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CEFAZOLIN 2 G POWDER FOR SOLUTION FOR INJECTION / INFUSION

Active substance(s): CEFAZOLIN SODIUM

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Package leaflet: Information for the user
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.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are
the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this
leaflet.

Cefazolin 2 g

powder for solution for injection / infusion
Cefazolin
What is in this leaflet:

Use in children and adolescents

1. What Cefazolin 2 g is and what it is used for
2. What you need to know before you use Cefazolin 2 g
3. How to use Cefazolin 2 g
4. Possible side effects
5. How to store Cefazolin 2 g
6. Contents of the pack and other information

Newborn infants and infants below the age of one month:

1. What Cefazolin 2 g is and what it is used for
This medicine contains the active substance cefazolin, which is an
antibiotic. Cefazolin 2 g is used to treat bacterial infections caused by
cefazolin-susceptible bacteria, e.g:
• Infections of skin and soft tissue
• Infections of bones and joints
Cefazolin can also be used before, during and after surgery to prevent
possible infections.

2. W
 hat you need to know before you use Cefazolin
2g

The safety in infants below the age of one month has not been
determined.

Children over the age of one month:
• Infections caused by bacteria susceptible to this medicine:
25 - 50 mg per kg body weight per day divided in 2-4 single doses,
every 6, 8 or 12 hours.
• Infections caused by bacteria less susceptible to this medicine:
Up to 100 mg cefazolin/kg body weight/day divided in 3-4 single
doses, every 6-8 hours.
This product is not recommended for children under 1 month of life.

Elderly patients
No dosage adjustment is required for elderly patients with normal
renal function.

Special dosage recommendations

Do not use Cefazolin 2 g if you

Prevention of infections during surgical procedures
1 g cefazolin 30 - 60 minutes before surgery.
In case of long surgical procedures (2 hours or more), additional
0.5 g - 1 g cefazolin during the operation.

Warnings and precautions

Patients with impaired kidney function
In patients with impairment of the kidney function, the elimination of
cefazolin is slower. For this reason, your doctor will adjust the dosage
according to the severity of the kidney impairment by reducing the
maintenance dose or prolongation of the dosage intervals.

• are allergic (hypersensitive) to any cephalosporin antibiotics.
• have ever had a severe allergic (hypersensitive) reaction to any
other type of betalactam antibiotic (penicillins, monobactams and
carbapenems).
Talk to your doctor before using Cefazolin 2 g if you
• are prone to allergic reactions (e.g. hay fever or bronchial asthma),
since then the risk of severe allergic reactions to Cefazolin 2 g is
increased.
• have had previously an allergic reaction to other beta-lactam
antibiotics (e.g. penicillins), since then there is an increased risk of
being allergic to Cefazolin 2 g as well.
• suffer from an impaired kidney or liver function.
• suffer from disorders of blood clotting (e.g. haemophilia) or your
present condition can lead to such defects (parenteral feeding,
malnutrition, liver or kidney diseases, reduction in blood platelets
which increases risk of bleeding or bruising (thrombocytopenia),
administration of medicines that prevent blood clotting
(anticoagulants like heparin)).
• suffer from diseases which can cause bleedings (e.g. gastrointestinal
ulcers).
• suffer from severe persistent diarrhoea during or after treatment
with Cefazolin 2 g. In this case contact your doctor immediately.
Do not take any anti-diarrhoea medicine without consulting your
doctor.

Children

• Cefazolin may not be used in newborn infants and infants below the
age of 1 month as the safety of use has not yet been established
in this group

Other medicines and Cefazolin 2 g

Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription.
Your doctor will take special care if you are using any of the following
medicines:
• Anticoagulants (medicines that prevent blood clotting): Cefazolin
may very rarely lead to disorders of blood clotting. Therefore, if
you simultaneously receive cefazolin and medicines that prevent
blood clotting (e. g. heparin), a careful and regular control of the
coagulation factors is necessary.
• Probenecid (medicine for the treatment of joint disease and gout).
• Medicines potentially harmful to kidney: Cefazolin may intensify
the harmful effect of certain antibiotics (aminoglycosides) and
of medicines that cause increase in urination (diuretics, e.g.
furosemide) on the kidney. Using Cefazolin 2 g and one of these
medicines at the same time requires regular monitoring of the
kidney function, especially in patients with kidney disease.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby, ask your doctor for advice before using
this medicine.
Cefazolin crosses the placenta and can affect the unborn child. Therefore,
if you are pregnant, your doctor should only give you cefazolin if clearly
necessary and after careful consideration of benefits and risks.
Cefazolin passes in small amounts into breast milk. Therefore, breastfeeding should be discontinued during treatment with Cefazolin 2 g.

