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HSA Approval

Ovidrel Solution for Injection 250 mcg

SIN13015P

Ovidrel Solution for Injection 250 mcg

Ovidrel Solution for Injection 250 mcg

July 13, 2004

MERCK PTE. LTD.

MERCK PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantMERCK PTE. LTD.
Licence HolderMERCK PTE. LTD.

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

INJECTION, SOLUTION

**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_.

SUBCUTANEOUS

Medical Information

**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.

**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

G03GA08

choriogonadotropin alfa

Manufacturer Information

MERCK PTE. LTD.

Merck Serono S.p.A.

Active Ingredients

Choriogonadotropin alfa

250 mcg

Documents

Package Inserts

Ovidrel_IFU.pdf

Approved: March 29, 2023

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Ovidrel Solution for Injection 250 mcg - HSA Approval | MedPath