PROSTAP 3 DCS Powder and solvent for suspension for injection in pre-filled syringe (2022)
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Περιεχόμενα
Name of the medicinal product
PROSTAP 3 DCS 11.25 mg Powder and Solvent for Prolonged-release Suspension for Injection in Pre-filled syringe.
Qualitative and quantitative composition
<u>PROSTAP 3 Powder:</u> contains 11.25 mg leuprorelin acetate (equivalent to 10.72 mg base). <u>Sterile Solvent:</u> Each ml contains carmellose sodium 5 mg, mannitol (E421) 50 mg, polysorbate 80 1 mg, ...
Pharmaceutical form
Powder and solvent for suspension for injection in pre-filled syringe. <u>Powder:</u> A sterile, lyophilised, white, odourless powder. <u>Solvent:</u> A clear, odourless, slightly viscous, sterile solvent. ...
Therapeutic indications
Metastatic prostate cancer. Locally advanced prostate cancer, as an alternative to surgical castration. As an adjuvant treatment to radiotherapy in patients with high-risk localised or locally advanced ...
Posology and method of administration
Posology Prostate Cancer The usual recommended dose is 11.25 mg presented as a three month depot injection and administered as a single subcutaneous injection at intervals of three months. The majority ...
Contraindications
Hypersensitivity to the active substance, any of the excipients or to synthetic gonadotrophin releasing homone (Gn-RH) or Gn-RH derivatives. <u>Women:</u> PROSTAP 3 is contra-indicated in women who are ...
Special warnings and precautions for use
PROSTAP 3 injectable suspension must be prepared at the time of use and, after reconstitution, used immediately. PROSTAP 3 <u>contains sodium</u>. This medicine contains less than 1 mmol sodium (23 mg) ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. Women and girls No known interactions. Men Since androgen deprivation treatment may prolong the QT interval, the concomitant use of PROSTAP 3 with medicinal ...
Fertility, pregnancy and lactation
Safe use of leuprorelin acetate in pregnancy has not been established clinically. Studies in animals have shown reproductive toxicity (see section 5.3). Before starting treatment with PROSTAP 3, pregnancy ...
Effects on ability to drive and use machines
PROSTAP 3 can influence the ability to drive and use machines due to visual disturbances and dizziness.
Undesirable effects
Adverse reactions seen with PROSTAP 3 are due mainly to the specific pharmacological action, namely increases and decreases in certain hormone levels. The following tables list adverse reactions with leuprorelin ...
Overdose
No case of overdose has been reported. In animal studies, doses of up to 500 times the recommended human dose resulted in dyspnoea, decreased activity and local irritation at the injection site. In cases ...
Pharmacodynamic properties
Pharmacotherapeutic group: Gonadotrophin-Releasing Hormone Analogues ATC code: L02AE02 PROSTAP 3 contains leuprorelin acetate, a synthetic nonapeptide analogue of naturally occurring gonadotrophin releasing ...
Pharmacokinetic properties
Leuprorelin acetate is well absorbed after subcutaneous and intramuscular injections. It binds to the LHRH receptors and is rapidly degraded. An initially high plasma level of leuprorelin acetate peaks ...
Preclinical safety data
Animal studies have shown that leuprorelin acetate has a high acute safety factor. No major overt toxicological problems have been seen during repeated administration. Whilst the development of pituitary ...
List of excipients
<u>PROSTAP 3 Powder:</u> Poly (D-L lactic acid) Mannitol (E421) <u>Sterile Solvent:</u> Carmellose sodium Mannitol (E421) Polysorbate 80 Acetic acid, glacial Water for injections
Incompatibilities
This drug must be injected alone.
Shelf life
3 years unopened. Once reconstituted with sterile solvent, the suspension should be administered immediately.
Special precautions for storage
Do not store above 25°C. Do not refrigerate or freeze. Store in the original container in order to protect from light.
Nature and contents of container
One dual chamber pre-filled syringe containing 11.25 mg leuprorelin acetate powder in the front chamber and 1 ml of Sterile Solvent in the rear chamber. 1 23 gauge syringe needle fitted with safety device. ...
Special precautions for disposal and other handling
Prepare the injectable suspension at the time of use and, after reconstituting, use immediately. Always ensure the safety device to prevent needle-stick injury is deployed after injection. Any unused product ...
Marketing authorization holder
Takeda UK Limited, 1 Kingdom Street, London, W2 6BD, United Kingdom
Marketing authorization number(s)
PL 16189/0013
Date of first authorization / renewal of the authorization
28/04/2011
Date of revision of the text
19/04/2022
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