Zinacef

Package leaflet: Information for the patient

Zinacef, 750 mg, powder for solution for injection or infusion
Zinacef, 1500 mg, powder for solution for injection or infusion
Cefuroximum
Please read this leaflet carefully before using this medicine, because it contains important
information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or nurse.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or nurse. See section 4.

Table of contents

1. What Zinacef is and what it is used for
2. Important information before using Zinacef
3. How to use Zinacef
4. Possible side effects
5. How to store Zinacef
6. Contents of the pack and other information

1. What Zinacef is and what it is used for
Zinacef is an antibiotic used in adults and children. It works by killing bacteria that cause infections. It belongs to a group of medicines called cephalosporins.
Zinacef is used to treat infections of:

• the lungs or chest
• the urinary tract
• the skin and soft tissues
• the abdomen

Zinacef is also used:

• to prevent infections during surgery.

Your doctor may test which type of bacteria caused your infection and may check during treatment whether the bacteria are sensitive to Zinacef.

2. Important information before using Zinacef

Do not use Zinacef:

• if you are allergic to cephalosporin antibiotics or to any of the other ingredients of this medicine (listed in section 6);
• if you have ever had a severe allergic reaction (hypersensitivity) to any other type of beta-lactam antibiotics (penicillins, monobactams or carbapenems);
• if you have ever developed severe skin rash, skin peeling, blisters and/or mouth ulcers after treatment with cefuroxime or other cephalosporin antibiotics.

➔ If you think any of the above apply to you, you must tell your doctor before starting treatment with Zinacef. You must not take Zinacef.
Warnings and precautions
Severe skin reactions have occurred during treatment with cefuroxime, such as: Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). If you notice any symptoms related to severe skin reactions described in section 4, seek immediate medical advice.
During treatment with Zinacef, be alert for symptoms such as allergic reactions, skin rashes, gastrointestinal disturbances (e.g. diarrhoea) or fungal infections. This will help reduce the risk of complications (see “Symptoms to watch for” in section 4).
If you have previously had allergic reactions to other antibiotics such as penicillin, you may also be allergic to Zinacef.
Blood and urine tests
Zinacef may affect the results of tests for glucose (sugar) in blood or urine, as well as a blood test called the Coombs test. If you are due to have such tests, you must:
➔ inform the person taking the sample that you are taking Zinacef.
Zinacef and other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, including medicines obtained without a prescription, as well as any you plan to take.
Some medicines may affect the action of Zinacef or increase the risk of side effects. These include:

• antibiotics known as aminoglycosides
• diuretic tablets (water tablets), e.g. furosemide
• probenecid
• oral anticoagulants (blood thinners) ➔ If this applies to you, tell your doctor. Additional monitoring of kidney function may be necessary during treatment with Zinacef.

Oral contraceptives
Zinacef may reduce the effectiveness of oral contraceptives. If you are taking oral contraceptives while being treated with Zinacef, you should use additional mechanical methods of contraception (e.g. condoms). Please consult your doctor for advice.
Pregnancy, breastfeeding and fertility
Inform your doctor before taking Zinacef:

• if you are pregnant, suspect you may be pregnant, or are planning to become pregnant,
• if you are breastfeeding.

Your doctor will assess whether the benefits of using Zinacef during pregnancy or breastfeeding outweigh any risks to the baby.
Driving and operating machinery
You should not drive or operate machinery if you do not feel well.
Zinacef contains sodium
This should be taken into account in patients who need to control their sodium intake.
Zinacef, 750 mg, powder for solution for injection or infusion
This medicine contains 42 mg of sodium (a main component of table salt) per vial. This corresponds to 2.1% of the maximum recommended daily sodium intake in adults.
Zinacef, 1500 mg, powder for solution for injection or infusion
This medicine contains 83 mg of sodium (a main component of table salt) per vial. This corresponds to 4.15% of the maximum recommended daily sodium intake in adults.

