Pimafucin suppositories vaginal

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

natamycin

Available from:

Temmler Italia S.r.L.

ATC code:

G01AA02

INN (International Name):

natamycin

Dosage:

100mg

Pharmaceutical form:

suppositories vaginal

Units in package:

(3/1x3/), (6/2x3/)

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2018-01-15

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
PIMAFUCIN 100 MG VAGINAL SUPPOSITORIES
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
100 mg natamycin per vaginal suppository.
Excipients: cetyl alcohol, sorbitol
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Vaginal suppositories.
Whitey-brown or light yellow coloured, torpedo shape suppositorywith
specific scent.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS For vaginitis, vulvitis, vulvovaginitis caused by Candida albicans.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Daily one vaginal suppositoryfor 3 to 6 days.
At bedtime insert one vaginalsuppository- while in reclining position
- as high as possible in the vagina.
4.3.
CONTRAINDICATIONS
Hypersensitivity to any ingredients of the medicinal product. No
allergic reaction to natamycin was reported to date.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Vaginal suppositories quickly dissolvedunder the body temperature,
forming a frothy mass, which contributes to
uniform distribution of the active substance. In the case of chronic
or recurrent infection topical treatment may be
supplemented by the appointment of tablets and cream Pimafucin.
The treatment should be discontinued during menstruation.During
treatment with suppositories is not necessary to
exclude sexual contacts. However, it is recommended to conduct a
survey of sexual partners and, in case of detection
of vulvovaginal lesions, a course of treatment Pimafucin. Also,
consider using a treatment period of barrier
contraceptives.
_Use in patients with impaired liver and kidneyfunction _
Pimafucin is used locally. Systemic absorption of the active substance
is virtually absent, therefore it is not required
the changes in dosing regimen for the patient with impaired liver or
kidneys function.
_Use in pediatric and geriatric practice _
The drug mayused at any age according to the standard scheme.
The cetyl alcohol and salts of sorbic acid (sorbitol) may cause local
skin reactions (e.g.: contact dermatitis).
OGYÉI/34825/2016
2
4.5.
INTERACTION W