OVIDREL SOLUTION FOR INJECTION 250 MCG [SIN13015P]

Product Info

OVIDREL SOLUTION FOR INJECTION 250 MCG

[SIN13015P]

Therapeutic indications
Ovidrel® is indicated in the treatment of

• Women undergoing superovulation prior to assisted reproductive technologies (ART) such as in vitro fertilisation (IVF): Ovidrel® is administered to trigger final follicular maturation and luteinisation after stimulation of follicular growth,

• Anovulatory or oligo-ovulatory women: Ovidrel® is administered to trigger ovulation and luteinisation in anovulatory or oligo-ovulatory patients after stimulation of follicular growth.

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

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

• Women undergoing superovulation prior to assisted reproductive technologies (ART) such as in vitro fertilisation (IVF): One pre-filled pen of Ovidrel® (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 pen of Ovidrel® (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, Ovidrel® injection.

Method of administration
For subcutaneous use. Self-administration of Ovidrel® should only be performed by patients who are adequately trained and have access to expert advice.
Ovidrel® is for single use only.

For instructions on the administration with the prefilled pen, see ‘Instructions for Use’ – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Contraindications

• Hypersensitivity to the active substance or to any of the excipients

• Tumours of the hypothalamus and pituitary gland

• Ovarian enlargement or cyst unrelated to polycystic ovarian syndrome

• Gynaecological haemorrhages of unknown aetiology

• Ovarian, uterine or mammary carcinoma

• Active thromboembolic disorders

Ovidrel® must not be used in conditions when an effective response cannot be obtained, such as

• primary ovarian failure

• malformations of sexual organs incompatible with pregnancy

• fibroid tumours of the uterus incompatible with pregnancy

• postmenopausal women