ELONVA Solution for injection (2022)
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Περιεχόμενα
Name of the medicinal product
Elonva 100 micrograms solution for injection. Elonva 150 micrograms solution for injection.
Qualitative and quantitative composition
<u>Elonva 100 micrograms solution for injection:</u> Each pre-filled syringe contains 100 micrograms of corifollitropin alfa* in 0.5 mL solution for injection. <u>Elonva 150 micrograms solution for injection: ...
Pharmaceutical form
Solution for injection (injection). Clear and colourless aqueous solution.
Therapeutic indications
Elonva is indicated for Controlled Ovarian Stimulation (COS) in combination with a Gonadotropin Releasing Hormone (GnRH) antagonist for the development of multiple follicles in women participating in an ...
Posology and method of administration
Treatment with Elonva should be initiated under the supervision of a physician experienced in the treatment of fertility problems. Posology In the treatment of women of reproductive age, the dose of Elonva ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Tumours of the ovary, breast, uterus, pituitary or hypothalamus. Abnormal (not menstrual) vaginal bleeding without ...
Special warnings and precautions for use
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Infertility evaluation before starting ...
Interaction with other medicinal products and other forms of interaction
No interaction studies with Elonva and other medicines have been performed. Since corifollitropin alfa is not a substrate of cytochrome P450 enzymes, no metabolic interactions with other medicinal products ...
Fertility, pregnancy and lactation
Pregnancy In case of inadvertent exposure to Elonva during pregnancy, clinical data are not sufficient to exclude an adverse outcome of pregnancy. In animal studies reproductive toxicity has been observed ...
Effects on ability to drive and use machines
No studies on the ability to drive and use machines have been performed. Elonva may cause dizziness. Patients should be advised that if they feel dizzy, they should not drive or use machines.
Undesirable effects
Summary of the safety profile The most frequently reported adverse reactions during treatment with Elonva in clinical trials (N=2,397) are pelvic discomfort (6.0%), OHSS (4.3%, see also section 4.4), headache ...
Overdose
In females More than one injection of Elonva within one treatment cycle or too high a dose of Elonva and/or (rec)FSH may increase the risk of OHSS (see OHSS in section 4.4). Paediatric population The effects ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> sex hormones and modulators of the genital system, gonadotropins <b>ATC code:</b> G03GA09 Mechanism of action Corifollitropin alfa is designed as a sustained follicle ...
Pharmacokinetic properties
Pharmacokinetic parameters of corifollitropin alfa were evaluated after subcutaneous administration in women undergoing a COS treatment cycle. Due to the long elimination half-life, after administration ...
Preclinical safety data
Preclinical data revealed no special hazard for humans based on conventional studies of single and repeated dose toxicity and safety pharmacology. Reproduction toxicology studies in rats and rabbits indicated ...
List of excipients
Sodium citrate Sucrose Polysorbate 20 Methionine Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Incompatibilities
In the absence of compatibility studies, the medicinal product must not be mixed with other medicinal products.
Shelf life
3 years.
Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. For convenience, the patient is allowed to store the product at or below 25°C for a period of not more than 1 month. Keep the syringe in the outer carton ...
Nature and contents of container
Elonva is supplied in pre-filled luerlock syringes of 1 mL (type I hydrolytic glass), closed with a bromobutyl elastomer plunger and a tip cap. The syringe is equipped with an automatic safety system to ...
Special precautions for disposal and other handling
Do not use Elonva if the solution is not clear. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
N.V. Organon, Kloosterstraat 6, 5349 AB Oss, The Netherlands
Marketing authorization number(s)
EU/1/09/609/001 EU/1/09/609/002
Date of first authorization / renewal of the authorization
Date of first authorisation: 25 January 2010 Date of latest renewal: 22 August 2014
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