Patient leaflet - Zinacef for injection or infusion
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 tissue
- the abdomen
Zinacef is also used:
- to prevent infections during surgery.
Your doctor may test the type of bacteria causing
your infection and monitor whether the bacteria
are sensitive to Zinacef during your treatment.
2 What you need to know before you are
given Zinacef
You must not be given Zinacef :
if you are allergic to any
cephalosporin antibiotics or any of the
other ingredients of Zinacef (listed in section 6).
if you have ever had a severe allergic
(hypersensitive) reaction to any other type of
betalactam antibiotic (penicillins, monobactams
and carbapenems).
if you have ever developed a severe skin rash
or skin peeling, blistering and/or mouth sores
after treatment with cefuroxime or any other
cephalosporin antibiotics.
Tell your doctor before you start on
Zinacef if you think that this applies to you.
You must not be given Zinacef.
Take special care with Zinacef
Serious skin reactions including Stevens-Johnson
syndrome, toxic epidermal necrolysis, drug
reaction with eosinophilia and systemic symptoms
(DRESS) have been reported in association with
cefuroxime treatment. Seek medical attention
immediately if you notice any of the symptoms
related to these serious skin reactions described
in section 4.
You must look out for certain symptoms such as
allergic reactions, skin rashes, gastrointestinal
disorders such as diarrhoea or fungal infections
while you are being given Zinacef. This will
reduce the risk of possible problems. See
(‘Conditions you need to look out for’) in section
- 4. If you have had any allergic reaction to other
antibiotics such as penicillin, you may also be
allergic to Zinacef.
If you need a blood or urine test
Zinacef can affect the results of urine or blood
tests for sugar and a blood test known as the
Coombs test. If you are having tests:
Tell the person taking the sample that you have been given Zinacef.
Other medicines and Zinacef
Tell your doctor if you are taking any other
medicines, if you’ve started taking any recently or
you start taking new ones. This includes medicines
you can obtain without a prescription.
Some medicines may affect how Zinacef works, or make it more likely that you’ll have side effects. These include:
- aminoglycoside-type antibiotics
- water tablets (diuretics), such as furosemide
- probenecid
- oral anticoagulants Tell your doctor if this applies to you. You may need extra check-ups to monitor your renal function while you are taking Zinacef.
Contraceptive pills
Zinacef may reduce the effectiveness of the contraceptive pill. If you are taking the contraceptive pill while you are being treated with Zinacef you also need to use a barrier method of contraception (such as a condom). Ask your doctor for advice.
Pregnancy and breast-feeding and fertility
Tell your doctor before you are given Zinacef:
if you are pregnant, think you might be
pregnant or are planning to become pregnant
- if you are breastfeeding
Your doctor will consider the benefit of treating you with Zinacef against the risk to your baby.
Driving and using machines
Don’t drive or use machines if you do not feel well.
Zinacef contains sodium
You need to take this into account if you are on a controlled sodium diet.
250 mg
This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’.
750 mg
This medicine contains 42 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 2.1 % of the recommended maximum daily dietary intake of sodium for an adult.
1.5 g
This medicine contains 83 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 4.15 % of the recommended maximum daily dietary intake of sodium for an adult.
3 How Zinacef is given
Zinacef is usually given by a doctor or nurse. It can be given as a drip (intravenous infusion) or as an injection directly into a vein or into a muscle.
The usual dose
The correct dose of Zinacef for you will be decided by your doctor and depends on: the severity and type of infection, whether you are on any other antibiotics; your weight and age; how well your kidneys are working.
Newborn babies (0 - 3 weeks) For every 1 kg the baby weighs, they’ll be given 30 to 100 mg Zinacef per day divided in two or three doses.
Babies (over 3 weeks) and children For every 1 kg the baby or child weighs, they’ll be given 30 to 100 mg of Zinacef per day divided in three or four doses.
Adults and adolescents
750 mg to 1.5 g of Zinacef two, three or four times daily. Maximum dose: 6 g per day.
Patients with kidney problems
If you have a kidney problem, your doctor may change your dose.
Talk to your doctor if this applies to you.
