Kocefano

Package leaflet: Information for the patient

Kocefan 1 g/10 ml powder and solvent for injectable solution for intravenous use, 2 g powder for infusion solution

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

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

Contents of this leaflet:

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

1. What Kocefan is and what it is used for

Kocefan 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.
Kocefan is used to treat the following infections:

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

It may also be administered:

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

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

Do not be given Kocefan if:

• you are allergic to ceftriaxone or to any of the other ingredients of this medicine (listed in section 6);
• you have previously had a sudden or severe allergic reaction to penicillin or similar antibiotics (such as cephalosporins, penicillins, monobactams, and carbapenems). Possible signs include sudden swelling of the throat or face, which may make breathing or swallowing difficult, sudden swelling of the hands, feet, and ankles, or a severe rash that develops rapidly;
• you are allergic to lidocaine and Kocefan is to be administered by intramuscular injection.

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

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

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

• you have recently received or are about to receive products containing calcium;
• you have recently had diarrhoea after taking an antibiotic; you have intestinal problems, particularly colitis (inflammation of the intestine);
• you have liver or kidney problems (see section 4);
• you have gallstones or kidney stones;
• you have other diseases, for example haemolytic anaemia (a reduction in red blood cells that may cause pale yellow skin, weakness, or shortness of breath);
• you are on a low-sodium diet;
• you are experiencing or have previously experienced any combination of the following symptoms: rash, skin redness, blistering of the lips, eyes, or mouth, skin peeling, high fever, flu-like symptoms, increased levels of liver enzymes detectable in blood tests, increase in a type of white blood cell (eosinophilia), and swollen lymph nodes (signs of serious skin reactions; see also section 4 “Possible side effects”).

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

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

Children
Talk to your doctor, pharmacist, or nurse before Kocefan is given to a child if:

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

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

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

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine.
Your doctor will assess the benefits of treatment with Kocefan for you and the possible risks to the unborn or breastfed child.

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

3. How Kocefan is administered

Kocefan is generally administered by a doctor or nurse through an intravenous infusion (IV infusion) or by direct injection into a vein. Kocefan will be prepared by a doctor, pharmacist, or nurse and must not be mixed or administered at the same time as injections containing calcium.

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

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

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

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

• 50–80 mg of Kocefan once daily per kg of the child’s body weight, depending on the severity and type of infection. If the child has a severe infection, the doctor may prescribe a higher dose, starting from 100 mg per kg of body weight, up to a maximum of 4 g per day. If the daily dose exceeds 2 g, it may be administered either as a single daily dose or as two separate doses.

• Children with a body weight equal to or greater than 50 kg should receive the adult usual dose.

Newborns (0–14 days of life):

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

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

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

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

If you stop Kocefan treatment
Do not stop taking Kocefan unless your doctor tells you to. If you have any doubts about using this medicine, consult your doctor or nurse.

4. Possible side effects

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

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

• sudden swelling of the face, throat, lips or mouth. This may make breathing or swallowing difficult;
• sudden swelling of the hands, feet and ankles.

Severe skin reactions (not known, frequency cannot be estimated from the available data)
If you experience a severe skin reaction, seek medical advice immediately.

• Signs may include a serious rash that develops rapidly, with blistering or peeling of the skin and possibly blisters in the mouth (Stevens-Johnson syndrome and toxic epidermal necrolysis, also known as SJS and TEN).
• Any combination of the following symptoms: widespread rash, high body temperature, increased liver enzymes, abnormalities in blood tests (eosinophilia), swollen lymph nodes and involvement of other organs in the body (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome).
• Jarisch-Herxheimer reaction, which may cause fever, chills, headache, muscle pain and rash, which usually resolves spontaneously. These symptoms may occur shortly after starting treatment with Kocefan for spirochetal infections such as Lyme disease.

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

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

Uncommon (may affect up to 1 in 100 people)

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

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

• Inflammation of the large intestine (colon). Signs include diarrhoea, often with blood and mucus, stomach pain and fever.
• Difficulty breathing (bronchospasm).
• Rash with raised lumps (urticaria), which may cover a large area of the body, associated with itching and swelling.
• Blood or sugar in the urine.
• Oedema (fluid accumulation).
• Chills. Treatment with ceftriaxone, especially in elderly patients with severe renal impairment or neurological disorders, may rarely cause reduced level of consciousness, abnormal movements, agitation and seizures.

