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

देश: ऑस्ट्रेलिया

भाषा: अंग्रेज़ी

स्रोत: Department of Health (Therapeutic Goods Administration)

सक्रिय संघटक:

flucloxacillin, Quantity: 1 g

थमां उपलब्ध:

Aspen Pharmacare Australia Pty Ltd

फार्मास्यूटिकल फॉर्म:

Injection, powder for

रचना:

Excipient Ingredients:

प्रशासन का मार्ग:

Intramuscular, Intravenous, Intraarticular, Intrapleural

चिकित्सीय संकेत:

For the treatment of confirmed or suspected Staphylococcal and other Gram-positive coccal infections. Indications include pneumonia, osteomyelitis, skin and skin structure and wound infections, infected burns and cellulitis.

उत्पाद समीक्षा:

Visual Identification: FINE WHITE TO OFF-WHITE HOMOGENOUS POWDER; Container Type: Vial; Container Material: Glass; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

प्राधिकरण का दर्जा:

Licence status A

प्राधिकरण की तारीख:

2003-01-09

सूचना पत्रक

FLUCIL CMI
Page 1 of 4
FLUCIL INJECTION
_Flucloxacillin sodium_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about FLUCI.
It does not contain all the available information.
It does not take the place of talking to your doctor and pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you receiving FLUCIL
against the benefits this medicine is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT HAVING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET. You may need to read it again.
WHAT FLUCIL IS USED FOR
FLUCIL is an antibiotic used to treat some infections in different
parts of the body caused by bacteria.
FLUCIL will not work against infections caused by viruses, such as
colds.
FLUCIL is an antibiotic that belongs to a group of medicines called
penicillins. These antibiotics work by
killing the bacteria that are causing your infection.
Your doctor may have prescribed FLUCIL
for another reason. Ask your doctor why FLUCIL
has been
prescribed for you.
This medicine is available only with a doctor’s prescription.
There is no evidence that FLUCIL
is addictive.
BEFORE YOU ARE GIVEN FLUCIL
_WHEN YOU MUST NOT BE GIVEN IT _
DO NOT USE FLUCIL IF:
•
YOUR SKIN AND/OR EYES HAVE TURNED YELLOW (JAUNDICE) WHILE, OR SOON
AFTER RECEIVING
FLUCLOXACILLIN (FLUCIL).
•
YOU HAVE AN ALLERGY TO FLUCIL OR OTHER PENICILLINS.
•
Some of the symptoms of an allergic reaction may include skin rash,
itching and difficult breathing.
•
YOU HAVE HAD AN ALLERGIC REACTION TO CEPHALOSPORINS.
•
You may have an increased chance of being allergic to FLUCIL
if you are allergic to cephalosporins.
If you are not sure whether you should be given FLUCIL, talk to your
doctor.
FLUCIL CMI
Page 2 of 4
_BEFORE YOU ARE GIVEN IT_
Flucloxacillin (FLUCIL) can cause jaundice (yellowing of skin and/or
eyes) and severe liver disease
which may last for a long time. This reaction is more frequent in
older patients (particularly those over
55 years of age) and

उत्पाद विशेषताएं

Flucil-inj-pi-27nov19
1
AUSTRALIAN PRODUCT INFORMATION
FLUCIL
FLUCLOXACILLIN (AS FLUCLOXACILLIN SODIUM)
POWDER FOR INJECTION
1
NAME OF THE MEDICINE
Flucloxacillin (as flucloxacillin sodium)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
FLUCIL Powder for Injection 500 mg vials contain flucloxacillin sodium
equivalent to 500 mg of
flucloxacillin.
FLUCIL
Powder
for
Injection
1
g
vials
contain
flucloxacillin
sodium
equivalent
to
1
g
of
flucloxacillin.
Each vial contains 95.0 to 105.0% of the stated amount of
flucloxacillin. Each one gram of
monograph substance represents 2 mmol of sodium.
3
PHARMACEUTICAL FORM
FLUCIL Powder for Injection is a fine white to off-white homogeneous
powder, soluble in water.
The injection is prepared by the addition of the appropriate volume of
Water for Injections to give
the desired concentration of flucloxacillin.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
For the treatment of confirmed or suspected Staphylococcal and other
Gram-positive coccal
infections. Indications include pneumonia, osteomyelitis, skin and
skin structure and wound
infections, infected burns and cellulitis.
4.2
D
OSE AND METHOD OF ADMINISTRATION
USUAL ADULT DOSE
Intramuscular
250 mg, 6-hourly
Intravenous
250 mg to 1 g, 6-hourly
Intrapleural
250 mg once daily
Intra-articular
250 mg to 500 mg once daily
NOTE: Systemic doses may be doubled where necessary in severe
infections.
USUAL CHILDREN'S DOSE
2 to 10 years
Half of the adult dose
under 2 years
Quarter of the adult dose
NOTE: In severe infections the dosage may be increased.
Flucil-inj-pi-27nov19
2
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 see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS
FOR USE.
DOSAGE IN PATIENTS WITH IMPAIRED RENAL FUNCTION
As flucloxacillin is excreted to a large extent by the kidney, the
dose or dose interval may need