3. How to use Zinacef

Zinacef is usually administered by a doctor or nurse. It may be given as an intravenous infusion
(infusion into a vein) or as an injection given directly into a vein or into a muscle.
Usual dose
The doctor will decide the appropriate dose of Zinacef for the patient, taking into account the severity and type
of infection, whether the patient is taking any other antibiotics, body weight, age, and kidney function.
Newborns and infants (aged 0–3 weeks)
Per kilogram of body weight, a daily dose of 30 to 100 mg of Zinacef is given, divided into two or three doses.
Infants (aged over 3 weeks) and children
Per kilogram of body weight, a daily dose of 30 to 100 mg of Zinacef is given, divided into three or four doses.
Adults and adolescents
750 mg to 1.5 g of Zinacef two, three, or four times daily. No more than 6 g per day.
Patients with impaired kidney function
If the patient has kidney problems, the doctor may adjust the dosage of the medicine.
➔ If this applies to the patient, they should inform the doctor.

4. Possible adverse reactions

Like all medicines, Zinacef can cause adverse reactions, although not everyone experiences them.
Conditions to be aware of
In a small number of people taking Zinacef, an allergic reaction or potentially severe skin reaction has been reported. Symptoms may include:

• Severe allergic reaction. Symptoms include: raised, itchy rash, swelling, sometimes of the face or lips, which may make breathing difficult.
• Skin rash, which may develop into blisters and appear as target lesions (dark spot in the center surrounded by a lighter ring with a dark rim around the edge).
• Widespread skin lesions, with blisters and peeling of the epidermis. (This may be a sign of Stevens-Johnson syndrome or toxic epidermal necrolysis - Lyell's syndrome).
• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Chest pain associated with allergic reaction, which may be a symptom of allergy-induced heart attack (Kounis syndrome).

Other conditions to be aware of during treatment with Zinacef

• Fungal infections. Medicines such as Zinacef may rarely cause overgrowth of yeast ( Candida ) in the body, which may lead to fungal infection (e.g. thrush). The risk of this adverse reaction is greater if Zinacef is used for a prolonged period.
• Severe diarrhoea (pseudomembranous colitis). Medicines such as Zinacef may cause inflammation of the colon (large intestine), leading to severe diarrhoea, usually with blood and mucus, abdominal pain and fever.

➔ If any of these symptoms occur in a patient, contact a doctor or nurse immediately.
Common adverse reactions
May occur in up to 1 in 10 patients:

• pain at the injection site, swelling and redness along the vein. ➔ If any of these adverse reactions occur in a patient, inform the doctor.

Common adverse reactions that may be revealed in blood tests:

• increased activity of substances (enzymes) produced in the liver
• change in white blood cell count (neutropenia or eosinophilia)
• decreased number of red blood cells (anaemia)

Uncommon adverse reactions
May occur in up to 1 in 100 patients:

• skin rash, urticaria
• diarrhoea, nausea, abdominal pain ➔ If any of these adverse reactions occur in a patient, inform the doctor.

Uncommon adverse reactions that may be revealed in blood tests:

• decreased number of white blood cells (leukopenia)
• increased bilirubin concentration (a substance produced by the liver)
• positive Coombs test

Other adverse reactions
Other adverse reactions occur in a very small number of patients, but the exact frequency is unknown:

• fungal infection
• high temperature (fever)
• allergic reactions (hypersensitivity)
• inflammation of the colon (large intestine), causing diarrhoea, usually with blood and mucus, abdominal pain
• inflammation of the kidneys and blood vessels
• excessive breakdown of red blood cells (haemolytic anaemia)
• skin rash, which may develop into blisters and appear as target lesions (dark spot in the center surrounded by a lighter ring with a dark rim around the edge).

➔ If any of these adverse reactions occur in a patient, inform the doctor.
Adverse reactions that may be revealed in blood tests:

• decreased number of platelets (cells involved in blood clotting - thrombocytopenia)
• increased serum urea and creatinine levels.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Zinacef