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

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

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

5. How to store Kocefan

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
The product should be used immediately after reconstitution.
The reconstituted solution may vary in colour from pale yellow to amber, depending on the concentration and storage period; this characteristic does not affect the efficacy or tolerability of the medicine.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Kocefan contains
Kocefan 1 g/10 ml powder and solvent for injectable solution for intravenous use
one vial of powder contains:
active substance: ceftriaxone disodium 3.5 H₂O 1.193 g, equivalent to ceftriaxone 1 g;
one solvent vial contains: water for injections.
Kocefan 2 g powder for infusion solution:
one vial contains:
active substance: ceftriaxone disodium 3.5 H₂O 2.386 g, equivalent to ceftriaxone 2 g.

Description of the appearance of Kocefan and contents of the pack
Kocefan 1 g/10 ml powder and solvent for injectable solution for intravenous use: 1 vial of powder + 1 solvent vial of 10 ml.
Kocefan 2 g powder for infusion solution: 1 vial of powder.

Marketing Authorization Holder
NEOPHARMED GENTILI S.p.A. - Via San Giuseppe Cottolengo, 15 - 20143 Milan, Italy.

Manufacturer
Laboratorio Farmaceutico C.T. S.r.l. - Via D. Alighieri, 71 - Sanremo (IM), Italy (for all pack sizes).

Package leaflet: information for the patient

Kocefan 250 mg/2 ml powder and solvent for injectable solution for intramuscular use, 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 sodium ceftriaxone)
Please read this leaflet carefully before this medicine is administered to you
because it contains important information for you.

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

Contents of this leaflet:

1. What Kocefan is and what it is used for
2. What you need to know before being given Kocefan
3. How Kocefan is administered
4. Possible side effects
5. How to store Kocefan
6. Package contents and other information

1. What Kocefan is and what it is used for

Kocefan contains the active substance ceftriaxone, which is an antibiotic administered to adults and
children (including newborns). It works by killing bacteria that cause infections. It belongs to a
group of medicines called cephalosporins.
Kocefan is used to treat infections of:

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

It may be administered:

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

2. What you need to know before being given Kocefan

Do not be given Kocefan if:

• you are allergic to ceftriaxone or to any of the other ingredients of this medicine (listed in section 6);
• you have previously had a sudden or severe allergic reaction to penicillin or to similar antibiotics (such as cephalosporins, penicillins, monobactams, and carbapenems). Possible signs include sudden swelling of the throat or face, which may make breathing or swallowing difficult, sudden swelling of hands, feet and ankles, and a severe rash that develops rapidly;
• you are allergic to lidocaine and Kocefan is to be administered by intramuscular injection.

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

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

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

• you have recently received or are about to receive products containing calcium;
• you have recently had diarrhoea after taking an antibiotic, or have had intestinal problems, particularly colitis (inflammation of the intestine);
• you have liver or kidney problems (see section 4);
• you have gallstones or kidney stones;
• you have other diseases, such as haemolytic anaemia (a reduction in red blood cells that may cause pale yellow skin, weakness or shortness of breath);
• you are on a low-sodium diet;
• you are experiencing or have previously experienced any combination of the following symptoms: skin rash, skin redness, blistering on lips, eyes and mouth, skin peeling, high fever, flu-like symptoms, increased levels of liver enzymes detectable in blood tests, increase in a type of white blood cells (eosinophilia), and swollen lymph nodes (signs of serious skin reactions, see also section 4 “Possible side effects”).

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

• inform the person collecting the sample that you have been administered Kocefan.

Children
Talk to your doctor, pharmacist, or nurse before Kocefan is given to a child if:

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

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

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

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Your doctor will assess the benefits of treatment with Kocefan for you and the possible risks to the unborn or breastfed child.

