XALKORI Hard capsule (2019)
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Περιεχόμενα
Name of the medicinal product
XALKORI 200 mg hard capsules. XALKORI 250 mg hard capsules.
Qualitative and quantitative composition
XALKORI 200 mg hard capsules: Each hard capsule contains 200 mg of crizotinib. XALKORI 250 mg hard capsules: Each hard capsule contains 250 mg of crizotinib. For the full list of excipients, see section ...
Pharmaceutical form
Hard capsule. XALKORI 200 mg hard capsules: White opaque and pink opaque hard capsule, with Pfizer imprinted on the cap and CRZ 200 on the body. XALKORI 250 mg hard capsules: Pink opaque hard capsule, ...
Therapeutic indications
XALKORI as monotherapy is indicated for: The first-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). The treatment of adults with previously ...
Posology and method of administration
Treatment with XALKORI should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. ALK and ROS1 testing An accurate and validated assay for either ALK or ...
Contraindications
Hypersensitivity to crizotinib or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Assessment of ALK and ROS1 status When assessing either ALK or ROS1 status of a patient, it is important that a well-validated and robust methodology is chosen to avoid false negative or false positive ...
Interaction with other medicinal products and other forms of interaction
Pharmacokinetic interactions Agents that may increase crizotinib plasma concentrations Coadministration of crizotinib with strong CYP3A inhibitors is expected to increase crizotinib plasma concentrations. ...
Fertility, pregnancy and lactation
Contraception in males and females Women of childbearing potential should be advised to avoid becoming pregnant while receiving XALKORI. Adequate contraceptive methods should be used during therapy, and ...
Effects on ability to drive and use machines
Caution should be exercised when driving or operating machines as patients may experience symptomatic bradycardia (e.g. syncope, dizziness, hypotension), vision disorder, or fatigue while taking XALKORI ...
Undesirable effects
Summary of the safety profile The data described below reflect exposure to XALKORI in 1669 patients with ALK-positive advanced NSCLC who participated in 2 randomised Phase 3 studies (Studies 1007 and 1014) ...
Overdose
Treatment of overdose with the medicinal product consists of general supportive measures. There is no antidote for XALKORI.
Pharmacodynamic properties
Pharmacotherapeutic group: Anti-neoplastic agents, protein kinase inhibitor ATC code: L01XE16 Mechanism of action Crizotinib is a selective small-molecule inhibitor of the ALK receptor tyrosine kinase ...
Pharmacokinetic properties
Absorption Following oral single dose administration in the fasted state, crizotinib is absorbed with median time to achieve peak concentrations of 4 to 6 hours. With twice daily dosing, steady state was ...
Preclinical safety data
In rat and dog repeat-dose toxicity studies up to 3-month duration, the primary target organ effects were related to the gastrointestinal (emesis, faecal changes, congestion), haematopoietic (bone marrow ...
List of excipients
Capsule content: Colloidal anhydrous silica Microcrystalline cellulose Anhydrous calcium hydrogen phosphate Sodium starch glycolate (Type A) Magnesium stearate Capsule shell: Gelatin Titanium dioxide (E171) ...
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
XALKORI 200 mg hard capsules: HDPE bottles with a polypropylene closure containing 60 hard capsules. PVC-foil blisters containing 10 hard capsules. Each carton contains 60 hard capsules. XALKORI 250 mg ...
Special precautions for disposal and other handling
Any unused 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)
XALKORI 200 mg hard capsules: EU/1/12/793/001 EU/1/12/793/002 XALKORI 250 mg hard capsules: EU/1/12/793/003 EU/1/12/793/004
Date of first authorization / renewal of the authorization
Date of first authorisation: 23 October 2012 Date of latest renewal: 29 July 2016
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