Ceftages

Package leaflet: Information for the patient

CEFTAGES 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

ceftriaxone (as ceftriaxone sodium)
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. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What CEFTAGES is and what it is used for

CEFTAGES 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. CEFTAGES is given by injection into a muscle in a solution containing lidocaine, which reduces the pain associated with the injection.
CEFTAGES 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 be administered:

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

2. What you need to know before you are given CEFTAGES

Do not be given CEFTAGES 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, carbapenems or monobactams). 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 CEFTAGES is to be administered by intramuscular injection;
• you suffer from a heart conduction disorder causing low blood pressure and slowed heart rate (complete atrioventricular block);
• you have a condition of reduced blood volume (hypovolemia).

CEFTAGES must not be administered 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 product containing calcium through a vein.

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

• you have recently received or are about to receive products containing calcium;
• you have recently had diarrhoea after taking an antibiotic; you have had intestinal problems, particularly colitis (inflammation of the intestine);
• you have liver or kidney problems (see section 4);
• you have gallstones or kidney stones;
• you have other diseases, for example haemolytic anaemia (a reduction in red blood cells that may cause pale yellow skin and lead to weakness or breathlessness);
• you are on a low-sodium diet;
• you suffer from loss of muscle function and weakness (myasthenia gravis);
• you suffer from 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);
• 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”).

If you are to undergo blood or urine tests
If you are given CEFTAGES for a prolonged period, you may need to have regular blood tests. CEFTAGES may affect the results of urine tests for sugar and a blood test known as the Coombs test. If you are to undergo tests:

• inform the person taking your sample that you have been given CEFTAGES.

If you are diabetic or require monitoring of blood glucose levels, do not use certain blood glucose monitoring systems that 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 CEFTAGES to a child if:

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

Other medicines and CEFTAGES
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, as they may interact with ceftriaxone:

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

Several drugs may interact with lidocaine, resulting in 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 might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Your doctor will evaluate the benefits of treatment with CEFTAGES for you and the possible risks for the baby.

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

CEFTAGES contains sodium

CEFTAGES 500 mg / 2 ml powder and solvent for injectable solution for intramuscular use
This medicine contains 41.4 mg of sodium (main component of table salt) per vial.
This corresponds to 2% of the maximum daily dietary intake recommended for an adult.

CEFTAGES 1 g / 3.5 ml powder and solvent for injectable solution for intramuscular use
This medicine contains 82.7 mg of sodium (main component of table salt) per vial.
This corresponds to 4.1% of the maximum daily dietary intake recommended for an adult.

3. How CEFTAGES is administered

CEFTAGES is generally administered by a doctor or nurse as an injection directly into a muscle. CEFTAGES 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 appropriate dose of CEFTAGES 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 function of your kidneys and liver. The number of days or weeks during which you will receive CEFTAGES will depend on the type of infection you have.
Adults, elderly patients, and children aged 12 years and older with a body weight of 50 kilograms (kg) or more:

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

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

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

Newborns (0–14 days of life):

• 20–50 mg of CEFTAGES 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.

Patients with liver or kidney problems
You may be given a different dose than the usual one. Your doctor will decide the amount of CEFTAGES you need and will monitor you closely, depending on the severity of your liver or kidney disease.
If you take more CEFTAGES than you should
If you are accidentally given more CEFTAGES than prescribed, contact your doctor or go to the nearest hospital immediately.
If you forget to take CEFTAGES
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 CEFTAGES
Do not stop taking CEFTAGES 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.

The following side effects may occur with this medicine:

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

Severe allergic reactions (frequency not known; frequency cannot be estimated from the available data)
If you experience 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 occurring during allergic reactions, which may be a symptom of an allergy-induced heart attack (Kounis syndrome).

