CAPRELSA Film-coated tablets (2020)
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Περιεχόμενα
Name of the medicinal product
Caprelsa 100 mg film-coated tablets. Caprelsa 300 mg film-coated tablets.
Qualitative and quantitative composition
Caprelsa 100 mg tablets: Each film-coated tablet contains 100 mg of vandetanib. Caprelsa 300 mg tablets: Each film-coated tablet contains 300 mg of vandetanib. For a full list of excipients, see section ...
Pharmaceutical form
Caprelsa 100 mg tablets: The Caprelsa 100 mg tablet is a round, biconvex, white film-coated tablet with Z100 impressed on one side. Caprelsa 300 mg tablets: The Caprelsa 300 mg tablet is an oval-shaped, ...
Therapeutic indications
Caprelsa is indicated for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease. Caprelsa is indicated in adults, ...
Posology and method of administration
Treatment should be initiated and supervised by a physician experienced in treatment of MTC and in the use of anticancer medicinal products and experienced in the assessment of electrocardiogram (ECG). ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Congenital long QTc syndrome. Patients with a QTc interval over 480 msec. Concomitant use of vandetanib with ...
Special warnings and precautions for use
In view of the associated risks, it is important to limit treatment with vandetanib to patients who are in real need for treatment, i.e. with a symptomatic-aggressive course of the disease. Either symptomatic ...
Interaction with other medicinal products and other forms of interaction
Pharmacokinetic interactions Effect of vandetanib on other medicinal products In healthy subjects, the exposure for midazolam (CYP3A4 substrate) was not affected when given together with a single dose ...
Fertility, pregnancy and lactation
Women of childbearing potential Women of childbearing potential must use effective contraception during therapy and for at least four months following the last dose. Pregnancy There is a limited amount ...
Effects on ability to drive and use machines
No studies to establish the effects of vandetanib on ability to drive and use machines have been conducted. However, fatigue and blurred vision have been reported and those patients who experience these ...
Undesirable effects
Summary of the safety profile The most commonly reported adverse drug reactions have been diarrhoea, rash, nausea, hypertension, and headache. Tabulated list of adverse reactions The following adverse ...
Overdose
There is no specific treatment in the event of overdose with vandetanib and possible symptoms of overdose have not been established. An increase in the frequency and severity of some adverse reactions, ...
Pharmacodynamic properties
Pharmacotherapeutic group: antineoplastic agent, protein kinase inhibitor ATC Code: L01XE12 Mechanism of action and pharmacodynamic effects Vandetanib is a potent inhibitor of vascular endothelial growth ...
Pharmacokinetic properties
Absorption Following oral administration of vandetanib absorption is slow with peak plasma concentrations typically achieved at a median of 6 hours, range 4-10 hours, after dosing. Vandetanib accumulates ...
Preclinical safety data
Vandetanib has shown no mutagenic or clastogenic potential. In repeat-dose toxicity studies of up to 9 months duration, effects included emesis, body weight loss and diarrhoea in dogs and physeal dysplasia ...
List of excipients
Tablet core: Calcium hydrogen phosphate dihydrate Microcrystalline cellulose Crospovidone (type A) Povidone (K 29-32) Magnesium stearate Film-coating: Hypromellose Macrogol (300) Titanium dioxide (E171) ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 4 years.
Special precautions for storage
Do not store above 30°C.
Nature and contents of container
PVC/ PVDC/Alu blisters, sealed with aluminium foil, each containing 30 film-coated tablets.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands
Marketing authorization number(s)
EU/1/11/749/001 EU/1/11/749/002
Date of first authorization / renewal of the authorization
Date of first authorisation: 17 February 2012 Date of latest renewal: 15 January 2019
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