ONCASPAR Solution for injection/infusion (2020)
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Περιεχόμενα
Name of the medicinal product
Oncaspar 750 U/ml solution for injection/infusion.
Qualitative and quantitative composition
One ml of solution contains 750 Units (U)** of pegaspargase*. One vial of 5 ml solution contains 3,750 Units. * The active substance is a covalent conjugate of Escherichia coli-derived L-asparaginase with ...
Pharmaceutical form
Solution for injection/infusion. Clear, colourless solution.
Therapeutic indications
Oncaspar is indicated as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years, and adult patients.
Posology and method of administration
Oncaspar should be prescribed and administered by physicians and/or 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 or to any of the excipients listed in section 6.1. Severe hepatic impairment (bilirubin >3 times upper limit of normal [ULN]; transaminases >10 times ULN). History ...
Special warnings and precautions for use
It is strongly recommended that every time Oncaspar is administered to a patient, the name and lot number of the product are recorded in order to link the patient and the lot of the product. Asparaginase ...
Interaction with other medicinal products and other forms of interaction
The decrease in serum proteins caused by pegaspargase can increase the toxicity of other medicinal products that are protein bound. In addition, by inhibiting protein synthesis and cell division, pegaspargase ...
Fertility, pregnancy and lactation
Women of childbearing potential/Contraception in males and females Men and women should use effective contraception during treatment and for at least 6 months after Oncaspar discontinuation. Since an indirect ...
Effects on ability to drive and use machines
Oncaspar has major influence on the ability to drive and use machines. The following adverse reactions have been reported in patients treated with Oncaspar along with other chemotherapy medicinal products: ...
Undesirable effects
Summary of the safety profile The adverse reactions described in this section are derived from clinical trial data and post-marketing experience of Oncaspar in ALL patients. The safety profile is based ...
Overdose
Cases of accidental overdose have been reported with Oncaspar. Following overdose, increased liver enzymes, rash and hyperbilirubinaemia have been observed. There is no specific pharmacological treatment ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic and immunomodulating agents, other antineoplastic agents ATC code: L01XX24 Mechanism of action The mechanism of action of L-asparaginase is the enzymatic cleavage ...
Pharmacokinetic properties
Oncaspar pharmacokinetic properties were based on asparaginase activity measured by an enzymatic assay after IM (CCG-1962) and IV (AALL07P4, DFCI 11-001) administration. In Study CCG-1962, mean asparaginase ...
Preclinical safety data
Acute toxicity Only very high doses of pegaspargase given to mice intraperitoneally as a single dose (25,000–100,000 U/kg body weight) caused the death of 14% of all treated mice. Mild hepatotoxicity was ...
List of excipients
Sodium dihydrogen phosphate monohydrate Disodium phosphate heptahydrate Sodium chloride Water for injections
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
Shelf life: 8 months. Chemical and physical in-use stability of the diluted solution has been demonstrated for 48 hours at 2°C-8°C. From a microbiological point of view, the product should be used immediately. ...
Special precautions for storage
Store in a refrigerator (2°C–8°C). Do not freeze.
Nature and contents of container
5 ml solution in a vial (type I glass) with stopper (rubber) and a seal (aluminium) with flip-off cap. Pack size of 1.
Special precautions for disposal and other handling
This medicinal product can cause irritation on contact. The solution must therefore be handled and administered with particular caution. Inhalation of the vapour and contact with the skin and mucous membranes, ...
Marketing authorization holder
Les Laboratoires Servier, 50, rue Carnot, 92284, Suresnes cedex, France
Marketing authorization number(s)
EU/1/15/1070/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 14 January 2016
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