CEFTAGES 500 mg /2 Ml Proszek I Rozpuszczalnik Do Roztworu Do Wstrzykiwań

Treść ulotki

1. CEFTAGES 1 g/10 ml powder and solvent for injectable solution for intravenous use
   1. What is CEFTAGES 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
2. CEFTAGES 2 g powder for solution for infusion
   1. What is CEFTAGES and what is it 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
3. CEFTAGES 500 mg / 2 ml powder and solvent for injectable solution for intramuscular use
   1. What is CEFTAGES and what is it 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

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

ceftriaxone (as ceftriaxone sodium)
Equivalent medicinal product

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 could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 given
• 4. Possible side effects
• 5. How to store CEFTAGES
• 6. Contents of the pack and other information

1. What is CEFTAGES 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 can be administered:

• to treat specific sexually transmitted infections (gonorrhea and syphilis);
• to treat patients with a low number of white blood cells in the blood (neutropenia) who have a 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 life;
• to prevent infections during a surgical procedure.

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

Do not be given CEFTAGES if:

• you are allergic to ceftriaxone or any of the other ingredients of this medicine (listed in section 6);
• you have had a sudden or severe allergic reaction to penicillin or similar antibiotics (such as cephalosporins, carbapenems and monobactams). Possible signs include a sudden swelling of the throat or face, which can make it difficult to breathe or swallow, a 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 given to you by injection into a muscle.

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 life) and has certain blood problems or jaundice (yellowing of the skin or the white of the eye) 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 problems with diarrhoea after taking an antibiotic. You have had problems with your intestines, in particular colitis (inflammation of the intestine);
• you have problems with your liver or kidneys (see section 4);
• you have gallstones or kidney stones;
• you have other illnesses, for example hemolytic anemia (a reduction in red blood cells that can make the skin pale yellow and cause weakness or shortness of breath);
• you are on a low-sodium diet;
• you develop or have developed in the past 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 and an increase in a type of white blood cells (eosinophilia) and swollen lymph nodes (signs of severe skin reactions, see also section 4 “Possible side effects”).

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

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

If you are diabetic or need monitoring of blood glucose levels, you should not use certain blood glucose monitoring systems that may detect blood glucose incorrectly during
treatment with ceftriaxone. If you use such systems, check the instructions for use and inform your doctor,
pharmacist or nurse. If necessary, alternative analytical methods should be used.

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 may
take any other medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• a type of antibiotic called an aminoglycoside;
• an antibiotic called chloramphenicol (used to treat infections, especially eye infections).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor for advice before taking this medicine.
The doctor will assess the benefits of treatment with CEFTAGES for you and the possible risks to the
child.

Driving and operating machinery
CEFTAGES can cause dizziness. If you feel dizzy, do not drive and do not use tools or machinery.
Contact your doctor if you experience these symptoms.

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

3. How CEFTAGES is administered

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

Usual dose
The doctor will determine the correct dose of CEFTAGES for you. The dose will depend on the severity and type of
infection, any concomitant treatment with other antibiotics, your weight and age, the degree
of functioning 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, the elderly and children aged 12 years or over 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, the doctor will administer a higher dose (up to 4 g per day). If your daily dose is greater than 2 g, you may take it as a single dose once daily or as two separate doses.

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

• 50-80 mg CEFTAGES once daily for each kg of the child's body weight depending on the severity and type of infection. If you have 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 your daily dose is greater than 2 g, you may take it as a single dose once daily or as two separate doses.
• Children with a body weight of 50 kg or more should be given the usual adult dose.

Newborns (0-14 days of life)

• 20-50 mg CEFTAGES once daily for each kg of the newborn's body weight depending on the severity and type of infection.
• The maximum daily dose should not exceed 50 mg per kg of the newborn's body weight.

People with liver and kidney problems
You may be given a different dose than usual. The doctor will decide the amount of
CEFTAGES you need and will monitor you closely, depending on the severity of the liver and kidney disease.

If you take more CEFTAGES than you should
If you are accidentally given more CEFTAGES than the prescribed dose, seek immediate
medical attention or go to the nearest hospital.

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

If you stop taking CEFTAGES
Do not stop taking CEFTAGES unless your doctor tells you to. If you have any doubts
about the use of this medicine, ask 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:
Treatment with ceftriaxone, especially in elderly patients with severe renal impairment or nervous system pathologies, may rarely cause a reduction in the state of consciousness, abnormal movements, agitation and convulsions.

