CEFTRIAXONE ALTER

Package leaflet: Information for the patient

CEFTRIAXONE ALTER 250 mg/ 2 ml powder and solvent for injectable solution for intramuscular use
CEFTRIAXONE ALTER 500 mg/ 2 ml powder and solvent for injectable solution for intramuscular use
CEFTRIAXONE ALTER 1 g / 3.5 ml powder and solvent for injectable solution for intramuscular use
Ceftriaxone (as ceftriaxone sodium)
Equivalent medicine
Please read this leaflet carefully before using 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 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 ALTER is and what it is used for
2. What you need to know before using CEFTRIAXONE ALTER
3. How to use CEFTRIAXONE ALTER
4. Possible side effects
5. How to store CEFTRIAXONE ALTER
6. Contents of the pack and other information

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

CEFTRIAXONE ALTER 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 ALTER 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 low white blood cell counts (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 using CEFTRIAXONE ALTER

Do not use CEFTRIAXONE ALTER if:

• you are allergic to ceftriaxone or to any of the other ingredients of this medicine (listed in section 6).
• you have previously experienced 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 skin rash that develops rapidly.
• you are allergic to lidocaine and CEFTRIAXONE ALTER is to be administered by intramuscular injection.

CEFTRIAXONE ALTER 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 the whites of the eyes), or is to receive a calcium-containing product intravenously. Inform your doctor, pharmacist or nurse before CEFTRIAXONE ALTER is administered to you if:
• you are experiencing or have previously experienced any combination of the following symptoms: skin rash, skin redness, blistering of the lips, eyes and mouth, skin peeling, high fever, flu-like symptoms, increased liver enzyme levels detectable in blood tests, increased levels of a type of white blood cell (eosinophilia), and swollen lymph nodes (signs of serious skin reactions, see also section 4 "Possible side effects").

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using CEFTRIAXONE ALTER if:

• you have recently received or are about to receive calcium-containing products.
• you have recently had diarrhoea after taking an antibiotic. You have had intestinal problems, particularly colitis (inflammation of the intestine).
• you have liver or kidney problems (see section 4).
• you have gallstones or kidney stones.
• you have other diseases, such as haemolytic anaemia (a reduction in red blood cells that may cause pale yellow skin and lead to weakness or shortness of breath).
• you are on a low-sodium diet.

If you are undergoing blood or urine tests
If you are receiving CEFTRIAXONE ALTER for a prolonged period, you may need to have regular blood tests. CEFTRIAXONE ALTER 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 administered CEFTRIAXONE ALTER.

Children
Talk to your doctor, pharmacist or nurse before CEFTRIAXONE ALTER is administered to the child if:

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

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

• an antibiotic called an aminoglycoside.
• an antibiotic called chloramphenicol (used 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, ask your doctor for advice before taking this medicine.
Your doctor will evaluate the benefits of treatment with CEFTRIAXONE ALTER for you and the potential risks for the unborn child.

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

3. How to use CEFTRIAXONE ALTER

CEFTRIAXONE ALTER is generally administered by a doctor or nurse via an injection given directly into a muscle. CEFTRIAXONE ALTER will be prepared by a doctor, pharmacist, or nurse and will not be mixed or administered simultaneously with calcium-containing injections.
Recommended dose
Your doctor will determine the appropriate dose of CEFTRIAXONE ALTER 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 degree of function of your kidneys and liver. The number of days or weeks during which you will receive CEFTRIAXONE ALTER will depend on the type of infection you have.
Adults, elderly patients, and children aged 12 years or older with a body weight equal to or greater than 50 kilograms (kg):

• 1 to 2 g once daily, depending on the severity and type of infection. If you have a severe infection, your doctor may administer a higher dose (up to 4 g per day). If your daily dose exceeds 2 g, it may be given either as a single daily dose or as 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 ALTER 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 equal to or greater than 50 kg should receive the standard adult dose.