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

• Severe rash that develops rapidly, with blistering or peeling of the skin and possible blistering in the mouth (Stevens-Johnson syndrome and toxic epidermal necrolysis, also known as SJS and TEN).
• Any combination of the following symptoms: widespread rash, high body temperature, increased liver enzymes, abnormalities in blood tests (eosinophilia), swollen lymph nodes, and involvement of other organs (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, usually resolving spontaneously. These symptoms typically occur shortly after starting CEFTAGES treatment for spirochete infections such as Lyme disease.

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

• Abnormalities in white blood cells (such as reduced leukocytes and increased eosinophils) and platelets (reduced thrombocytes).
• Soft stools or diarrhea.
• Changes in blood test results indicating liver function 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 (anemia).
• Blood clotting problems. Signs include easy bruising, joint pain, and swelling.
• Headache.
• Dizziness.
• Nausea or vomiting.
• Itching.
• Pain or burning sensation along the vein where CEFTAGES 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 diarrhea, often with blood and mucus, stomach pain, and fever.
• Breathing difficulties (bronchospasm).
• Skin rash with wheals (urticaria), possibly covering large areas of the body, associated with itching and swelling.
• Blood or sugar in the urine.
• Edema (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 anemia characterized by destruction of red blood cells (hemolytic anemia).
• Severe decrease in white blood cells (agranulocytosis).
• Seizures.
• Vertigo.
• Inflammation of the pancreas (pancreatitis). Signs include severe stomach pain radiating to the back.
• Inflammation of the mouth lining (stomatitis).
• Inflammation of the tongue (glossitis). Signs include swelling, redness, and irritation of the tongue.
• Gallbladder and/or liver problems that may cause pain, nausea, vomiting, yellowing of the skin, itching, unusually dark urine, and 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 blood test to detect blood-related problems).
• False positive test for galactosemia (an abnormal accumulation of the sugar galactose).
• CEFTAGES may interfere with certain types of blood glucose tests; please consult your doctor.

Following accidental intravascular injection of lidocaine during intramuscular administration of CEFTAGES 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 per minute).
• Interruption of normal blood circulation due to cardiac arrest and reduced blood flow.
• Loss of balance, tingling around the mouth, tongue numbness, 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 cessation of breathing.
• Unusual drowsiness or fatigue during the day or fainting.

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

5. How to store CEFTAGES

This medicinal product does not require any special storage conditions.
From a microbiological standpoint, the product should be used immediately after reconstitution. If not used
immediately, the conditions and duration of storage prior to use are the responsibility of the user. Chemical
and physical stability of the medicinal product after reconstitution has been demonstrated for 24 hours
between +2°C and +8°C and for 6 hours when stored below 25°C.
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 stored in its original, intact packaging and correctly stored.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.

6. Package contents and other information

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

Description of the appearance of CEFTAGES and contents of the pack
CEFTAGES 500 mg/2 ml powder and solvent for injectable solution for intramuscular use:
1 vial of powder + 1 solvent ampoule of 2 ml.
CEFTAGES 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
S.F. Group S.r.l. – Via Tiburtina, 1143 – 00156 Rome, Italy
Manufacturer
Laboratorio Farmaceutico CT S.r.l. - Via Dante Alighieri, 71 - 18038 Sanremo (IM), Italy

Patient information leaflet

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

ceftriaxone (as ceftriaxone sodium)
Equivalent 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. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

7. What CEFTAGES is and what it is used for
8. What you need to know before you are given CEFTAGES
9. How CEFTAGES is administered
10. Possible side effects
11. How to store CEFTAGES
12. Package contents and other information

1. What CEFTAGES is and what it is used for

CEFTAGES 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.

CEFTAGES is used to treat infections:

• of the brain (meningitis);
• of the lungs;
• of the middle ear;
• of the abdomen and abdominal wall (peritonitis);
• of the urinary tract and kidneys;
• of the 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 CEFTAGES

Do not be given CEFTAGES 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, carbapenems and monobactams). 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 CEFTAGES is to be administered by intramuscular injection.

