ประเทศ: อิสราเอล
ภาษา: อังกฤษ
แหล่งที่มา: Ministry of Health
FOLLITROPIN DELTA
FERRING PHARMACEUTICALS LTD
G03GA10
SOLUTION FOR INJECTION
FOLLITROPIN DELTA 12 MCG / 0.36 ML
S.C
Required
FERRING GmbH ,GERMANY
FOLLITROPIN DELTA
Controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle. There is no clinical trial experience with Rekovelle in the long GnRH agonist protocol
2022-10-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only REKOVELLE 12/36/72 SOLUTION FOR INJECTION UNDER THE SKIN COMPOSITION: Each Rekovelle 12 multi-dose pen contains 12 mcg follitropin delta Each Rekovelle 36 multi-dose pen contains 36 mcg follitropin delta Each Rekovelle 72 multi-dose pen contains 72 mcg follitropin delta INACTIVE INGREDIENTS - See section 6 ‘Additional information’. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. This medicine is intended for adult women over 18 years old. 1. WHAT IS THIS MEDICINE INTENDED FOR? Rekovelle is a medicine that contains follitropin delta. This is a follicle stimulating hormone which belongs to the family of hormones called gonadotropins. Gonadotropins are involved in reproduction and fertility. Rekovelle is used in the treatment of women undergoing assisted reproduction programmes such as _ in vitro_ fertilisation (IVF) and intracytoplasmic sperm injection (ICSI) micromanipulation. Rekovelle stimulates the ovaries to produce several follicles from which eggs are collected and fertilised in the laboratory. THERAPEUTIC GROUP: gonadotropins 2. BEFORE USING THIS MEDICINE Before starting treatment, you and your partner in the fertility treatment process must be checked by a fertility specialist. _DO NOT USE THIS MEDICINE IF:_ you are sensitive (allergic) to follitropin delta or any of the inactive ingredients in this medicine (see section 6) you have a tumour of the uterus, ovaries, breasts, pituitary gland or hypothalamus you have enlarged ovaries or cysts on your ovaries (unless caused by polycystic ovarian syndrome) you have vaginal bleeding for an unkno อ่านเอกสารฉบับเต็ม
1 1. NAME OF THE MEDICINAL PRODUCT REKOVELLE 12 REKOVELLE 36 REKOVELLE 72 2. QUALITATIVE AND QUANTITATIVE COMPOSITION REKOVELLE 12 One pre-filled multidose pen/cartridge delivers 12 micrograms follitropin delta* in 0.36 mL solution. REKOVELLE 36 One pre-filled multidose pen/cartridge delivers 36 micrograms follitropin delta* in 1.08 mL solution. REKOVELLE 72 One pre-filled multidose pen/cartridge delivers 72 micrograms follitropin delta* in 2.16 mL solution. One mL of solution contains 33.3 micrograms of follitropin delta* *recombinant human follicle-stimulating hormone (FSH) produced in a human cell line (PER.C6) by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection in a pre-filled pen (injection) /cartridge. Clear and colourless solution with a pH of 6.0-7.0. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as an _in vitro f_ ertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle. There is no clinical trial experience with REKOVELLE in the long GnRH agonist protocol (see section 5.1). _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated under the supervision of a physician experienced in the treatment of fertility problems. Posology The posology of REKOVELLE is individualised for each patient and aims to obtain an ovarian response which is associated with a favourable safety/efficacy profile, i.e. aims to achieve an adequate number of oocytes retrieved and reduce the interventions to prevent ovarian hyperstimulation syndrome (OHSS). REKOVELLE is dosed in micrograms (see section 5.1). The dosing regimen is specific for REKOVELLE and the microgram dose cannot be applied to other gonadotropins. For the first treatment cycle, the individual daily dose will be determined on the basis of the woman’s serum anti-Müllerian hormone (AMH) concentration and her body weight. อ่านเอกสารฉบับเต็ม