ZINACEF FOR INJECTION OR INFUSION

Active substance: CEFUROXIME SODIUM

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10000000101890

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Prophylaxis: The usual dose is 1.5 g i.v. with
induction of anaesthesia for abdominal,
pelvic and orthopaedic operations, but may
be supplemented with two 750 mg i.m.
doses eight and sixteen hours later. In cardiac
pulmonary oesophageal and vascular operations, the usual dose is 1.5 g i.v. with
induction of anaesthesia continuing with 750 mg i.m. t.d.s. for a further 24 to 48 hours.
In total joint replacement, 1.5 g cefuroxime powder may be mixed dry with each
pack of methyl methacrylate cement polymer before adding the liquid monomer.

Information for the Healthcare Professional

Sequential therapy:
cefuroxime

Pneumonia:
1.5 g bd (i.v. or im) for 48-72 hours, followed by 500 mg bd Zinnat (cefuroxime axetil)
oral therapy for 7 days.
.
Acute exacerbations of chronic bronchitis:
. .
750 mg bd (i.v. or im) for 48-72 hours, followed by 500 mg bd Zinnat
(cefuroxime axetil) oral therapy for 5-7 days.

1.5 g, 750 mg and 250 mg

Dosage and Administration Information Only
Please refer to the Summary of Product Characteristics for further information

Duration of both parenteral and oral therapy is determined by the severity of
the infection and the clinical status of the patient.

Pharmaceutical Form
Cefuroxime is a white to cream powder to which appropriate amounts of
water are added to prepare an off-white suspension for intramuscular use or
a yellowish solution for intravenous administration.
Posology and method of administration
Intramuscular
Add 1 ml Water for Injections to 250 mg Zinacef or 3 ml Water for Injections
to 750 mg Zinacef. Shake gently to produce an opaque suspension.
Intravenous
Dissolve Zinacef in Water for Injections using at least 2 ml for 250 mg, at least 6 ml
for 750 mg or 15 ml for 1.5 g. For short intravenous infusion (e.g. up to 30 minutes),
1.5 g may be dissolved in 50 ml Water for Injections. These solutions may be given
directly into the vein or introduced into the tubing of the giving set if the patient is
receiving parenteral fluids.
General recommendations
Adults: Many infections will respond to 750 mg t.i.d. by i.m. or i.v. injection. For
more severe infections, this dose should be increased to 1.5 g t.i.d. i.v. The frequency
of i.m. or i.v. injection can be increased to six-hourly if necessary, giving total doses
of 3 g to 6 g daily.

Dosage in impaired renal function
Cefuroxime is excreted by the kidneys. Therefore, as with all such antibiotics,
in patients with markedly impaired renal function it is recommended that the
dosage of Zinacef should be reduced to compensate for its slower excretion.
However, it is not necessary to reduce the dose until the creatinine clearance
falls below 20 ml/min. In adults with marked impairment (creatinine clearance
10-20 ml/min) 750 mg bd is recommended and with severe impairment
(creatinine clearance <10 ml/min) 750 mg once daily is adequate. For patients
on haemodialysis a further 750 mg dose should be given at the end of each
dialysis. When continuous peritoneal dialysis is being used, a suitable dosage
is usually 750 mg twice daily.
For patients in renal failure on continuous arteriovenous haemodialysis or high-flux
haemofiltration in intensive therapy units a suitable dosage is 750 mg twice daily.
For low-flux haemofiltration follow the dosage recommended under impaired renal
function.
Cefuroxime is also available as the axetil ester (Zinnat) for oral administration.
This permits parenteral therapy with cefuroxime to be followed by oral therapy in
situations where a change from parenteral to oral is clinically indicated.

Where clinically indicated adults with pneumonia and acute exacerbations of chronic
bronchitis have been shown to respond to 750 mg or 1.5 g bd, followed by oral
therapy with Zinnat (see Sequential therapy).

Incompatibilities

Infants and children: Doses of 30 to 100 mg/kg/day given as three or four divided
doses. A dose of 60 mg/kg/day will be appropriate for most infections.