CEFTAGES must not be given to children in the following cases:

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

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

• you have recently received or are about to receive products containing calcium;
• 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, such as haemolytic anaemia (a reduction in red blood cells which may cause pale yellow skin, weakness or breathlessness);
• you are on a low-sodium diet;
• you are experiencing or have previously experienced any combination of the following symptoms: skin rash, skin redness, blistering of the lips, eyes and mouth, skin peeling, high fever, flu-like symptoms, increased levels of liver enzymes detectable in blood tests, increase in a type of white blood cells (eosinophilia), and swollen lymph nodes (signs of serious skin reactions, see also section 4 “Possible side effects”).

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

If you are diabetic or need to monitor your 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 CEFTAGES to a child if:

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

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

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

Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breast-feeding, ask your doctor for advice before taking this medicine.
Your doctor will weigh the benefits of treatment with CEFTAGES for you against the possible risks to your baby.

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

CEFTAGES contains sodium
This medicine contains 82.7 mg of sodium (a main component of table salt) per vial.
This is equivalent to 4.1% of the maximum daily recommended dietary intake of sodium for an adult.

3. How CEFTAGES is administered

CEFTAGES is generally administered by a doctor or nurse through an intravenous infusion (intravenous drip) or via an injection directly into a vein.
CEFTAGES 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 appropriate dose of CEFTAGES for you. The dose will depend on the severity and type of infection, any concomitant treatment with other antibiotics, your body weight and age, and the degree of kidney and liver function. The number of days or weeks during which you will receive CEFTAGES will depend on the type of infection you have.
Adults, elderly patients, and children aged 12 years or older with a body weight equal to or greater than 50 kilograms (kg):

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

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

• 50–80 mg of CEFTAGES 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 will prescribe a higher dose, starting from 100 mg per kg of body weight, up to a maximum of 4 g per day. If your daily dose exceeds 2 g, it may be given as a single daily dose or divided into two separate doses.
• Children with a body weight equal to or greater than 50 kg should receive the usual adult dose.

Neonates (0–14 days of life):

• 20–50 mg of CEFTAGES 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 CEFTAGES you need and will closely monitor you, depending on the severity of your liver or kidney disease.
If you are given more CEFTAGES than you should
If you are accidentally given more CEFTAGES than prescribed, contact your doctor or go to the nearest hospital immediately.
If you miss a dose of CEFTAGES
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 CEFTAGES
Do not stop taking CEFTAGES unless your doctor tells you to. If you have any doubts about using this medicine, consult your doctor or nurse.

4. Possible side effects

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

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

• Severe rash that develops rapidly, with blistering or peeling of the skin and possible formation of 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 treatment with CEFTAGES for spirochete infections such as Lyme disease.

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

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

Uncommon (may affect up to 1 in 100 people)

• Fungal infections (e.g., thrush).
• Decreased number of white blood cells (granulocytopenia).
• Reduced number of red blood cells (anaemia).
• Blood clotting problems. Signs include easy bruising, joint pain, and swelling.
• Headache.
• Dizziness.
• Nausea or vomiting.
• Itching.
• Pain or burning sensation along the vein where CEFTAGES 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 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.

Frequency not known (cannot be estimated from available data)

• Secondary infections that may not respond to the prescribed antibiotic.
• A form of anaemia characterized 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 oral mucosa (stomatitis).
• Inflammation of the tongue (glossitis). Signs include swelling, redness, and irritation of the tongue.
• Gallbladder and/or liver problems that may cause pain, nausea, vomiting, yellowing of the skin, itching, unusually dark urine, and clay-coloured stools.
• A neurological condition that may develop in newborns with severe jaundice (kernicterus).
• Kidney problems caused by calcium-ceftriaxone deposits. You may experience pain when urinating, or a reduced amount of urine produced.
• False positive Coombs test result (a test to detect blood problems).
• False positive result for galactosaemia (an abnormal accumulation of the sugar galactose).
• CEFTAGES may interfere with certain types of blood glucose tests; please consult your doctor.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, 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.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store CEFTAGES

