Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CORIFOLLITROPIN ALFA
ORGANON MALAYSIA SDN. BHD.
CORIFOLLITROPIN ALFA
0.5ml mL
VETTER PHARMA-FERTIGUNG GMBH & CO KG
Copyright 2021 Organon group of companies. All rights reserved. 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ ELONVA ® SOLUTION FOR INJECTION corifollitropin alfa (100 mcg/0.5ml, 150 mcg/0.5ml) WHAT IS IN THIS LEAFLET 1. What _ELONVA _ is used for 2. How _ELONVA _ works 3. Before you use _ELONVA _ 4. How to use _ELONVA _ 5. While you are using it 6. Side effects 7. Storage and Disposal of _ELONVA _ 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT _ELONVA _IS USED FOR _ELONVA _ is used to help achieve pregnancy in women undergoing infertility treatment. HOW _ELONVA _WORKS _ELONVA _ contains corifollitropin alfa, a medicine belonging to the group of gonadotropic hormones. Gonadotropic hormones play an important role in human fertility and reproduction. One of these gonadotropic hormones is follicle- stimulating hormone (FSH), which is needed in women for the growth and development of follicles. _ELONVA _ is especially designed to work much longer than FSH. One single injection of _ELONVA _ can replace a whole week of daily FSH injections in women having infertility treatment, such as _in vitro _ fertilization (IVF). IVF involves collecting the follicles from the ovary, fertilizing them in the laboratory, and transferring the embryos into the uterus a few days later. _ELONVA _ causes the growth and development of several follicles (small round sacs in your ovaries that contain the eggs) at the same time by a controlled stimulation of the ovaries. BEFORE YOU USE _ELONVA _ _-_ _ _ _When you must not use it _ _ _ DO NOT USE _ELONVA _IF YOU: are ALLERGIC (hypersensitive) to corifollitropin alfa or any of the other ingredients of _ELONVA _ (for a list of all ingredients, see “ PRODUCT DESCRIPTION ”) are pregnant or think you may be pregnant have CANCER of the ovary, breast, uterus, or brain (pituitary gland or hypothalamus) have recently had UNEXPECTED VAGINAL BLEEDING, OTHER THAN MENSTRUAL, WITHOUT A DIAGNOSED CAUSE have ovaries that do not Baca dokumen lengkap
S-LPC-OG8962-SOi-022019 Copyright 2021 Organon group of companies. All rights reserved. 1. NAME OF THE MEDICINAL PRODUCT Elonva 100 micrograms solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 100 micrograms of corifollitropin alfa in a 0.5 mL solution for injection. Corifollitropin alfa is a glycoprotein 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. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear and colorless aqueous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Controlled Ovarian Stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women participating in an Assisted Reproductive Technology (ART) program. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Elonva should be initiated under the supervision of a physician experienced in the treatment of fertility problems. S-LPC-OG8962-SOi-022019 Copyright 2021 Organon group of companies. All rights reserved. Posology In the treatment of women of reproductive age, the dose of Elonva is based on weight and age. - A single 100-microgram dose is recommended in women who weigh less than or equal to 60 kilograms and who are 36 years of age or younger. - A single 150-microgram dose is recommended in women: - who weigh more than 60 kilograms, regardless of age. - who weigh 50 kilograms or more and who are older than 36 years of age. Women older than 36 years of age who weighed less than 50 kilograms were not studied. Body Weight Less than 50 kg 50 – 60 kg More than 60 kg Age 36 years or younger 100 micrograms 100 micrograms 150 micrograms Older than 36 years Not studied. 150 micrograms 150 micrograms The recommended doses of Elonva have only been established in a treatment cycle with a Gn Baca dokumen lengkap