Neonates (0–14 days of life):

• 20–50 mg of CEFTRIAXONE ALTER 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 standard one. Your doctor will decide the amount of CEFTRIAXONE ALTER you will need and will closely monitor you, depending on the severity of your liver or kidney disease.
If you use more CEFTRIAXONE ALTER than you should
If you are accidentally given more CEFTRIAXONE ALTER than prescribed, contact your doctor or the nearest hospital immediately.
If you forget to use CEFTRIAXONE ALTER
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 use a double dose (two injections together) to make up for the missed dose.
If you stop treatment with CEFTRIAXONE ALTER
Do not stop taking CEFTRIAXONE ALTER unless instructed by your doctor. If you have any doubts about using this medicine, consult your doctor or nurse.

4. Possible side effects

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

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

• severe rash that develops rapidly, with blistering or peeling of the skin and possibly blistering in the mouth (Stevens-Johnson syndrome and toxic epidermal necrolysis, also known as SJS and TEN).
• any combination of the following symptoms: widespread rash, high body temperature, increased liver enzymes, abnormalities in blood tests (eosinophilia), swollen lymph nodes and involvement of other organs in the body (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome).
• Jarisch-Herxheimer reaction, which may cause fever, chills, headache, muscle pain and skin rash, which generally resolves spontaneously. These symptoms occur shortly

after starting treatment with CEFTRIAXONE ALTER for spirochetal 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 white blood cells and increased eosinophils) and platelets (reduced thrombocytes).
• loose stools or diarrhoea.
• changes in blood test results for liver function.
• skin 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 ALTER 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).
• skin rash with wheals (urticaria), which may cover a large area of the body, associated with itching and swelling.
• blood or sugar in the urine.
• oedema (fluid accumulation).
• chills.

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

• secondary infections that may not respond to the prescribed antibiotic.
• a form of anaemia characterised by destruction of red blood cells (haemolytic anaemia).
• severe decrease in the number of white blood cells (agranulocytosis).
• seizures.
• 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 and/or liver problems that may cause pain, nausea and vomiting, yellowing of the skin, itching, unusually dark urine and clay-coloured stools.
• a neurological condition that may develop in newborns with severe jaundice (kernicterus).
• kidney problems caused by calcium-ceftriaxone deposits. You may experience pain when urinating, or your urine output may decrease.
• false positive Coombs test (a blood test to detect blood-related problems).
• false positive test for galactosaemia (an abnormal accumulation of the sugar galactose).
• CEFTRIAXONE ALTER may interfere with certain types of tests to measure blood glucose; please check with your doctor.

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

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

5. How to store CEFTRIAXONE ALTER

Keep this medicine out of the sight and reach of children.
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.
Expiry date: see expiry date on the packaging.
Warning: do not use this medicine after the expiry date stated on the packaging.
The stated expiry date refers to the product stored in its original, unopened packaging and correctly stored.
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

What CEFTRIAXONE ALTER contains
CEFTRIAXONE Alter 250 mg/2 ml powder and solvent for injectable solution for intramuscular use
One vial of powder contains: active substance: ceftriaxone disodium 3.5 H2O 298.2 mg equivalent to ceftriaxone 250 mg; one solvent ampoule contains: aqueous solution of 1% lidocaine.
CEFTRIAXONE Alter 500 mg/2 ml powder and solvent for injectable solution for intramuscular use
One vial of powder contains: active substance: ceftriaxone disodium 3.5 H2O 596.5 mg equivalent to ceftriaxone 500 mg; one solvent ampoule contains: aqueous solution of 1% lidocaine.
CEFTRIAXONE Alter 1 g / 3.5 ml powder and solvent for injectable solution for intramuscular use
One vial of powder contains: active substance: ceftriaxone disodium 3.5 H2O 1.193 g equivalent to ceftriaxone 1 g; one solvent ampoule contains: aqueous solution of 1% lidocaine.

