Ceftriaxone Doc Generici: detailed information

Package leaflet: Information for the patient

CEFTRIAXONE DOC Generici

500 mg/2 ml powder and solvent for injectable solution for intramuscular use
1 g/3.5 ml powder and solvent for injectable solution for intramuscular use
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, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What CEFTRIAXONE DOC Generici is and what it is used for
What you need to know before being administered CEFTRIAXONE DOC Generici
How CEFTRIAXONE DOC Generici is administered
Possible side effects
How to store CEFTRIAXONE DOC Generici
Contents of the pack and other information

1. What CEFTRIAXONE DOC Generici is and what it is used for

CEFTRIAXONE DOC Generici 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 DOC Generici 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 DOC Generici

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

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

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

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given CEFTRIAXONE DOC Generici if:

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

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

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

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

Other medicines and CEFTRIAXONE DOC Generici
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 assess the benefits of treatment with CEFTRIAXONE DOC Generici for you and the possible risks to the unborn or breastfed child.

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

CEFTRIAXONE DOC Generici contains sodium

The 500 mg/2 ml dose contains 41 mg of sodium (the main component of table salt) per vial of powder. This corresponds to 2% of the maximum daily dietary intake recommended for an adult.
The 1 g/3.5 ml dose contains 83 mg of sodium (the main component of table salt) per vial of powder. This corresponds to 4% of the maximum daily dietary intake recommended for an adult.

3. How CEFTRIAXONE DOC Generici is administered

CEFTRIAXONE DOC Generici is generally administered by a doctor or nurse via an injection directly into a muscle. CEFTRIAXONE DOC Generici 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 DOC Generici 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 DOC Generici will depend on the type of infection you have.

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

1 to 2 g once daily, depending on the severity and type of infection. If you have a severe infection, your doctor will administer a higher dose (up to 4 g per day). If your daily dose exceeds 2 g, it may be given as a single dose once daily 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 DOC Generici 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 dose once daily or as 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 DOC Generici once daily per kg of the neonate's body weight, depending on the severity and type of infection.
The maximum daily dose must not exceed 50 mg per kg of the neonate's body weight.

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

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

If you forget to take CEFTRIAXONE DOC Generici
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 DOC Generici
Do not stop taking CEFTRIAXONE DOC Generici 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 experience 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, inform a doctor immediately.
Signs may include:

Severe rash developing rapidly, with blistering or peeling of the skin and possible blistering in the mouth (Stevens-Johnson syndrome and toxic epidermal necrolysis, also known as SJS and TEN).
Any combination of the following symptoms: widespread rash, high body temperature, increased liver enzymes, abnormalities in blood tests (eosinophilia), swollen lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome).
Jarisch-Herxheimer reaction, which may cause fever, chills, headache, muscle pain and rash, which usually resolves spontaneously. These symptoms may occur shortly after starting treatment with CEFTRIAXONE DOC Generici 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 leucocytes and increased eosinophils) and platelets (reduced thrombocytes).
Soft stools or diarrhoea.
Changes in blood test results indicating liver function abnormalities.
Rash.

Uncommon (may affect up to 1 in 100 people)

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

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

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

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, which may cause pain, nausea, vomiting, yellowing of the skin, itching, unusually dark urine and pale stools.
A neurological condition that may develop in newborns with severe jaundice (kernicterus).
Kidney problems caused by calcium-ceftriaxone deposits. You may experience pain when urinating, or a reduced amount of urine produced.
False positive Coombs test (a test to detect blood problems).
False positive test for galactosaemia (an abnormal accumulation of the sugar galactose).
CEFTRIAXONE DOC Generici may interfere with certain types of tests to measure blood glucose; please check with your doctor.

Treatment with ceftriaxone, particularly in elderly patients with severe renal impairment or neurological disorders, may rarely cause reduced 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 DOC Generici

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

6. Package Contents and Other Information

What CEFTRIAXONE DOC Generici Contains
CEFTRIAXONE DOC Generici 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 DOC Generici 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 DOC Generici and Contents of the Package
CEFTRIAXONE DOC Generici 500 mg/2 ml powder and solvent for injectable solution for intramuscular use: 1 vial of powder + 1 solvent ampoule of 2 ml.
CEFTRIAXONE DOC Generici 1 g/3.5 ml powder and solvent for injectable solution for intramuscular use: 1 vial of powder + 1 solvent ampoule of 3.5 ml.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milano – Italy.

Manufacturers

ACS Dobfar S.p.A. - Plant located in S. Nicolò a Tordino, Nucleo Industriale S. Atto - Teramo, Italy (production of powder vials).
ACS Dobfar S.p.A. - Via A. Fleming 2 - 37135 Verona - Italy (production of powder vials).
InfoRLife SA - Plant located in Campascio CH-7748, Casai - Switzerland (production of solvent ampoules).

Package leaflet: information for the patient

CEFTRIAXONE DOC Generici

1 g/10 ml powder and solvent for injectable solution for intravenous use
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 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:

What CEFTRIAXONE DOC Generici is and what it is used for
What you need to know before being administered CEFTRIAXONE DOC Generici
How CEFTRIAXONE DOC Generici is administered
Possible side effects
How to store CEFTRIAXONE DOC Generici
Package contents and other information

2. What CEFTRIAXONE DOC Generici is and what it is used for

CEFTRIAXONE DOC Generici 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 DOC Generici is used to treat infections of:

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

It may also be administered:

to treat specific sexually transmitted infections (gonorrhoea and syphilis)
to treat patients with a low white blood cell count (neutropenia) who have fever due to 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

4. What you need to know before you are given CEFTRIAXONE DOC Generici

Do not receive CEFTRIAXONE DOC Generici 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 hands, feet and ankles, chest pain, and a severe rash that develops rapidly.
you are allergic to lidocaine and CEFTRIAXONE DOC Generici is to be administered by intramuscular injection.

