ZINACEF FOR INJECTION OR INFUSION

Active substance: CEFUROXIME SODIUM

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Information for the Healthcare Professional

M/6 Sodium Lactate Injection
Compound Sodium Lactate Injection BP (Hartmann’s Solution).
The stability of cefuroxime sodium in Sodium Chloride Injection BP 0.9% w/v and in
5% Dextrose Injection is not affected by the presence of hydrocortisone sodium
phosphate.
Cefuroxime sodium has also been found compatible for 24 h at room temperature
when admixed in i.v. infusion with:
Heparin (10 and 50 units/ml) in 0.9% Sodium Chloride Injection; Potassium
Chloride (10 and 40 mEqL) in 0.9% Sodium Chloride Injection.

1.5 g, 750 mg and 250 mg
cefuroxime
Instructions for reconstitution
Addition volumes and solution concentrations, which may be useful when fractional
doses are required.

Marketing Authorisation Number
PL 00004/0263

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

Leaflet date: February 2014
Zinacef is a registered trademark of the GlaxoSmithKline group of companies
© 2014 GlaxoSmithKline 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.
Compatibility
1.5 g cefuroxime sodium constituted with 15 ml Water for Injections 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 h at 4°C or 6 h 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 h 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:
Sodium Chloride Injection BP 0.9% w/v
5% Dextrose Injection BP
0.18% w/v Sodium Chloride plus 4% Dextrose Injection BP
5% Dextrose and 0.9% Sodium Chloride Injection
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
Lactated Ringer’s Injection USP

Pregnancy and breast-feeding and fertility
Package Leaflet: Information for the Patient

Uncommon side effects
These may affect up to 1 in 100 people:
hives)
➔ Tell your doctor

Zinacef ® 1.5 g, 750 mg and 250 mg
cefuroxime

tests:

Read all of this leaflet carefully before you
start using this medicine because it contains
important information for you.

Other formats

leucopenia)

Driving and using machines
Important information about some of the
ingredients of Zinacef

What is in this leaflet:

Product name

Zinacef 1.5 g,
750 mg or 250 mg

Other side effects

fever)

3 How Zinacef is given

1 What Zinacef is and what it is used for

Zinacef is usually given by a doctor or nurse.
drip
injection
The usual dose

(haemolytic anaemia)

erythema multiformae.
➔ Tell your doctor

cephalosporins.
Zinacef is used to treat infections

thrombocytopenia)
Newborn babies (0 - 3 weeks)
For every 1 kg the baby weighs,

2 What you need to know before you
are given Zinacef

Babies (over 3 weeks) and children
For every 1 kg the baby or child weighs,

You must not be given Zinacef :
if you are allergic hypersensitive
cephalosporin antibiotics

If you get any side effects
➔ Tell your doctor or pharmacist.

Adults and adolescents

any

hypersensitive

5 How to store Zinacef

Patients with kidney problems

➔ Tell your doctor before

➔ Talk to your doctor

4 Possible side effects
Take special care with Zinacef
Conditions you need to look out for
Conditions you need to look out for

If you need a blood or urine test

Coombs test
Tell the person taking the sample
Other medicines and Zinacef

severe allergic reaction
raised
and itchy rash, swelling
difficulty in breathing
skin rash,
blister
small targets
a widespread rash
blisters
peeling
skin.
Stevens-Johnson
syndrome toxic epidermal necrolysis
fungal infections

6 Contents of the pack and other
information
What Zinacef contains

What Zinacef looks like and contents of
the pack

Candida
➔ Contact a doctor or nurse immediately if
you get any of these symptoms.
aminoglycoside-type antibiotics
water tablets

Common side effects
These may affect up to 1 in 10 people:

➔ Tell your doctor

➔ Tell your doctor

Contraceptive pills

tests:

Marketing Authorisation Holder and
Manufacturer

enzymes
barrier method
of contraception

neutropenia

eosinophilia)
(anaemia)

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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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