The pH of 2.74% w/v sodium bicarbonate injection BP considerably affects the colour
of solutions and therefore this solution is not recommended for the dilution of
Zinacef. However, if required, for patients receiving sodium bicarbonate injection by
infusion the Zinacef may be introduced into the tube of the giving set.

Neonates: Doses of 30 to 100 mg/kg/day given as two or three divided doses. In the
first weeks of life the serum half-life of cefuroxime can be three to five times that
in adults.
Elderly: See dosage in adults.

Cefuroxime is compatible with most commonly used intravenous fluids and
electrolyte solutions.

Zinacef should not be mixed in the syringe with aminoglycoside antibiotics.
Shelf life and special precautions for storage

Other recommendations

Three years when stored below 25ºC and protected from light.

Gonorrhoea: 1.5 g should be given as a single dose. This may be given as 2 x 750 mg
injections into different sites e.g. each buttock.

After constitution, Zinacef should be stored at 2 - 8ºC for no longer than 24 hours.

Meningitis: Zinacef is suitable for sole therapy of bacterial meningitis due to
sensitive strains. The following dosages are recommended:

PL 00004/0263

Infants and children: 200 to 240 mg/kg/day i.v. in three or four divided doses.
This dosage may be reduced to 100 mg/kg/day i.v. after three days or when clinical
improvement occurs.
Neonates: The initial dosage should be 100 mg/kg/day i.v. A reduction to
50 mg/kg/day i.v. may be made when clinically indicated.

Marketing Authorisation Number
Leaflet Date: December 2011
Zinacef and Zinnat are registered trademarks of the GlaxoSmithKline
group of companies
© 2011 GlaxoSmithKline group of companies

Adults: 3 g i.v. every eight hours. Data are not yet sufficient to recommend a dose
for intrathecal administration.

Zinacef ® 1.5 g, 750 mg and 250 mg
cefuroxime

Read all of this leaflet carefully before you
start taking this medicine.
• eep this leaflet. You may need to read it again.
K
• f you have any further questions, ask your
I
doctor or pharmacist.
• his medicine has been prescribed for you.
T
Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
• f any of the side effects gets serious, or if you
I
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1 What Zinacef is and what it is used for
2 Before you have Zinacef
3 How Zinacef is given
4 Possible side effects
5 How to store Zinacef
6 Further information

1 What Zinacef is and what it is used for
What Zinacef is
Zinacef 1.5 g, 750 mg or 250 mg (called ‘Zinacef’
in this leaflet) is a cephalosporin antibiotic
for intravenous (IV) injection or infusion or
intramuscular (IM) infusion. The intravenous
injection or infusion is made into a vein and
intramuscular infusion is made into a muscle.
Zinacef contains a medicine called cefuroxime
(present as cefuroxime sodium).
What Zinacef is used for
Zinacef is used to treat infections in different
parts of the body caused by bacteria.

2 Before you have Zinacef
Do not have Zinacef if you:
• re allergic (hypersensitive) to cefuroxime,
a
cefuroxime sodium or cephalosporin antibiotics
• ave ever had an allergic (hypersensitive)
h
reaction to any antibiotic. This can include a
skin rash or swelling of the face or neck
• have kidney problems
Do not have Zinacef if any of the above apply.
If you are not sure, talk to your doctor, pharmacist
or nurse before having Zinacef.
Meningitis
Please note that like other medicines used to
treat meningitis, Zinacef may take a while to clear
the body of all the meningitis infection. Because
of this, hearing loss caused by meningitis has
occurred in a few patients after using Zinacef to
treat the disease.
Blood tests
If you are having any blood tests, let the doctor or
nurse know that you are on Zinacef. This is because
Zinacef can affect the results of these tests.
.
. .

Taking other medicines
Please tell your doctor or pharmacist if
you are taking or have recently taken
any other medicines. This includes
medicines that can be bought without
a prescription and herbal medicines.
This is because Zinacef can affect the
way some other medicines work. Also
some other medicines can affect the
way Zinacef works.

