Ceftriaxone Git: detailed information

Package leaflet: Information for the patient

Ceftriaxone GIT 2 g powder for solution for infusion

Ceftriaxone (as ceftriaxone sodium)
Generic medicine
Read this entire leaflet carefully before this medicine is administered to you
because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Never give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

Ceftriaxone GIT 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 GIT is used to treat the following infections:

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

It may also be administered:

to treat specific sexually transmitted infections (gonorrhoea and syphilis).
to treat patients with a low number of white blood cells in the blood (neutropenia) who have fever due to bacterial infection.
to treat chest infections in adults with chronic bronchitis.
to treat Lyme disease (caused by tick bites) in adults and children, including newborns from 15 days of age.
to prevent infections during surgical procedures.

2. What you need to know before taking Ceftriaxone GIT

Do not take Ceftriaxone GIT if:

you are allergic to ceftriaxone or to any of the other ingredients of this medicine (listed in section 6).
you have had an immediate 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 GIT is to be administered by intramuscular injection.

Ceftriaxone GIT 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 GIT if:

you are experiencing or have previously experienced any combination of the following symptoms: 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. 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 a blood or urine test
If you are being given Ceftriaxone GIT for a prolonged period, you may need to have regular blood tests. Ceftriaxone GIT 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 GIT.

If you are diabetic or require monitoring of blood glucose levels, do not use certain blood glucose monitoring systems which may incorrectly measure blood glucose during treatment with ceftriaxone. If such systems are used, check the instructions for use and inform your doctor, pharmacist or nurse. Alternative testing methods should be used if necessary.
Children
Talk to your doctor, pharmacist or nurse before giving Ceftriaxone GIT 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 GIT
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

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

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Your doctor will assess the benefits that treatment with Ceftriaxone GIT would provide you and the potential risks for your baby.
Driving and using machines
Ceftriaxone GIT may cause dizziness. If you feel dizzy, do not drive or use tools or machinery. Contact your doctor if you experience these symptoms.
Ceftriaxone GIT contains sodium
Ceftriaxone GIT 2 g contains 165.6 mg of sodium (the main component of table salt) per 2 g vial. This corresponds to 8.28% of the maximum daily dietary intake recommended for an adult.

3. How Ceftriaxone GIT is administered

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

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

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

50–80 mg of Ceftriaxone GIT 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 adult usual dose.

Neonates (0–14 days of life)

20–50 mg of Ceftriaxone GIT 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 neonate.

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 GIT you need and will monitor you closely, depending on the severity of your liver or kidney disease.
If you are given more Ceftriaxone GIT than you should
If you are accidentally given more Ceftriaxone GIT than prescribed, contact your doctor or go to the nearest hospital immediately.
If you miss a dose of Ceftriaxone GIT
If you miss an injection, it should be given as soon as possible. However, if it is almost time for your next scheduled injection, skip the missed dose. Do not take a double dose (two injections together) to make up for a missed dose.
If you stop treatment with Ceftriaxone GIT
Do not stop taking Ceftriaxone GIT 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 experiences 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 rashes (not known, frequency cannot be estimated from the available data)
If you develop a severe skin rash, seek medical advice immediately.
Signs may include:

a severe rash that develops rapidly, with blistering or peeling of the skin and possibly blisters in the mouth (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 body 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, which generally resolves spontaneously. These symptoms may occur shortly after starting treatment with Ceftriaxone GIT 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.
Skin 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 GIT was administered. Pain at the injection site.
Fever.
Abnormal results in 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 hives (urticaria), which may cover a large area of the body, associated with itching and swelling.
Blood or sugar in the urine.
Oedema (fluid accumulation).
Chills.