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

Marketing Authorization Holder
Laboratori Alter S.r.l., via Egadi, 7 – 20144 Milano
Manufacturer
Laboratorio Farmaceutico CT S.r.l. - Via Dante Alighieri, 71 - 18038 Sanremo (IM)

Patient Information Leaflet: Information for the Patient

CEFTRIAXONE ALTER 1 g/10 ml powder and solvent for injectable solution for intravenous use
Ceftriaxone (as ceftriaxone sodium)
Generic medicine
Please read this leaflet carefully before using 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 others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What CEFTRIAXONE ALTER is and what it is used for
2. What you need to know before using CEFTRIAXONE ALTER
3. How to use CEFTRIAXONE ALTER
4. Possible side effects
5. How to store CEFTRIAXONE ALTER
6. Package contents and other information

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

CEFTRIAXONE ALTER 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 ALTER is used to treat infections of:

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

It may also be administered:

• to treat specific sexually transmitted infections (gonorrhoea and syphilis).
• to treat patients with a low 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 using CEFTRIAXONE ALTER

Do not use CEFTRIAXONE ALTER if:

• you are allergic to ceftriaxone or to any of the other ingredients of this medicine (listed in section 6).
• you have previously experienced 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, or a severe skin rash that develops rapidly.
• you are allergic to lidocaine and CEFTRIAXONE ALTER is to be administered by intramuscular injection.

CEFTRIAXONE ALTER 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 the whites of the eyes), or is to receive a calcium-containing product intravenously. Inform your doctor, pharmacist or nurse before being administered CEFTRIAXONE ALTER if:
• you have experienced or have previously experienced any combination of the following symptoms: skin 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").

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using CEFTRIAXONE ALTER if:

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

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

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

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

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

• an antibiotic called an aminoglycoside.
• an antibiotic called chloramphenicol (used to treat infections, particularly eye infections).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine.
Your doctor will evaluate the benefits that treatment with CEFTRIAXONE ALTER may provide you against any possible risks to the unborn child.
Driving and using machines
CEFTRIAXONE ALTER 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 ALTER is administered

CEFTRIAXONE ALTER is generally administered by a doctor or nurse as an intravenous infusion (IV infusion) or by direct injection into a vein. CEFTRIAXONE ALTER will be prepared by a doctor, pharmacist, or nurse and must not be mixed or co-administered with calcium-containing injections.

Usual dose
Your doctor will determine the correct dose of CEFTRIAXONE ALTER for you. The dose will depend on the severity and type of infection, whether you are receiving concomitant treatment with other antibiotics, your body weight and age, and the function of your kidneys and liver. The number of days or weeks during which you will receive CEFTRIAXONE ALTER will depend on the type of infection you have.

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

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

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

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

Neonates (0–14 days of life):

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

Patients with liver or kidney problems
You may be given a different dose than the usual one. Your doctor will decide how much CEFTRIAXONE ALTER you need and will monitor you closely, depending on the severity of your liver or kidney disease.

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

If you forget to receive CEFTRIAXONE ALTER
If you miss an injection, it should be given as soon as possible. However, if it is almost time for your next scheduled injection, skip the missed dose. Do not administer a double dose (two injections together) to make up for the missed dose.

If you stop treatment with CEFTRIAXONE ALTER
Do not stop receiving CEFTRIAXONE ALTER unless your doctor tells you to. If you have any doubts about using this medicine, consult your doctor or nurse.

4. Possible side effects

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

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

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

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

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

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

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

Uncommon (may affect up to 1 in 100 people)

• Fungal infections (e.g. thrush).
• 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 ALTER was administered. Pain at the injection site.
• Fever.
• Abnormal kidney function tests (increased creatinine in the blood).

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

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

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

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

Reporting of side effects
If you 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store CEFTRIAXONE ALTER

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

6. Package contents and other information

What CEFTRIAXONE ALTER contains
CEFTRIAXONE Alter 1 g / 10 ml powder and solvent for injectable solution for intravenous use
one vial of powder contains: active substance: ceftriaxone disodium 3.5 H2O 1.193 g equivalent to ceftriaxone 1 g; one
solvent vial contains: water for injection.
Description of the appearance of CEFTRIAXONE ALTER and contents of the pack
CEFTRIAXONE Alter 1 g / 10 ml powder and solvent for injectable solution for intravenous use:
1 vial of powder + 1 solvent vial of 10 ml.
Marketing Authorization Holder
Laboratori Alter S.r.l., via Egadi, 7 – 20144 Milano
Manufacturer
Laboratorio Farmaceutico CT S.r.l. - Via Dante Alighieri, 71 - 18038 Sanremo (IM)

