GONAPEPTYL DEPOT Powder and solvent for suspension for injection prolonged release (2015)
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Περιεχόμενα
Name of the medicinal product
GONAPEPTYL DEPOT 3.75 mg. Powder and solvent for suspension for injection.
Qualitative and quantitative composition
One pre-filled syringe contains 3.75 mg triptorelin (as acetate) to be suspended in one ml sodium containing suspension agent. The product contains 3.69 mg/ml equivalent to 0.160 mmol/ml sodium after reconstitution. ...
Pharmaceutical form
Powder and solvent for suspension for injection prolonged release in pre-filled syringes. Visual description Before mixing: White to faintly yellow powder and a clear colourless aqueous liquid. After mixing: ...
Therapeutic indications
Men Treatment of hormone dependent locally advanced or metastatic prostate cancer. Women Preoperative reduction of myoma size to reduce the symptoms of bleeding and pain in women with symptomatic uterine ...
Posology and method of administration
The product should only be used under the supervision of an appropriate specialist having requisite facilities for regular monitoring of response. The treatment of children with triptorelin should be under ...
Contraindications
General Known hypersensitivity to triptorelin, poly-(d,l lactide coglycolide), dextran, or to any of the excipients. Hypersensitivity to gonadotrophin-releasing hormone (GnRH) or any other GnRH analogue. ...
Special warnings and precautions for use
General The use of GnRH agonists may cause 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 ...
Interaction with other medicinal products and other forms of interaction
When triptorelin is co-administered with drugs affecting pituitary secretion of gonadotropins caution should be given and it is recommended that the patients hormonal status should be supervised. Since ...
Pregnancy and lactation
Prior to treatment, potentially fertile women should be examined carefully to exclude pregnancy. Very limited data on the use of triptorelin during pregnancy do not indicate an increased risk of congenital ...
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
Adverse experiences reported among patients treated with triptorelin during clinical trials and from post-marketing surveillance are shown below. As a consequence of decreased testosterone or oestrogen ...
Overdose
There is insufficient experience of overdosing with triptorelin to draw conclusions on possible adverse effects. Considering the package form and the pharmaceutical form, overdosing is not expected. If ...
Pharmacodynamic properties
Pharmacotherapeutic group: Gonadorelinanaloga ATC code: L02AE04 Triptorelin is a synthetic decapeptide analogue of the natural gonadotrophin-releasing hormone (GnRH). GnRH is a decapeptide, which is synthesised ...
Pharmacokinetic properties
After intramuscular administration of GONAPEPTYL Depot, the plasma concentrations of triptorelin are determined by the (slow) degradation of the poly-(d,l lactide coglycolide) polymer. The mechanism inherent ...
Preclinical safety data
In rats, but not in mice treated over a long period of time with triptorelin, an increase in pituitary tumors has been detected. The influence of triptorelin on pituitary abnormalities in humans is unknown. ...
List of excipients
<u>One pre-filled syringe with powder contains:</u> Poly-(d,l lactide coglycolide) Propylene glycol dicaprylocaprate <u>One pre-filled syringe with one ml suspension agent contains:</u> Dextran 70 Polysorbate ...
Incompatibilities
In the absence of compatibility studies this medicinal product should not be mixed with other medicinal products.
Shelf life
3 years. Reconstituted suspension: 3 minutes.
Special precautions for storage
Store at 2°C-8°C (in a refrigerator). Keep the container in the outer carton.
Nature and contents of container
<u>Powder:</u> Pre-filled syringe. <u>Solvent:</u> Pre-filled syringe. Pre-filled syringes (borosilicate glass type I, clear) with a connector (polypropylene), black chlorobutyl rubber stopper (plunger ...
Special precautions for disposal and other handling
GONAPEPTYL Depot is for single use only and any unused suspension should be discarded. 1. Preparation Instructions for the physician how to prepare the suspension. Since successful treatment depends upon ...
Marketing authorization holder
Ferring Pharmaceuticals Ltd., Drayton Hall, Church Road, West Drayton, UB7 7PS, United Kingdom
Marketing authorization number(s)
PL 03194/0085
Date of first authorization / renewal of the authorization
15th April 2009
Date of revision of the text
May 2015
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