DIPHERELINE 0.1 MG

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

TRIPTORELIN AS ACETATE

Fáanlegur frá:

MEDISON PHARMA LTD

ATC númer:

L02AE04

Lyfjaform:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Samsetning:

TRIPTORELIN AS ACETATE 0.1 MG/VIAL

Stjórnsýsluleið:

S.C

Gerð lyfseðils:

Required

Framleitt af:

IPSEN PHARMA, FRANCE

Meðferðarhópur:

TRIPTORELIN

Lækningarsvæði:

TRIPTORELIN

Ábendingar:

Female infertility: Management of ovarian stimulation in association with the gonadotrophins (hMG, FSH, hCG) in view of in vitro fertilisation and embrio transfer (I.V.F.E.T.) and other assisted conception techniques.

Leyfisdagur:

2011-01-31

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADENAME OF THE MEDICINAL PRODUCT
DIPHERELINE 0.1 MG, POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
(S.C.).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition of the powder
Triptorelin
...................................................................................
0.0001 g
:
Mannitol
......................................................................................
0.0100 g
For one dose
Composition of the solvent
Sodium chloride
...........................................................................
0.009 g
:
Water for injections q.s.
.............................................................. 1 ml
For one ampoule
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection (S.C.)
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Female infertility: Management of ovarian stimulation in association
with the
gonadotrophins (hMG, FSH, hCG) in view of in vitro fertilisation and
embrio
transfer (I.V.F.E.T.) and other assisted conception techniques.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
PROSTATE CANCER
One daily injection of 0.1 mg triptorelin by subcutaneous route from
Day 1 to
Day 7, before changing to the prolonged release form.
FEMALE INFERTILITY
: in combination with gonadotrophins.
One daily subcutaneous injection from Day 2 of the menstrual cycle (at
the same time
as ovarian stimulation starts) until the day before the day set for
induction, i.e. an
average period of 10 to 12 days for each attempt.
4.3
CONTRA-INDICATIONS
Hypersensitivity to GnRH, its analogues or to one of the constituents.
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
PROSTATE CANCER
Warnings on beginning treatment
It has been reported that clinical symptoms (particularly bone pain)
may worsen on
beginning treatment but these cases are isolated and generally
transient. These
cases justify a careful medical supervision during the first few weeks
of treatment,
particularly in patients presenting with urinary tract obstruction and
in those with
vertebral metastases (se