DECAPEPTYL SR Powder for suspension for injection (2017)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Decapeptyl SR 3 mg, powder for suspension for injection.
Qualitative and quantitative composition
Triptorelin (I.N.N.) 4.2 mg, as triptorelin acetate. The vial contains an overage to ensure that a dose of 3 mg is administered to the patient. For a full list of excipients, see section 6.1.
Pharmaceutical form
Powder for suspension for injection, sustained release formulation.
Therapeutic indications
Treatment of patients with locally advanced, non-metastatic prostate cancer, as an alternative to surgical castration (see section 5.1). Treatment of metastatic prostate cancer. As adjuvant treatment to ...
Posology and method of administration
Prostate cancer One intramuscular injection should be administered every 4 weeks (28 days). No dosage adjustment is necessary in the elderly. Decapeptyl is also available as a 3-month treatment (Decapeptyl ...
Contraindications
Hypersensitivity to GnRH (gonadotropin releasing hormone), its analogues or to any of the excipients listed in section 6.1. Pregnancy and lactation. In the pre-menopausal breast cancer setting: Initiation ...
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 3 mg is co-administered with drugs affecting pituitary ...
Pregnancy and lactation
Triptorelin should not be used during pregnancy since concurrent use of GnRH agonists is associated with a theoretical risk of abortion or fetal abnormality. Prior to treatment, potentially fertile women ...
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
There is no human experience of overdosage. Animal data do not predict any effects other than those on sex hormone concentration and consequent effect on the reproductive tract. If overdosage occurs, symptomatic ...
Pharmacodynamic properties
Pharmacotherapeutic group: Gonadotropin-Releasing Hormone analogue L02AE04: Antineoplastic and immunomodulator Triptorelin is a decapeptide analogue of GnRH which initially stimulates release of pituitary ...
Pharmacokinetic properties
SUBCUTANEOUS FORM In healthy volunteers Subcutaneously administered triptorelin (100 μg) is rapidly absorbed (T<sub>max</sub> = 0.63 ± 0.26 hr for peak plasma concentration = 1.85 ± 0.23 ng/mL). Elimination ...
Preclinical safety data
Preclinical findings were only those related to the expected pharmacological activity of triptorelin, namely down-regulation of the hypothalamic-pituitary-gonadal axis. These included atrophy of the testes ...
List of excipients
D,L-lactide/glycolide copolymer Mannitol Carmellose sodium Polysorbate 80
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in 6.6.
Shelf life
3 years. The product should be used immediately after reconstitution.
Special precautions for storage
Do not store above 25°C. Keep the container in the outer carton.
Nature and contents of container
A type I, 5 mL capacity glass vial with an elastomer stopper and an aluminium cap containing the powder. Type I, 3 mL capacity glass ampoule containing 2 mL of the suspension vehicle. Box containing 1 ...
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, Berkshire, SL1 3XE, United Kingdom
Marketing authorization number(s)
PL 34926/0002
Date of first authorization / renewal of the authorization
Date of first authorisation: 29 December 1994 Date of last renewal: 13 September 2001
Date of revision of the text
8 September 2017
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