PIXUVRI Powder for concentrate for solution for infusion (2020)
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Περιεχόμενα
Name of the medicinal product
Pixuvri 29 mg powder for concentrate for solution for infusion.
Qualitative and quantitative composition
One vial contains pixantrone dimaleate equivalent to 29 mg pixantrone After reconstitution, each ml of concentrate contains pixantrone dimaleate equivalent to 5.8 mg pixantrone. Excipient with known effect: ...
Pharmaceutical form
Powder for concentrate for solution for infusion. Dark blue lyophilised powder.
Therapeutic indications
Pixuvri is indicated as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive Non-Hodgkin B-cell Lymphomas (NHL). The benefit of pixantrone treatment has not been ...
Posology and method of administration
Pixuvri must be administered by physicians who are familiar with the use of antineoplastic agents and have the facilities for regular monitoring of clinical, haematological, and biochemical parameters ...
Contraindications
Hypersensitivity to pixantrone dimaleate, or to any of the excipients listed in section 6.1. Immunisation with live virus vaccines. Profound bone marrow suppression. Severe abnormal hepatic function. ...
Special warnings and precautions for use
All initial treatment with Pixuvri should be preceded by a careful baseline assessment of blood counts, serum levels of total bilirubin, serum levels of total creatinine, and cardiac function as measured ...
Interaction with other medicinal products and other forms of interaction
No drug interactions have been reported in human subjects and no drug-drug interaction studies in humans have been performed. In vitro inhibition studies In vitro studies with the most common human cytochrome ...
Pregnancy and lactation
Women of childbearing potential Women of childbearing potential and their partners should be advised to avoid pregnancies. Women and men must use effective contraception during and up to 6 months after ...
Effects on ability to drive and use machines
It is not known whether Pixuvri has an effect on the ability to drive a car or use machines.
Undesirable effects
Summary of the safety profile The most common toxicity is bone marrow suppression, particularly of the neutrophil lineage. Although the incidence of severe marrow suppression with clinical consequences ...
Overdose
In the clinical trial program, there has been one report of overdose with Pixuvri with no reported concomitant adverse events. Single doses of pixantrone up to 158 mg/m² have been given in dose-escalation ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, anthracyclines, and related substances. ATC code: L01DB11 Mechanism of action The active substance of Pixuvri is pixantrone, a cytotoxic aza-anthracenedione. ...
Pharmacokinetic properties
Absorption Following intravenous administration, plasma concentrations of pixantrone reached the maximal concentration at the end of infusion and then declined poly-exponentially. The pharmacokinetics ...
Preclinical safety data
After a single intravenous administration of Pixuvri at 29 mg/kg and 38 mg/kg, immediate deaths were seen in mice (114 mg/m², LD10). Decreases in white and red blood cells and alterations in bone marrow, ...
List of excipients
Sodium chloride Lactose monohydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
Shelf life Unopened vial: 5 years. Reconstituted and diluted solution: Chemical and physical in-use stability has been demonstrated for 24 hours at room temperature (15°C to 25°C) and daylight exposure ...
Special precautions for storage
Store in a refrigerator (2°C to 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
Type I glass vial with grey butyl rubber stopper with aluminium seal and red plastic cap containing 50 mg pixantrone dimaleate equivalent to 29 mg pixantrone. Pack size of 1 vial.
Special precautions for disposal and other handling
Reconstitution and dilution Aseptically reconstitute each 29 mg vial with 5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection. The lyophilised powder should completely dissolve in 60 seconds ...
Marketing authorization holder
Les Laboratoires Servier, 50, rue Carnot, 92284, Suresnes cedex, France
Marketing authorization number(s)
EU/1/12/764/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 10 May 2012 Date of latest renewal: 06 June 2019
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