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

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1. CEFRAG 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
   1. What CEFRAG is and what it is used for
   2. What you need to know before you are given CEFRAG
   3. How CEFRAG is administered
   4. Possible side effects
   5. How to store CEFRAG
   6. Contents of the pack and other information
2. CEFRAG 1 g / 10 ml powder and solvent for injectable solution for intravenous use
   1. What CEFRAG is and what it is used for
   2. What you need to know before you are given CEFRAG
   3. How CEFRAG is administered
   4. Possible side effects
   5. How to store CEFRAG
   6. Package Contents and Other Information
3. CEFRAG 2 g powder for solution for infusion
   1. What is CEFRAG and what is it used for
   2. What you need to know before you are given CEFRAG
   3. How CEFRAG is administered
   4. Possible side effects
   5. How to store CEFRAG
   6. Package Contents and Other Information

CEFRAG 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)

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 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:

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

1. What CEFRAG is and what it is used for

CEFRAG 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.
CEFRAG 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 CEFRAG

You must not be givenCEFRAGif:

• 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, penicillins, monobactams and carbapenems). 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 CEFRAG is to be given to you by injection into a muscle.

CEFRAGmust not be given to children in the following cases:

• the child is premature.
• the child is a newborn (up to 28 days old) and has some 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 CEFRAG if:

• you experience or have experienced 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”).
• 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 suffer from liver or kidney problems.
• 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 have liver or kidney problems (see section 4).

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

Children
Talk to your doctor, pharmacist or nurse before giving CEFRAG to the child if:

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

Other medicines andCEFRAG
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 may be 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 CEFRAG for you and the possible risks to the
child.

Driving and operating machinery
CEFRAG 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.

CEFRAG contains sodium
Each gram of CEFRAG contains 3.6 mmol (82.8 mg) of sodium. This should be taken into consideration in people
with reduced kidney function or who are on a low-sodium diet.

3. How CEFRAG is administered

CEFRAG is generally administered by a doctor or nurse via an injection given
directly into a muscle. CEFRAG 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 right dose of CEFRAG 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
CEFRAG will depend on the type of infection you have.

Adults, 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 can 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 of CEFRAG 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 for each kg of body weight up to a maximum of 4 g per day. If your daily dose is more than 2 g, you can 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 of CEFRAG 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 how much
CEFRAG you need and will monitor you carefully, depending on the severity of the liver and kidney disease.

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

If you forget to takeCEFRAG
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 takingCEFRAG
Do not stop taking CEFRAG 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

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

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

• Chest pain in the context of allergic reactions, which may be a symptom of a heart attack triggered by an allergy (Kounis syndrome).
• 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.

Serious skin reactions (frequency not known, the frequency cannot be estimated based on the available data)
If you develop a serious skin reaction, seek immediate medical attention.
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 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 Cefrag 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).
• 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 CEFRAG was administered. Pain where the injection was given.
• 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 (the frequency cannot be estimated based on the 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 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).
• CEFRAG 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, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at: 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 CEFRAG

Expiry date: see the expiry date indicated on the packaging
Warning: do not use the medicine after the expiry date indicated on the packaging.
The indicated expiry date refers to the product in intact packaging, correctly stored.
This medicine does not require any particular storage conditions
From a microbiological point of view, the product should 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.
They may vary in colour from pale yellow to amber depending on the concentration and period
of storage; this characteristic does not affect the efficacy or tolerability of the drug.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What CEFRAG contains
CEFRAG 500 mg / 2 ml powder and solvent for injectable solution for intramuscular use
One vial of powder contains:
active ingredient: ceftriaxone disodium 3.5 H O 596.5 mg equivalent to ceftriaxone 500 mg;
one solvent vial contains: 1% lidocaine aqueous solution.

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

Description of the appearance of CEFRAG and contents of the pack
CEFRAG 500 mg/ 2 ml powder and solvent for injectable solution for intramuscular use: 1 vial of
powder + 1 solvent vial of 2 ml.
CEFRAG 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
Aesculapius Farmaceutici S.r.l. – Via Cefalonia, 70 – 25124 Brescia

Manufacturer
MITIM S.r.l. - Via Cacciamali, 34-36-38 - 25125 Brescia.

