SPECTRILA Powder for concentrate for solution for infusion (2019)
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Περιεχόμενα
Name of the medicinal product
Spectrila 10,000 U powder for concentrate for solution for infusion.
Qualitative and quantitative composition
Each vial contains 10,000 units of asparaginase*. One unit (U) is defined as the quantity of enzyme required to liberate one μmol ammonia per minute at pH 7.3 and 37°C. After reconstitution each ml contains ...
Pharmaceutical form
Powder for concentrate for solution for infusion. White powder.
Therapeutic indications
Spectrila is indicated as a component of antineoplastic combination therapy for the treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years and adults.
Posology and method of administration
Spectrila should be prescribed and administered by physicians and health care personnel experienced in the use of antineoplastic products. It should only be given in a hospital setting where appropriate ...
Contraindications
Hypersensitivity to the active substance, any native (non-pegylated) E. coli-asparaginase preparation or to any of the excipients listed in section 6.1. Pancreatitis. Severe hepatic impairment (bilirubin ...
Special warnings and precautions for use
Traceability It is strongly recommended that every time Spectrila is administered to a patient, the tradename and batch number of the product should clearly be recorded in order to link the patient and ...
Interaction with other medicinal products and other forms of interaction
General Asparaginase may increase the toxicity of other medicinal products through its effect on liver function, e.g. increased hepatotoxicity with potentially hepatotoxic medicines, increased toxicity ...
Fertility, pregnancy and lactation
Women of childbearing potential/Contraception in males and females Women of childbearing potential have to use effective contraception and avoid becoming pregnant while being treated with asparaginase-containing ...
Effects on ability to drive and use machines
Spectrila has moderate influence on the ability to drive and use machines, especially through its potential effects on the nervous and gastrointestinal systems (see section 4.8).
Undesirable effects
Summary of the safety profile The primary toxicity of asparaginase results from immunologic reactions caused by exposure to the bacterial protein. Hypersensitivity reactions range from transient flushing ...
Overdose
No case of asparaginase overdose with clinical symptoms has been reported. There is no specific antidote. Treatment is symptomatic and supportive.
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents; Other antineoplastic agents ATC code: L01XX02 Mechanism of action Asparaginase hydrolyses asparagine to aspartic acid and ammonia. In contrast to normal ...
Pharmacokinetic properties
Pharmacokinetic parameters of Spectrila were determined in 7 adult patients after intravenous infusion of 5,000 U/m². Absorption Asparaginase is not absorbed by the gastrointestinal tract, thus Spectrila ...
Preclinical safety data
Non-clinical repeat-dose toxicity and safety pharmacology studies in rats revealed no special hazard for humans, except a slight but significant saluretic effect at doses below the recommended dose for ...
List of excipients
Sucrose
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
<u>Unopened vials:</u> 4 years. <u>Reconstituted and diluted solution:</u> Chemical and physical in-use stability has been demonstrated for 2 days at 2°C–8°C. From a microbiological point of view, the ...
Special precautions for storage
Store in a refrigerator (2°C–8°C). Keep the vial in the outer carton in order to protect from light. For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3. ...
Nature and contents of container
Colourless 20 ml glass vial (Type I glass) closed with butylrubber stopper, aluminium seal and plastic flip-off cap, containing 10,000 units of asparaginase. Each pack contains either 1 or 5 vials. Not ...
Special precautions for disposal and other handling
To dissolve the powder, 3.7 ml of water for injections are carefully squirted against the inner wall of the vial with an injection syringe (do not squirt directly on or into the powder). Dissolution of ...
Marketing authorization holder
medac Gesellschaft für klinische Spezialpräparate mbH, Theaterstr. 6, 22880 Wedel, Germany, Tel.: +49 4103 8006-0, Fax: +49 4103 8006-100, E-mail: contact@medac.de
Marketing authorization number(s)
EU/1/15/1072/001 EU/1/15/1072/002
Date of first authorization / renewal of the authorization
14 January 2016
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