FLUBICLOX flucloxacillin (as sodium) 2g powder for injection vial

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

flucloxacillin sodium monohydrate, Quantity: 2176 mg (Equivalent: flucloxacillin, Qty 2000 mg)

Disponible desde:

Juno Pharmaceuticals Pty Ltd

formulario farmacéutico:

Injection, powder for

Composición:

Excipient Ingredients:

Vía de administración:

Intravenous, Intravenous Infusion

Unidades en paquete:

1, 10

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

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.

Resumen del producto:

Visual Identification: White to off white powder.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Estado de Autorización:

Registered

Fecha de autorización:

2019-05-23

Información para el usuario

FLUBICLOX
1
FLUBICLOX INJECTION
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I BEING GIVEN FLUBICLOX?
FLUBICLOX contains the active ingredient flucloxacillin sodium
monohydrate. FLUBICLOX is an antibiotic used to treat some
infections in different parts of the body caused by bacteria.
For more information, see Section 1. Why am I being given FLUBICLOX?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN FLUBICLOX?
Do not use if you have ever had an allergic reaction to FLUBICLOX,
other penicillins or any of the ingredients listed at the end
of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I am
given FLUBICLOX?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with FLUBICLOX and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW AM I GIVEN FLUBICLOX?
FLUBICLOX will be given to you by a doctor or nurse. Your doctor will
decide what the dose is and how long you will receive
FLUBICLOX. This depends on your infection and other factors, such as
your weight. For most infections, FLUBICLOX is usually
given in divided doses throughout the day.
More instructions can be found in Section 4. How am I given FLUBICLOX?
in the full CMI.
5.
WHAT SHOULD I KNOW AFTER RECEIVING FLUBICLOX?
THINGS YOU
SHOULD DO
•
If the symptoms of your infection do not improve within a few days, or
if they become worse, tell your
doctor.
•
If you develop itching with swelling or skin rash or difficulty
breathing after you have been given
FLUBICLOX, contact your doctor immediately.
•
If you develop yello

Ficha técnica

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
_ _
_ _
_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