Serious allergic reactions (frequency not known, cannot be estimated based on available data)
If you have a serious allergic reaction, seek medical attention immediately.
Signs may include:

• sudden swelling of the face, throat, lips or mouth. This can make it difficult to breathe or swallow;
• 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).

Serious skin reactions (frequency not known, cannot be estimated based on available data)
If you develop a serious 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 by the acronyms 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 of the body (drug reaction with eosinophilia and systemic symptoms, also known by the acronym DRESS or drug hypersensitivity syndrome).
• Jarisch-Herxheimer reaction, which can cause fever, chills, headache, muscle pain and rash, which generally tends to resolve spontaneously. These symptoms occur shortly after starting treatment with CEFTAGES to treat infections from spirochetes such as Lyme disease.

Other possible side effects:

Common (may affect up to 1 in 10 people)

• White blood cell abnormalities (such as decreased leukocytes and increased eosinophils) and platelets (decreased thrombocytes).
• Soft stools or diarrhea.
• Changes in blood tests for liver function.
• Rash.

Uncommon (may affect up to 1 in 100 people)

• Fungal infections (for example, thrush).
• Decrease in the number of white blood cells (granulocytopenia).
• Decrease in the 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 values in kidney function tests (increased creatinine in the blood).

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

• Inflammation of the large intestine (colon). Signs include diarrhea, often with blood and mucus, stomach pain and fever.
• Difficulty breathing (bronchospasm).
• Rash with wheals (urticaria) that can cover a large area of the body, associated with itching and swelling.
• Blood or sugar in the urine.
• Edema (fluid retention).
• Chills.

Frequency not known (cannot be estimated based on available data)

• Secondary infections that may not respond to the prescribed antibiotic.
• A form of anemia characterized by the destruction of red blood cells (hemolytic anemia).
• Severe decrease in the number of white blood cells (agranulocytosis).
• Convulsions.
• Vertigo.
• Inflammation of the pancreas (pancreatitis). Signs include severe stomach pain that spreads to the back.
• Inflammation of the oral mucosa (stomatitis).
• Inflammation of the tongue (glossitis). Signs include swelling, redness and irritation of the tongue.
• Problems with the gallbladder and/or liver that can cause pain, nausea and vomiting, yellowing of the skin, itching, unusually dark urine and clay-colored stools.
• A neurological condition that can develop in newborns with severe jaundice (Kernicterus).
• Kidney problems caused by calcium-ceftriaxone deposits. Pain may occur when urinating, or the amount of urine produced may be reduced.
• A false positive Coombs test (a test to detect blood problems).
• A false positive for galactosemia (an abnormal accumulation of galactose sugar).
• CEFTAGES may interfere with some types of tests to measure blood glucose; check with your doctor.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through 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 CEFTAGES

This medicine does not require any particular storage conditions.
From a microbiological point of view, the product must be used immediately after reconstitution. If
not used immediately, the conditions and period of conservation before use are
the responsibility of the user. The chemical and physical stability of the medicine after reconstitution has been
demonstrated for 24 hours between +2°C and +8°C and for 6 hours for the product stored at a temperature below 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported 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 intact packaging, correctly stored.
Do not dispose of any medicine in the drain or with household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack 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 ingredient is 1.193 g of ceftriaxone bisodium 3.5 H O equivalent to 1 g of ceftriaxone;
one solvent vial contains: water for injection.

Description of the appearance of CEFTAGES and contents of the pack
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 Authorisation Holder and Manufacturer
Marketing Authorisation Holder
S.F. Group S.r.l. – Via Tiburtina, 1143 – 00156 Roma

Manufacturer
Laboratorio Farmaceutico CT S.r.l. - Via Dante Alighieri, 71 - 18038 Sanremo (IM)

CEFTAGES 2 g powder for solution for infusion

ceftriaxone (as ceftriaxone sodium)
Equivalent medicinal product

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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 given
• 10. Possible side effects
• 11. How to store CEFTAGES
• 12. Contents of the pack and other information

1. What is CEFTAGES and what is it used for

CEFTAGES contains the active ingredient 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 can be administered:

• to treat specific sexually transmitted infections (gonorrhea and syphilis);
• to treat patients with a low number of white blood cells in the blood (neutropenia) who have a 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 life;
• to prevent infections during a surgical procedure.