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

Secondary infections that may not respond to the prescribed antibiotic.
A form of anaemia characterised by destruction of red blood cells (haemolytic anaemia).
Severe decrease in the number of white blood cells (agranulocytosis).
Seizures.
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 affecting 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 a reduced amount of urine produced.
False positive Coombs test (a blood test to detect blood-related problems).
False positive test for galactosaemia (an abnormal accumulation of the sugar galactose).
Ceftriaxone GIT 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 level of consciousness, abnormal movements, agitation and seizures.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at the following 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 GIT

Expiry and storage
Expiry: see the expiry date stated on the packaging
Do not use this medicine after the expiry date printed on the box following .
The expiry date refers to the last day of that month.
The stated expiry date applies to the product in its original, unopened packaging stored under the recommended conditions.
For the reconstituted solution, see "Instructions for administration".
KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN.
Chemical and physical in-use stability has been demonstrated for at least 6 hours at a temperature below 25 °C, or up to 24 hours at 2–8 °C.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the duration and conditions of storage prior to use are the responsibility of the user and must not exceed the time limits indicated above for chemical and physical in-use stability.
Medicines must not be disposed of 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 GIT contains
Ceftriaxone GIT 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 GIT and package contents
Pharmaceutical form and contents
Ceftriaxone GIT 2 g powder for solution for infusion: 1 vial of powder.
Marketing Authorization Holder and manufacturer
SF GROUP S.r.l. – Via Tiburtina 1143, 00156 Rome
Manufacturer
Esseti Farmaceutici S.r.l. Via Campobello, 15 – 00040 Pomezia (Rome)

Patient information leaflet

Ceftriaxone GIT 500 mg/2 ml powder and solvent for injectable solution for

intramuscular use
Ceftriaxone (as sodium ceftriaxone)
Lidocaine (as lidocaine hydrochloride)
Generic medicine
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 other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What Ceftriaxone GIT is and what it is used for
What you need to know before you are given Ceftriaxone GIT
How Ceftriaxone GIT is administered
Possible side effects
How to store Ceftriaxone GIT
Contents of the pack and other information

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

Ceftriaxone GIT 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 GIT is given by injection into a muscle in a solution containing lidocaine, which reduces the pain associated with the injection.

Ceftriaxone GIT is used to treat infections of:

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

It may be administered:

to treat specific sexually transmitted infections (gonorrhoea and syphilis).
to treat patients with a low number of white blood cells in the blood (neutropenia) who have fever due to bacterial infection.
to treat chest infections in adults with chronic bronchitis.
to treat Lyme disease (caused by tick bites) in adults and children, including newborns from 15 days of age.
to prevent infections during surgery.

2. What you need to know before taking Ceftriaxone GIT

Do not take Ceftriaxone GIT if:

you are allergic to ceftriaxone or to any of the other ingredients of this medicine (listed in section 6).
you have had a sudden or severe allergic reaction to penicillin or to similar antibiotics (such as cephalosporins, penicillins, monobactams, and carbapenems). Possible signs include sudden swelling of the throat or face, which may make it difficult to breathe or swallow, sudden swelling of hands, feet, and ankles, chest pain, and a severe rash that develops rapidly.
you are allergic to lidocaine and Ceftriaxone GIT is to be administered by intramuscular injection.
you have a heart conduction disorder causing low blood pressure and slowed heart rate (complete atrioventricular block).
you have a reduced blood volume (hypovolemia).

Ceftriaxone GIT 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 a calcium-containing product intravenously.

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

you are experiencing or have previously experienced any combination of the following symptoms: rash, skin redness, blistering on lips, eyes, or mouth, skin peeling, high fever, flu-like symptoms, increased liver enzymes detectable in blood tests, increased levels of 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 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, weakness, or shortness of breath).
you are on a low-sodium diet.
you have muscle weakness and loss of muscle function (myasthenia gravis).
you have seizures (epilepsy).
you have any heart conditions, especially if they affect your heart rate.
you have breathing problems.
you have porphyria (a rare inherited disease affecting the skin and nervous system).

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

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

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

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

Other medicines and Ceftriaxone GIT
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).

Several medicines can interact with lidocaine, leading to altered effects. These include:

medicines used to treat infections (clarithromycin, erythromycin).
medicines used to treat stomach ulcers (e.g. cimetidine).
strong painkillers such as codeine and meperidine (narcotic or opioid medicines).
medicines used to treat irregular heart rate (e.g. mexiletine, tocainide).

