XALUPRINE Oral suspension (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Xaluprine 20 mg/ml oral suspension.
Qualitative and quantitative composition
One ml of suspension contains 20 mg mercaptopurine (as monohydrate). __Excipients with known effect:_ One ml of suspension contains 3 mg aspartame, 1 mg methyl hydroxybenzoate (as the sodium salt), 0.5 ...
Pharmaceutical form
Oral suspension. The suspension is pink to brown in colour.
Therapeutic indications
Xaluprine is indicated for the treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children.
Posology and method of administration
Xaluprine treatment should be supervised by a physician or other healthcare professionals experienced in the management of patients with ALL. Posology The dose is governed by cautiously monitored haematotoxicity ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Concomitant use with yellow fever vaccine (see section 4.5).
Special warnings and precautions for use
Cytotoxicity and haematological monitoring Treatment with 6-mercaptopurine causes bone marrow suppression leading to leucopenia and thrombocytopenia and, less frequently, to anaemia. Careful monitoring ...
Interaction with other medicinal products and other forms of interaction
The administration of 6-mercaptopurine with food may decrease systemic exposure slightly but this is unlikely to be of clinical significance. Therefore, Xaluprine may be taken with food or on an empty ...
Fertility, pregnancy and lactation
Contraception in males and females Evidence of the teratogenicity of 6-mercaptopurine in humans is equivocal. Both sexually active men and women should use effective methods of contraception during treatment ...
Effects on ability to drive and use machines
No studies on the effect on the ability to drive and use machines have been performed. A detrimental effect on these activities cannot be predicted from the pharmacology of the active substance.
Undesirable effects
Summary of the safety profile The main adverse reaction of treatment with 6-mercaptopurine is bone marrow suppression leading to leucopenia and thrombocytopenia. For mercaptopurine there is a lack of modern ...
Overdose
Symptoms and signs Gastrointestinal effects, including nausea, vomiting and diarrhoea and anorexia may be early symptoms of overdose having occurred. The principal toxic effect is on the bone marrow, resulting ...
Pharmacodynamic properties
Pharmacotherapeutic group: antineoplastic agents, antimetabolites, purine analogues ATC code: L01BB02 Mechanism of action 6-mercaptopurine is an inactive pro-drug which acts as a purine antagonist but ...
Pharmacokinetic properties
Absorption The bioavailability of oral 6-mercaptopurine shows considerable inter-individual variability, which probably results from its first-pass metabolism. When administered orally at a dosage of 75 ...
Preclinical safety data
Genotoxicity 6-mercaptopurine, in common with other antimetabolites, is mutagenic and causes chromosomal aberrations in vitro and in vivo in mice and rats. Carcinogenicity Given its genotoxic potential, ...
List of excipients
Xanthan gum Aspartame (E951) Concentrated raspberry juice Sucrose Sodium methyl parahydroxybenzoate (E219) Sodium ethyl parahydroxybenzoate (E215) Potassium sorbate (E202) Sodium hydroxide Purified water ...
Incompatibilities
Not applicable.
Shelf life
15 months. After first opening: 56 days.
Special precautions for storage
Do not store above 25°C. Keep the bottle tightly closed (see section 6.6).
Nature and contents of container
Amber type III glass bottle with tamper evident child-resistant closure (HDPE with expanded polyethylene liner) containing 100 ml of oral suspension. Each pack contains one bottle, an HDPE bottle adaptor ...
Special precautions for disposal and other handling
Safe handling Anyone handling Xaluprine should wash their hands before and after administering a dose. To decrease the risk of exposure, parents and care givers should wear disposable gloves when handling ...
Marketing authorization holder
Nova Laboratories Ireland Limited, 3<sup>rd</sup> Floor, Ulysses House, Foley Street, Dublin 1, D01 W2T2, Ireland
Marketing authorization number(s)
EU/1/11/727/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 09 March 2012 Date of latest renewal: 18 November 2016
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