DECAPEPTYL SR Powder and solvent for suspension for injection (2016)
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Περιεχόμενα
Name of the medicinal product
Decapeptyl SR 22.5 mg powder and solvent for suspension for injection.
Qualitative and quantitative composition
Triptorelin (I.N.N) 28 mg as triptorelin pamoate. The vial contains an overage to ensure that a dose of 22.5 mg is administered to the patient. For a full list of excipients see section 6.1.
Pharmaceutical form
Powder and solvent for suspension for injection, sustained release formulation. Powder: White to off-white powder. Solvent: Clear solution.
Therapeutic indications
Treatment of patients with locally advanced, non-metastatic prostate cancer, as an alternative to surgical castration. Treatment of metastatic prostate cancer. As adjuvant treatment to radiotherapy in ...
Posology and method of administration
Posology The recommended dose of Decapeptyl SR 22.5 mg is 22.5 mg of triptorelin (1 vial) administered every six months (twenty four weeks) as a single intramuscular injection. In patients treated with ...
Contraindications
Hypersensitivity to GnRH, its analogues or to any of the excipients of the medicinal product listed in section 6.1 (see also section 4.8). Triptorelin is contraindicated during pregnancy and lactation ...
Special warnings and precautions for use
The use of GnRH agonists may cause a reduction in bone mineral density. In men, preliminary data suggest that the use of a bisphosphonate in combination with a GnRH agonist may reduce bone mineral loss. ...
Interaction with other medicinal products and other forms of interaction
Drugs which raise prolactin levels should not be prescribed concomitantly as they reduce the level of GnRH receptors in the pituitary. When Decapeptyl SR 22.5 mg is co-administered with drugs affecting ...
Fertility, pregnancy and lactation
Pregnancy Decapeptyl SR 22.5 mg is indicated for adult men and children. There are very limited data on the use of triptorelin in pregnant women. It should be confirmed that the patient is not pregnant ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. However, the ability to drive and use machines may be impaired should the patient experience dizziness, somnolence ...
Undesirable effects
General tolerance in men Since patients suffering from locally advanced or metastatic, hormone-dependent prostate cancer are generally old and have other diseases frequently encountered in this aged population, ...
Overdose
The pharmaceutical properties of Decapeptyl SR 22.5 mg and its mode of administration make accidental or intentional overdose unlikely. There is no experience of overdose from clinical trials. Animal tests ...
Pharmacodynamic properties
Pharmacotherapeutic group: Hormones and related agents, gonadotropin releasing hormone agonists. ATC code: L02AE04 Mechanism of action and pharmacodynamic effects Triptorelin, a GnRH agonist, acts as a ...
Pharmacokinetic properties
Absorption Following a single intramuscular injection of Decapeptyl SR 22.5 mg in patients with prostate cancer, T<sub>max</sub> was 3 (2-12) hours and C<sub>max</sub> (0-169 days) was 40.0 (22.2-76.8)ng/mL. ...
Preclinical safety data
The compound did not demonstrate any specific toxicity in animal toxicological studies. The effects observed are related to the pharmacological properties of triptorelin on the endocrine system.
List of excipients
<u>Powder:</u> Poly (d,l-lactide-co-glycolide) Mannitol Carmellose sodium Polysorbate 80 <u>Solvent:</u> Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be reconstituted with other medicinal products.
Shelf life
3 years.
Special precautions for storage
Do not store above 25°C. Keep the container in the outer carton. The reconstituted suspension for injection should be used immediately.
Nature and contents of container
6 mL septum vial with bromobutyl stopper and aluminium flip-off cap. Ampoule containing 2 mL of sterile solvent for suspension. Box of: 1 vial, 1 ampoule and 1 blister containing 1 injection syringe and ...
Special precautions for disposal and other handling
The suspension for injection must be reconstituted using an aseptic technique and only using the ampoule of solvent for injection. The instructions for reconstitution hereafter and in the leaflet must ...
Marketing authorization holder
Ipsen Limited, 190 Bath Road, Slough SL1 3XE, United Kingdom
Marketing authorization number(s)
PL 34926/0013
Date of first authorization / renewal of the authorization
14 Sept 2010
Date of revision of the text
17 December 2016
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