Land: Israel
Språk: engelska
Källa: Ministry of Health
TRIPTORELIN AS ACETATE
MEDISON PHARMA LTD
L02AE04
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
TRIPTORELIN AS ACETATE 0.1 MG/VIAL
S.C
Required
IPSEN PHARMA, FRANCE
TRIPTORELIN
TRIPTORELIN
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.
2011-01-31
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 Läs hela dokumentet