FYREMADEL Solution for injection in pre-filled syringe (2020)
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Περιεχόμενα
1. Name of the medicinal product
Fyremadel 0.25 mg/0.5 ml solution for injection in pre-filled syringe.
2. Qualitative and quantitative composition
Each pre-filled syringe contains 0.25 mg of ganirelix (as acetate) in 0.5 ml aqueous solution. The active substance ganirelix (as acetate) (INN) is a synthetic decapeptide with high antagonistic activity ...
3. Pharmaceutical form
Solution for injection in pre-filled syringe. Clear and colourless aqueous solution with a pH between 4.5 to 5.5 and an osmolality between 250 to 350 mOsm/kg.
4.1. Therapeutic indications
Ganirelix 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 ...
4.2. Posology and method of administration
Ganirelix should only be prescribed by a specialist experienced in the treatment of infertility. Posology Ganirelix is used to prevent premature LH surges in women undergoing COH. Controlled ovarian hyperstimulation ...
4.3. 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 ...
4.4. 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 ...
4.5. 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.
4.6. 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 ...
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
4.8. Undesirable effects
Summary of the safety profile The table below shows all adverse reactions in women treated with ganirelix in clinical studies using recFSH for ovarian stimulation. The adverse reactions with ganirelix ...
4.9. Overdose
Overdose in humans may result in a prolonged duration of action. No data on acute toxicity of ganirelix in humans are available. Clinical studies with subcutaneous administration of ganirelix at single ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Pituitary and hypothalamic hormones and analogues, anti-gonadotrophin releasing-hormones <b>ATC code:</b> H01CC01 Mechanism of action Ganirelix is a GnRH antagonist, which ...
5.2. Pharmacokinetic properties
Pharmacokinetic parameters after multiple subcutaneous dosing of ganirelix (once daily injection) were similar to those after a single subcutaneous dose. After repeated dosing 0.25 mg/day steady-state ...
5.3. 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 ...
6.1. List of excipients
Acetic acid, glacial (E260) Mannitol (E421) Water for injection The pH may have been adjusted with sodium hydroxide and acetic acid, glacial.
6.2. Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3. Shelf life
2 years.
6.4. Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5. Nature and contents of container
Pre-filled syringes made of colourless type I glass containing 0.5 ml of sterile, ready for use, aqueous solution closed with the grey rubber plunger stopper and polypropylene plunger rod. Injection needles ...
6.6. 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 ...
7. Marketing authorization holder
Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132 JH Hoofddorp, The Netherlands
8. Marketing authorization number(s)
PL 31750/0055
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 22 May 2013 Date of latest renewal: 31 August 2018
10. Date of revision of the text
09/04/2020
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