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ZINACEF FOR INJECTION OR INFUSION

Active substance: CEFUROXIME SODIUM

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• Lactated Ringer’s Injection USP
• M/6 Sodium Lactate Injection
• Compound Sodium Lactate Injection BP (Hartmann’s Solution).

10000000127009

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Information for the Healthcare Professional

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10000000127009
Cefuroxime

GSK-ITA-Verona-ITVER

1.5 g, 750 mg and 250 mg

Instructions for reconstitution
Additional volumes and concentrations, which may be useful when fractional doses
are required.

United Kingdom-GBR
Zinacef
N/A
D94225LEA

N/A
N/A
1
K

0

Additional volumes and concentrations, which may be useful when
fractional doses are required
Approximate
Vial size Route of
Physical
Amount of
cefuroxime
administration
State
water to be
concentration
added (mL)
(mg/ml)**
250 mg powder for solution for injection
216
suspension 1 ml
250 mg intramuscular
116
at least 2 ml
solution
intravenous bolus
at least 2 ml* 116
intravenous infusion solution
750 mg powder for solution for injection or infusion
216
suspension 3 ml
750 mg intramuscular
At least 6 ml 116
solution
intravenous bolus
At least 6 ml 116
intravenous infusion solution
1.5 g powder for solution for injection or infusion
216
suspension 6 ml
1.5 g
intramuscular
at least 15 ml 94
solution
intravenous bolus
94
15 ml*
intravenous infusion solution

The stability of cefuroxime sodium in 0.9% w/v Sodium Chloride Injection BP and
in 5% Dextrose Injection is not affected by the presence of hydrocortisone sodium
phosphate.
Cefuroxime sodium has also been found compatible for 24 hours at room temperature
when admixed in IV. infusion with:
•  eparin (10 and 50 units/ml) in 0.9% w/v Sodium Chloride Injection; Potassium
H
Chloride (10 and 40 mEqL) in 0.9% Sodium Chloride Injection.
.
Marketing authorisation number

. .


PL 00004/0263
his leaflet was last revised in December 2014.
T

Zinacef is a registered trade mark of the GSK group of companies
© 2014 GSK group of companies. All rights reserved


* Reconstituted solution to be added to 50 or 100 ml of compatible infusion fluid (see
information on compatibility, below)
** The resulting volume of the solution of cefuroxime in reconstitution medium is
increased due the displacement factor of the drug substance resulting in the listed
concentrations in mg/ml.

0

Compatibility
1.5 g cefuroxime sodium constituted with 15 mL Water for Injection may be added to
metronidazole injection (500 mg/100 mL) and both retain their activity for up to 24 hours
below 25°C.
1.5 g cefuroxime sodium is compatible with azlocillin 1 g (in 15 mL) or 5 g (in 50 mL)
for up to 24 hours at 4°C or 6 hours below 25°C.
Cefuroxime sodium (5 mg/mL) in 5% w/v or 10% w/v xylitol injection may be stored
for up to 24 hours at 25°C.
Cefuroxime sodium is compatible with aqueous solutions containing up to 1%
lidocaine hydrochloride.
Cefuroxime sodium is compatible with the following infusion fluids. It will retain
potency for up to 24 hours at room temperature in:
• 0.9% w/v Sodium Chloride Injection BP
• 5% Dextrose Injection BP
• 0.18% w/v Sodium Chloride plus 4% Dextrose Injection BP
• 5% Dextrose and 0.9% w/v Sodium Chloride Injection BP
• 5% Dextrose and 0.45% Sodium Chloride Injection
• 5% Dextrose and 0.225% Sodium Chloride Injection
• 10% Dextrose Injection
• 10% Invert Sugar in Water for Injections
• Ringer’s Injection USP

Zinacef ® 1.5 g, 750 mg and 250 mg
Cefuroxime

Read all of this leaflet carefully before you
start using this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
-  you have any further questions, ask your
If
doctor or nurse.
-  you get any side effects, talk to your doctor
If
or nurse. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet:
1 What Zinacef is and what it is used for
2 
What you need to know before you are given
Zinacef
3 How Zinacef is given
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

8.5pt
10.0pt
100%
8.5pt
No

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  hat you need to know before you
W
are given Zinacef
You must not be given Zinacef :
• you are allergic to any cephalosporin
if
antibiotics or any of the other ingredients of
Zinacef (listed in section 6).
• you have ever had a severe allergic
if
(hypersensitive) reaction to any other
type of betalactam antibiotic (penicillins,
monobactams and carbapenems).
➔  ell your doctor before you start on Zinacef
T
if you think that this applies to you. You must
not be given Zinacef.
Take special care with Zinacef
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:
➔  ell the person taking the sample that you
T
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
➔  ell your doctor if this applies to you. You
T
may need extra check-ups to monitor your
renal function while you are taking Zinacef.

Pregnancy and breast-feeding and fertility
Tell your doctor before you are given Zinacef:
• you are pregnant, think you might be
if
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.
Zinacef strength

Amount per vial

250 mg

14 mg

750 mg

42 mg

1.5 g

83 mg

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.
•  rash, which may blister, and looks like
skin
small targets (central dark spot surrounded by
a paler area, with a dark ring around the edge).
• widespread rash with blisters and peeling
a
skin. (These may be signs of Stevens-Johnson
syndrome or toxic epidermal necrolysis).
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
➔  ontact a doctor or nurse immediately if
C
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.
➔  ell your doctor if any of these are troubling
T
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
•  blood cells destroyed too quickly
red
(haemolytic anaemia).
•  rash, which may blister, and looks like
skin
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.

the hospital in packs of 1 (1.5 g), 5 (250 mg and
750 mg) or 100 (750 mg). Your doctor, pharmacist
or nurse will make the injection up with Water for
Injections for your muscle or vein injection. When
made up for injection into a muscle, it becomes
off-white and opaque. When made up for injection
into a vein, it is yellowish.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder: Glaxo Operations
UK Limited, Stockley Park West, Uxbridge,
Middlesex. UB11 1BT
Manufacturer: GlaxoSmithKline Manufacturing S.p.A.,
Verona, Italy.
Other formats
To listen to or request a copy of this leaflet in
Braille, large print or audio please call, free of
charge:

0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name 
Zinacef 1.5 g,
750 mg or 250 mg
Reference number 00004/0263
This is a service provided by the Royal National
Institute of Blind People.
This leaflet was last revised in December 2014.
Zinacef is a registered trade mark of the GSK
group of companies
© 2014 GSK group of companies. All rights reserved

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. By reporting side
effects you can help provide more information on
the safety of this medicine.

5 How to store Zinacef
Zinacef is for use in hospital only and the expiry
date and storage instructions stated on the vial
label and carton are for the doctor, nurse or
pharmacist’s information. The doctor, pharmacist
or nurse will make up your medicine.
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.
Don’t 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  ontents of the pack and other
C
information
What Zinacef contains
•  active substance is 1.5 g, 750 mg or 250 mg
The
of cefuroxime (present as cefuroxime sodium).
•  are no other ingredients. However, see
There
section 2 for further important information
about one of the ingredients of Zinacef, sodium.
What Zinacef looks like and contents of the
pack
Zinacef 1.5 g, 750 mg or 250 mg is supplied as
white to cream powder in moulded glass vials with
a rubber bung and flip-off cap. Each individual
vial is packed in a carton. These are supplied to

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10000000127009

Package Leaflet: Information for the Patient

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.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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