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

Do not receive CEFTAGES if:

• you are allergic to ceftriaxone or any of the other ingredients of this medicine (listed in section 6);
• you have had a sudden or severe allergic reaction to penicillin or similar antibiotics (such as cephalosporins, carbapenems and monobactams). Possible signs include a sudden swelling of the throat or face, which can make it difficult to breathe or swallow, a 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 given to you by injection into a muscle.

CEFTAGES should 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 problems or jaundice (yellowing of the skin or the white of the eye) 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 problems with diarrhea after taking an antibiotic. You have had problems with your intestines, in particular colitis (inflammation of the intestine);
• you have problems with your liver or kidneys (see section 4);
• you have gallstones or kidney stones;
• you have other illnesses, for example hemolytic anemia (a reduction in red blood cells that can make the skin pale yellow and cause weakness or shortness of breath);
• you are on a low-sodium diet
• you develop or have developed in the past any combination of the following symptoms: rash, skin redness, blisters on lips, eyes and mouth, skin peeling, high fever, flu-like symptoms, increased levels of liver enzymes detectable in blood tests and an increase in a type of white blood cells (eosinophilia) and swollen lymph nodes (signs of severe skin reactions, see also section 4 “Possible side effects”).

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

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

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

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, tell your doctor or pharmacist if you are taking any of the following medicines:

• a type of antibiotic called an aminoglycoside;
• an antibiotic called chloramphenicol (used to treat infections, especially eye infections).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor for advice before taking this medicine.
The doctor will assess the benefits that treatment with CEFTAGES would bring you and the possible risks to the
child.

Driving and operating machinery
CEFTAGES can cause dizziness. If you feel dizzy, do not drive and do not use tools or machinery.
Contact your doctor if you experience these symptoms.

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

3. How CEFTAGES is administered

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

Usual dose
The doctor will determine the correct dose of CEFTAGES for you. The dose will depend on the severity and type of
infection, any concomitant treatment with other antibiotics, your weight and age, the degree
of functioning 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, the elderly and children aged 12 years or older with a body weight of 50
kilograms (kg) or more:

• 1 to 2 g once a day depending on the severity and type of infection. If you have a serious infection, the doctor will administer a higher dose (up to 4 g per day). If your daily dose is greater than 2 g, you may take it as a single dose once a day or as two separate doses.

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

• 50-80 mg CEFTAGES once a day for each kg of the child's body weight depending on the severity and type of infection. If you have a serious infection, the doctor will prescribe a higher dose starting from 100 mg for each kg of body weight up to a maximum of 4 g per day. If your daily dose is greater than 2 g, you may take it as a single dose once a day or as two separate doses.
• Children with a body weight of 50 kg or more should be given the usual adult dose.

Newborns (0-14 days of life)

• 20-50 mg CEFTAGES once a day for each kg of the newborn's body weight depending on the severity and type of infection.
• The maximum daily dose should not exceed 50 mg for each kg of the newborn's body weight.

People with liver and kidney problems
You may be given a different dose than usual. The doctor will decide the amount of
CEFTAGES you need and will monitor you carefully, depending on the severity of the liver and kidney disease.

If you take more CEFTAGES than you should
If you are accidentally given more CEFTAGES than the prescribed dose, seek immediate
medical attention or go to the nearest hospital.

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

If you stop taking CEFTAGES
Do not stop taking CEFTAGES unless your doctor tells you to. If you have any doubts
about the use of this medicine, ask 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:
Treatment with ceftriaxone, especially in elderly patients with severe kidney failure or nervous system disorders, may rarely cause a decrease in consciousness, abnormal movements, agitation and convulsions.

Serious 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 can make it difficult to breathe or swallow;
• 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).

Serious skin reactions (frequency not known, cannot be estimated from available data)
If you develop a severe skin reaction, tell your 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 by the acronyms SJS and TEN).
• Any combination of the following symptoms: widespread rash, high fever, increased liver enzymes, abnormalities in blood tests (eosinophilia), swollen lymph nodes and involvement of other organs of the body (drug reaction with eosinophilia and systemic symptoms, also known by the acronym DRESS or drug hypersensitivity syndrome).
• Jarisch-Herxheimer reaction, which can cause fever, chills, headache, muscle pain and rash, which generally tends to resolve spontaneously. These symptoms occur shortly after starting treatment with CEFTAGES to treat infections caused by spirochetes such as Lyme disease.