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Your doctor will assess the benefits of treatment with Ceftriaxone GIT for you and the possible risks for your baby.

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

Ceftriaxone GIT contains sodium
Ceftriaxone GIT 500 mg / 2 ml contains 41.4 mg of sodium (the main component of table salt) per 500 mg vial. This corresponds to 2.07% of the maximum daily recommended dietary intake of sodium for an adult.

3. How Ceftriaxone GIT is administered

Ceftriaxone GIT is generally administered by a doctor or a nurse via an injection given directly into a muscle. Ceftriaxone GIT will be prepared by a doctor, pharmacist, or nurse and will not be mixed or administered simultaneously with injections containing calcium.
Usual dose
Your doctor will determine the correct dose of Ceftriaxone GIT 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 GIT 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 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 GIT 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 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 GIT 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 GIT you need and will closely monitor you, depending on the severity of your liver or kidney disease.
If you take more Ceftriaxone GIT than you should
If you are accidentally given more Ceftriaxone GIT than prescribed, contact your doctor or go to the nearest hospital immediately.
If you forget to take Ceftriaxone GIT
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 GIT
Do not stop taking Ceftriaxone GIT 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, contact your doctor 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 rashes (not known, frequency cannot be estimated from the available data)
If you develop a severe skin rash, contact your doctor 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 may occur shortly after starting Ceftriaxone GIT 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 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).
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 GIT 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).
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.
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 a reduced amount of urine produced.
False positive Coombs test (a blood test to detect blood-related problems).
False positive test for galactosaemia (an abnormal accumulation of the sugar galactose).
Ceftriaxone GIT 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.

Following accidental injection of lidocaine into a blood vessel during intramuscular administration of Ceftriaxone GIT i.m., additional side effects may occur, which may include:
Not known (frequency cannot be estimated from the available data)

Changes in heart rhythm and rate.
Low blood pressure.
Slowed heart rate (less than 60 beats/minute).
Interruption of normal blood circulation due to cardiac arrest and reduced blood flow.
Loss of balance, tingling around the mouth, numbness of the tongue, difficulty tolerating everyday sounds (hyperacusis), ringing in the ears (tinnitus), dizziness or lightheadedness, confusion, nervousness, involuntary rhythmic muscle contractions, seizures or epileptic fits, deep unconsciousness (coma).
Blurred vision, double vision or temporary loss of vision.
Feeling unwell (nausea or vomiting).
Breathing difficulties.
Reduced respiratory rate or possible interruption of breathing.
Unusual drowsiness or fatigue during the day or fainting.

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 the following 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 GIT

Expiry and storage
Expiry: see the expiry date stated on the packaging
Do not use this medicinal product after the expiry date stated on the box after .
The expiry date refers to the last day of that month.
The stated expiry date applies to the product in its original, unopened packaging, stored correctly.
KEEP THIS MEDICINAL PRODUCT OUT OF THE SIGHT AND REACH OF CHILDREN
Chemical and physical stability during use of the reconstituted product has been demonstrated for at least 6 hours at a temperature below 25 °C, or for 24 hours at 2–8 °C.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the duration and conditions of storage prior to use are the responsibility of the user and must not exceed the time periods indicated above for chemical and physical stability during use.
Medicinal products must not be disposed of 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 GIT contains
Ceftriaxone GIT 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 vial contains: aqueous 1% lidocaine solution.
Description of the appearance of Ceftriaxone GIT and package contents
Pharmaceutical form and contents
Ceftriaxone GIT 500 mg/2 ml powder and solvent for injectable solution for intramuscular use:
1 vial of powder + 1 solvent vial of 2 ml
Marketing Authorization Holder and Manufacturer
SF GROUP S.r.l. – Via Tiburtina 1143, 00156 Roma
Manufacturer
Esseti Farmaceutici S.r.l. Via Campobello, 15 – 00040 Pomezia (Roma)

Patient information leaflet

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

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

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

It may be administered:

to treat specific sexually transmitted infections (gonorrhoea and syphilis).
to treat patients with a low number of white blood cells in the blood (neutropenia) who have fever due to bacterial infection.
to treat chest infections in adults with chronic bronchitis.
to treat Lyme disease (caused by tick bites) in adults and children, including newborns from 15 days of age.
to prevent infections during surgery.