Patient information leaflet

CEFTRIAXONE ALTER 2 g powder for solution for infusion

Ceftriaxone (as ceftriaxone sodium)
Equivalent medicine
Please read this leaflet carefully before using 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 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, consult your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

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

CEFTRIAXONE ALTER 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 ALTER 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 low white blood cell counts (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 using CEFTRIAXONE ALTER

Do not use CEFTRIAXONE ALTER if:

• you are allergic to ceftriaxone or to any of the other ingredients of this medicine (listed in section 6).
• you have previously experienced 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, or a severe skin rash that develops rapidly.
• you are allergic to lidocaine and CEFTRIAXONE ALTER is to be administered by intramuscular injection.

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

• the child is premature.
• the child is a newborn (up to 28 days of age) and has certain blood disorders or jaundice (yellowing of the skin or whites of the eyes), or is to receive, via intravenous route, a product containing calcium. Inform your doctor, pharmacist, or nurse before CEFTRIAXONE ALTER is administered to you if:
• you are experiencing or have previously experienced any combination of the following symptoms: skin rash, skin redness, blistering of lips, eyes, and mouth, skin peeling, high fever, flu-like symptoms, increased liver enzyme levels 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”).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using CEFTRIAXONE ALTER 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 (see section 4).
• you have gallstones or kidney stones.
• you have other diseases, such as haemolytic anaemia (a reduction in red blood cells that may cause pale yellow skin and lead to weakness or shortness of breath).
• you are on a low-sodium diet.

If you are undergoing blood or urine tests
If you are receiving CEFTRIAXONE ALTER for a prolonged period, you may need to undergo regular blood tests. CEFTRIAXONE ALTER may affect the results of urine sugar tests and a blood test known as the Coombs test. If you are about to have tests performed:

• inform the person collecting your sample that you have been administered CEFTRIAXONE ALTER.

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

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

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

• an antibiotic known as 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 assess the benefits of treatment with CEFTRIAXONE ALTER for you and the potential risks for the unborn or breastfed child.

Driving and using machines
CEFTRIAXONE ALTER 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 to use CEFTRIAXONE ALTER

CEFTRIAXONE ALTER is usually administered by a doctor or nurse through

• an intravenous infusion (IV infusion) or via an injection directly into a vein.

CEFTRIAXONE ALTER will be prepared by a doctor, pharmacist, or nurse and must not be mixed or co-administered with calcium-containing solutions.
Usual dose
Your doctor will determine the appropriate dose of CEFTRIAXONE ALTER 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 ALTER 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 either 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 ALTER 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 either 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 ALTER 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 ALTER you need and will monitor you closely, depending on the severity of your liver or kidney condition.

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

If you miss a dose of CEFTRIAXONE ALTER
If you miss an injection, it should be given as soon as possible. However, if it is almost time for your next scheduled injection, skip the missed dose. Do not administer a double dose (two injections together) to make up for the missed dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone 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 reactions (not known, frequency cannot be estimated from the available data)
If you develop a severe skin reaction, inform a doctor immediately.
Signs may include:

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

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

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

Uncommon (may affect up to 1 in 100 people)

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

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

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

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

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

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

5. How to store CEFTRIAXONE ALTER

Keep this medicine out of the sight and reach of children.
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.
Expiry date: see the expiry date stated on the packaging.
Warning: do not use this medicine after the expiry date stated on the packaging.
The stated expiry date refers to the product in its original, undamaged packaging stored under appropriate conditions.
Keep the vial in its original container.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What CEFTRIAXONE ALTER contains
CEFTRIAXONE Alter 2 g powder for solution for infusion: one vial contains:
Active substance: ceftriaxone disodium 3.5 H2O 2.386 g, equivalent to ceftriaxone 2 g.
Description of the appearance of CEFTRIAXONE ALTER and contents of the pack
CEFTRIAXONE Alter 2 g powder for solution for infusion: 1 vial of powder
Marketing Authorization Holder
Laboratori Alter S.r.l., via Egadi, 7 – 20144 Milano
Manufacturer
Laboratorio Farmaceutico CT S.r.l. - Via Dante Alighieri, 71 - 18038 Sanremo (IM)