infusion (IV infusion) or by injection directly into a vein. CEFTRIAXONE BIOPHARMA 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 BIOPHARMA 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 BIOPHARMA will depend on the type of infection you have.
Adults, elderly patients, and children aged 12 years or older with a body weight of 50 kilograms (kg) or more:

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

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

• 50–80 mg of CEFTRIAXONE BIOPHARMA 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 standard adult dose.

Newborns (0–14 days of life)

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

Patients with liver or kidney problems
You may be given a different dose from the standard one. Your doctor will decide how much CEFTRIAXONE BIOPHARMA you need and will closely monitor you, depending on the severity of your liver or kidney disease.
If you receive more CEFTRIAXONE BIOPHARMA than you should
If you are accidentally given more CEFTRIAXONE BIOPHARMA than prescribed, contact your doctor or go to the nearest hospital immediately.
If you miss a dose of CEFTRIAXONE BIOPHARMA
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 BIOPHARMA
Do not stop taking CEFTRIAXONE BIOPHARMA unless your doctor tells you to. If you have any doubts about using this medicine, consult your doctor or nurse.

4. Possible side effects

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

Severe allergic reactions (not known, frequency cannot be determined from 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.
• Chest pain in the context of allergic reactions, which may be a symptom of a heart attack triggered by an allergy (Kounis syndrome).

Severe skin reactions (not known, frequency cannot be determined from 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 (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 Biopharma 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).
• 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 BIOPHARMA 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 hives (urticaria), which may cover a large area of the body, associated with itching and swelling.
• Blood or sugar in the urine.
• Oedema (fluid retention).
• Chills.
• 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.

Not known (frequency cannot be determined from 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 and/or liver problems that 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 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 BIOPHARMA 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,
talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CEFTRIAXONE BIOPHARMA

This medicinal product does not require any special storage conditions.
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 medicinal product 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 use this medicinal product after the expiry date stated on the carton. The expiry date refers to the product in its original, unopened packaging stored correctly.
The expiry date refers to the last day of that month.
Keep this medicinal product out of the sight and reach of children.
Do not dispose of any medicinal product via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What CEFTRIAXONE BIOPHARMA contains
CEFTRIAXONE BIOPHARMA 2 g powder for solution for infusion
One vial of powder contains:
Active substance: ceftriaxone disodium 3.5 H₂O 2.386 g, equivalent to ceftriaxone 2 g.
Description of the appearance of CEFTRIAXONE BIOPHARMA and contents of the pack
CEFTRIAXONE BIOPHARMA 2 g powder for solution for infusion
One carton contains: 1 vial of powder.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Biopharma S.r.l. – Via Paolo Mercuri, 8 - 00193 Rome - Italy
Responsible manufacturer for batch release:
Biopharma S.r.l. – Via delle Gerbere, 22/30 - 00134 S. Palomba (RM) - Italy