CEFRAG 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 as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Never give it to other people, 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:

• 7. What CEFRAG is and what it is used for
• 8. What you need to know before CEFRAG is given to you
• 9. How CEFRAG is given to you
• 10. Possible side effects
• 11. How to store CEFRAG
• 12. Contents of the pack and other information

7. What CEFRAG is and what it is used for

CEFRAG 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.
CEFRAG 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.

8. What you need to know before you are given CEFRAG

You must not be givenCEFRAGif:

• 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 similar antibiotics (such as cephalosporins, penicillins, monobactams and carbapenems). Possible signs include a sudden swelling of the throat or face, which can make it difficult to breathe or swallow, a swelling

suddenly of hands, feet and ankles, chest pain and a severe skin rash that develops
rapidly.

• you are allergic to lidocaine and CEFRAG is to be given to you by injection into a muscle.

CEFRAGmust 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 CEFRAG if:

• you have or have had in the past any combination of the following symptoms: skin rash, skin redness, blisters on lips, eyes and mouth, peeling of the skin, high fever, flu-like symptoms, increased levels of liver enzymes detectable in blood tests and increased of a type of white blood cells (eosinophilia) and enlarged lymph nodes (signs of severe skin reactions, see also section 4 “Possible side effects”).
• you have recently received or are about to receive products containing calcium.
• you have recently had problems with diarrhoea after taking an antibiotic. You have had problems with your intestines, in particular colitis (inflammation of the intestine).
• you suffer from liver or kidney problems.
• you have gallstones or kidney stones.
• you have other diseases, for example hemolytic anemia (a reduction of 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 have liver or kidney problems (see section 4).

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

Children
Talk to your doctor, pharmacist or nurse before giving CEFRAG to the child if:

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

Other medicines andCEFRAG
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 may be 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 that treatment with CEFRAG would bring you and the possible risks to the
child.

Driving and operating machinery
CEFRAG 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.

CEFRAG contains sodium
Each gram of CEFRAG contains 3.6 mmol (82.8 mg) of sodium. This should be taken into consideration in people
with reduced kidney function or who are on a low-sodium diet.

9. How CEFRAG is administered

CEFRAG is generally administered by a doctor or nurse via an intravenous infusion (IV) or through an injection directly into a vein. CEFRAG 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 CEFRAG 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 CEFRAG will depend on the type of infection you have.

Adults, elderly and children 12 years of age and 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, your 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 less than 50 kg

• 50-80 mg of CEFRAG 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, 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 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 of CEFRAG 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 CEFRAG you need and will monitor you closely, depending on the severity of the liver and kidney disease.

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

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

10. Possible side effects

Treatment with ceftriaxone, especially in elderly patients with severe renal impairment or nervous system pathologies, may in rare cases cause a reduction in the state of consciousness, abnormal movements, agitation and convulsions.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
With this medicine you may experience the following side effects:

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:

• Chest pain in the context of allergic reactions, which may be a symptom of a heart attack triggered by an allergy (Kounis syndrome).
• 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.

Serious skin reactions (frequency not known, cannot be estimated based on available data)
If you experience a serious skin reaction, seek medical attention 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), enlarged 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 Cefrag for 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 (for example, thrush).
• Decreased number of white blood cells (granulocytopenia).
• Decreased number of red blood cells (anemia).
• Blood clotting problems. Signs include easy bruising, pain and swelling of the joints.
• Headache.
• Dizziness.
• Nausea or vomiting.
• Itching.
• Pain or burning sensation along the vein where CEFRAG was administered. Pain where the injection was given.
• 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 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 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 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).
• CEFRAG 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: www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

11. How to store CEFRAG

Expiry date: see the expiry date indicated on the packaging
Warning: do not use the medicine after the expiry date indicated on the packaging.
The indicated expiry date refers to the product in intact packaging, correctly stored.
This medicine does not require any particular storage conditions
From a microbiological point of view, the product should 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.
They may vary in colour from pale yellow to amber depending on the concentration and period
of storage; this characteristic does not affect the efficacy or tolerability of the drug.
Medicines should not be disposed of via drains or household waste. Ask your pharmacist
how to dispose of medicines that you no longer use. This will help to protect the environment.

