PACKAGE LEAFLET Pregnancy and breast-feeding and • widespread rash, high • high temperature

fertility Tell your doctor before body temperature and (fever)

Package leaflet: Information for you are given Zinacef: enlarged lymph nodes (DRESS
the user
• allergic reactions
• if you are pregnant, syndrome or drug
think you might be pregnant or hypersensitivity syndrome).
• inflammation of the
Zinacef 250 mg powder for colon (large intestine), causing
are planning to become • chest pain in the
solution or suspension for diarrhoea, usually with blood
pregnant context of allergic reactions,
injection and mucus, stomach pain
• if you are breast- which may be a symptom of
Zinacef 750 mg powder for
feeding. allergy triggered cardiac
• inflammation in the
solution or suspension for kidney and blood vessels
infarction (Kounis syndrome).
injection Zinacef 1.5 g powder for • red blood cells
Your doctor will consider the Other symptoms you need to be
solution for injection or infusion
benefit of treating you with Zinacef aware of while taking Zinacef destroyed too quickly
against the risk to your baby. include: (haemolytic anaemia)
cefuroxime
What is in this leaflet
3. How Zinacef is given • fungal infections on • skin rash, which may
Zinacef is usually given by a doctor rare occasions, medicines like blister, and looks like small
1. What Zinacef is and or nurse. It can be given as a drip targets (central dark spot
Zinacef can cause an
what it is used for (intravenous infusion) or as an overgrowth of yeast (Candida) surrounded by a paler area,
2. What you need to know injection directly into a vein or into in the body which can lead to with a dark ring around the
before you are given Zinacef a muscle. fungal infections (such as edge) erythema multiformae.
3. How Zinacef is given The usual dose thrush). This side effect is ➔ Tell your doctor if you get any of
The correct dose of Zinacef for you more likely if you take Zinacef these.
4. Possible side effects
will be decided by your doctor and for a long time. Side effects that may show up in
5. How to store Zinacef depends on: the severity and type blood tests:
• severe diarrhoea
6. Contents of the pack of infection, whether you are on
(Pseudomembranous colitis).
• decrease in number of
and other information any other antibiotics; your weight blood platelets (cells that help
Medicines like Zinacef can
and age; how well your kidneys are blood to clot - thrombocytopenia) •
cause inflammation of the
1. What Zinacef is and working. increase in levels of
colon (large intestine), causing
what it is used for Newborn babies (0 - 3 weeks) urea nitrogen and serum creatinine
severe diarrhoea, usually with
Zinacef is an antibiotic used in For every 1 kg the baby weighs, in the blood.
blood and mucus, stomach
adults and children. It works by they’ll be given 30 to 100 mg 5. How to store Zinacef
pain, fever
killing bacteria that cause Zinacef per day divided in two or Keep this medicine out of the sight
➔ Contact a doctor or nurse
infections. It belongs to a group of three doses. and reach of children.
immediately if you get any of
medicines called cephalosporins. Babies (over 3 weeks) and children
these symptoms.
Zinacef is used to treat infections For every 1 kg the baby or child Do not use this medicine after the
Common side effects
of: weighs, they’ll be given 30 to 100 expiry date shown on the pack
These may affect up to 1 in 10
mg of Zinacef per day divided in after EXP. The expiry date refers to
• the lungs or chest people:
three or four doses. the last day of that month.
• the urinary tract • the Adults and adolescents
• injection site pain, swelling and
skin and soft tissue • the redness along a vein.
750 mg to 1.5 g of Zinacef two, Store below 25°C. Keep the vial in
abdomen. ➔ Tell your doctor if any of these
three or four times daily. Maximum the outer carton in order to protect
Zinacef is also used: are troubling you.
dose: 6 g per day. from light.
Common side effects that may
• to prevent infections Patients with kidney problems
show up in blood tests:
during surgery. If you have a kidney problem, your When reconstituted for injection,
Your doctor may test the type of doctor may change your dose. ➔ • increases in substances can be stored for 5 hours if stored
bacteria causing your infection and Talk to your doctor if this applies (enzymes) produced by the below 25°C, or 72 hours if stored 2
monitor whether the bacteria are to you. liver to 8°C.
sensitive to Zinacef during your 4. Possible side effects • changes in your white
treatment. Like all medicines, Zinacef can blood cell count (neutropenia When reconstituted for infusion,
2. What you need to know cause side effects, although not or eosinophilia) can be stored for 3 hours if stored
before you are given Zinacef everybody gets them. • low levels of red blood below 25°C, or 72 hours if stored 2
You must not be given Zinacef: Conditions you need to look out to 8°C.
cells (anaemia).
• if you are allergic to any for Uncommon side effects
cephalosporin antibiotics or A small number of people taking From a microbiological point of
These may affect up to 1 in 100
any of the other ingredients of Zinacef get an allergic reaction or view, the medicine should be used
people: • skin rash, itchy, bumpy
Zinacef (listed in section 6) potentially serious skin reaction. immediately. If not used
rash (hives)
Symptoms of these reactions immediately, in-use storage times
• if you have ever had a
include:
• diarrhoea, nausea, stomach pain.
➔ Tell your doctor if you get any of and conditions prior to use are the
severe allergic (hypersensitive)
reaction to any other type of • severe allergic reaction. these. responsibility of the user and
Signs include raised and itchy Uncommon side effects that may would normally not be longer than
betalactam antibiotic
rash, swelling, sometimes of show up in blood tests: 24 hours at 2 to 8°C unless
(penicillins, monobactams and
the face or mouth causing reconstitution has taken place in
carbapenems) • low levels of white
controlled and validated aseptic
difficulty in breathing.
• if you have ever blood cells (leucopenia)
conditions.
developed a severe skin rash • skin rash, which may • increase in bilirubin (a
or skin peeling, blistering blister, and looks like small substance produced by the Do not throw away any medicines
and/or mouth sores after targets (central dark spot liver) via wastewater or household
treatment with cefuroxime or surrounded by a paler area,
with a dark ring around the • positive Coomb’s test. waste. Your doctor or nurse will
any other cephalosporin Other side effects dispose of any medicine that is no
antibiotics. edge).
Other side effects have occurred in longer required. These measures
➔ Tell your doctor before you start • a widespread rash with
a very small number of people but will help to protect the
on Zinacef if you think that this blisters and peeling skin. environment.
their exact frequency is unknown:
applies to you. You must not be (These may be signs of
given Zinacef. Stevens-Johnson syndrome or • fungal infections
toxic epidermal necrolysis).