Zinacef

Leaflet accompanying the packaging: patient information

Zinacef, 750 mg, powder for solution for injection or infusion

Zinacef, 1500 mg, powder for solution for injection or infusion

Cefuroxime

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or nurse.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Zinacef and what is it used for

Zinacef is an antibiotic used in adults and children. The medicine 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
• of the urinary tract
• of the skin and soft tissues
• of the abdomen

Zinacef is also used:

• to prevent infections during surgery.

The doctor may check what type of bacteria caused the patient's infection and check during treatment if the bacteria are sensitive to Zinacef.

2. Important information before taking Zinacef

When not to take Zinacef:

• if the patient is allergic to cephalosporin antibioticsor any of the other ingredients of Zinacef (listed in section 6);
• if the patient has ever had a severe allergic reaction (hypersensitivity) to any other type of beta-lactam antibiotic (penicillins, monobactams or carbapenems).
• if the patient has ever had a severe skin rash or peeling of the skin, blisters and (or) ulcers of the mouth after treatment with cefuroxime or other cephalosporin antibiotics.

➔
If the patient thinks they are affected by the above circumstances, they should tell their doctor
beforestarting to take Zinacef. The patient must not take Zinacef.

Warnings and precautions

Severe skin reactions have occurred with cefuroxime treatment, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). If the patient notices any of the symptoms associated with severe skin reactions described in section 4, they should seek medical advice immediately.
During treatment with Zinacef, the patient should be aware of the following symptoms: allergic reactions, skin rashes, gastrointestinal disorders (e.g., diarrhea) or fungal infections. This will reduce the risk of complications (see “Symptoms to watch out for”in section 4).
If the patient has had allergic reactions to other antibiotics, such as penicillin, they may also be allergic to Zinacef.

Blood and urine tests

Zinacef may affect the results of tests that detect sugar in the urine or blood and the blood test called the Coombs test. If the patient is to have these tests, they should:
➔
tell the person taking the test samplesthat they are taking Zinacef.

Zinacef and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This includes medicines that are available without a prescription.
Some medicines may affect the action of Zinacef or increase the risk of side effects. These include:

• aminoglycoside antibiotics
• diuretic tablets(e.g., furosemide)
• probenecid
• oral anticoagulant medicines(e.g., warfarin) ➔ If this applies to the patient, they should tell their doctor. During treatment with Zinacef, the patient may need to have additional kidney function tests.

Oral contraceptives

Zinacef may reduce the effectiveness of oral contraceptives. If the patient is taking oral contraceptives while taking Zinacef, they should also use mechanical
methods of contraception(e.g., condoms). The patient should consult their doctor for advice.

Pregnancy, breastfeeding, and fertility

The patient should inform their doctor before taking Zinacef:

• if they are pregnant, think they may be pregnant, or plan to become pregnant,
• if they are breastfeeding.

The doctor will assess whether the benefits of taking Zinacef during pregnancy and breastfeeding outweigh the risks to the baby.

Driving and using machines

The patient should not drive or operate machinery if they do not feel well.

Zinacef contains sodium

This should be taken into account for patients on a controlled sodium diet.
Zinacef, 750 mg, powder for solution for injection or infusion
The medicine contains 42 mg of sodium (the main ingredient of common salt) per vial. This is equivalent to 2.1% of the maximum recommended daily intake of sodium in the diet for adults.
Zinacef, 1500 mg, powder for solution for injection or infusion
The medicine contains 83 mg of sodium (the main ingredient of common salt) per vial. This is equivalent to 4.15% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Zinacef

Zinacef is usually given by a doctor or nurse.It can be given as an infusion(intravenous infusion) or as an injectiondirectly into a vein or muscle.

Usual dose

The doctor will decide on the appropriate dose of Zinacef for the patient, taking into account the severity and type of infection, any other antibiotics the patient is taking, their body weight, age, and kidney function.

Newborns and infants (0-3 weeks old)

For every kilogram of the infant's body weight, a dose of 30 to 100 mg of Zinacef is given per day, divided into two or three doses.

Infants (over 3 weeks old) and children

For every kilogram of the infant's or child's body weight, a dose of 30 to 100 mg of Zinacef is given per day, divided into three or four doses.

Adults and adolescents

750 mg to 1.5 g of Zinacef, two, three, or four times a day. No more than 6 g per day.

Patients with kidney problems

If the patient has kidney problems, the doctor may change the dose of Zinacef.
➔
If this applies to the patient, they should tell their doctor.

4. Possible side effects

Like all medicines, Zinacef can cause side effects, although not everybody gets them.

Symptoms to watch out for

A small number of people taking Zinacef have reported an allergic reaction or potentially severe skin reaction. The symptoms may be:

• Severe allergic reaction. Symptoms include: raised, itchy rash, swelling, sometimes of the face or mouth, which can make breathing difficult.
• Skin rash, which can develop into blistersand look like small targets(a dark spot in the center surrounded by a lighter border with a dark ring around the edge).
• Widespread skin lesionswith blisters and peeling skin. (This may be a sign of Stevens-Johnson syndrome or toxic epidermal necrolysis, also known as Lyell's disease).
• Widespread rash, high fever, swollen lymph nodes(DRESS or drug hypersensitivity syndrome),
• Chest painassociated with an allergic reaction, which can be a sign of allergic myocardial infarction(Kounis syndrome).

