Esmya 5mg tablets

Država: Armenija

Jezik: angleščina

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivna sestavina:

ulipristal (ulipristal acetate)

Dostopno od:

Gedeon Richter PLC

Koda artikla:

G03XB02

INN (mednarodno ime):

ulipristal (ulipristal acetate)

Odmerek:

5mg

Farmacevtska oblika:

tablets

Enote v paketu:

(28/2x14/) in blister, (84/6x14/) in blister

Tip zastaranja:

Prescription

Status dovoljenje:

Registered

Datum dovoljenje:

2018-12-13

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
ESMYA®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5.00 mg of ulipristal acetate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to off-white, round biconvex tablet , engraved with “ES5” on
one face.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ulipristal acetate is indicated for one treatment course of
pre-operative treatment of moderate to severe
symptoms of uterine fibroids in adult women of reproductive age.
Ulipristal acetate is indicated for intermittent treatment of moderate
to severe symptoms of uterine
fibroids in adult women of reproductive age who are not eligible for
surgery.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Esmya treatment is to be initiated and supervised by physicians
experienced in the diagnosis and
treatment of uterine fibroids.
Posology
The treatment consists of one tablet of 5 mg to be taken once daily
for treatment courses of up to
3 months each. Tablets may be taken with or without food.
Treatments should only be initiated when menstruation has occurred:
- The first treatment course should start during the first week of
menstruation.
- Re-treatment courses should start at the earliest during the first
week of the second menstruation_ _
following the previous treatment course completion.
The treating physician should explain to the patient the requirement
for treatment free intervals.
Repeated intermittent treatment has been studied up to 4 intermittent
courses.
If a patient misses a dose, the patient should take ulipristal acetate
as soon as possible. If the dose was
missed by more than 12 hours, the patient should not take the missed
dose and simply resume the
usual dosing schedule.
_Special population_
_Renal impairment _
No dose adjustment is recommended in patients with mild or moderate
renal impairment. In the
absence of specific studies, ulipristal acetate is not recommended in
patients with severe renal
impairment unless the patient is cl