ORGALUTRAN Solution for injection (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Orgalutran 0.25 mg/0.5 mL solution for injection.
Qualitative and quantitative composition
Each pre-filled syringe contains 0.25 mg of ganirelix in 0.5 mL aqueous solution. The active substance ganirelix (INN) is a synthetic decapeptide with high antagonistic activity to the naturally occurring ...
Pharmaceutical form
Solution for injection. Clear and colourless aqueous solution.
Therapeutic indications
Orgalutran is indicated for the prevention of premature luteinising hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproduction techniques (ART). In clinical ...
Posology and method of administration
Orgalutran should only be prescribed by a specialist experienced in the treatment of infertility. Posology Orgalutran is used to prevent premature LH surges in women undergoing COH. Controlled ovarian ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hypersensitivity to gonadotrophin-releasing hormone (GnRH) or any other GnRH analogue. Moderate or severe impairment ...
Special warnings and precautions for use
Hypersensitivity reaction Special care should be taken in women with signs and symptoms of active allergic conditions. Cases of hypersensitivity reactions (both generalised and local), have been reported ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. The possibility of interactions with commonly used medicinal products, including histamine liberating medicinal products, cannot be excluded.
Fertility, pregnancy and lactation
Pregnancy There are no adequate data from the use of ganirelix in pregnant women. In animals, exposure to ganirelix at the time of implantation resulted in litter resorption (see section 5.3). The relevance ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
Undesirable effects
Summary of the safety profile The table below shows all adverse reactions in women treated with Orgalutran in clinical studies using recFSH for ovarian stimulation. The adverse reactions with Orgalutran ...
Overdose
Overdose in humans may result in a prolonged duration of action. No data on acute toxicity of Orgalutran in humans are available. Clinical studies with subcutaneous administration of Orgalutran at single ...
Pharmacodynamic properties
Pharmacotherapeutic group: Pituitary and hypothalamic hormones and analogues, anti-gonadotrophin-releasing hormones ATC code: H01CC01 Mechanism of action Orgalutran is a GnRH antagonist, which modulates ...
Pharmacokinetic properties
Pharmacokinetic parameters after multiple subcutaneous dosing of Orgalutran (once daily injection) were similar to those after a single subcutaneous dose. After repeated dosing 0.25 mg/day steady-state ...
Preclinical safety data
Preclinical data reveal no special hazard for humans based on safety pharmacology, repeated dose toxicity and genotoxicity. Reproduction studies carried out with ganirelix at doses of 0.1 to 10 μg/kg/day ...
List of excipients
Acetic acid Mannitol Water for injections The pH may have been adjusted with sodium hydroxide and acetic acid.
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Do not freeze. Store in the original package in order to protect from light.
Nature and contents of container
Disposable pre-filled syringes (siliconised type I glass), containing 0.5 mL of sterile, ready for use, aqueous solution closed with a rubber piston that does not contain latex. Each pre-filled syringe ...
Special precautions for disposal and other handling
Inspect the syringe before use. Use only syringes with clear, particle-free solutions and from undamaged containers. Any unused medicinal product or waste material should be disposed of in accordance with ...
Marketing authorization holder
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Marketing authorization number(s)
EU/1/00/130/001, 1 pre-filled syringe EU/1/00/130/002, 5 pre-filled syringes
Date of first authorization / renewal of the authorization
Date of first authorisation: 17 May 2000 Date of last renewal: 10 May 2010
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