Mycostatin

Country: Nýja-Sjáland

Tungumál: enska

Heimild: Medsafe (Medicines Safety Authority)

Virkt innihaldsefni:

Nystatin 25 mg/g equivalent to 100,000 U/g based on potency of 4400U/g, micropulverised, plus 10% overage.;  ; Nystatin 25 mg/g equivalent to 100,000 U/g based on potency of 4400 U/g, micropulverised, plus 10% overage.

Fáanlegur frá:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (Alþjóðlegt nafn):

Nystatin 25 mg/g (=100,000 U/g based on potency of 4400U/g, micropulverised, plus 10% overage.)

Skammtar:

100000 U/mL

Lyfjaform:

Topical cream

Samsetning:

Active: Nystatin 25 mg/g equivalent to 100,000 U/g based on potency of 4400U/g, micropulverised, plus 10% overage.   Excipient: Aluminium hydroxide gel Perfume Promulgen D Propylene glycol Purified water Simeticone Sorbitol Titanium dioxide Water White soft paraffin Active: Nystatin 25 mg/g equivalent to 100,000 U/g based on potency of 4400 U/g, micropulverised, plus 10% overage. Excipient: Aluminium hydroxide gel Promulgen D Propylene glycol Purified water Simeticone Sorbitol Titanium dioxide Water White soft paraffin

Einingar í pakka:

Tube, 1 x 15 g, 15 g

Tegund:

Pharmacy only

Gerð lyfseðils:

Pharmacy only

Framleitt af:

Patheon Capua SpA

Ábendingar:

The treatment of candidal infections of the skin.

Vörulýsing:

Package - Contents - Shelf Life: Tube, - 15 g - 24 months from date of manufacture stored at or below 25°C

Leyfisdagur:

1972-05-05

Vara einkenni

NEW ZEALAND DATA SHEET
1.
MYCOSTATIN (TOPICAL CREAM, 100000 U/ML)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Mycostatin (Nystatin), 100,000 units/g: 15 g.
3.
PHARMACEUTICAL FORM
Topical cream 15g.
4.
CLINICALT PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Nystatin topical preparations are indicated in the treatment of
cutaneous or
mucocutaneous mycotic infections caused by Candida species.
This preparation is not indicated for systemic use.
4.2 DOSE AND METHOD OF ADMINISTRATION
Apply liberally to affected areas twice daily or as indicated until
healing is
complete.
4.3 CONTRAINDICATIONS
Known sensitivity to nystatin or other components.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Should a reaction of hypersensitivity occur, the drug should be
immediately
withdrawn and appropriate measures taken. Nystatin topical
preparations
should not be used for the treatment of systemic or ophthalmic
infections.
It is recommended that KOH smears, cultures, or other diagnostic
methods
be used to confirm the diagnosis of cutaneous or mucocutaneous
candidiasis
and to rule out infection caused by other pathogens.
INFORMATION FOR THE PATIENT
Patients using these medications should receive the following
information and
instructions:
1. The patient should be instructed to use the medication as directed
(including the replacement of missed doses). The medication is not for
any disorder other than that for which it was prescribed.
2. Even if symptomatic relief occurs within the first few days of
treatment,
the patient should be advised not to interrupt or discontinue the
medication until the prescribed course of treatment is completed.
3. If symptoms of irritation develop, the patient should be advised to
notify
the physician promptly.
LABORATORY TEST
If there is a lack of therapeutic response, KOH smears, cultures or
other
diagnostic methods should be repeated.
CARCINOGENESIS AND MUTAGENESIS
No long-term animal studies have been performed to evaluate the
carcinogenic potential of nystatin.
4.5 INTERACTION WITH OTHER MEDICINES AND OTHER FO