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SPC, UK: Firmagon 80mg Injection (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Ferring Pharmaceuticals Ltd
Διεύθυνση :
Drayton Hall, Church Road, West Drayton, UB7 7PS, UK
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Δωρεάν εγγραφή

Name of the medicinal product

FIRMAGON 80 mg powder and solvent for solution for injection.

Qualitative and quantitative composition

Each vial contains 80 mg degarelix (as acetate). After reconstitution, each ml of solution contains 20 mg of degarelix. For a full list of excipients, see section 6.1.

Pharmaceutical form

Powder and solvent for solution for injection (Powder for injection and solvent). Powder: White to off-white powder Solvent: Clear, colourless solution

Therapeutic indications

FIRMAGON is a gonadotrophin releasing hormone (GnRH) antagonist indicated for treatment of adult male patients with advanced hormone-dependent prostate cancer.

Posology and method of administration

Posology Starting dose Maintenance dose – monthly administration 240 mg administered as two subcutaneous injections of 120 mg each 80 mg administered as one subcutaneous injection The first maintenance ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Special warnings and precautions for use

The data available on efficacy and safety experience with degarelix is limited to a one year treatment. Effect on QT/QTc interval Long-term androgen deprivation therapy may prolong the QT interval. In ...

Interaction with other medicinal products and other forms of interaction

No formal drug-drug interaction studies have been performed. Since androgen deprivation treatment may prolong the QTc interval, the concomitant use of degarelix with medicinal products known to prolong ...

Pregnancy and lactation

There is no relevant indication for use of FIRMAGON in women.

Effects on ability to drive and use machines

No studies on the effects of degarelix on the ability to drive and use machines have been performed. However, fatigue and dizziness are common adverse reactions that might influence the ability to drive ...

Undesirable effects

The most commonly observed adverse reactions during degarelix therapy in the confirmatory phase III study (N=409) were due to the expected physiological effects of testosterone suppression, including hot ...

Overdose

There is no clinical experience with the effects of an acute overdose with degarelix. In the event of an overdose the patient should be monitored and appropriate supportive treatment should be given, if ...

Pharmacodynamic properties

Pharmacotherapeutic group: Other hormone antagonists and related agents ATC code: L02BX02 Degarelix is a selective gonadotrophin releasing-hormone (GnRH) antagonist that competitively and reversibly binds ...

Pharmacokinetic properties

Absorption Following subcutaneous administration of 240 mg degarelix at a concentration of 40 mg/ml to prostate cancer patients in the pivotal study CS21, AUC<sub>0-28</sub> days was 635 (602-668) day*ng/ml, ...

Preclinical safety data

Animal reproduction studies showed that degarelix caused infertility in male animals. This is due to the pharmacological effect; and the effect was reversible. In female reproduction toxicity studies degarelix ...

List of excipients

Powder: Mannitol (E421) Solvent: Water for injections

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Shelf life

3 years. After reconstitution Chemical and physical in-use stability has been demonstrated for 2 hours at 25ºC. From a microbiological point of view, unless the method of reconstitution precludes the risk ...

Special precautions for storage

This medicinal product does not require any special storage conditions. For storage conditions of the reconstituted medicinal product, see section 6.3.

Nature and contents of container

Vials of glass Type I with bromobutyl rubber stopper and aluminium flip-off seal. 1 vial containing 80 mg powder for solution for injection 1 vial containing 6 ml solvent 1 syringe (5 ml with dual-line ...

Special precautions for disposal and other handling

No special requirements for disposal. Instructions for use The instructions for reconstitution must be followed carefully. Administration of other concentrations is not recommended because the gel depot ...

Marketing authorization holder

Ferring Pharmaceuticals A/S Kay Fiskers Plads 11 DK-2300 Copenhagen S Denmark Tel: +45 88 33 88 34

Marketing authorization number(s)

EU/1/08/504/001 EU/1/08/504/003

Date of first authorization / renewal of the authorization

17/02/2009

Date of revision of the text

19/07/10