Ovaleap (follitropin alfa) 300IU/0.5ml Solution for Injection
1. Name of the medicinal product
Ovaleap 300 IU/0.5 mL solution for injection
Ovaleap 450 IU/0.75 mL solution for injection
Ovaleap 900 IU/1.5 mL solution for injection
2. Qualitative and quantitative composition
Each mL of the solution contains 600 IU (equivalent to 44 micrograms) follitropin alfa*.
Ovaleap 300 IU/0.5 mL solution for injection
Each cartridge contains 300 IU (equivalent to 22 micrograms) follitropin alfa in 0.5 mL solution for injection.
Ovaleap 450 IU/0.75 mL solution for injection
Each cartridge contains 450 IU (equivalent to 33 micrograms) follitropin alfa in 0.75 mL solution for injection.
Ovaleap 900 IU/1.5 mL solution for injection
Each cartridge contains 900 IU (equivalent to 66 micrograms) follitropin alfa in 1.5 mL solution for injection.
*Follitropin alfa (recombinant human follicle-stimulating hormone [r-hFSH]) is produced in Chinese Hamster Ovary Cells (CHO DHFR-) by recombinant DNA technology.
Excipient(s) with known effect:
Ovaleap contains 0.02 mg per mL of benzalkonium chloride
Ovalea contains 10.0 mg per mL of benzyl alcohol
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection (injection).
Clear, colourless solution.
The pH of the solution is 6.8-7.2.
4. Clinical particulars
4.1 Therapeutic indications
In adult women
• Anovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomifene citrate.
• Stimulation of multifollicular development in women undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer and zygote intra-fallopian transfer.
• Ovaleap in association with a luteinising hormone (LH) preparation is recommended 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 level < 1.2 IU/L.
In adult men
• Ovaleap is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotropic hypogonadism with concomitant human chorionic gonadotropin (hCG) therapy.
4.2 Posology and method of administration
Treatment with follitropin alfa should be initiated under the supervision of a physician experienced in the treatment of fertility disorders.
Posology
The dose recommendations given for follitropin alfa are those in use for urinary FSH. Clinical assessment of follitropin alfa indicates that its daily doses, regimens of administration and treatment monitoring procedures should not be different from those currently used for urinary FSH-containing medicinal products. It is advised to adhere to the recommended starting doses indicated below.
Comparative clinical studies have shown that on average patients require a lower cumulative dose and shorter treatment duration with follitropin alfa compared with urinary FSH. Therefore, it is considered appropriate to give a lower total dose of follitropin alfa than generally used for urinary FSH, not only in order to optimise follicular development but also to minimise the risk of unwanted ovarian hyperstimulation (see section 5.1).
Women with anovulation (including polycystic ovarian syndrome)
Follitropin alfa may be given as a course of daily injections. In menstruating women treatment sho |
