OVITRELLE Solution for injection in pre-filled syringe (2019)
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Περιεχόμενα
Name of the medicinal product
Ovitrelle 250 micrograms/0.5 mL solution for injection in pre-filled syringe.
Qualitative and quantitative composition
Each pre-filled syringe contains 250 micrograms choriogonadotropin alfa* (equivalent to approximately 6,500 IU) in 0.5 mL solution. * recombinant human chorionic gonadotropin, r-hCG produced in Chinese ...
Pharmaceutical form
Solution for injection in pre-filled syringe. Clear, colourless to slightly yellow solution. The pH of the solution is 7.0 ± 0.3, its osmolality 250-400 mOsm/kg.
Therapeutic indications
Ovitrelle is indicated in the treatment of: Adult women undergoing superovulation prior to assisted reproductive techniques such as in vitro fertilisation (IVF): Ovitrelle is administered to trigger final ...
Posology and method of administration
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 ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 Tumours of the hypothalamus or pituitary gland Ovarian enlargement or cyst due to reasons other than polycystic ...
Special warnings and precautions for use
Before starting treatment, the couples infertility should be assessed as appropriate and putative contraindications for pregnancy evaluated. In particular, patients should be evaluated for hypothyroidism, ...
Interaction with other medicinal products and other forms of interaction
No specific interaction studies with Ovitrelle and other medicinal products have been performed; however, no clinically significant medicinal product interactions have been reported during hCG therapy. ...
Fertility, pregnancy and lactation
Pregnancy There is no indication for the use of Ovitrelle during pregnancy. No clinical data on exposed pregnancies are available. No reproduction studies with choriogonadotropin alfa in animals were performed ...
Effects on ability to drive and use machines
Ovitrelle is expected to have no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile In comparative trials with different doses of Ovitrelle, the following adverse reactions were found to be associated with Ovitrelle in a dose-related fashion: OHSS, vomiting ...
Overdose
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).
Pharmacodynamic properties
Pharmacotherapeutic group: Sex hormones and modulators of the genital system, gonadotropins ATC code: G03GA08 Mechanism of action Ovitrelle is a medicinal product of choriogonadotropin alfa produced by ...
Pharmacokinetic properties
Following intravenous administration, choriogonadotropin alfa is distributed to the extracellular fluid space with a distribution half-life of around 4.5 hours. The steady-state volume of distribution ...
Preclinical safety data
Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity. Studies on carcinogenic potential were not performed. ...
List of excipients
Mannitol Methionine Poloxamer 188 Phosphoric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
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.
Special precautions for storage
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. ...
Nature and contents of container
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.
Special precautions for disposal and other handling
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. ...
Marketing authorization holder
Merck Europe B.V., Gustav Mahlerplein 102, 1082 MA Amsterdam, The Netherlands
Marketing authorization number(s)
EU/1/00/165/007
Date of first authorization / renewal of the authorization
Date of first authorisation: 02 February 2001 Date of latest renewal: 02 February 2006
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