Fluconazole-Baxter

Země: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktivní složka:

Fluconazole 2 mg/mL

Dostupné s:

Baxter Healthcare Ltd

INN (Mezinárodní Name):

Fluconazole 2 mg/mL

Dávkování:

0.2% w/v

Léková forma:

Solution for infusion

Složení:

Active: Fluconazole 2 mg/mL Excipient: Hydrochloric acid Sodium chloride Water for injection

Jednotky v balení:

Bottle, glass, Clear, colourless Type I with bromobutyl stopper 50 mL, 50 mL

Třída:

Prescription

Druh předpisu:

Prescription

Výrobce:

Mylan Laboratories Limited

Terapeutické indikace:

Cryptococcosis, including cryptococcal meningitis and infections of other sites (e.g. pulmonary, cutaneous). Normal hosts, and patients with AIDS, organ transplants or other causes of immunosuppression may be treated. Fluconazole-Claris can be used as maintenance therapy to prevent relapse of cryptococcal disease in patients with AIDS.

Přehled produktů:

Package - Contents - Shelf Life: Bottle, glass, Clear, colourless Type I with bromobutyl stopper 50 mL - 50 mL - 36 months from date of manufacture stored at or below 30°C protect from light. Do not refrigerate - Bottle, glass, Clear, colourless Type I with bromobutyl stopper 100 mL - 100 mL - 36 months from date of manufacture stored at or below 30°C protect from light. Do not refrigerate - Bottle, glass, Clear, colourless Type I with bromobutyl stopper 200 mL - 200 mL - 36 months from date of manufacture stored at or below 30°C protect from light. Do not refrigerate

Datum autorizace:

2006-05-19

Charakteristika produktu

NEW ZEALAND DATA SHEET
Fluconazole‐Baxter Data Sheet 22 February 2022
Page 1 of 23
Baxter Healthcare Ltd
1 FLUCONAZOLE‐BAXTER (0.2% w/v, solution for infusion)
FLUCONAZOLE‐BAXTER 0.2% w/v (2mg/mL) solution for infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
FLUCONAZOLE‐BAXTER, solution for infusion contains 2mg fluconazole
per mL.
Each 50mL vial of solution for infusion contains 100mg fluconazole.
Each 100mL vial of solution for infusion contains 200mg fluconazole.
Each 200mL vial of solution for infusion contains 400mg fluconazole.
_Excipient(s) with known effect _
Each mL contains 9mg sodium chloride (equivalent to 0.154 mmol sodium)
(see section 4.4).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
FLUCONAZOLE‐BAXTER is a colourless solution. The pH of the solution
is 4.0 ‐ 8.0
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
FLUCONAZOLE‐BAXTER intravenous solution for infusion should be used
only when fluconazole cannot
be administered orally.
FLUCONAZOLE‐BAXTER is indicated for the treatment of the following
conditions:
•
Cryptococcosis, including cryptococcal meningitis and infections of
other sites (e.g., pulmonary,
cutaneous). Normal hosts, and patients with AIDS, organ transplants or
other causes of
immunosuppression may be treated. FLUCONAZOLE‐BAXTER can be used as
maintenance therapy
to prevent relapse of cryptococcal disease in patients with AIDS.
•
Systemic candidiasis including candidaemia, disseminated candidiasis
and other forms of
invasive candidal infection including infections of the peritoneum,
endocardium and pulmonary
and urinary
tracts. Patients with malignancy, in intensive care units, receiving
cytotoxic or
immunosuppressive therapy, or with other factors predisposing to
candidal infection may be
treated.
•
Mucosal candidiasis. These include oropharyngeal, oesophageal,
non‐invasive
bronchopulmonary infections, candiduria, mucocutaneous and chronic
oral atrophic candidiasis
(denture sore mouth). Normal hosts an