BOSULIF Film-coated tablet (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Bosulif 100 mg film-coated tablets. Bosulif 400 mg film-coated tablets. Bosulif 500 mg film-coated tablets.
Qualitative and quantitative composition
Bosulif 100 mg film-coated tablets: Each film-coated tablet contains 100 mg bosutinib (as monohydrate). Bosulif 400 mg film-coated tablets: Each film-coated tablet contains 400 mg bosutinib (as monohydrate). ...
Pharmaceutical form
Film-coated tablet. Bosulif 100 mg film-coated tablets: Yellow oval (width: 5.6 mm; length: 10.7 mm) biconvex, film-coated tablet debossed with Pfizer on one side and 100 on the other side. Bosulif 400 ...
Therapeutic indications
Bosulif is indicated for the treatment of adult patients with: newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML). CP, accelerated phase (AP), and ...
Posology and method of administration
Therapy should be initiated by a physician experienced in the diagnosis and the treatment of patients with CML. Posology Newly-diagnosed CP Ph+ CML The recommended dose is 400 mg bosutinib once daily. ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hepatic impairment (see sections 5.1 and 5.2).
Special warnings and precautions for use
Liver function abnormalities Treatment with bosutinib is associated with elevations in serum transaminases (alanine aminotransferase [ALT], aspartate aminotransferase [AST]). Transaminase elevations generally ...
Interaction with other medicinal products and other forms of interaction
Effects of other medicinal products on bosutinib CYP3A inhibitors The concomitant use of bosutinib with strong CYP3A inhibitors (including, but not limited to itraconazole, ketoconazole, posaconazole, ...
Fertility, pregnancy and lactation
Women of childbearing potential/Contraception Women of childbearing potential should be advised to use effective contraception during treatment with bosutinib and for at least 1 month after the last dose ...
Effects on ability to drive and use machines
Bosutinib has no or negligible influence on the ability to drive and use machines. However, if a patient taking bosutinib experiences dizziness, fatigue, visual impairment or other undesirable effects ...
Undesirable effects
Summary of safety profile A total of 1,272 leukaemia patients received at least 1 dose of single-agent bosutinib. The median duration of therapy was 13.8 months (range: 0.03 to 123.3 months). These patients ...
Overdose
Experience with bosutinib overdose in clinical studies was limited to isolated cases. Patients who take an overdose of bosutinib should be observed and given appropriate supportive treatment.
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors ATC code: L01XE14 Mechanism of action Bosutinib belongs to a pharmacological class of medicinal products known as kinase inhibitors. ...
Pharmacokinetic properties
Absorption Following administration of a single dose of bosutinib (500 mg) with food in healthy subjects, the absolute bioavailability was 34%. Absorption was relatively slow, with a median time-to-peak ...
Preclinical safety data
Bosutinib has been evaluated in safety pharmacology, repeated dose toxicity, genotoxicity, reproductive toxicity, and photoxicity studies. Safety pharmacology Bosutinib did not have effects on respiratory ...
List of excipients
Tablet core: Microcrystalline cellulose (E460) Croscarmellose sodium (E468) Poloxamer 188 Povidone (E1201) Magnesium stearate (E470b) Film coating: Bosulif 100 mg film-coated tablets: Polyvinyl alcohol ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 4 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
White opaque 3-ply PVC/Polychlorotrifluoroethene/PVC blister sealed with push-through foil backing containing either 14 or 15 tablets. Bosulif 100 mg film-coated tablets: Each carton contains 28, 30 or ...
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
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Marketing authorization number(s)
Bosulif 100 mg film-coated tablets: EU/1/13/818/001 EU/1/13/818/002 EU/1/13/818/005 Bosulif 400 mg film-coated tablets: EU/1/13/818/006 EU/1/13/818/007 Bosulif 500 mg film-coated tablets: EU/1/13/818/003 ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 27 March 2013 Date of latest renewal: 18 February 2019
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