Driving and using machines

Cefazolin 2 g has no or negligible influence on the ability to drive and
use machines.

3. How to use Cefazolin 2 g
Administration:

Cefazolin 2 g is always administered by healthcare personnel. It will be
given as an injection or infusion (into a vein) after being dissolved. Your
doctor will inform you about the necessary duration and frequency of
administration of Cefazolin 2 g.

The recommended doses are:
Adult patients with normal kidney function
• Infections caused by bacteria susceptible to this medicine:
1-2 g daily, divided into 2-3 doses.
• Infections caused by bacteria less susceptible to this medicine:
3-4 g daily, divided into 3-4 doses.
An increase of the daily dose up to 6 g in three or four equal doses
is possible.

Duration of treatment
The treatment duration depends on the severity of the infection as
well as on your recovery from your illness.

If a dose of Cefazolin 2 g has been forgotten
A double dose must not be given to make up for a forgotten dose. A
forgotten dose should only be given before the next regular dose if the
time until the next regular dose is long enough.

If too much of Cefazolin 2 g has been used:
Symptoms of overdose are headache, dizziness (vertigo), sensation of
pricking or tingling on the skin (paraesthesia), restlessness (agitation),
involuntary twitching of a muscle or a group of muscles (myoclonia)
and cramps (convulsions). Contact your physician if these symptoms
occur!
In emergencies, your physician must take the necessary measures for
the treatment of symptoms of overdose.

If the treatment with Cefazolin 2 g is interrupted or
discontinued too early
Low dosage, irregular administration or stopping the treatment
too early can compromise the outcome of the therapy or lead to a
relapse, that is more difficult to treat. Please follow the instructions
of your doctor.
If you have any further questions on the use of this medicine, ask your
doctor, pharmacist or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.

You must stop taking the medicine and speak to your doctor
straight away if you notice any of these symptoms:
Uncommon side effects (occurring in 1 to 10 out of 1,000 treated
patients) are:
• redness of the skin (erythema), widespread skin rash (erythema
multiforme or exanthema), hives (red, itchy, bumpy skin rash) on
the surface of the skin (urticaria), fever, swelling beneath the skin
(angioedema) and/or swelling of the lung tissue possibly with a cough
and breathing difficulties (interstitial pneumonia or pneumonitis), as
these side effects may indicate an allergic reaction to this medicine.
Rare (occurring in 1 to 10 out of 10,000 treated patients)
• jaundice (yellow colour in the skin and whites of the eyes)
• severe skin rash with flushing, fever, blisters or ulcers (Stevens
Johnson syndrome) or a severe rash with reddening, peeling and
swelling of the skin that looks like a burn (toxic epidermal necrolysis).
Very rare (occurring in less than 1 out of 10,000 treated patients)
• a severe allergic reaction (anaphylactic shock) with breathing
difficulty , swelling of the throat, face, eyelids or lips, increased
heart rate and falling blood pressure. This reaction may start soon
after you first take the medicine, or it might start later.
The following side effect has been reported but its frequency of
occurrence is unknown:
• severe and frequent diarrhoea, sometimes containing blood, as this
may indicate a more serious condition (pseudomembranous colitis).
The following side effects may also occur during the use of cefazolincontaining products:

Common side effects, occurring in 1 to 10 out of 100
treated patients:
• mild gastrointestinal disturbances ( loss of appetite, diarrhoea,
nausea, vomiting, severe and frequent diarrhoea). These side
effects usually resolve after a few days.
• injection into the muscle may cause pain at the location of the
injection which may sometimes include hardening of the skin and
soft tissue at the same site.

Uncommon side effects, occurring in 1 to 10 out of 1,000
treated patients:
• oral thrush (thick white or cream-coloured deposits in the mouth
and tongue).
• fits/convulsions in patients with kidney problems.
• swelling of a vein caused by a blood clot forming following injection
into the muscle (thrombophlebitis).