This medicinal product does not require any special storage conditions.
From a microbiological standpoint, the product should be used immediately after reconstitution. If not used
immediately, the conditions and duration of storage prior to use are the responsibility of the user. Chemical and
physical stability of the medicinal product after reconstitution has been demonstrated for 24 hours between +2°C
and +8°C and for 6 hours when stored at temperatures below 25°C.
Keep this medicinal product out of the sight and reach of children.
Do not use this medicinal product after the expiry date which is stated on the packaging after “Exp.”. The expiry
date refers to the last day of that month.
The expiry date indicated refers to the product in its original, unopened packaging, correctly stored.
Do not dispose of any medicinal product via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What CEFTAGES contains
CEFTAGES 1 g/10 ml powder and solvent for injectable solution for intravenous use
one vial of powder contains:
the active substance is 1.193 g of ceftriaxone disodium 3.5 H₂O, equivalent to 1 g of ceftriaxone;
one solvent vial contains: water for injection.
Description of the appearance of CEFTAGES and package contents
CEFTAGES 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
S.F. Group S.r.l. – Via Tiburtina, 1143 – 00156 Rome
Manufacturer
Laboratorio Farmaceutico CT S.r.l. - Via Dante Alighieri, 71 - 18038 Sanremo (IM)

Patient Information Leaflet

CEFTAGES 2 g powder for solution for infusion

ceftriaxone (as ceftriaxone sodium)
Equivalent medicinal product
Please read this leaflet carefully before you are given this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

13. What CEFTAGES is and what it is used for
14. What you need to know before you are given CEFTAGES
15. How CEFTAGES is administered
16. Possible side effects
17. How to store CEFTAGES
18. Contents of the pack and other information

1. What CEFTAGES is and what it is used for

CEFTAGES 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.
CEFTAGES is used to treat infections of:

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

It may also be administered:

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

2. What you need to know before being given CEFTAGES

Do not be given CEFTAGES 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, carbapenems, and monobactams). 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 CEFTAGES is to be administered by intramuscular injection.

CEFTAGES must not be given to children in the following cases:

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before being given CEFTAGES if:

• you have recently received or are about to receive products containing calcium;
• 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, weakness, or shortness of breath);
• you are on a low-sodium diet;
• you are experiencing or have previously experienced any combination of the following symptoms: skin rash, skin redness, blistering of lips, eyes and mouth, skin peeling, high fever, flu-like symptoms, increased levels of liver enzymes detectable in blood tests, increase in a type of white blood cell (eosinophilia), and swollen lymph nodes (signs of serious skin reactions; see also section 4 “Possible side effects”).

If you are undergoing blood or urine tests
If you are given CEFTAGES for a prolonged period, you may need regular blood tests. CEFTAGES may affect the results of urine sugar tests and a blood test known as the Coombs test. If you are about to undergo testing:

• inform the person collecting your sample that you have been given CEFTAGES.

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 administering CEFTAGES to a child if:

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

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

• an antibiotic called an aminoglycoside;
• an antibiotic called chloramphenicol (used in the treatment of infections, particularly eye infections).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine.
Your doctor will assess the benefits that treatment with CEFTAGES would provide you against the possible risks to the baby.

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

CEFTAGES contains sodium
This medicine contains 165.7 mg of sodium (a main component of table salt) per vial.
This is equivalent to 8.2% of the maximum daily dietary intake recommended for an adult.

3. How CEFTAGES is administered

CEFTAGES is generally administered by a doctor or nurse through an intravenous infusion (IV infusion) or via an injection directly into a vein.
CEFTAGES will be prepared by a doctor, pharmacist, or nurse and will not be mixed with, nor administered simultaneously with, calcium-containing injections.