Other possible side effects:

Common (may affect up to 1 in 10 people)

• White blood cell abnormalities (such as decreased leukocytes and increased eosinophils) and platelets (decreased thrombocytes).
• Soft stools or diarrhea.
• Changes in blood tests 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).
• Decrease in the 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 values in kidney function tests (increased creatinine in the blood).

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

• Inflammation of the large intestine (colon). Signs include diarrhea, often with blood and mucus, stomach pain and fever.
• Difficulty breathing (bronchospasm).
• Rash with hives (urticaria) that can cover a large area of the body, associated with itching and swelling.
• Blood or sugar in the urine.
• Edema (fluid retention).
• Chills

Frequency not known (cannot be estimated from available data)

• Secondary infections that may not respond to the prescribed antibiotic.
• A form of anemia characterized by the destruction of red blood cells (hemolytic anemia).
• Severe decrease in the number of white blood cells (agranulocytosis).
• Convulsions.
• Vertigo.
• Inflammation of the pancreas (pancreatitis). Signs include severe stomach pain that extends to the back.
• Inflammation of the oral mucosa (stomatitis).
• Inflammation of the tongue (glossitis). Signs include swelling, redness and irritation of the tongue.
• Problems with the gallbladder and/or liver that can cause pain, nausea, vomiting, yellowing of the skin, itching, unusually dark urine and clay-colored stools.
• A neurological condition that can develop in newborns with severe jaundice (Kernicterus).
• Kidney problems caused by calcium-ceftriaxone deposits. Pain when urinating may occur, or the amount of urine produced may be reduced.
• A false positive Coombs test (a test to detect blood problems).
• A false positive test for galactosemia (an abnormal accumulation of galactose sugar).
• CEFTAGES may interfere with some types of tests to measure blood glucose; check with your doctor.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly through
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 CEFTAGES

This medicine does not require any particular storage conditions.
From a microbiological point of view, the product must be used immediately after reconstitution. If
not used immediately, the conditions and period of conservation before use are
the responsibility of the user. The chemical and physical stability of the medicine after reconstitution has been
demonstrated for 24 hours between +2°C and +8°C and for 6 hours for the product stored at a temperature below 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported 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 intact packaging, correctly stored.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What CEFTAGES contains

CEFTAGES 2 g powder for solution for infusion
one vial contains:
the active ingredient is 2.386 g of ceftriaxone bisodium 3.5 H O 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 Authorisation Holder and Manufacturer
Marketing Authorisation 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)

CEFTAGES 500 mg / 2 ml powder and solvent for injectable solution for intramuscular use

CEFTAGES 1 g / 3.5 ml powder and solvent for injectable solution for intramuscular use
ceftriaxone (as ceftriaxone sodium)
lidocaine (as lidocaine hydrochloride)
Generic medicine

Read this leaflet carefully before this medicine is administered to you 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell 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 CEFTAGES is administered to you
• 15. How CEFTAGES is administered
• 16. Possible side effects
• 17. How to store CEFTAGES
• 18. Contents of the pack and other information

1. What is CEFTAGES and what is it 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
administered by injection into a muscle in a solution containing lidocaine, which reduces the pain
associated with the injection.
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 can be administered:

• to treat specific sexually transmitted infections (gonorrhea and syphilis);
• to treat patients with a low number of white blood cells in the blood (neutropenia) who have a 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 life;
• to prevent infections during surgery.

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

You must not be given CEFTAGES if:

• you are allergic to ceftriaxone or any of the other ingredients of this medicine (listed in section 6);
• you have had a sudden or severe allergic reaction to penicillin or similar antibiotics (such as cephalosporins, carbapenems and monobactams). Possible signs include a sudden swelling of the throat or face, which can make it difficult to breathe or swallow, a sudden swelling of hands, feet and ankles, chest pain and a severe skin rash that develops rapidly;
• you are allergic to lidocaine and CEFTAGES is to be given to you by injection into a muscle;
• you suffer from an abnormality in the propagation of the heart impulse that causes a reduction in blood pressure and a slowing of the heart rate (complete atrioventricular block);
• you suffer from a state of reduced blood volume (hypovolemia).

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 life) and has some blood problems or jaundice (yellowing of the skin or the white of the eye) or must receive through a vein a product containing calcium.

