Pevaryl Foaming

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Econazole 1%{relative};  ;  

Available from:

iNova Pharmaceuticals (New Zealand) Limited

INN (International Name):

Econazole 1% w/w

Dosage:

1 %

Pharmaceutical form:

Topical solution

Composition:

Active: Econazole 1%{relative}     Excipient: Benzyl alcohol Hydrochloric acid Macrogol 6000 distearate Miraspec TL/LDK Polysorbate 20 Purified water Sorbitan laurate

Units in package:

Sachet, 3 x 10ml, 30 mL

Class:

Pharmacy only

Prescription type:

Pharmacy only

Manufactured by:

Siegfried Ltd

Product summary:

Package - Contents - Shelf Life: Sachet, 3 x 10ml - 30 mL - 36 months from date of manufacture stored at or below 25°C

Authorization date:

1984-05-28

Summary of Product characteristics

NEW ZEALAND DATA SHEET
PEVARYL 1% W/W FOAMING SOLUTION
PEVARYL Cream
Page 1 of 5
1 PRODUCT NAME
PEVARYL 1% w/w foaming solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Econazole nitrate 1.0% w/w (as econazole base)
Excipients with known effect:
Benzyl alcohol
For a full list of excipients, see section6.1.
3 PHARMACEUTICAL FORM
Topical solution
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
PEVARYL Foaming Solution is indicated for the treatment of fungal skin
infections and tinea.
4.2
Dose and method of administration
PEVARYL Foaming Solution should be applied to the wet body on three
consecutive evenings. The
foam should not be rinsed off but allowed to dry. The drug should
develop its effect during the
nights and may be removed the next morning by washing it off. Should
fungal skin infection and
tinea not be cured after a period of two weeks the treatment must be
repeated. Repeat the course 1
month and 3 months after initial treatment to prevent relapse.
4.3
Contraindications
Although no specific contraindications are known, the product should
not be used in patients known to
be sensitive to any of the components.
4.4
Special warnings and precautions for use
Eyes
Avoid introduction of econazole foaming solution into the eyes.
Local irritation or hypersensitivity
Discontinue treatment if irritation or hypersensitivity occurs.
Lack of Response
If there is a lack of response to econazole, appropriate microbial
studies should be carried out to
confirm the diagnosis and rule out other pathogens. Intractable
candidiasis may be the presenting
symptom of unrecognised diabetes, thus appropriate urine/blood studies
may be indicated in patients
not responding to treatment.
Contraceptive diaphragms
Avoid contact with contraceptive diaphragms and this product since the
rubber may be damaged by
the preparation.
Prolonged use
NEW ZEALAND DATA SHEET
PEVARYL 1% W/W FOAMING SOLUTION
PEVARYL Cream
Page 2 of 5
Overgrowth of non-susceptible organisms may occur with prolonged use
of any topical antimicrobial
agent, including