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: EXP. The expiry date refers to the last day of the stated month.
The abbreviation 'EXP' on the packaging indicates the expiry date.
The abbreviation 'Lot' on the packaging indicates the batch number.
Store below 25°C. Keep the vial in the original packaging to protect it from light.
After reconstitution for injection solution, the medicine can be stored for 5 hours at a temperature below 25°C or for 72 hours at a temperature between 2°C and 8°C.
After reconstitution for infusion solution, the medicine can be stored for 3 hours at a temperature below 25°C or for 72 hours at a temperature between 2°C and 8°C.
From a microbiological point of view, the medicine should be used immediately after reconstitution. If not used immediately, the responsibility for storage conditions and duration lies with the user. The storage time should not exceed 24 hours at a temperature between 2°C and 8°C, except when reconstitution is carried out under controlled and validated aseptic conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Zinacef contains
750 mg, powder for solution for injection or infusion:
The active substance is cefuroxime. Each vial contains 750 mg of cefuroxime (as cefuroxime sodium).
1500 mg, powder for solution for injection or infusion:
The active substance is cefuroxime. Each vial contains 1500 mg of cefuroxime (as cefuroxime sodium).
The medicine does not contain any excipients.

What Zinacef looks like and contents of the pack
Zinacef is a white or slightly yellowish powder.
The vial is made of colourless glass, with a bromobutyl rubber stopper and an aluminium cap with a plastic flip-off cap, containing 750 mg or 1500 mg of cefuroxime (as cefuroxime sodium) in powder form. Packs of 1 or 10 vials.
Vials containing cefuroxime powder may also be supplied with ampoules of water for injections as solvent.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria

Manufacturer:
ACS Dobfar S.p.A
Via Alessandro Fleming 2
37135 Verona
Italy

This medicine is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
750 mg, powder for solution for injection or infusion
Belgium, Cyprus, Czech Republic, Finland, Greece, Hungary, Iceland, Ireland, Luxembourg, Malta, Norway, Poland, Slovenia, Sweden, United Kingdom (Northern Ireland) – Zinacef
France – Zinnat
Italy – Curoxim

1500 mg, powder for solution for injection or infusion
Austria – Curocef
Belgium, Cyprus, Czech Republic, Finland, Greece, Hungary, Iceland, Ireland, Luxembourg, Norway, Poland, Slovenia, Sweden, United Kingdom (Northern Ireland) – Zinacef
France – Zinnat

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
(logo of the Marketing Authorisation Holder)

Information intended exclusively for medical professionals:

Reconstitution instructions
Volumes of water added and concentrations useful when partial doses need to be administered.

* The prepared solution should be added to 50 or 100 ml of a compatible infusion fluid (compatibility information – see below).
** The volume of cefuroxime solution in the solvent increases due to the phase displacement factor of the active substance, resulting in the concentrations [mg/ml] stated above.

Compatibility
1.5 g of sodium cefuroxime dissolved in 15 ml of water for injections may be added to a solution of metronidazole (500 mg/100 ml).
1.5 g of sodium cefuroxime is compatible with a 1 g solution of azlocillin (in 15 ml of solution) or 5 g of azlocillin (in 50 ml of solution).
Sodium cefuroxime (5 mg/ml) in 5% w/v or 10% w/v xylitol injection solution may be used for intravenous administration only.
Sodium cefuroxime is compatible with aqueous solutions containing not more than 1% lidocaine hydrochloride (for intramuscular administration). This mixture must be used for intramuscular administration only.

Sodium cefuroxime is compatible with the following infusion fluids:

• 0.9% w/v sodium chloride solution (BP)
• 5% glucose injection solution (BP)
• 0.18% w/v sodium chloride with 4% glucose injection solution (BP)
• 5% glucose and 0.9% w/v sodium chloride injection solution (BP)
• 5% glucose and 0.45% sodium chloride injection solution
• 5% glucose and 0.225% sodium chloride injection solution
• 10% glucose injection solution
• Sodium lactate (Ringer's) injection solution (USP)
• Sodium lactate injection solution (M/6)
• Multi-electrolyte sodium lactate injection solution (Hartmann's solution, BP)

The stability of sodium cefuroxime in 0.9% w/v sodium chloride injection solution (BP) and 5% glucose injection solution is not affected in the presence of sodium phosphate hydrocortisone.

Sodium cefuroxime is also compatible when added to intravenous infusion solutions containing:

• Heparin (10 or 50 units/ml) in 0.9% w/v sodium chloride injection solution
• Potassium chloride (10 or 40 mEq/L) in 0.9% sodium chloride injection solution

Any unused portions of the medicinal product or waste material should be disposed of in accordance with local regulations.