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 problems with diarrhoea after taking an antibiotic. You have had problems with your intestines, in particular colitis (inflammation of the intestine);
• you have problems with your liver or kidneys (see section 4);
• you have gallstones or kidney stones;
• you have other diseases, for example hemolytic anemia (a reduction in red blood cells that can make the skin pale yellow and cause weakness or shortness of breath);
• you are following a low-sodium diet
• you suffer from loss of muscle function and weakness (myasthenia gravis).
• you suffer from seizures (epilepsy)
• you suffer from any heart problem, especially if this affects the heart rate.
• you have breathing problems
• you suffer from porphyria (a rare hereditary disease that affects the skin and nervous system)
• you experience or have experienced in the past any combination of the following symptoms: skin rash, skin redness, blistering on lips, eyes and mouth, skin peeling, high fever, flu-like symptoms, increased levels of liver enzymes detectable in blood tests and an increase in a type of white blood cells (eosinophilia) and swollen lymph nodes (signs of severe skin reactions, see also section 4 “Possible side effects”)

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

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

If you are diabetic or need monitoring of blood glucose levels, you should not use some
blood glucose monitoring systems that may detect blood glucose incorrectly during treatment with ceftriaxone. If you use such systems, check the
instructions for use and inform your doctor, pharmacist or nurse. If necessary, alternative analysis methods must be used.

Children
Talk to your doctor, pharmacist or nurse before giving CEFTAGES to the 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 may
take any other medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines, as
they may interact with ceftriaxone:

• a type of antibiotic called an aminoglycoside;
• an antibiotic called chloramphenicol (used to treat infections, especially eye infections).

Several drugs can interact with lidocaine, resulting in altered effects. These drugs
include:

• medicines used to treat infections (clarithromycin, erythromycin).
• medicines used in the treatment of stomach ulcers (e.g. cimetidine).
• potent painkillers such as codeine and pethidine (narcotic or opioid drugs).
• medicines used to treat irregular heartbeat (e.g. mexiletine, tocainide).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor for advice before taking this medicine.
The doctor will assess the benefits of treatment with CEFTAGES and the possible risks to the
child.

Driving and operating machinery
CEFTAGES can cause dizziness. If you feel dizzy, do not drive and do not use tools or machinery.
Contact your doctor if you experience these symptoms.

CEFTAGES contains sodium

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

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

3. How CEFTAGES is administered

CEFTAGES is generally administered by a doctor or nurse via an injection
performed directly into a muscle. CEFTAGES will be prepared by a doctor, pharmacist or
nurse and will not be mixed, nor will it be administered simultaneously with injections containing calcium.

Usual dose
The doctor will determine the correct dose of CEFTAGES for you. The dose will depend on the severity and type of
infection, any concomitant treatment with other antibiotics, your weight and age, the degree
of 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, the elderly and children aged 12 years or older with a body weight of 50
kilograms (kg) or more:

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

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

• 50-80 mg CEFTAGES once a day for each kg of the child's body weight depending on the severity and type of infection. If you have a severe infection, the doctor will prescribe a higher dose starting from 100 mg per each kg of body weight up to a maximum of 4 g per day. If your daily dose is more than 2 g, you may take it as a single dose once a day or as two separate doses.
• Children with a body weight of 50 kg or more should be given the usual adult dose.

Newborns (0-14 days of life)

• 20-50 mg CEFTAGES once a day for each kg of the newborn's body weight depending on the severity and type of infection.
• The maximum daily dose should not exceed 50 mg for each kg of the newborn's body weight.

People with liver and kidney problems
You may be given a different dose than usual. The doctor will decide the amount of
CEFTAGES you need and will monitor you closely, depending on the severity of the liver and kidney disease.

If you take more CEFTAGES than you should
If you are accidentally given more CEFTAGES than the prescribed dose, seek immediate
medical attention or go to the nearest hospital.

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

If you stop taking CEFTAGES
Do not stop taking CEFTAGES unless your doctor tells you to. If you have any doubts
about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
With this medicine you may experience the following side effects:
Treatment with ceftriaxone, especially in elderly patients with severe kidney failure or nervous system disorders, may rarely cause a decrease in consciousness, abnormal movements, agitation and convulsions.

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

• sudden swelling of the face, throat, lips or mouth. This can make it difficult to breathe or swallow;
• 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).