2. What you need to know before taking Ceftriaxone GIT

Do not take Ceftriaxone GIT 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 GIT is to be administered by intramuscular injection.

Ceftriaxone GIT 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 intravenously a product containing calcium.

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

you are experiencing or have previously experienced any combination of the following symptoms: 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. 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 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 GIT for a prolonged period, you may need to have regular blood tests. Ceftriaxone GIT 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 administered Ceftriaxone GIT.

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

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

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

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, plan 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 GIT would provide to you and the potential risks to the baby.

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

Ceftriaxone GIT contains sodium
Ceftriaxone GIT 1 g/10 ml contains 82.8 mg of sodium (the main component of table salt) per 1 g vial. This corresponds to 4.14% of the maximum daily dietary intake recommended for an adult.

3. How Ceftriaxone GIT is administered

Ceftriaxone GIT is generally administered by a doctor or a nurse via intravenous infusion (IV infusion) or by direct injection into a vein. Ceftriaxone GIT will be prepared by a doctor, pharmacist, or nurse and will not be mixed or administered simultaneously with calcium-containing injections.

Standard dose

Your doctor will determine the correct dose of Ceftriaxone GIT 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 GIT 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 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 GIT 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.

Newborns (0–14 days of life):

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

Patients with liver or kidney problems

You may be given a different dose than the standard one. Your doctor will decide the amount of Ceftriaxone GIT you need and will monitor you closely, depending on the severity of your liver or kidney disease.

If you receive more Ceftriaxone GIT than you should

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

If you miss a dose of Ceftriaxone GIT

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

If you stop treatment with Ceftriaxone GIT

Do not stop taking Ceftriaxone GIT 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 immediate medical attention.
Signs may include:

sudden swelling of the face, throat, lips or mouth. This may make breathing or swallowing difficult.
sudden swelling of the hands, feet and ankles.
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 rashes (not known, frequency cannot be estimated from the available data)
If you develop a severe skin rash, seek immediate medical attention.
Signs may include:

a severe rash that develops rapidly, with blistering or peeling of the skin and possibly blisters in the mouth (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 skin rash, which usually resolves spontaneously. These symptoms occur shortly after starting treatment with Ceftriaxone GIT 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.
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 GIT 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 affect 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.
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, vomiting, yellowing of the skin, itching, unusually dark urine and clay-coloured stools.
A neurological condition that may develop in newborns with severe jaundice (kernicterus).
Kidney problems caused by calcium-ceftriaxone deposits. You may experience pain when urinating, or your urine output may decrease.
False positive Coombs test (a test to detect blood problems).
False positive test for galactosaemia (an abnormal accumulation of the sugar galactose).
Ceftriaxone GIT 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 cause reduced level of consciousness, abnormal movements, agitation and seizures.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell 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 GIT

Expiry and storage
Expiry: see the expiry date stated on the packaging
Do not use this medicine after the expiry date shown on the carton after .
The expiry date refers to the last day of that month.
The stated expiry date applies to the product in its original packaging, correctly stored.
KEEP THIS MEDICINE OUT OF SIGHT AND REACH OF CHILDREN
The chemical and physical stability of the reconstituted product has been demonstrated for at least 6 hours at a temperature below 25 °C, or up to 24 hours at 2-8 °C.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the period and conditions of storage prior to use are the responsibility of the user and must not exceed the times indicated above for chemical and physical stability during use.
Medicines should not be disposed of 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 GIT contains
Ceftriaxone GIT 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 GIT and package contents
Pharmaceutical form and contents
Ceftriaxone GIT 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
SF GROUP S.r.l. – Via Tiburtina 1143, 00156 Rome
Manufacturer
Esseti Farmaceutici S.r.l., Via Campobello, 15 – 00040 Pomezia (Rome)

