VAGIFEM® VAGINAL TABLET 10MCG

País: Cingapura

Língua: inglês

Origem: HSA (Health Sciences Authority)

Ingredientes ativos:

Estradiol hemihydrate 0.0103mg equivalent to estradiol (anhydrous)

Disponível em:

NOVO NORDISK PHARMA (SINGAPORE) PTE LTD

Código ATC:

G03CA03

Forma farmacêutica:

TABLET, FILM COATED

Composição:

Estradiol hemihydrate 0.0103mg equivalent to estradiol (anhydrous) 0.0100 mg

Via de administração:

VAGINAL

Tipo de prescrição:

Prescription Only

Fabricado por:

Novo Nordisk A/S

Status de autorização:

ACTIVE

Data de autorização:

2015-10-21

Características técnicas

1
1.
Name of the medicinal product
Vagifem
®
10 micrograms
Vaginal tablets
2.
Qualitative and quantitative composition
Each vaginal tablet contains: Estradiol hemihydrate equivalent to
estradiol 10 micrograms.
For the full list of excipients, see section 6.1.
3.
Pharmaceutical form
Vaginal tablet.
White, film-coated, biconvex tablet, engraved with NOVO 278 on one
side. Diameter 6 mm.
4.
Clinical particulars
4.1
Therapeutic indications
Treatment of vaginal atrophy due to oestrogen deficiency in
postmenopausal women (see section 5.1).
The experience of treating women older than 65 years is limited.
4.2
Posology and method of administration
Vagifem
®
is administered intravaginally as a local oestrogen therapy by use of
an applicator.
Initial dose: One vaginal tablet daily for two weeks.
Maintenance dose: One vaginal tablet twice a week.
Treatment may be started on any convenient day.
If a dose is forgotten, it should be taken as soon as the patient
remembers. A double dose should be
avoided.
For initiation and continuation of treatment of postmenopausal
symptoms, the lowest effective dose
for the shortest duration (see also section 4.4) should be used.
For oestrogen products for vaginal application of which the systemic
exposure to the oestrogen
remains within the normal postmenopausal range, such as Vagifem
®
, it is not recommended to add a
progestagen (but see section 4.4, ‘Special warnings and precautions
for use’, ‘Endometrial hyperplasia
and carcinoma’).
Vagifem
®
may be used in women with or without an intact uterus.
Vaginal infections should be treated before start of the Vagifem
®
therapy.
Administration:
1.
Open the blister pack at the plunger end.
2.
Insert the applicator in the vagina until resistance is met (8-10 cm).
3.
Release the tablet by pressing the plunger.
4.
Withdraw the applicator and discard.
4.3
Contraindications
•
Known, past or suspected breast cancer
•
Known, past or suspected oestrogen-dependent malignant tumours (e.g.
endometrial cancer)
•
Undiagnosed genital bleeding