Zinacef should not be taken without first
discussing this with your doctor if you
are also taking:
• ater tablets (diuretics) such as furosemide
w
If you still need to have Zinacef, you will have
regular tests to check your kidneys.
• minoglycoside-type antibiotics such as
a
neomycin or gentamycin
Zinacef may stop the contraceptive pill working.
You will need to use extra contraceptive
precautions, such as using a condom. If you need
any advice, talk to your doctor or pharmacist.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before
taking any medicine if you think you might be or
if you are pregnant or if you are breast-feeding.

3 How Zinacef is given
You will never give yourself this medicine. A
qualified person, like a doctor or a nurse, will give
you this medicine.
• he correct dose of Zinacef will be decided
T
by your doctor and depends on the type
of infection, whether you are on any other
antibiotics and your weight and age.
• f your condition has not improved within
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72 hours of receiving treatment, the doctor will
review your treatment.
• inacef will usually be given by a doctor or
Z
nurse either directly into a vein (IV) or into a
muscle (IM). In some cases, it may be added
to a “drip” or intravenous infusion. Zinacef is
made up by adding the following amount of
Water for Injections or other recommended
diluting solution.
Vial size
250 mg
750 mg
1.5 g
short
1.5 g
infusion
(up to 30
minutes)

Intramuscular Intravenous Intravenous
injection
injection
infusion
(suspension) (solution)
(solution)
1 ml
3 ml
---

at least 2 ml
at least 6 ml
15 ml

-------

---

---

50 ml

The usual doses are given below.
Adults
• ost infections: 750 mg three times a day by
M
IM or IV.
• ore severe infections: 1.5 g three times a
M
day IV.
The frequency of the IM or IV injection can be
increased to 6 hourly if necessary, giving total
doses of between 3 g and 6 g per day.
• neumonia: 1.5 g twice a day IV or IM for
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48 to 72 hours followed by treatment with
another medicine, Zinnat® Tablets (500 mg
twice a day for 7 days).
The duration of treatment with Zinacef or
Zinnat will depend on how severe your
infection is and how well you are responding
to the treatment.
• hronic bronchitis: 750 mg twice a day IV or
C
IM for 48 to 72 hours followed by treatment
with another medicine, Zinnat Tablets (500 mg
twice a day for 5 to 7 days).
The duration of treatment with Zinacef or
Zinnat will depend on how severe your
infection is and how well you are responding
to the treatment.
• onorrhoea (a sexually transmitted
G
disease): a single 1.5 g dose. This may be
given as 2 x 750 mg injections.
• Meningitis: 3 g by IV every 8 hours.
• o stop infections during and after
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abdominal, pelvic or orthopaedic surgery:
1.5 g by IV when you have your anaesthetic.
It may be supplemented with 2 x 750 mg IM
doses 8 and 16 hours later.
• o stop infections during and after total
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joint replacement surgery: 1.5 g of unmade
up powder may be mixed with the material
used to make the joint.
• o stop infections during and after cardiac,
T
pulmonary, oesophageal and vascular
surgery: 1.5 g by IV when you have your
anaesthetic. It may be supplemented with
750 mg IM three times a day for a further 24
to 48 hours.
Babies over one month and Children
• ost infections: 60 mg per kilogram of the
M
child’s body weight per day. Doses will be
given in 3 to 4 divided doses. Doses of 30 mg
to 100 mg per kilogram of the child’s body
weight per day may be given.