4 Possible side effects
Like all medicines, Zinacef can cause side effects, although not everybody gets them. Conditions you need to look out for
A small number of people taking Zinacef get an allergic reaction or potentially serious skin reaction. Symptoms of these reactions include:
severe allergic reaction. Signs include
raised and itchy rash, swelling,
sometimes of the face or mouth causing difficulty in breathing.
skin rash, which may blister, and looks like
small targets (central dark spot surrounded by a paler area, with a dark ring around the
edge).
a widespread rash with blisters and
peeling skin. (These may be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis).
widespread rash, high body temperature and
enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
chest pain in the context of allergic reactions,
which may be a symptom of allergy triggered cardiac infarction (Kounis syndrome)
Other symptoms you need to be aware of while taking Zinacef include:
fungal infections on rare occasions,
medicines like Zinacef can cause an overgrowth of yeast (Candida) in the body which can lead to fungal infections (such as thrush). This side effect is more likely if you take Zinacef for a long time.
severe diarrhoea
(Pseudomembranous colitis). Medicines like Zinacef can cause inflammation of the colon (large intestine), causing severe diarrhoea, usually with blood and mucus, stomach pain, fever
Contact a doctor or nurse immediately if you get any of these symptoms.
Common side effects
These may affect up to 1 in 10 people:
injection site pain, swelling and redness along
a vein.
Tell your doctor if any of these are troubling you.
Common side effects that may show up in blood tests:
increases in substances (enzymes) produced
by the liver
changes in your white blood cell count
(neutropenia or eosinophilia)
- low levels of red blood cells (anaemia)
Uncommon side effects
These may affect up to 1 in 100 people:
- skin rash, itchy, bumpy rash (hives)
diarrhoea, nausea, stomach pain
Tell your doctor if you get any of these.
Uncommon side effects that may show up in blood tests:
- low levels of white blood cells (leucopenia)
increase in bilirubin (a substance produced by
the liver)
- positive Coomb’s test.
Other side effects
Other side effects have occurred in a very small number of people but their exact frequency is unknown:
- fungal infections
- high temperature (fever)
- allergic reactions
inflammation of the colon (large intestine),
causing diarrhoea, usually with blood and mucus, stomach pain
- inflammation in the kidney and blood vessels
red blood cells destroyed too quickly
(haemolytic anaemia).
skin rash, which may blister, and looks like
small targets (central dark spot surrounded by a paler area, with a dark ring around the edge) erythema multiformae.
Tell your doctor if you get any of these.
Side effects that may show up in blood tests:
decrease in number of blood
platelets (cells that help blood to
clot - thrombocytopenia)
increase in levels of urea nitrogen and serum
creatinine in the blood.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this 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 shown on the pack after EXP. The expiry date refers to the last day of that month.
Store below 25 °C. Keep the vial in the outer carton in order to protect from light.
When reconstituted for injection, can be stored for 5 hours if stored below 25 °C, or 72 hours if stored 2 to 8 °C.
When reconstituted for infusion, can be stored for 3 hours if stored below 25 °C, or 72 hours if stored 2 to 8 °C.
From a microbiological point of view, the medicine should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C unless reconstitution has taken place in controlled and validated aseptic conditions.
Do not throw away any medicines via wastewater or household waste. Your doctor or nurse will dispose of any medicine that is no longer required. These measures will help to protect the environment.
6 Contents of the pack and other
information
What Zinacef contains
250 mg powder for Injection or Infusion The active substance is cefuroxime. Each vial contains 250 mg of cefuroxime (as cefuroxime sodium).
750 mg powder for Injection or Infusion The active substance is cefuroxime. Each vial contains 750 mg of cefuroxime (as cefuroxime sodium).
1.5 g powder for Injection or Infusion
The active substance is cefuroxime. Each vial contains 1.5 g of cefuroxime (as cefuroxime sodium).
There are no other ingredients
What Zinacef looks like and contents of the pack
Colourless glass vials, with a bromobutyl rubber plug and aluminium overseal with flip off plastic lid, containing 250 mg, 750 mg or 1.5 g of cefuroxime (as cefuroxime sodium) powder.
The vials of cefuroxime powder may also be supplied with ampoules of water for injection as solvent
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Sandoz Pharmaceuticals d.d., Verovškova ulica 57, 1000 Ljubljana, Slovenia
Manufacturer: ACS Dobfar S.p.A., Via Alessandro Fleming 2, 37135 Verona, Italy
This leaflet was last revised in July 2024.
Trade marks are owned by or licenced to the Sandoz group of companies.
© 2021 Sandoz group of companies or its licensor.
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