MOZOBIL Solution for injection (2020)
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Περιεχόμενα
Name of the medicinal product
Mozobil 20 mg/ml solution for injection.
Qualitative and quantitative composition
One ml of solution contains 20 mg plerixafor. Each vial contains 24 mg plerixafor in 1.2 ml solution. Excipients with known effect: Each ml contains approximately 5 mg (0.2 mmol) of sodium. For the full ...
Pharmaceutical form
Solution for injection. Clear, colourless to pale yellow solution, with a pH of 6.0-7.5 and an osmolality of 260-320 mOsm/kg.
Therapeutic indications
Adult patients Mozobil is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent ...
Posology and method of administration
Mozobil therapy should be initiated and supervised by a physician experienced in oncology and/or haematology. The mobilisation and apheresis procedures should be performed in collaboration with an oncology-haematology ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Tumour cell mobilisation in patients with lymphoma and multiple myeloma When Mozobil is used in conjunction with G-CSF for haematopoietic stem cell mobilisation in patients with lymphoma or multiple myeloma‚ ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. In vitro tests showed that plerixafor was not metabolised by P450 CYP enzymes, did not inhibit or induce P450 CYP enzymes. Plerixafor did not act as a substrate ...
Fertility, pregnancy and lactation
Women of childbearing potential Women of childbearing potential have to use effective contraception during treatment. Pregnancy There are no adequate data on the use of plerixafor in pregnant women. Based ...
Effects on ability to drive and use machines
Mozobil may influence the ability to drive and use machines. Some patients have experienced dizziness, fatigue or vasovagal reactions; therefore caution is advised when driving or operating machines. ...
Undesirable effects
Summary of the safety profile Safety data for Mozobil in conjunction with G-CSF in oncology patients with lymphoma and multiple myeloma were obtained from 2 placebo-controlled Phase III studies (301 patients) ...
Overdose
No case of overdose has been reported. Based on limited data at doses above the recommended dose and up to 0.48 mg/kg the frequency of gastrointestinal disorders, vasovagal reactions, orthostatic hypotension, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Other immunostimulants ATC code: L03AX16 Mechanism of action Plerixafor is a bicyclam derivative, a selective reversible antagonist of the CXCR4 chemokine receptor and blocks ...
Pharmacokinetic properties
The pharmacokinetics of plerixafor have been evaluated in lymphoma and multiple myeloma patients at the clinical dose level of 0.24 mg/kg following pre-treatment with G-CSF (10 μg/kg once daily for 4 consecutive ...
Preclinical safety data
The results from single dose subcutaneous studies in rats and mice showed plerixafor can induce transient but severe neuromuscular effects (uncoordinated movement), sedative-like effects (hypoactivity), ...
List of excipients
Sodium chloride Hydrochloric acid, concentrated (pH adjustment) Sodium hydroxide (pH adjustment) Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Unopened vial: 3 years. After opening: From a microbiological point of view the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility ...
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Clear type I glass 2 ml vial with a chlorobutyl/butyl rubber stopper and aluminium seal with a plastic flip-off cap. Each vial contains 1.2 ml solution. Pack size of 1 vial.
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP, Amsterdam, The Netherlands
Marketing authorization number(s)
EU/1/09/537/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 31 July 2009 Date of latest renewal: 11 April 2014
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