Flucil

País: Nueva Zelanda

Idioma: inglés

Fuente: Medsafe (Medicines Safety Authority)

Ingredientes activos:

Flucloxacillin sodium monohydrate 524mg equivalent to flucloxacillin 500 mg

Disponible desde:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

Designación común internacional (DCI):

Flucloxacillin sodium 524 mg (equivalent to flucloxacillin 500 mg)

Dosis:

500 mg

formulario farmacéutico:

Powder for injection

Composición:

Active: Flucloxacillin sodium monohydrate 524mg equivalent to flucloxacillin 500 mg

tipo de receta:

Prescription

Fabricado por:

Fresenius Kabi Anti-Infectives S.r.l.

indicaciones terapéuticas:

Flucil is indicated for the treatment of skin and soft tissue infections caused by susceptible organisms and infections due to penicillinase producing staphylococci and for mixed streptococcal and staphylococcal infections where the staphylococci are resistant to penicillin. For example, infections of the joints, respiratory tract and urinary tract, otitis media, endocarditis, septicaemia, and meningitis. Flucil is also used in the prophylaxis of staphylococcal infections during major surgical procedures, particularly in cardiothoracic or orthopaedic surgery.

Resumen del producto:

Package - Contents - Shelf Life: Vial, glass, 10 mL with bromobutyl rubber closure and grey flip off aluminium seal - 5 dose units - 36 months from date of manufacture stored at or below 25°C protect from light and moisture

Fecha de autorización:

2012-07-20

Información para el usuario

New Zealand Consumer Medicine Information
FLUCIL Injection
1
FLUCIL INJECTION
_FLUCLOXACILLIN SODIUM MONOHYDRATE _
500 mg & 1 g, powder for injection
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using FLUCIL.
This leaflet answers some common questions about FLUCIL. 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 using
FLUCIL against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
Keep this leaflet with the medicine. You may need to read it again.
WHAT FLUCIL IS USED FOR
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.
FLUCIL is an antibiotic used to treat some infections in different
parts of the body
caused by bacteria. It is used to:
•
treat skin and soft tissue infections caused by bacteria which are
resistant to
penicillin.
e.g. infections of the joints, respiratory tract, urinary tract,
inflammation (pain,
heat, swelling or redness) of the middle ear, inflammation of the
endocardium
(a membrane that covers the inside surface of the heart), infected
blood and
meningitis.
•
prevent infections resulting from surgery, in particular chest, bone
and joint
procedures.
Flucil is also used in the prophylaxis of staphylococcal infections
during major
surgical procedures, particularly in cardiothoracic or orthopaedic
surgery.
FLUCIL will not work against infections caused by viruses, such as
colds.
Your doctor may have prescribed FLUCIL for another reason.
FLUCIL Injection
2
Ask your doctor if you have any questions about 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 FLUCIL _
Do not use

Ficha técnica

FLUCIL Injection – Data Sheet
1 / 11
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
FLUCIL
Powder for Injection 500 mg & 1 g
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
FLUCIL Powder for Injection 500 mg vials contain flucloxacillin sodium
monohydrate equivalent
to 500 mg of flucloxacillin.
FLUCIL Powder for Injection 1 g vials contain flucloxacillin sodium
monohydrate 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
THERAPEUTIC INDICATIONS
FLUCIL is indicated for the treatment of skin and soft tissue
infections caused by susceptible
organisms
and
infections
due
to
penicillinase
producing
staphylococci
and
for
mixed
streptococcal and staphylococcal infections where the staphylococci
are resistant to penicillin.
For example, infections of the joints, respiratory tract and urinary
tract, otitis media, endocarditis,
septicaemia, and meningitis.
FLUCIL is also used in the prophylaxis of staphylococcal infections
during major surgical
procedures, particularly in cardiothoracic or orthopaedic surgery.
4.2
DOSE 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
Children have been give doses of 12.5 mg/kg body weight four times a
day.
FLUCIL Injection – Data Sheet
2 / 11
DOSAGE IN PATIENTS WITH IMPAIRED LIVER FUNCTION
Adjustment of dosage may not be necessary as flucloxacillin is not
metabolised in the liver to an