Country: Нови Зеланд
Језик: Енглески
Извор: Medsafe (Medicines Safety Authority)
Corifollitropin alfa 0.3 mg/mL;
Organon (New Zealand) Limited
Corifollitropin alfa 0.3 mg/mL
150 mcg/0.5mL
Solution for injection
Active: Corifollitropin alfa 0.3 mg/mL Excipient: Hydrochloric acid Methionine Polysorbate 20 Sodium citrate Sodium hydroxide Sucrose Water for injection
Syringe, glass, Pre-filled glass syringe, closed with rubber plunger and tip cap., 1 dose unit
Prescription
Prescription
NV Organon
Controlled ovarian stimulation (COS) for the development of multiple follicles and pregnancy in women undergoing in-vitro fertilisation techniques.
Package - Contents - Shelf Life: Syringe, glass, Pre-filled glass syringe, closed with rubber plunger and tip cap. - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 1 months from date of manufacture stored at or below 25°C
2009-05-22
S-CCPPI-MK8962-SOi-022019 1 ELONVA ® _Corifollitropin alfa (rch) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ELONVA. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using ELONVA against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, TELL YOUR DOCTOR OR PHARMACIST. ELONVA is used to help achieve pregnancy in women having infertility treatment, such as IVF. ELONVA causes the growth and development of several follicles at the same time by controlled stimulation of the ovaries. The eggs are collected from the ovary, fertilised in the laboratory and the embryos are transferred into the uterus a few days later. ELONVA is not addictive. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. • have malformations of the sexual organs which make a normal pregnancy impossible. • have fibroid tumours in the uterus which make a normal pregnancy impossible. • Have risk factors of ovarian hyperstimulation syndrome (OHSS). OHSS is a serious medical problem that can happen when the ovaries are overly stimulated (see _BEFORE YOU START _ _TO USE IT: OVARIAN _ _HYPERSTIMULATION SYNDROME _ _(OHSS) _ for further explanation). o have polycystic ovarian syndrome (PCOS) KEEP THIS LEAFLET WITH THE MEDICINE. You may want to read it again. WHAT ELONVA IS USED FOR ELONVA contains corifollitropin alfa, a medicine belonging to the group of gonadotrophic hormones. These hormones play an important part in human fertility and reproduction. One of these gonadotrophic hormones is follicle- stimulating hormone (FSH), which is needed in women for the growth and development of follicles (small round sacs in your ovaries that contain the eggs). ELONVA is especially designed to work much longer than FSH. One single injection of ELONVA can replace a Прочитајте комплетан документ
NEW ZEALAND DATA SHEET 1. PRODUCT NAME ELONVA ® 100 micrograms solution for injection ELONVA ® 150 micrograms solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 100 micrograms or 150 micrograms of corifollitropin alfa in 0.5 mL solution for injection. Corifollitropin alfa, a gonadotrophin designed as a sustained follicle stimulant is a glycoprotein consisting of two non-covalently linked non-identical subunits called α and β. The α-subunit is identical to that of human follicle-stimulating hormone (FSH); the β-subunit is composed of the complete β- subunit of human FSH (residues 1-111) extended with the carboxy-terminal peptide (CTP) of the β– subunit of human chorionic gonadotrophin (hCG) (residues 118-145). _CAS No_.: 195962-23-3. α -subunit APDVQDCPEC TLQENPFFSQ PGAPILQCMG CCFSRAYPTP * * LRSKKTMLVQ KNVTSESTCC VAKSYNRVTV MGGFKVENHT ACHCSTCYYH KS β -subunit * * NSCELTNITI AIEKEECRFC ISINTTWCAG YCYTRDLVYK DPARPKIQKT CTFKELVYET VRVPGCAHHA DSLYTYPVAT && QCHCGKCDSD STDCTVRGLG PSYCSFGEMK ESSSSKAPPP & & & & SLPSPSRLPG PSDTPILPQ * = N-glycosylation sites & = O-glycosylation sites Corifollitropin alfa is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology, using a chemically defined cell culture medium without the addition of antibiotics, human- or animal- derived proteins (protein-free) or any other components of human or animal origin. Excipient(s) with known effect: ELONVA contains less than 1 mmol sodium (23 mg) per injection, i.e. essentially ‘sodium-free’. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear and colourless aqueous solution. Page 2 of 13 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Controlled Ovarian Stimulation (COS) for the development of multiple follicles and pregnancy in women undergoing _in vitro _fertilisation techniques 4.2 DOSE AND METHOD OF ADMINISTRATION Treatment with ELONVA should be initiated under the supervision of a physician experienced Прочитајте комплетан документ