CEFTRIAXONE DOC Generici 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 must receive a calcium-containing product intravenously.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before you are given CEFTRIAXONE DOC Generici if:

you are experiencing or have previously experienced any combination of the following symptoms: skin rash, skin redness, blistering on lips, eyes and mouth, skin peeling, high fever, flu-like symptoms, increased levels of liver enzymes detectable in blood tests, increase in a type of white blood cells (eosinophilia), and swollen lymph nodes (signs of serious skin reactions, see also section 4 “Possible side effects”).
you have recently received or are about to receive products containing calcium.
you have recently had diarrhoea after taking an antibiotic, or have 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 need to undergo blood or urine tests
If you are given CEFTRIAXONE DOC Generici for a prolonged period, you may need to have regular blood tests. CEFTRIAXONE DOC Generici may affect the results of urine sugar tests and a blood test known as the Coombs test.
If you are about to undergo tests:

inform the person taking your sample that you have been given CEFTRIAXONE DOC Generici.

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

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

Other medicines and CEFTRIAXONE DOC Generici
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, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
Your doctor will assess the benefits of treatment with CEFTRIAXONE DOC Generici for you and the possible risks for your baby.

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

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

5. How CEFTRIAXONE DOC Generici is administered

CEFTRIAXONE DOC Generici is generally administered by a doctor or nurse
via intravenous infusion (IV infusion) or by injection directly into a vein.
CEFTRIAXONE DOC Generici will be prepared by a doctor, pharmacist, or nurse and will not be
mixed or co-administered with calcium-containing injections.
Usual dose
Your doctor will determine the correct dose of CEFTRIAXONE DOC Generici 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 DOC Generici depends 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 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 DOC Generici 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 administered as a single daily dose or as two separate doses.
Children with a body weight equal to or greater than 50 kg should receive the usual adult dose.

Newborns (0–14 days of life)

20–50 mg of CEFTRIAXONE DOC Generici 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 of the newborn.

Patients with liver or kidney problems
You may be given a different dose from the usual one. Your doctor will decide the amount of
CEFTRIAXONE DOC Generici you need and will monitor you closely, depending on the severity of your liver or kidney disease.
If you are given more CEFTRIAXONE DOC Generici than you should
If you are accidentally given more CEFTRIAXONE DOC Generici than prescribed, contact your doctor or the nearest hospital immediately.
If you miss a dose of CEFTRIAXONE DOC Generici
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 DOC Generici
Do not stop taking CEFTRIAXONE DOC Generici unless your doctor tells you to. 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 everyone gets them.
With this medicine, you may experience the following side effects:

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

Sudden swelling of the face, throat, lips, or mouth. This may make breathing or swallowing difficult.
Sudden swelling of the hands, feet, and ankles.
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 (frequency not known, cannot be estimated from the available data)
If you develop a severe skin reaction, inform a doctor immediately.
Signs may include:

Severe rash developing rapidly, with blistering or peeling of the skin and possible 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, elevated 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 skin rash, usually resolving spontaneously. These symptoms may occur shortly after starting treatment with CEFTRIAXONE DOC Generici 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 leukocytes and increased eosinophils) and platelets (reduced thrombocytes).
Soft stools or diarrhoea.
Changes in blood test results indicating liver function abnormalities.
Rash.

Uncommon (may affect up to 1 in 100 people)

Fungal infections (e.g., 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 DOC Generici 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).
Rash with raised red patches (urticaria), which may cover large areas of the body, associated with itching and swelling.
Blood or sugar in the urine.
Oedema (fluid accumulation).
Chills.

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

Secondary infections that may not respond to the prescribed antibiotic.
A form of anaemia characterised by destruction of red blood cells (haemolytic anaemia).
Severe decrease in 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 and/or liver problems, which may cause pain, nausea, vomiting, yellowing of the skin, itching, unusually dark urine, and pale stools.
A neurological condition that may develop in newborns with severe jaundice (kernicterus).
Kidney problems caused by calcium-ceftriaxone deposits. You may experience pain when urinating, or a reduced amount of urine produced.
False positive Coombs test (a test to detect blood-related problems).
False positive test for galactosaemia (an abnormal accumulation of the sugar galactose).
CEFTRIAXONE DOC Generici may interfere with certain types of blood glucose tests; please consult your doctor.

Treatment with ceftriaxone, especially in elderly patients with severe renal impairment or neurological disorders, may rarely cause reduced 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 DOC Generici

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

6. Package contents and other information

What CEFTRIAXONE DOC Generici contains
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 injectable preparations.

Description of the appearance of CEFTRIAXONE DOC Generici and contents of the pack
CEFTRIAXONE DOC Generici 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 and Manufacturer
Marketing Authorization Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milan – Italy.

Manufacturers

ACS Dobfar S.p.A. - Site located in S. Nicolò a Tordino, Nucleo Industriale S. Atto - Teramo, Italy (production of powder vials).
ACS Dobfar S.p.A. - Via A. Fleming 2 - 37135 Verona - Italy (production of powder vials).
InfoRLife SA - Site located in Campascio CH-7748, Casai - Switzerland (production of solvent vials).