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Ιατροφαρμακευτική πληροφόρηση για τον επαγγελματία υγείας

Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
Κλαύδιος Γαληνός
Είσοδος χρηστών
Όνομα χρήστη
Συνθηματικό
Εικονίδιο Είσοδος χρήστη
Εικονίδιο Δωρεάν εγγραφή
Εικονίδιο Ανανέωση συνθηματικού

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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Firmagon 80mg Injection (2012)

Εκδότης

Εκδότης Ferring Pharmaceuticals Ltd
Διεύθυνση Drayton Hall, Church Road, West Drayton, UB7 7PS, UK
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Περιεχόμενα

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 ...

Pharmaceutical form

Powder and solvent for solution for injection (Powder for injection and solvent). Powder: White to off-white ...

Therapeutic indications

FIRMAGON is a gonadotrophin releasing hormone (GnRH) antagonist indicated for treatment of adult male ...

Posology and method of administration

Posology Starting dose Maintenance dose – monthly administration 240 mg administered as two subcutaneous ...

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. ...

Interaction with other medicinal products and other forms of interaction

No formal drug-drug interaction studies have been performed. Since androgen deprivation treatment may ...

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. ...

Undesirable effects

The most commonly observed adverse reactions during degarelix therapy in the confirmatory phase III study ...

Overdose

There is no clinical experience with the effects of an acute overdose with degarelix. In the event of ...

Pharmacodynamic properties

Pharmacotherapeutic group: Other hormone antagonists and related agents ATC code: L02BX02 Degarelix is ...

Pharmacokinetic properties

Absorption Following subcutaneous administration of 240 mg degarelix at a concentration of 40 mg/ml to ...

Preclinical safety data

Animal reproduction studies showed that degarelix caused infertility in male animals. This is due to ...

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 ...

Shelf life

3 years. After reconstitution Chemical and physical in-use stability has been demonstrated for 2 hours ...

Special precautions for storage

This medicinal product does not require any special storage conditions. For storage conditions of the ...

Nature and contents of container

Vials of glass Type I with bromobutyl rubber stopper and aluminium flip-off seal. 1 vial containing 80 ...

Special precautions for disposal and other handling

No special requirements for disposal. Instructions for use The instructions for reconstitution must be ...

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
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.