• eningitis: 200 mg to 240 mg by IV per
M
kilogram per day in 3 or 4 divided doses.
This may be reduced to 100 mg per kilogram
per day IV after 3 days or when the baby or
child starts to get better.
Newborn babies up to one month
• ost infections: 30 mg to 100 mg per
M
kilogram of the child’s body weight per day
may be given in 2 to 3 divided doses.
• eningitis: The initial dose will be 100 mg by
M
IV per kilogram of the child’s body weight per
day. However, the doctor may prescribe 50 mg
by IV per kilogram per day.
Elderly patients and patients with kidney
problems
If you are elderly or have kidney problems:
• ou may be given a different dose to the usual
y
dose. The doctor or nurse will advise how
much Zinacef you will need, depending on the
severity of any kidney disease
• our doctor will keep a close check on you and
y
you may have more regular kidney function tests.
If you have too much Zinacef
It is unlikely you will be given too much, but if
you think you have been given too much Zinacef,
tell your doctor, pharmacist or nurse immediately.
Signs might include fits (convulsions).
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4 Possible side effects
Like all medicines, Zinacef can cause side effects,
although not everybody gets them.
Very rarely, a sudden and severe allergic
reaction to Zinacef can occur. If you get any
of the following symptoms tell your doctor,
pharmacist or nurse immediately:
• welling of the face, lips, tongue or other parts
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of the body.
• reathing difficulties.
B
Other side effects include:
The following is uncommon (affects less than 1 in
100 people)
• igh temperature (fever), chills, a sore throat
h
or other signs of an infection or if they bruise
more easily. These may be signs of a problem
with your blood cells.
The following are very rare (affects less than
1 in 10,000 people)
• nflammation of the large bowel (colon) with
i
diarrhoea sometimes containing blood, pain
and fever
• skin reaction known as ‘erythema multiforme’
a
where you may develop: itchy reddish-purple
patches on the skin especially on the palms of
the hands or the soles of the feet, ‘hive-like’
raised swollen areas on the skin, tender areas
of the surfaces of the mouth, eyes and private
parts. You may have a fever and be very tired
• ther severe skin reactions can include:
o
changes in skin colour, bumps under the skin,
blistering, pustules, peeling, redness, pain, itch,
scaling. These may be associated with fever,
headaches and body aches
• ash or pinpoint flat red round spots under the
r
skin surface or bruising of the skin. This is due
to inflammation of blood vessel walls due to an
allergic reaction. It can be associated with joint
pain (arthritis) and kidney problems
If any of the above happen to you speak to
your doctor or nurse straight away as your
medicine should be stopped.
Sometimes you may get less severe skin
reactions such as:
• mildly itchy rash (round, pink-red patches),
A
‘hive-like’ swollen areas on forearms, legs,
palms, hands, or feet. This is uncommon
(affects less than 1 in 100 people).
If you have this talk to your doctor or nurse
as Zinacef will need to be stopped.

Uncommon (affects less than 1 in 100 people)
• skin rashes
• itching
• alse positive red blood cell status tests
f
(Coombs or rhesus test)
• decrease in the number of red blood cells in
a
your blood, a symptom may be tiredness
• feeling sick (nausea)
• diarrhoea
• stomach pain
Rare (affects less than 1 in 1,000 people)
• hrush (a yeast infection of the vagina, mouth
t
or skin folds), you can get treatment for thrush
from your doctor or pharmacist
• he blood may take longer to clot than it
t
normally would. You may notice this if you
have a nosebleed or cut yourself
• fever associated with an allergic reaction
a
which disappears on discontinuation
Very rare (affects less than 1 in 10,000 people)
• n excessive breakdown of red blood cells
a
causing a form of anaemia. Signs include:
tiredness, headaches, shortness of breath,
dizziness, looking pale and yellowing of the
skin and the whites of the eyes
• inflammation of blood vessels in the skin
• kidney problems.
If any of the side effects get serious, or if you have
any side effects not listed in this leaflet, please
tell your doctor or pharmacist.

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.

6 Further information
What Zinacef contains
• he active substance is 1.5 g, 750 mg or
T
250 mg of cefuroxime (present as cefuroxime
sodium).
• here are no other ingredients. However, see
T
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 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: GlaxoSmithKline
UK, 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

Z
inacef 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.

The other possible side effects are:

Leaflet Date: August 2009

Common (affects less than 1 in 10 people)
• hanges to your white blood cells which might
c
make you more susceptible to infections
• brief rise in the amount of liver enzymes in
a
your body which might show up if you have a
blood test
• ain or inflammation at the site of the injection.
p

Zinnat and Zinacef are registered trademarks of
the GlaxoSmithKline group of companies
© 2009 GlaxoSmithKline group of companies
.
. .

10000000101890

Package leaflet: Information for the patient

Important information about one of the
ingredients of Zinacef
Zinacef 1.5 g contains 81.29 mg of sodium.
Zinacef 750 mg contains 40.65 mg of sodium.
Zinacef 250 mg contains 13.55 mg of sodium.
This should be considered if you are on a
controlled sodium diet.

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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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