Rare side effects, occurring in 1 to 10 out of 10,000
treated patients:
• b
 acterial infection of male or female genitals with symptoms such as
itching, redness, swelling and female discharge (genital candidasis,
monoliasis, vaginitis).
• increase or decrease in blood glucose concentration (hyperglycemia
or hypoglycemia).
• reversible blood abnormalities including the reduction or
increase in the number of red and white blood cells (leukopenia,
granulocytopenia, neutropenia, thrombocytopenia, leukocytosis,
granulocytosis, monocytosis, lymphocytopenia, basophilia and
eosinophilia) which may cause bleeding, easy bruising and/or skin
discolouration (confirmed by blood test).
• feelings of dizziness, tiredness and a general feeling of being unwell.
• chest pain, excess fluid in the lungs, shortness of breath, cough,
stuffy nose (rhinitis).
• liver problems (such as alkaline phosphatise or transient hepatitis)
with symptoms such as an increase in liver enzymes (alanine
transaminase (ALT), aspartate transaminase (AST), gammaglutamyl transpeptidase (gamma GT) and lactate dehydrogenase
(LDH)) and bilrubin (a product of the breakdown of blood cells) in
bile or urine (diagnosed by blood test).
• kidney problems (nephrotoxicity, interstitial nephritis, undefined
nephropathy, proteinuria) with symptoms such as kidney swelling
and an increase of nitrogen in the body that may be diagnosed by
urine tests, usually only occurring in patients taking cefazolin at the
same time as other medicines that can cause kidney problems.

Very rare side effects, occurring in less than 1 out of
10,000 treated patients:
• itching of the anus or genitalia (pruritus).
• blood not clotting properly which may result in increased bleeding.
This may be resolved by increasing vitamin K intake and should be
confirmed by blood test (see section 2).

Side effects with unknown frequency
• long-term or repeated treatment with Cefazolin may lead to further
infection by Cefazolin resistant fungi or bacteria (superinfection).
• sleep disorders including nightmares and being unable to sleep
(insomnia).
• feelings of nervousness or anxiety, drowsiness, weakness, hot
flushes, disturbed colour vision, vertigo and epileptic seizures
(involuntary rapid and repeated muscle contraction and relaxation).
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any side effects not listed in this leaflet.

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes
any possible side effects not listed in this leaflet. You can also report
side effects directly via 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 Cefazolin 2 g
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is stated on the
outer carton and the label after ”EXP“. The expiry date refers to the
last day of that month.
Do not store above 30°C. Keep the vial in the outer carton in order
to protect from light.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.

6. Contents of the pack and other information

Intravenous injection:
2 g dry powder are dissolved in at least 10 ml water for injection or a
compatible solvent (see below).
Reconstitution table for intravenous injection
Content per vial

Minimum amount of
diluent to be added

Approximate
concentration

2g

10 ml

200 mg/ml

Cefazolin is to be injected slowly over three to five minutes. In no case
should the solution be injected in less than 3 minutes. This should be
done directly into the vein or into the tube from which the patient
receives intravenous solution.
Single doses exceeding 1 g should be given as intravenous infusion
over 30 to 60 minutes.
Intravenous infusion
2 g dry powder is dissolved in 8 ml water for injections and diluted to
50-100 ml with a compatible diluent.
Dilution table for intravenous infusion
Content
per vial

Dilution

Minimum amount of
diluent to be added

Amount of diluent
to be added

8 ml

50 ml 100 ml

2g

• The active substance is cefazolin. Each vial contains 2 g cefazolin
(as cefazolin sodium).
• There are no other ingredients.

What Cefazolin 2 g looks like and contents of the pack
White or almost white powder.
Cefazolin 2 g is available in packages with 1, 5 or 10 colourless glass
vials (15 or 100 ml) with a chlorobutyl rubber stopper and a flip-off
cap. Not all pack sizes may be marketed.

Marketing authorisation holder
MIP Pharma GmbH
Kirkeler Straße 41
66440 Blieskastel
Germany
Tel. +49 (0) 6842 9609 0
Fax +49 (0) 6842 9609 355

Manufacturer

MIP Pharma GmbH
Kirkeler Str. 41
66440 Blieskastel
Germany
This leaflet was last revised 21/02/2014.
-------------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only:

Mode of application

Compatibility with intravenous liquids
The following solvents are suitable for preparation of the solution:
• water for injections
• 9 mg/ml (0.9 %) sodium chloride solution
• 50 mg/ml (5%) glucose solution
The reconstituted solution is clear, pale yellow and should be protected
from light.
Only clear solutions, free from particles, must be used.

