OVITRELLE Solution for injection in pre-filled syringe Ref.[6664] Active ingredients: Choriogonadotropin alpha

Treatment with Ovitrelle should be performed under the supervision of a physician experienced in the treatment of fertility problems.

Posology

The maximum dose is 250 micrograms. The following dose regimen should be used:

• Women undergoing superovulation prior to assisted reproductive techniques such as in vitro fertilisation (IVF): One pre-filled syringe of Ovitrelle (250 micrograms) is administered 24 to 48 hours after the last administration of a follicle stimulating hormone (FSH) or human menopausal gonadotropin (hMG) preparation, i.e. when optimal stimulation of follicular growth is achieved.
• Anovulatory or oligo-ovulatory women: One pre-filled syringe of Ovitrelle (250 micrograms) is administered 24 to 48 hours after optimal stimulation of follicular growth is achieved. The patient is recommended to have coitus on the day of, and the day after, Ovitrelle injection.

Special populations

Renal or hepatic impairment

Safety, efficacy and pharmacokinetics of Ovitrelle in patients with renal or hepatic impairment have not been established.

Paediatric population

There is no relevant use of Ovitrelle in the paediatric population.

Method of administration

For subcutaneous use. Self-administration of Ovitrelle should only be performed by patients who are adequately trained and have access to expert advice.

Ovitrelle is for single use only.

The effects of an overdose of Ovitrelle are unknown. Nevertheless, there is a possibility that OHSS may result from an overdose of Ovitrelle (see section 4.4).

2 years.

After opening, the medicinal product should be used immediately. However, the in-use stability has been demonstrated for 24 hours at + 2°C to 8°C.

Store in a refrigerator (2°C-8°C). Store in the original package. Within its shelf-life, the solution may be stored at or below 25°C for up to 30 days without being refrigerated again during this period. It must be discarded if not used after these 30 days.

0.5 mL of solution in a pre-filled syringe (type I glass) with a plunger stopper (halobutyl rubber) and plunger (plastic), and with a needle for injection (stainless) – pack of 1.

Only clear solution without particles should be used. For single use only.

Self-administration of Ovitrelle should only be performed by patients who are adequately trained and have access to expert advice.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.