FLUCLOXACILLIN SODIUM flucloxacillin 1g (as sodium) powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

flucloxacillin sodium monohydrate

Available from:

Pfizer Australia Pty Ltd

Authorization status:

Registered

Patient Information leaflet

DBL™ FLUCLOXACILLIN
SODIUM FOR INJECTION
_flucloxacillin Injection (floo-klox-a-SILL-in)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DBL Flucloxacillin
Sodium for Injection. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given
flucloxacillin against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT DBL
FLUCLOXACILLIN SODIUM
FOR INJECTION IS USED
FOR
This medicine is an antibiotic that is
used for the treatment of infections in
different parts of the body caused by
bacteria.
This medicine belongs to a group of
medicines known as the penicillins.
It works by killing the bacteria
causing your infection or by stopping
its growth.
It will not work against infections
caused by viruses such as colds or
the flu.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU ARE GIVEN
DBL FLUCLOXACILLIN
SODIUM FOR INJECTION
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU MUST NOT BE GIVEN DBL
FLUCLOXACILLIN SODIUM FOR INJECTION
IF YOU HAVE AN ALLERGY TO:
•
flucloxacillin
•
any other penicillins
•
any of the ingredients listed at the
end of this leaflet
•
any medicines belonging to
another group of antibiotics
called the cephalosporins.
Symptoms of an allergic reaction
may include shortness of breath,
wheezing or difficulty breathing;
swelling of the face, lips, tongue or
other parts of the body; rash, itching
or hives on the skin.
YOU MUST NOT BE GIVEN THIS
MEDICINE IF YOU HAVE A HISTORY OF
LIVER PROBLEMS THAT WERE ASSOCIATED
WITH BEING TREATED WITH
FLUCLOXACILLIN SODIUM MONOHYDR

Summary of Product characteristics

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AUSTRALIAN
PRODUCT
INFORMATION
–
DBL™ FLUCLOXACILLIN
SODIUM
POWDER
FOR
INJECTION
(FLUCLOXACILLIN
SODIUM
MONOHYDRATE)
1.
NAME OF THE MEDICINE
Flucloxacillin sodium monohydrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each injection contains:
DBL
™
Flucloxacillin
Sodium
Powder
for
Injection
contains
1
g
of
flucloxacillin
as
flucloxacillin sodium monohydrate. DBL
™
Flucloxacillin Sodium Powder for Injection is the
sodium
salt
of
flucloxacillin.
Flucloxacillin
sodium
monohydrate
is
3-(2'-chloro-6'-
fluorophenyl)-5-methyl-4-isoxazolylpenicillin monohydrate. It is a
member of the beta-
lactamase-stable group of penicillins derived from the penicillin
nucleus, 6-amino-penicillanic
acid. Flucloxacillin sodium monohydrate is closely related to
cloxacillin.
It should be recognised that each 1 gram of flucloxacillin sodium
monohydrate contains 2.2
mmol of sodium.
For the full list of excipients see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Flucloxacillin sodium monohydrate is a white or almost white,
crystalline powder for injection,
hygroscopic, freely soluble in water and in methanol, soluble in
alcohol.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of confirmed or suspected staphylococcal and other
Gram-positive coccal
infections. Indications include pneumonia, osteomyelitis and skin and
skin structure infections,
such as wound infections, infected burns and cellulitis.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
_USUAL ADULT DOSAGE _
Intramuscular
250 mg 6 hourly
Intravenous
250 mg to 1 g 6 hourly
Intrapleural
250 mg once daily
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Intra-articular
250 mg to 500 mg once daily
NOTE:
Systemic doses may be doubled where necessary in severe infections.
_USUAL CHILDREN'S DOSAGE _
2 to 10 years
1/2 adult dose
under 2 years
1/4 adult dose
NOTE:
In severe infections the dosage may be increased.
METHOD OF ADMINISTRATION
INTRAMUSCULAR:
Dissolve 1 g vial content in 2.5 mL Water for Inj