Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
Follitropin alfa, Quantity: 625 IU/mL; Lutropin alfa, Quantity: 312.5 IU/mL
Merck Healthcare Pty Ltd
Injection, solution
Excipient Ingredients: sucrose; poloxamer; methionine; phenol; arginine hydrochloride; dibasic sodium phosphate dihydrate; monobasic sodium phosphate monohydrate; sodium hydroxide; phosphoric acid; water for injections
Subcutaneous
1 cartridge + 14 needles
(S4) Prescription Only Medicine
PERGOVERIS is indicated for the stimulation of follicular development in women with severe LH and FSH deficiency.
Visual Identification: Clear colourless solution; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
2018-06-29
PERGOVERIS ® _Follitropin alfa (rch)/Lutropin alfa (rch) Solution for Injection_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about PERGOVERIS. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you using PERGOVERIS against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR, NURSE OR PHARMACIST. KEEP THIS INFORMATION WITH YOUR MEDICINE. You may need to read it again later. WHAT PERGOVERIS IS USED FOR PERGOVERIS is a medicine containing follitropin alfa, a recombinant follicle stimulating hormone (FSH) and lutropin alfa, a recombinant luteinising hormone (LH), which are essentially similar to the hormones found naturally in humans, but they are made by means of biotechnology. They belong to the family of hormones called gonadotrophins, which are involved in the normal control of reproduction. PERGOVERIS is for the treatment of women who have been shown to produce very low levels of some of the hormones involved in the natural reproductive cycle. PERGOVERIS is used to bring about the development of a single mature follicle. Follicles are structures in the ovaries that mature the eggs (ova). Once adequate follicular development is achieved, a single injectable dose of human chorionic gonadotrophins (hCG) is given, which leads to the release of an egg from the follicle (ovulation). ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY PERGOVERIS HAS BEEN PRESCRIBED FOR YOU. You doctor may have prescribed it for another reason. PERGOVERIS is available only on a doctor's prescription. PERGOVERIS is not habit-forming. BEFORE YOU ARE GIVEN PERGOVERIS _WHEN YOU MUST NOT USE IT_ DO NOT USE PERGOVERIS IF: • you have a history of allergy to gonadotrophins or to any of the ingredients listed at the end of this leaflet. Symptoms of an allergic reaction may include: • sho Lesen Sie das vollständige Dokument
Version: A004-0220 Page 1 of 15 Supersedes: A003-0819 AUSTRALIAN PRODUCT INFORMATION – PERGOVERIS ® (FOLLITROPIN ALFA (RCH)/LUTROPIN ALFA (RCH)) SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Follitropin alfa (rch)/lutropin alfa (rch) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION PERGOVERIS contains follitropin alfa (recombinant human follicle stimulating hormone (r- hFSH)) and lutropin alfa (recombinant human luteinising hormone (r-hLH)) produced by genetically engineered Chinese Hamster Ovary (CHO) cells. Each cartridge of PERGOVERIS contains: • 300 IU (equivalent to 21.84 microgram) of follitropin alfa (r-hFSH) and 150 Iutropin alfa (equivalent to 6 microgram) of lutropin alfa (r-hLH) in 0.48 mL solution, or • 450 IU (equivalent to 32.76 microgram) of follitropin alfa (r-hFSH) and 225 IU (equivalent to 9 microgram) of lutropin alfa (r-hLH) in 0.72 mL, or • 900 IU (equivalent to 65.52 microgram) of follitropin alfa (r-hFSH) and 450 IU (equivalent to 18 microgram) of lutropin alfa (r-hLH) in 1.44 mL solution. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Solution for injection. PERGOVERIS is presented as a sterile solution for injection in a cartridge, pre-assembled in a disposable pen. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS PERGOVERIS is indicated for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials, these patients were defined by an endogenous serum LH of less than 1.2 IU/L. 4.2 D OSE AND METHOD OF ADMINISTRATION Treatment with PERGOVERIS should be initiated under the supervision of a physician experienced in the treatment of fertility problems. The injection site should be alternated daily to prevent lipoatrophy. Self-administration of PERGOVERIS should only be performed by patients who are well-motivated, adequately trained and with access to expert advice. In LH and FSH deficient women, the objective of PERGOVERIS therapy is to develop a single mature Graafian follicle from which the oocyte Lesen Sie das vollständige Dokument