Patient information leaflet

Ceftriaxone GIT 1g/3.5 ml powder and solvent for injectable solution for

intramuscular use
Ceftriaxone (as ceftriaxone sodium)
Lidocaine (as lidocaine hydrochloride)
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 yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Ceftriaxone GIT is and what it is used for
What you need to know before you are given Ceftriaxone GIT
How Ceftriaxone GIT is administered
Possible side effects
How to store Ceftriaxone GIT
Package contents and other information

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

Ceftriaxone GIT 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 GIT is administered by injection into a muscle using a solution containing lidocaine, which reduces the pain associated with the injection.

Ceftriaxone GIT is used to treat infections of:

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

It may be administered:

to treat specific sexually transmitted infections (gonorrhoea and syphilis).
to treat patients with a low number of white blood cells in the blood (neutropenia) who have fever due to bacterial infection.
to treat chest infections in adults with chronic bronchitis.
to treat Lyme disease (caused by tick bites) in adults and children, including newborns from 15 days of age.
to prevent infections during surgical procedures.

2. What you should know before being given Ceftriaxone GIT

Do not use Ceftriaxone GIT 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 GIT is to be administered by intramuscular injection.
you have a heart conduction disorder causing low blood pressure and slowed heart rate (complete atrioventricular block).
you have a condition of reduced blood volume (hypovolemia).

Ceftriaxone GIT must not be given to children in the following cases:

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

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

you are experiencing or have previously experienced any combination of the following symptoms: rash, skin redness, blistering on lips, eyes, or mouth, skin peeling, high fever, flu-like symptoms, increased levels of liver enzymes detectable in blood tests, 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. 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 that may cause pale yellow skin and lead to weakness or shortness of breath).
you are on a low-sodium diet.
you suffer from loss of muscle function and weakness (myasthenia gravis).
you have seizures (epilepsy).
you have any heart condition, especially if it affects your heart rate.
you have breathing problems.
you suffer from porphyria (a rare inherited disease affecting the skin and nervous system).

If you are to undergo blood or urine tests
If you are given Ceftriaxone GIT for a prolonged period, you may need to have regular blood tests. Ceftriaxone GIT 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 GIT.

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

an antibiotic called an aminoglycoside.
an antibiotic called chloramphenicol (used to treat infections, particularly eye infections). Several medicines can interact with lidocaine, leading to altered effects. These include:
medicines used to treat infections (clarithromycin, erythromycin).
medicines used to treat stomach ulcers (e.g. cimetidine).
strong painkillers such as codeine and meperidine (narcotic or opioid drugs).
medicines used to treat irregular heart rate (e.g. mexiletine, tocainide).

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 GIT for you and the potential risks to the unborn or nursing child.

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

Ceftriaxone GIT contains sodium
Ceftriaxone GIT 1 g/3.5 ml contains 82.8 mg of sodium (the main component of table salt) per 1 g vial. This corresponds to 4.14% of the maximum daily recommended dietary intake for an adult.

3. How Ceftriaxone GIT is administered

Ceftriaxone GIT is generally administered by a doctor or nurse via an injection given directly into a muscle. Ceftriaxone GIT will be prepared by a doctor, pharmacist, or nurse and will not be mixed or administered simultaneously with injections containing calcium.
Usual dose
Your doctor will determine the correct dose of Ceftriaxone GIT 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 GIT will depend on the type of infection you have.
Adults, elderly patients, and children aged 12 years or older with a body weight equal to or greater than 50 kilograms (kg):

1 to 2 g once daily, depending on the severity and type of infection. If you have a severe infection, your doctor will administer a higher dose (up to 4 g per day). If your daily dose exceeds 2 g, it may be given as a single daily dose or 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 GIT once daily per kg of the child's body weight, depending on the severity and type of infection. If the child has a severe infection, the doctor will prescribe a higher dose starting from 100 mg per kg of body weight, up to a maximum of 4 g per day. If the daily dose exceeds 2 g, it may be administered as a single daily dose or 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 GIT once daily per kg of the newborn's body weight, depending on the severity and type of infection.
The maximum daily dose must not exceed 50 mg per kg of the newborn's body weight.

