DBL™ Flucloxacillin Sodium Powder for Injection

Nazione: Nuova Zelanda

Lingua: inglese

Fonte: Medsafe (Medicines Safety Authority)

Principio attivo:

Flucloxacillin sodium monohydrate 1.05 g Equivalent to 1 g flucloxicillin.;  

Commercializzato da:

Pfizer New Zealand Limited

INN (Nome Internazionale):

Flucloxacillin sodium monohydrate 1.05 g (Equivalent to 1 g flucloxicillin.)

Dosaggio:

1 g

Forma farmaceutica:

Powder for injection

Composizione:

Active: Flucloxacillin sodium monohydrate 1.05 g Equivalent to 1 g flucloxicillin.  

Confezione:

Vial, glass, 5x1g, 5 g

Classe:

Prescription

Tipo di ricetta:

Prescription

Prodotto da:

Fresenius Kabi Anti-Infectives S.r.l.

Indicazioni terapeutiche:

For the treatment of confirmed or suspected staphylococcal and other Gram-positive coccal infections.

Dettagli prodotto:

Package - Contents - Shelf Life: Vial, glass, 1g - 5 dose units - 36 months from date of manufacture stored at or below 25°C - Vial, glass, 1g - 10 dose units - 36 months from date of manufacture stored at or below 25°C

Data dell'autorizzazione:

1993-10-07

Scheda tecnica

Version pfdflucv10519
Supersedes: Version 6.0
Page 1
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
DBL™ Flucloxacillin Sodium 1g Powder for Injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
DBL Flucloxacillin Sodium Powder for Injection is the sodium salt of
flucloxacillin.
DBL Flucloxacillin Sodium Powder for Injection contains 1 g of
flucloxacillin as flucloxacillin
sodium.
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.
3. PHARMACEUTICAL FORM
Powder for injection.
Flucloxacillin sodium is a white or almost white, crystalline powder,
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
Dose
Usual adult dosage
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.
Special populations
Renal impairment
As flucloxacillin is excreted to a large extent by the kidney, the
dose or dose interval may need
modification in patients with renal failure, as the half life in
patients with renal failure is increased.
However dosage recommendations for various plasma creatinine levels
for patients with impaired
renal function are not available. Flucloxacillin is not significantly
removed by haemodialysis.
Version pfdflucv10519
Supersedes: Version 6.0
Page 2
Hepatic impairment
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.
Paediatric population
2 to 10