BEROMUN Powder for solution for infusion (2020)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
Name of the medicinal product
Beromun 1 mg powder for solution for infusion.
Qualitative and quantitative composition
Each vial contains 1 mg tasonermin*, corresponding to 3.0-6.0 10<sup>7</sup> IU (International Units). * tumor necrosis factor alfa-1a (TNFα-1a) produced by recombinant DNA technology in E. coli. Excipient(s) ...
Pharmaceutical form
Powder for solution for infusion (powder for infusion). The powder is white to off-white.
Therapeutic indications
Beromun is indicated in adults. as an adjunct to surgery for subsequent removal of the tumour so as to prevent or delay amputation, or in the palliative situation, for irresectable soft tissue sarcoma ...
Posology and method of administration
This treatment should be undertaken in specialised centres by surgical teams experienced in the management of limb sarcomas and ILP procedure, with an intensive care unit readily available and with the ...
Contraindications
Contraindications to Beromun ILP, subdivided by components of the procedure, are: Contraindications to Beromun: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. ...
Special warnings and precautions for use
ILP should be undertaken in specialised centres by surgical teams experienced in the management of limb sarcomas and ILP procedure, with an intensive care unit readily available and with the facilities ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. Beromun has been co-administered with interferon-gamma in the ILP setting but no added value has been demonstrated. The addition of interferon-gamma to the tasonermin ...
Fertility, pregnancy and lactation
Pregnancy There are no adequate data from the use of tasonermin in pregnant women. Animal studies are insufficient with respect to effects on pregnancy, embryonal development and postnatal development ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
Summary of the safety profile Undesirable effects may be related to Beromun, to melphalan, or to the ILP procedure and associated measures, or to a combination of these factors. The most frequent adverse ...
Overdose
Should accidental overdose occur, ILP should be terminated immediately and the limb washed out using at least 2 litres of dextran 70 intravenous infusion or similar fluid (see also section 4.4). If signs ...
Pharmacodynamic properties
Pharmacotherapeutic group: Other immunostimulants ATC code: L03AX11 Mechanism of action In vivo antitumour activity is probably based on direct and indirect effects. Direct inhibition of tumour cell proliferation ...
Pharmacokinetic properties
Systemic pharmacokinetics The systemic pharmacokinetic information on tasonermin is sparse. A dose-dependency has been observed as indicated by a decrease in clearance and an increase in half-life at increasing ...
Preclinical safety data
The toxicological profile of tasonermin has been investigated in preclinical studies using mice, rats, rabbits, dogs and monkeys. Haematological and circulatory changes, decreased well-being and weight ...
List of excipients
Sodium dihydrogen phosphate dihydrate Disodium phosphate dodecahydrate Human serum albumin
Incompatibilities
At ILP, no incompatibilities with other constituents of the perfusate, with hyperthermia or with the membrane oxygenator and the silicone tubing are known. Perfusate samples of several ILPs showed plateau ...
Shelf life
Shelf life: 3 years. Reconstituted solution: Chemical and physical in-use stability has been demonstrated for up to 48 hours at 25°C. From a microbiological point of view, the reconstituted product should ...
Special precautions for storage
Store in a refrigerator (2°C-8°C). For storage conditions after reconstitution of the medicinal product, see section 6.3.
Nature and contents of container
Powder vial: Type I glass vial with chlorobutyl rubber stopper and sealed with aluminium flip-off cap. Each pack contains 4 vials.
Special precautions for disposal and other handling
Instructions for reconstitution The content of one vial of Beromun powder should be reconstituted with 5.3 ml sterile 0.9% sodium chloride solution for injection. A homogeneous solution will be obtained ...
Marketing authorization holder
BELPHARMA s.a., 2, Rue Albert 1er, L-1117, Luxembourg, Grand Duchy of Luxembourg
Marketing authorization number(s)
EU/1/99/097/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 13 April 1999 Date of latest renewal: 13 April 2009
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