SOMAVERT Powder and solvent for solution for injection (2019)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
Name of the medicinal product
SOMAVERT 10 mg powder and solvent for solution for injection. SOMAVERT 15 mg powder and solvent for solution for injection. SOMAVERT 20 mg powder and solvent for solution for injection. SOMAVERT 25 mg ...
Qualitative and quantitative composition
SOMAVERT 10 mg powder and solvent for solution for injection: One vial contains 10 mg of pegvisomant. After reconstitution, 1 ml of solution contains 10 mg of pegvisomant.* Excipient with known effect: ...
Pharmaceutical form
Powder and solvent for solution for injection (powder for injection). The powder is white to slightly off-white.
Therapeutic indications
Treatment of adult patients with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalize ...
Posology and method of administration
Treatment should be initiated under the supervision of a physician experienced in the treatment of acromegaly. Posology A loading dose of 80 mg pegvisomant should be administered subcutaneously under medical ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Growth hormone-secreting tumours Growth hormone-secreting pituitary tumours may sometimes expand, causing serious complications (for example, visual field defects). Treatment by pegvisomant does not reduce ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. It should be considered whether to continue treatment with somatostatin analogues. The use of this medicine in combination with other medicinal products for ...
Fertility, pregnancy and lactation
Women of childbearing potential See section 4.4. Pregnancy For pegvisomant no clinical data on exposed pregnancies are available. Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
Undesirable effects
Summary of the safety profile The list below contains adverse reactions seen in clinical trials with SOMAVERT. In clinical studies, for patients treated with pegvisomant (n=550), the majority of adverse ...
Overdose
There is limited experience of overdose with pegvisomant. In the one reported incident of acute overdose, where 80 mg/day was administered for 7 days, the patient experienced a slight increase in fatigue ...
Pharmacodynamic properties
Pharmacotherapeutic group: Other anterior pituitary lobe hormones and analogues ATC code: H01AX01 Mechanism of action Pegvisomant is an analogue of human growth hormone that has been genetically modified ...
Pharmacokinetic properties
Absorption Absorption of pegvisomant following subcutaneous administration is slow and prolonged, and peak serum pegvisomant concentrations are not generally attained until 33-77 hours after administration. ...
Preclinical safety data
Non-clinical data revealed no special hazard for humans based on studies of repeated dose toxicity in rat and monkey. However, due to the marked pharmacological response in monkey, systemic exposures higher ...
List of excipients
Powder: Glycine Mannitol (E421) Disodium phosphate anhydrous Sodium dihydrogen phosphate monohydrate Solvent: Water for Injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life: 3 years. After reconstitution, the product should be used immediately.
Special precautions for storage
Store the powder vial(s) in a refrigerator (2°C–8°C). Do not freeze. Keep the vial(s) in their outer carton in order to protect from light. Store the pre-filled syringe(s) below 30C or store in a refrigerator ...
Nature and contents of container
10 mg or 15 mg or 20 mg or 25 mg or 30 mg of pegvisomant in powder in a vial (type I flint glass) with a stopper (chlorobutylrubber) and 1 ml solvent (water for injections) in a pre-filled syringe (type ...
Special precautions for disposal and other handling
The syringe and safety needle used to administer the injection are provided with the medicinal product. Before attaching the supplied safety needle the syringe cap will need to be removed from the pre-filled ...
Marketing authorization holder
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium
Marketing authorization number(s)
EU/1/02/240/001 10 mg 30 vials EU/1/02/240/002 15 mg 30 vials EU/1/02/240/004 20 mg 1 vial EU/1/02/240/003 20 mg 30 vials EU/1/02/240/009 25 mg 1 vial EU/1/02/240/010 25 mg 30 vials EU/1/02/240/011 30 ...
Date of first authorization / renewal of the authorization
Date of first authorization: 13 November 2002 Date of latest renewal: 20 September 2007
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