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

3. How Kocefan is administered

Kocefan is generally administered by a doctor or nurse through an injection given directly into a muscle. Kocefan will be prepared by a doctor, pharmacist, or nurse and will not be mixed or administered at the same time as injections containing calcium.
Usual dose
Your doctor will determine the correct dose of Kocefan for you. The dose will depend on the severity and type of infection, whether you are receiving concomitant treatment with other antibiotics, your body weight and age, and the functioning of your kidneys and liver. The number of days or weeks during which you will receive Kocefan will depend on the type of infection you have.
Adults, elderly patients, and children aged 12 years or older with a body weight of 50 kilograms (kg) or more:

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

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

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

Newborns (0–14 days of age):

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

Patients with liver or kidney problems
You may be given a different dose than the usual one. Your doctor will decide how much Kocefan you need and will monitor you closely, depending on the severity of your liver or kidney disease.
If you are given more Kocefan than you should
If you are accidentally given more Kocefan than prescribed, contact your doctor or go to the nearest hospital immediately.
If you miss a dose of Kocefan
If you miss an injection, you should receive it as soon as possible. However, if it is almost time for your next scheduled injection, skip the missed dose. Do not administer a double dose (two injections together) to make up for the missed dose.
If you stop treatment with Kocefan
Do not stop taking Kocefan unless instructed by your doctor. If you have any doubts about using this medicine, consult your doctor or nurse.

4. Possible side effects

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

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

• sudden swelling of the face, throat, lips or mouth. This may make breathing or swallowing difficult.
• sudden swelling of the hands, feet and ankles.

Severe skin reactions (not known, frequency cannot be estimated from the available data)
If you experience a severe skin reaction, seek medical advice immediately.

• Signs may include a severe rash that develops rapidly, with blistering or peeling of the skin and possibly blisters in the mouth (Stevens-Johnson syndrome and toxic epidermal necrolysis, also known as SJS and TEN).
• Any combination of the following symptoms: widespread rash, high body temperature, increased liver enzymes, abnormalities in blood tests (eosinophilia), swollen lymph nodes and involvement of other organs in the body (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome).
• Jarisch-Herxheimer reaction, which may cause fever, chills, headache, muscle pain and rash, which usually resolves spontaneously. These symptoms may occur shortly after starting treatment with Kocefan for spirochete infections such as Lyme disease.

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

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

Uncommon (may affect up to 1 in 100 people)

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

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

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

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

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

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

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

5. How to store Kocefan

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
The product should be used immediately after reconstitution.
The reconstituted solution may vary in colour from pale yellow to amber depending on the
concentration and storage period; this characteristic does not affect the efficacy or
tolerability of the medicine.
Do not use this medicine after the expiry date stated on the carton and blister after
“EXP”. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Kocefan contains
Kocefan 250 mg/2 ml powder and solvent for injectable solution for intramuscular use
One vial of powder contains:
Active substance: ceftriaxone disodium 3.5 H₂O 298.2 mg, equivalent to ceftriaxone 250 mg;
One ampoule of solvent contains: aqueous solution of 1% lidocaine.
Kocefan 500 mg/2 ml powder and solvent for injectable solution for intramuscular use
One vial of powder contains:
Active substance: ceftriaxone disodium 3.5 H₂O 596.5 mg, equivalent to ceftriaxone 500 mg;
One ampoule of solvent contains: aqueous solution of 1% lidocaine.
Kocefan 1 g/3.5 ml powder and solvent for injectable solution for intramuscular use
One vial of powder contains:
Active substance: ceftriaxone disodium 3.5 H₂O 1.193 g, equivalent to ceftriaxone 1 g;
One ampoule of solvent contains: aqueous solution of 1% lidocaine.

Description of the appearance of Kocefan and contents of the pack
Kocefan 250 mg/2 ml powder and solvent for injectable solution for intramuscular use: 1 vial of powder + 1 solvent ampoule of 2 ml.
Kocefan 500 mg/2 ml powder and solvent for injectable solution for intramuscular use: 1 vial of powder + 1 solvent ampoule of 2 ml.
Kocefan 1 g/3.5 ml powder and solvent for injectable solution for intramuscular use: 1 vial of powder + 1 solvent ampoule of 3.5 ml.

Marketing Authorization Holder
NEOPHARMED GENTILI S.p.A. - Via San Giuseppe Cottolengo, 15 - 20143 Milan, Italy.

Manufacturer
Laboratorio Farmaceutico C.T. S.r.l. - Via D. Alighieri, 71 - Sanremo (IM), Italy (for all pack sizes).
MITIM S.r.l. – Via Cacciamali, 34/38 – Brescia – (only for the 1 g/3.5 ml pack size, AIC n. 035965033).