FLUBICLOX flucloxacillin (as sodium)1g powder for injection vial

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

flucloxacillin, Quantity: 1 g

Διαθέσιμο από:

Juno Pharmaceuticals Pty Ltd

Φαρμακοτεχνική μορφή:

Injection, powder for

Σύνθεση:

Excipient Ingredients:

Οδός χορήγησης:

Intravenous, Intramuscular, Intrapleural, Intraarticular

Μονάδες σε πακέτο:

1 x 5 vials, 10 vials

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

Treatment of confirmed or suspected staphylococcal infections and other Gram-positive coccal infections including pneumonia, skin and skin structure and wound infections, infected burns and cellulitis.

Περίληψη προϊόντος:

Visual Identification: CLEAR GLASS VIALS CONTAINING A WHITE TO OFF-WHITE POWDER; Container Type: Vial; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2003-02-14

Φύλλο οδηγιών χρήσης

FLUBICLOX™ FOR INJECTION
Flucloxacillin for Injection
_(floo-klox-s-SILL-in) _
_ _
CONSUMER MEDICINE INFORMATION
_ _
_Consumer Name _
_ _
_Consumer Address _
_ _
_Date of Dispensing _
_ _
_Pharmacist Name _
_ _
_Pharmacist Address _
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WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
FLUBICLOX.
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 taking
FLUBICLOX against the
benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS
ABOUT BEING GIVEN THIS
MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET IN A SAFE
PLACE
You may need to read it
again.
WHAT IS FLUBICLOX
USED FOR
FLUBICLOX is an antibiotic
that belongs to a group of
medicines called penicillins.
These antibiotics work by
killing the bacteria that are
causing your infection.
FLUBICLOX, like other
antibiotics, 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
FLUBICLOX
_ _
_WHEN YOU MUST NOT BE GIVEN _
_IT _
DO NOT USE FLUBICLOX IF:
1. You have had an allergic
reaction to flucloxacillin or
other penicillins. Symptoms
of an allergic reaction may
include skin rash, itching,
difficulty breathing or
swelling.
2. You have had an allergic
reaction to cephalosporin
antibiotics.
You may have an increased
chance of being allergic to
FLUBICLOX if you are
allergic to cephalosporins.
3. You have a previous
history of inflammation of the
liver or yellow skin caused by
flucloxacillin.
4. The packaging is torn or
shows signs of tampering.
5. The expiry date (exp)
printed on the pack has
passed. If you use this
medicine after the expiry date
has passed, it may not work
as well.

Αρχείο Π.Χ.Π.

Australian Product Information
PI v 1.0
Page | 1
AUSTRALIAN PRODUCT INFORMATION
FLUBICLOX -_ (FLUCLOXACILLIN (AS SODIUM) FOR INJECTION) _
_ _
1 NAME OF THE MEDICINE
The name of the medicine is Flubiclox and it contains the active
ingredient flucloxacillin as the
sodium salt.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Flubiclox is a white to off-white powder contained in a clear glass
vial.
Each vial contains 95- 105% of the stated amount of flucloxacillin.
Each gram of flucloxacillin sodium monohydrate contains approximately
2 mmol of sodium.
Each 2 g product vial contains 2g flucloxacillin (as flucloxacillin
sodium monohydrate) and
approximately 4.52 mmol (104 mg) sodium.
This product contains no excipients.
3. PHARMACEUTICAL FORM
Flucloxacillin 500 mg powder for injection.
Flucloxacillin 1 gram powder for injection.
Flucloxacillin 2 gram powder for injection.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of confirmed or suspected staphylococcal infections and
other Gram-positive coccal
infections including pneumonia, skin and skin structure and wound
infections, infected burns
and cellulitis.
4.2 DOSE AND METHOD OF ADMINISTRATION
_USUAL ADULT DOSAGE: _
_Intramuscular: _
250 mg 6 hourly.
_IV injection/infusion: _
250 mg to 1 g 6 hourly.
_Intrapleural: _
250 mg once daily.
_Intra-articular: _
250 to 500 mg once daily.
NOTE
: Systemic doses may be doubled where necessary in severe infections.
Australian Product Information
PI v 1.0
Page | 2
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_CHILDREN'S DOSAGE: _
2 to 10 years: half adult dose. Under 2 years: quarter adult dose.
NOTE
: In severe infections dosage may be increased.
_ _
_DOSAGE IN PATIENTS WITH IMPAIRED LIVER FUNCTION: _
Adjustment of dosage may not be necessary
as flucloxacillin is not metabolised in the liver to any appreciable
extent. However, during
prolonged treatment it is advisable to check periodically for hepatic
dysfunction.
_ _
_DOSAGE IN PATIENTS WITH IMPAIRED RENAL FUNCTION: _
As flucloxacillin is excreted to a large extent
by the kidney, the dose or dose interval