Usual dose
Your doctor will determine the appropriate dose of CEFTAGES for you. The dose will depend on the severity and type of infection, any concomitant treatment with other antibiotics, your body weight and age, and the extent of your kidney and liver function. The number of days or weeks during which you will receive CEFTAGES will depend on the type of infection you have.

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

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

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

• 50–80 mg of CEFTAGES 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 divided into two separate doses.
• Children with a body weight equal to or greater than 50 kg should receive the adult usual dose.

Newborns (0–14 days of life):

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

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

If you miss a dose of CEFTAGES
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 CEFTAGES
Do not stop taking CEFTAGES unless instructed by your doctor. If you have any doubts about using this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
With this medicine, you may experience the following side effects:
Treatment with ceftriaxone, especially in elderly patients with severe renal insufficiency or neurological disorders, may rarely cause reduced level of consciousness, abnormal movements, agitation, and seizures.

Severe allergic reactions (not known, frequency cannot be determined from 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, which may make breathing or swallowing difficult;
• Sudden swelling of the hands, feet, and ankles;
• Chest pain during allergic reactions, which may be a symptom of an allergy-induced heart attack (Kounis syndrome).

Severe skin reactions (not known, frequency cannot be determined from 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, usually resolving spontaneously. These symptoms may occur shortly after starting CEFTAGES 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 (decreased thrombocytes).
• Soft stools or diarrhoea.
• Changes in blood test results related to liver function.
• Rash.

Uncommon (may affect up to 1 in 100 people)

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

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

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

Not known (frequency cannot be determined from available data)

• Secondary infections that may not respond to the prescribed antibiotic.
• A form of anaemia characterised by destruction of red blood cells (haemolytic anaemia).
• Severe decrease in white blood cell count (agranulocytosis).
• Seizures.
• Dizziness.
• Inflammation of the pancreas (pancreatitis). Signs include severe stomach pain spreading to the back.
• Inflammation of the mouth lining (stomatitis).
• Inflammation of the tongue (glossitis). Signs include swelling, redness, and irritation of the tongue.
• Gallbladder and/or liver problems that may cause pain, nausea, vomiting, yellowing of the skin, itching, unusually dark urine, and clay-coloured stools.
• A neurological condition that may develop in newborns with severe jaundice (kernicterus).
• Kidney problems caused by calcium-ceftriaxone deposits. You may experience pain when urinating, or a reduced amount of urine produced.
• False positive Coombs test (a blood test to detect blood-related problems).
• False positive test for galactosemia (an abnormal accumulation of the sugar galactose).
• CEFTAGES may interfere with certain types of blood glucose tests; please consult your doctor.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, 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.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store CEFTAGES

This medicinal product does not require any special storage conditions.
From a microbiological point of view, the product should be used immediately after reconstitution. If not used
immediately, the conditions and duration of storage prior to use are the responsibility of the user. Chemical and
physical stability of the medicinal product after reconstitution has been demonstrated for 24 hours between +2°C
and +8°C, and for 6 hours when stored at temperatures below 25°C.
Keep this medicinal product out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the packaging after “Exp.”. The expiry date refers
to the last day of that month.
The expiry date indicated refers to the product in its original, unopened packaging, correctly stored.
Do not dispose of any medicinal product via wastewater or household waste. Ask your pharmacist how to dispose
of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What CEFTAGES contains
CEFTAGES 2 g powder for solution for infusion
One vial contains:
The active substance is 2.386 g of ceftriaxone disodium 3.5 H₂O, equivalent to 2 g of ceftriaxone.
Description of the appearance of CEFTAGES and contents of the pack
CEFTAGES 2 g powder for solution for infusion: 1 vial of powder.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
S.F. Group S.r.l. – Via Tiburtina, 1143 – 00156 Rome, Italy
Manufacturer
Laboratorio Farmaceutico CT S.r.l. - Via Dante Alighieri, 71 - 18038 Sanremo (IM), Italy