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SPC: OVALEAP Solution for injection (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

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.

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 ...

Pharmaceutical form

Solution for injection (injection). Clear, colourless solution. The pH of the solution is 6.8-7.2.

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 ...

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 ...

Contraindications

Hypersensitivity to the active substance follitropin alfa, FSH or to any of the excipients listed in section 6.1; tumours of the hypothalamus or pituitary gland; ovarian enlargement or ovarian cyst not ...

Special warnings and precautions for use

Traceability In order to improve the traceability of biological medicinal products, the trade name and batch number of the administered medicinal product should be clearly recorded in the patient file. ...

Interaction with other medicinal products and other forms of interaction

Concomitant use of follitropin alfa with other medicinal products used to stimulate ovulation (e.g. hCG, clomifene citrate) may potentiate the follicular response, whereas concurrent use of a GnRH agonist ...

Fertility, pregnancy and lactation

Pregnancy There is no indication for use of Ovaleap during pregnancy. Data on a limited number of exposed pregnancies (less than 300 pregnancy outcomes) indicate no malformative or foeto/neonatal toxicity ...

Effects on ability to drive and use machines

Ovaleap has no or negligible influence on the ability to drive and use machines.

Undesirable effects

Summary of the safety profile The most commonly reported adverse reactions are headache, ovarian cysts and local injection site reactions (e.g. pain, erythema, haematoma, swelling and/or irritation at ...

Overdose

The effects of an overdose of follitropin alfa are unknown, nevertheless, there is a possibility that OHSS may occur (see section 4.4).

Pharmacodynamic properties

Pharmacotherapeutic group: Sex hormones and modulators of the genital systems, gonadotropins ATC code: G03GA05 Ovaleap is a biosimilar medicinal product. Detailed information is available on the website ...

Pharmacokinetic properties

Following intravenous administration, follitropin alfa is distributed to the extracellular fluid space with an initial half-life of around 2 hours and eliminated from the body with a terminal half-life ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of single and repeated dose toxicity and genotoxicity additional to that already stated in other sections of this SmPC. ...

List of excipients

Sodium dihydrogen phosphate dihydrate Sodium hydroxide (2 M) (for pH adjustment) Mannitol Methionine Polysorbate 20 Benzyl alcohol Benzalkonium chloride Water for injections

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Shelf life

Shelf life: 3 years. Shelf life and storage conditions after first opening: The cartridge in-use in the pen may be stored for a maximum of 28 days. Do not store above 25°C. The patient should write down ...

Special precautions for storage

Store in a refrigerator (2°C-8°C). Do not freeze. Keep the cartridge in the outer carton in order to protect from light. Before opening and within its shelf life, the medicinal product may be removed from ...

Nature and contents of container

Ovaleap 300 IU/0.5 mL solution for injection: Cartridge (type I glass) with a rubber piston (bromobutyl rubber) and a crimp-cap (aluminium) with a septum (bromobutyl rubber), containing 0.5 mL of solution. ...

Special precautions for disposal and other handling

No special requirements for disposal. The solution must not be used if it contains particles or if the solution is not clear. Ovaleap is designed for use in conjunction with the Ovaleap Pen only. The instructions ...

Marketing authorization holder

Theramex Ireland Limited 3<sup>rd</sup> Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland

Marketing authorization number(s)

Ovaleap 300 IU/0.5 mL solution for injection: EU/1/13/871/001 Ovaleap 450 IU/0.75 mL solution for injection: EU/1/13/871/002 Ovaleap 900 IU/1.5 mL solution for injection: EU/1/13/871/003

Date of first authorization / renewal of the authorization

Date of first authorisation: 27 September 2013 Date of latest renewal: 16 May 2018

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