Serious skin reactions (frequency not known, cannot be estimated from available data)
If you develop a serious skin reaction, tell your 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 by the acronyms SJS and TEN).
• Any combination of the following symptoms: widespread rash, high body temperature, increased liver enzymes, abnormalities in blood tests (eosinophilia), swollen lymph nodes and involvement of other organs in the body (drug reaction with eosinophilia and systemic symptoms, also known by the acronym DRESS or drug hypersensitivity syndrome).
• Jarisch-Herxheimer reaction, which can cause fever, chills, headache, muscle pain and rash, which generally tends to resolve spontaneously. These symptoms occur shortly after starting treatment with CEFTAGES to treat infections caused by spirochetes such as Lyme disease.

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

• White blood cell abnormalities (such as decreased leukocytes and increased eosinophils) and platelets (decreased thrombocytes).
• Soft stools or diarrhea.
• Changes in blood test results for liver function.
• Rash.

Uncommon (may affect up to 1 in 100 people)

• Fungal infections (for example, thrush).
• Decreased number of white blood cells (granulocytopenia).
• Decreased 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 values in kidney function tests (increased creatinine in the blood).

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

• Inflammation of the large intestine (colon). Signs include diarrhea, often with blood and mucus, stomach pain and fever.
• Difficulty breathing (bronchospasm).
• Rash with wheals (urticaria) that can cover a large area of the body, associated with itching and swelling.
• Blood or sugar in the urine.
• Edema (fluid retention).
• Chills.

Frequency not known (cannot be estimated from available data)

• Secondary infections that may not respond to the prescribed antibiotic.
• A form of anemia characterized by the destruction of red blood cells (hemolytic anemia).
• Severe decrease in the number of white blood cells (agranulocytosis).
• Convulsions.
• Vertigo.
• Inflammation of the pancreas (pancreatitis). Signs include severe stomach pain that radiates to the back.
• Inflammation of the oral mucosa (stomatitis).
• Inflammation of the tongue (glossitis). Signs include swelling, redness and irritation of the tongue.
• Problems with the gallbladder and/or liver that can cause pain, nausea and vomiting, yellowing of the skin, itching, unusually dark urine and clay-colored stools.
• A neurological condition that can develop in newborns with severe jaundice (kernicterus).
• Kidney problems caused by calcium-ceftriaxone deposits. Pain may occur when urinating, or the amount of urine produced may be reduced.
• A false positive result to the Coombs test (a test to detect blood problems).
• A false positive result for galactosemia (an abnormal accumulation of galactose sugar).
• CEFTAGES may interfere with some types of tests to measure blood glucose; check with your doctor.

After accidental injection of lidocaine into a blood vessel during intramuscular administration of CEFTAGES i.m., other side effects may occur, which may include:

Frequency not known (cannot be estimated from available data)

• Alterations in the rhythm and rate of the heart.
• Low blood pressure.
• Slowing of the heart rate (less than 60 beats/minute).
• Interruption of normal blood circulation due to cardiac arrest and decreased 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, convulsions or seizures, deep state of unconsciousness (coma).
• Blurred vision, double vision or temporary loss of vision.
• Feeling unwell (nausea or vomiting).
• Difficulty breathing.
• Decreased respiratory rate or possible respiratory arrest.
• An unusual feeling of sleepiness or fatigue during the day or fainting.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through 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 CEFTAGES

This medicine does not require any particular storage conditions
From a microbiological point of view, the product must be used immediately after reconstitution. If
not used immediately, the conditions and period of storage before use are
the responsibility of the user. The chemical and physical stability of the medicine after reconstitution has been
demonstrated for 24 hours between +2°C and +8°C and for 6 hours for the product stored at a temperature below 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine 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 intact packaging, correctly stored.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack 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 ingredient is 596.5 mg of ceftriaxone disodium 3.5 H O equivalent to 500 mg of ceftriaxone;
one solvent vial contains: aqueous solution of lidocaine 1%.

CEFTAGES 1 g / 3.5 ml powder and solvent for injectable solution for intramuscular use
One vial of powder contains:
active ingredient is 1.193 g of ceftriaxone disodium 3.5 H O equivalent to 1g of ceftriaxone;
one solvent vial contains: aqueous solution of lidocaine 1%.

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 powder + 1 solvent vial of 2 ml.
CEFTAGES 1 g / 3.5 ml powder and solvent for injectable solution for intramuscular use:
1 vial of powder + 1 solvent vial of 3.5 ml.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
S.F. Group S.r.l. – Via Tiburtina, 1143 – 00156 Roma

Manufacturer
Laboratorio Farmaceutico CT S.r.l. - Via Dante Alighieri, 71 - 18038 Sanremo (IM)