Patients with liver or kidney problems
You may be given a different dose from the usual one. Your doctor will decide the amount of Ceftriaxone GIT you need and will monitor you closely, depending on the severity of your liver or kidney disease.
If you receive more Ceftriaxone GIT than you should
If you are accidentally given more Ceftriaxone GIT than prescribed, contact your doctor or go to the nearest hospital immediately.
If you miss a dose of Ceftriaxone GIT
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 GIT
Do not stop taking Ceftriaxone GIT 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 experiences 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, contact your doctor 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 rashes (not known, frequency cannot be estimated from the available data)
If you develop a severe skin rash, contact your doctor 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 skin rash, which usually resolves spontaneously. These symptoms occur shortly after starting treatment with Ceftriaxone GIT 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 GIT was administered.

Pain at the injection site.

Fever.
Abnormal kidney function test results (increased creatinine in blood).

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

Inflammation of the large intestine (colon). Signs include diarrhoea, often with blood and mucus, stomach pain and fever.
Difficulty breathing (bronchospasm).
Skin rash with raised red patches (urticaria), which may cover a large area of the body, associated with itching and swelling.
Blood or sugar in the urine.
Oedema (fluid accumulation).
Chills.

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

Secondary infections that may not respond to the prescribed antibiotic.
A form of anaemia characterised by destruction of red blood cells (haemolytic anaemia).
Severe decrease in the number of white blood cells (agranulocytosis).
Seizures.
Vertigo.
Inflammation of the pancreas (pancreatitis). Signs include severe stomach pain extending 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 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 result (a test to detect blood problems).
False positive result for galactosemia (an abnormal accumulation of the sugar galactose).
Ceftriaxone GIT 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.

Changes in heart rhythm and rate.
Low blood pressure.
Slowing of the heart rate (less than 60 beats per minute).
Interruption of normal blood circulation due to cardiac arrest and reduced blood flow.
Loss of balance, tingling around the mouth, numbness of the tongue, difficulty tolerating everyday sounds (hyperacusis), ringing in the ears (tinnitus), dizziness or lightheadedness, confusion, nervousness, involuntary rhythmic muscle contractions, seizures or epileptic fits, profound unconsciousness (coma).
Blurred vision, double vision or temporary loss of vision.
Feeling unwell (nausea or vomiting).
Breathing difficulties.
Reduced respiratory rate or possible cessation of breathing.
Unusual drowsiness or tiredness during the day or fainting.

5. How to store Ceftriaxone GIT

Expiry and storage
Expiry: see the expiry date stated on the packaging.
Do not use this medicine after the expiry date printed on the box after .
The expiry date refers to the last day of that month.
The stated expiry date applies to the product in its original, unopened packaging stored under
recommended conditions.
KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF
CHILDREN
Chemical and physical in-use stability of the reconstituted product has been demonstrated for at least 6
hours at a temperature below 25 °C, or for 24 hours at 2-8 °C.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the duration and conditions of storage prior to use are the responsibility of the user and must not exceed the time limits indicated above for chemical and physical in-use stability.
Medicines must not be disposed of 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 GIT contains
Ceftriaxone GIT 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 ampoule of solvent contains: aqueous solution of 1% lidocaine.

Description of the appearance of Ceftriaxone GIT and package contents
Pharmaceutical form and contents
Ceftriaxone GIT 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
SF GROUP S.r.l. – Via Tiburtina 1143, 00156 Rome
Manufacturer
Esseti Farmaceutici S.r.l., Via Campobello, 15 – 00040 Pomezia (Rome)
LA FA. RE. S.r.l. – Via Sacerdote Benedetto Cozzolino, 77 – 80056 Ercolano (NA)