12. Package Contents and Other Information

What CEFRAG contains
CEFRAG 1 g / 10 ml powder and solvent for injectable solution for intravenous use
one vial of powder contains:
active ingredient: ceftriaxone disodium 3,5 H O 1.193 g equivalent to ceftriaxone 1g;
one solvent vial contains: water for injection.

Description of the appearance of CEFRAG and package contents
CEFRAG 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
Aesculapius Farmaceutici S.r.l. – Via Cefalonia, 70 – 25124 Brescia

Manufacturer
MITIM S.r.l. - Via Cacciamali, 34-36-38 - 25125 Brescia.

CEFRAG 2 g powder for solution for infusion

Ceftriaxone (as ceftriaxone sodium)

Equivalent medicinal product
Read this leaflet carefully before you are administered this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Never give it to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, ask your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

13. What is CEFRAG and what is it used for

CEFRAG 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.
CEFRAG 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.

14. What you need to know before you are given CEFRAG

You must not be givenCEFRAGif:

• 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, penicillins, monobactams and carbapenems). Possible signs include a sudden swelling of the throat or face, which can make it difficult to breathe or swallow, a swelling

suddenly of hands, feet and ankles, chest pain and a severe rash that develops
rapidly.

• you are allergic to lidocaine and CEFRAG is to be given by injection into a muscle.

CEFRAGmust 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 a product containing calcium through a vein.

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

• you have or have had 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”).
• 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 suffer from liver or kidney problems.
• 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 following a low-sodium diet.
• you have liver or kidney problems (see section 4).

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

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

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

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

Other medicines andCEFRAG
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
ask your doctor for advice before taking this medicine.
The doctor will assess the benefits of treatment with CEFRAG for you and the possible risks to the
child.

Driving and operating machinery
CEFRAG 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.

CEFRAG contains sodium
Each gram of CEFRAG contains 3.6 mmol (82.8 mg) of sodium. This should be taken into consideration in people
with impaired kidney function or who are on a low-sodium diet.

15. How CEFRAG is administered

CEFRAG is generally administered by a doctor or nurse via an intravenous infusion (intravenous
infusion) or via an injection directly into a vein. CEFRAG 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 CEFRAG 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
CEFRAG will depend on the type of infection you have.

Adults, 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 of CEFRAG 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 for 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 of CEFRAG 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
CEFRAG you need and will monitor you closely, depending on the severity of the liver and kidney disease.

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

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

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

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

• Chest pain in the context of allergic reactions, which may be a symptom of a heart attack triggered by an allergy (Kounis syndrome).
• 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.

Serious skin reactions (frequency not known, the frequency cannot be estimated on the basis of the available data)
If you experience a serious skin reaction, seek medical attention immediately.
The 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 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 Cefrag 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. The signs include easy bruising, pain and swelling of the joints.
• Headache.
• Dizziness.
• Nausea or vomiting.
• Itching.
• Pain or burning sensation along the vein where CEFRAG was administered. Pain where the injection was given.
• 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). The 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 (the frequency cannot be estimated on the basis of the 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). The signs include severe stomach pain that extends to the back.
• Inflammation of the oral mucosa (stomatitis).
• Inflammation of the tongue (glossitis). The 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).
• CEFRAG 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 the address: www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

17. How to store CEFRAG

Expiry date: see the expiry date indicated on the packaging
Warning: do not use the medicine after the expiry date indicated on the packaging.
The indicated expiry date refers to the product in intact packaging, correctly stored.
This medicine does not require any particular storage conditions
From a microbiological point of view, the product should 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.
They may vary in colour from pale yellow to amber depending on the concentration and period
of storage; this characteristic does not affect the efficacy or tolerability of the drug.
Medicines should not be disposed of via drains or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

18. Package Contents and Other Information

What CEFRAG contains
CEFRAG 2 g powder for solution for infusion
one vial contains:
active ingredient: ceftriaxone disodium 3,5 H O 2,386 g equivalent to ceftriaxone 2 g.

Description of the appearance of CEFRAG and package contents
CEFRAG 2 g powder for solution for infusion: 1 vial of powder.

Marketing Authorisation Holder
Aesculapius Farmaceutici S.r.l. – Via Cefalonia, 70 – 25124 Brescia

Manufacturer
MITIM S.r.l. - Via Cacciamali, 34-36-38 - 25125 Brescia.