Product Dossier
FLUCLOXACILLIN KABI
Product Dossier for FLUCLOXACILLIN KABI (flucloxacillin, Fresenius Kabi). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Fresenius Kabi
- Active ingredient: flucloxacillin
- Therapeutic area: Infectious Disease
- Related brand: FLUCIL
- Related brand: FLOPEN VIATRIS
- Related brand: FLUBICLOX
- Same area: RETROVIR
- Same area: Savacol Antiseptic Mouth & Throat Rinse
I cannot write a complete
Brand Dossier for FLUCLOXACILLIN KABI based on the provided documents. The sources contain detailed information about STAPHYLEX (a different brand of flucloxacillin supplied by Alphapharm/Viatris), and ARTG registration records showing that FLUCLOXACILLIN KABI consists of two powder-for-injection formulations (500 mg and 1000 mg vials).
However, the available documents do not contain product-specific information for FLUCLOXACILLIN KABI such as: — Approved indications specific to this brand — Dosing guidelines for the injection formulations — Key safety warnings tailored to injectable use — PBS listing details (strength, item number, restriction type, price) — Regulatory history (PBAC decisions, AusPAR, approval dates) — Contraindications specific to this brand
The ARTG record confirms only that FLUCLOXACILLIN KABI 500 mg and 1000 mg powder for injection vials were first listed on 7 June 2021 under licence category RE, but does not provide the clinical or regulatory detail needed for a comprehensive Brand Dossier.
To produce an accurate, properly cited Brand Dossier for FLUCLOXACILLIN KABI, I would require source documents containing the product information sheet, PBS records, and regulatory submission details specific to this brand.