Ipca-Fluconazole
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Summary of Product characteristics
(SPC)
05-01-2024
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Active ingredient:
Fluconazole 200mg
Available from:
Ipca Pharma (NZ) Pty Limited
INN (International Name):
Fluconazole 200 mg
Dosage:
200 mg
Pharmaceutical form:
Capsule
Composition:
Active: Fluconazole 200mg Excipient: Colloidal silicon dioxide Erythrosine Gelatin Indigo carmine Lactose Magnesium stearate Maize starch Methyl hydroxybenzoate Propyl hydroxybenzoate Purified water Sodium laurilsulfate Titanium dioxide
Units in package:
Blister pack, Alu foil and PVC/PVDC Alu foil, 7 capsules
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Mylan Laboratories Limited
Therapeutic indications:
Fluconazole capsules are indicated for the treatment of Cryptococcosis
Product summary:
Package - Contents - Shelf Life: Blister pack, Alu foil and PVC/PVDC Alu foil - 7 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, Alu foil and PVC/PVDC Alu foil - 10 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, Alu foil and PVC/PVDC Alu foil - 14 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, Alu foil and PVC/PVDC Alu foil - 20 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, Alu foil and PVC/PVDC Alu foil - 28 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, Alu foil and PVC/PVDC Alu foil - 40 capsules - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE - 50 capsules - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE - 100 capsules - 24 months from date of manufacture stored at or below 25°C
Authorization date:
2009-12-08
Summary of Product characteristics
Version 1.0
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Ipca- Fluconazole, 50 mg, 150 mg and 200 mg, capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 50 mg, 150 mg or 200 mg of fluconazole.
Excipient with known effect:lactose, methyl hydroxybenzoate, propyl
hydroxybenzoate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule 50 mg: Size ‘4’ capsules with a white body and a blue cap
and are filled with a white
homogenous white to off white powder which contains 50 mg fluconazole.
Capsule 150 mg:
Size ‘1’ capsules with a blue body and cap and are filled with a
white
homogenous white to off white powder which contains 150 mg
fluconazole.
Capsule 200 mg: Size ‘0’ capsules with a white body and a purple
cap and are filled with a white
homogenous white to off white powder which contains 200 mg
fluconazole.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fluconazole Capsules are 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 capsules 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 and patients with compromised
immune function may be
treated.
●
Vaginal candidiasis, acute or recurrent.
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