Other symptoms to watch out for while taking Zinacef

• Fungal infections. Medicines like Zinacef can rarely cause an overgrowth of yeast (Candida) in the body, leading to a fungal infection (e.g., thrush). The risk of this side effect is higher if Zinacef is taken for a long time.
• Severe diarrhea (pseudomembranous colitis). Medicines like Zinacef can cause inflammation of the colon (large intestine), leading to severe diarrhea, usually with blood and mucus, abdominal pain, and fever.

➔

If the patient experiences any of these symptoms, they should contact their doctor or nurse immediately.

Common side effects

May occur in more than 1 in 10 patients:

• pain at the injection site, swelling, and redness along the vein. ➔ If the patient experiences any of these side effects, they should tell their doctor.

Common side effects that may appear in blood test results:

• increased activity of substances (enzymes) produced in the liver
• change in the number of white blood cells (neutropenia or eosinophilia)
• decrease in the number of red blood cells (anemia)

Uncommon side effects

May occur in more than 1 in 100 patients:

• skin rash, hives
• diarrhea, nausea, abdominal pain ➔ If the patient experiences any of these side effects, they should tell their doctor.

Uncommon side effects that may appear in blood test results:

• decrease in the number of white blood cells (leukopenia)
• increase in bilirubin levels (a substance produced by the liver)
• positive Coombs test result

Other side effects

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

• fungal infection
• high fever
• allergic reactions (hypersensitivity)
• inflammation of the colon (large intestine), leading to diarrhea, usually with blood and mucus, abdominal pain
• inflammation of the kidneys and blood vessels
• rapid breakdown of red blood cells (hemolytic anemia)
• skin rash, which can develop into blisters and look like small targets (a dark spot in the center surrounded by a lighter border with a dark ring around the edge).

➔ If the patient experiences any of these side effects, they should tell their doctor.
Side effects that may appear in blood test results:

• decrease in the number of platelets (cells involved in blood clotting - thrombocytopenia)
• increase in urea and creatinine levels in the blood.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Zinacef

The medicine should be stored out of 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 month stated.
The abbreviation ‘EXP’ on the packaging means expiry date.
The abbreviation ‘Lot’ on the packaging means batch number.
Store in a temperature below 25°C. The vial should be stored in the original packaging to protect it from light.
After reconstitution to prepare the solution for injection, 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 to prepare the solution for infusion, 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 storage time and conditions are the responsibility of the user. The storage time should not exceed 24 hours at a temperature between 2°C and 8°C, except for reconstitution performed in controlled and validated aseptic conditions.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging 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 yellow powder.
A vial made of colorless glass with a rubber stopper and an aluminum 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 in powder form may also be supplied with ampoules of water for injections as a solvent.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria

Manufacturer:

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

This medicine is authorized in the Member States of 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
In order to obtain more detailed information on this medicine, the patient should contact their local representative of the marketing authorization holder
Date of last revision of the leaflet:06/2024
(logo of the marketing authorization holder)
-----------------------------------------------------------------------------------------------------------------------------

Information intended for healthcare professionals only:

Instructions for dissolution

Volumes of water and concentrations useful when partial doses are needed.

* The reconstituted solution should be added to 50 or 100 ml of compatible infusion fluid (see compatibility information below)
** The resulting volume of the cefuroxime solution in the solvent increases due to the phase shift coefficient of the active substance, resulting in the presented concentrations [mg/ml].
Compatibility
1.5 g of cefuroxime sodium dissolved in 15 ml of water for injections can be added to a metronidazole solution (500 mg/100 ml).
1.5 g of cefuroxime sodium is compatible with a 1 g azlocillin solution (in 15 ml solution) or 5 g azlocillin (in 50 ml solution).
Cefuroxime sodium (5 mg/ml) in 5% w/v or 10% w/v xylitol solution for injection can only be used for intravenous administration.
Cefuroxime sodium is compatible with aqueous solutions containing no more than 1% lidocaine hydrochloride (for intramuscular administration). This suspension should only be used intramuscularly.
Cefuroxime sodium is compatible with the following infusion fluids:
0.9% w/v sodium chloride solution (BP)
5% glucose solution for injection (BP)
0.18% w/v sodium chloride solution with 4% glucose solution for injection (BP)
5% glucose solution and 0.9% w/v sodium chloride solution for injection (BP)
5% glucose solution and 0.45% sodium chloride solution for injection
5% glucose solution and 0.225% sodium chloride solution for injection
10% glucose solution for injection
Ringer's lactate solution for injection (USP)
Sodium lactate solution for injection (M/6)
Multi-electrolyte sodium lactate solution for injection (Hartmann's solution, BP)
The stability of cefuroxime sodium in 0.9% w/v sodium chloride solution for injection (BP) and in 5% glucose solution for injection is not affected by the presence of sodium hydrocortisone phosphate.
Cefuroxime sodium is also compatible if added to an intravenous infusion solution containing:
heparin (10 or 50 units/ml) in 0.9% w/v sodium chloride solution for injection; potassium chloride (10 or 40 mEq/L) in 0.9% sodium chloride solution for injection.
Any unused product or waste material should be disposed of in accordance with local requirements.