Storage after reconstitution
Shelf-life of the prepared infusion solution
The chemical and physical stability of the prepared solution is 12
hours at 25°C and 24 hours at 2-8°C. From a microbiological point
of view, the prepared solution should be used immediately. If not used
immediately, in-use storage times and conditions are the responsibility
of the user.
The reconstituted product is for single use only. Any unused medicinal
product or waste material should be disposed of in accordance with
local requirements.

Adult patients with renal impairment
Creatinine clearance
[ml/min]

Serum creatinine
[mg/dl]

Dosage

≥ 55

≤ 1.5

Normal dose and normal
dosage interval

35 - 54

1.6 - 3.0

Normal dose, every
8 hours

11 - 34

3.1 - 4.5

Half of the normal dose
every 12 hours

≤ 10

≥ 4.6

Half of the normal dose
every 18-24 hours

Guidelines for paediatric dosage
The content of 1 vial (2000 mg cefazolin) is dissolved in 10 ml of
a compatible solvent (i.e. concentration approx. 200 mg/ml). The
respective volume of this solution to be used is indicated in the
following table in addition to the dose in mg.
Alternatively, the dosage can be given as intravenous infusion, using
the diluted solution (10 mg/ml) described above.
5 kg

10 kg

15 kg

20 kg

25 kg

Divided dose every
63 mg;
12 hours at 25 mg / kg
0.3 ml
body weight per day

125 mg; 188 mg; 250 mg; 313 mg;
0,65 ml 0.95 ml 1.3 ml
1.55 ml

Divided dose every
8 hours at 25 mg / kg
body weight per day

42 mg;
0.2 ml

85 mg;
0.4 ml

125 mg; 167 mg; 208 mg;
0.65 ml 0.85 ml 1.05 ml

Divided dose every
6 hours at 25 mg / kg
body weight per day

31 mg; 62 mg;
0.15 ml 0.3 ml

94 mg; 125 mg; 156 mg;
0.45 ml 0.65 ml 0.8 ml

Divided dose every
125 mg; 250 mg; 375 mg; 500 mg; 625 mg;
12 hours at 50 mg / kg
0.65 ml 1.3 ml
1.9 ml
2.5 ml
3.15 ml
body weight per day
Divided dose every
8 hours at 50 mg / kg
body weight per day

83 mg;
0.4 ml

166 mg; 250 mg; 333 mg; 417 mg;
0.85 ml 1.3 ml
1.65 ml 2.1 ml

Divided dose every
6 hours at 50 mg / kg
body weight per day

63 mg;
0.3 ml

125 mg; 188 mg; 250 mg; 313 mg;
0.65 ml 0.95 ml 1.3 ml
1.55 ml

Divided dose every
167 mg; 333 mg; 500 mg; 667 mg; 833 mg;
8 hours at 100 mg / kg
0.85 ml 1.7 ml
2.5 ml
3.5 ml
4.15 ml
body weight per day
Divided dose every
125 mg; 250 mg; 375 mg; 500 mg; 625 mg;
6 hours at 100 mg / kg
0.65 ml 1.3 ml
1.9 ml
2.5 ml
3.15 ml
body weight per day

Paediatric patients with renal impairment
Children with renal impairment (like adults) may need a lower dose to
avoid overlapping.
This lower dose may be guided by determining blood levels. If not
possible, the dosage of creatinine clearance may be determined
according to the following guidelines.
In children with moderate impairment (creatinine clearance 40-20 ml /
min), 25% of the normal daily dose, divided into doses every 12 hours
are sufficient.
In children with severe impairment (creatinine 20-5 ml / min) will be
10% of normal daily dose, given every 24 hours are sufficient.
All these guidelines are valid after an initial starting dose.
2014/02 GBR

Cefazolin 2 g for injection or infusion may be administered by slow
intravenous injection or by intravenous infusion after dilution.
For each route of administration see the table for addition volumes
and solution concentrations, which may be useful when fractional
doses are required.

 4 mg/ml 3
19 mg/ml

If smaller doses are needed, it is recommended to use half of the
reconstituted solution (about 4 ml with 1 g cefazolin; i.e. half of the
vial content) and to add a compatible diluent to a final volume of
100 ml (resulting concentration about 10 mg/ml). The required
amount of this diluted solution can then be administered to the patient
over the prescribed time.

Body weight

What Cefazolin 2 g contains

Approximate
concentration

Reconstitution

Cefazolin 2g UK - 210 x 440 mm

Expand view ⇕

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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