m-Fluconazole

Kraj: Nowa Zelandia

Język: angielski

Źródło: Medsafe (Medicines Safety Authority)

Składnik aktywny:

Fluconazole 150mg (polymorph Form II)

Dostępny od:

Multichem NZ Limited

INN (International Nazwa):

Fluconazole 150 mg (polymorph Form II)

Dawkowanie:

150 mg

Forma farmaceutyczna:

Capsule

Skład:

Active: Fluconazole 150mg (polymorph Form II) Excipient: Colloidal silicon dioxide Gelatin Lactose monohydrate Magnesium stearate Microcrystalline cellulose Pregelatinised maize starch Quinoline yellow Sodium laurilsulfate Sunset yellow aluminium lake Titanium dioxide

Sztuk w opakowaniu:

Blister pack, PVC and Aluminium, 1 capsule

Klasa:

Restricted

Typ recepty:

Restricted

Wyprodukowano przez:

Mylan Laboratories Limited

Wskazania:

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

Podsumowanie produktu:

Package - Contents - Shelf Life: Blister pack, PVC and Aluminium - 1 capsules - 48 months from date of manufacture stored at or below 25°C protect from light and moisture

Data autoryzacji:

2003-05-22

Charakterystyka produktu

_M-_
FLUCONAZOLE 
FLUCONAZOLE 50MG, 100MG, 150MG AND 200MG CAPSULES  
FLUCONAZOLE 2MG/ML SOLUTION FOR IV INFUSION 

FLUCONAZOLE 
Fluconazole is a bis-triazole: 
2-(2,4-difluorophenyl)-1,3-bis(1H-1,2,4-triazol-1-yl)-2-propanol. It
has the following structural 
formula: 

CAS 
86386-73-4 

C
13
H
12
F
2
N
6
O 

PRESENTATION 
_m-_Fluconazole 50mg capsules are size 2 green and white
capsules typically weighing 
180.5mg. Each capsule contains 50mg fluconazole. 
_m-_Fluconazole 100mg capsules are size 1 buff
coloured capsules typically weighing 310mg. 
Each capsule contains 100mg fluconazole. 
_m-_Fluconazole 150mg capsules are size 0 yellow capsules typically
weighing 445.6mg. Each 
capsule contains 150mg fluconazole. 
_m-_Fluconazole 200mg capsules are size 0 white capsules
typically weighing 562mg. Each 
capsule contains 200mg fluconazole. 
_m-_Fluconazole 2mg/ml solution for IV infusion is a
clear colourless solution containing 2mg/ml 
fluconazole in 0.9% saline solution. Each 25ml vial contains 50mg
fluconazole, each 50ml vial 
contains 100mg fluconazole and each 100ml vial contains 200mg
Fluconazole.   
USES 
_ACTIONS _
Fluconazole, a member of a new class of triazole antifungal agents,
is a potent and specific 
inhibitor of fungal sterol synthesis.  
Fluconazole, both orally and intravenously administered, is active
in a variety of animal fungal 
infection models. Activity has been demonstrated
against opportunistic mycoses, such as 
infections with _Candida_ spp,
including systemic candidiasis and in immunocompromised 
animals; with _Cryptococcus neoformans,_ including intracranial
infections, with _Microsporum_ 
spp; and with _Trichophyton_ spp.
Fluconazole has also been shown to be active in animal 
models of endemic mycoses, including infections with _Blastomyces
dermatitidis_; with 
_Coccidioides immitis,_ including intracranial infection;
and with _Histoplasma capsulatum_ in 
norma