VIZIMPRO Film-coated tablet (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Vizimpro 15 mg film-coated tablets. Vizimpro 30 mg film-coated tablets. Vizimpro 45 mg film-coated tablets.
Qualitative and quantitative composition
Vizimpro 15 mg film-coated tablets: Each film-coated tablet contains dacomitinib monohydrate equivalent to 15 mg dacomitinib. Excipients with known effect: Each film-coated tablet contains 40 mg of lactose ...
Pharmaceutical form
Film-coated tablet (tablet). Vizimpro 15 mg film-coated tablets: Blue film-coated, 6.35 mm, round biconvex tablet, debossed with Pfizer on one side and DCB15 on the other. Vizimpro 30 mg film-coated tablets: ...
Therapeutic indications
Vizimpro, as monotherapy, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating ...
Posology and method of administration
Treatment with Vizimpro should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. EGFR mutation status should be established prior to initiation of dacomitinib ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Assessment of EGFR mutation status When assessing the EGFR mutation 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
Co-administration of dacomitinib with agents that increase gastric pH The aqueous solubility of dacomitinib is pH dependent, with low (acidic) pH resulting in higher solubility. Data from a study in 24 ...
Fertility, pregnancy and lactation
Woman of childbearing potential / Contraception Women of childbearing potential should be advised to avoid becoming pregnant while receiving Vizimpro. Women of childbearing potential who are receiving ...
Effects on ability to drive and use machines
Vizimpro has minor influence on the ability to drive and use machines. Patients experiencing fatigue or ocular adverse reactions while taking dacomitinib should exercise caution when driving or operating ...
Undesirable effects
Summary of safety profile The median duration of treatment with Vizimpro across the pooled data set was 66.7 weeks. The most common (>20%) adverse reactions in patients receiving dacomitinib were diarrhoea ...
Overdose
The adverse reactions observed at doses greater than 45 mg once daily were primarily gastrointestinal, dermatological, and constitutional (e.g., fatigue, malaise, and weight loss). There is no known antidote ...
Pharmacodynamic properties
Pharmacotherapeutic group: Anti-neoplastic agents, protein kinase inhibitors ATC code: L01XE47 Mechanism of action Dacomitinib is a pan-human epidermal growth factor receptor (HER) (EGFR/HER1, HER2, and ...
Pharmacokinetic properties
Absorption Following the administration of a single 45 mg dose of dacomitinib tablets, the mean oral bioavailability of dacomitinib is 80% (range: 65% to 100%) compared to intravenous administration, with ...
Preclinical safety data
Repeated-dose toxicity In oral repeated-dose toxicity studies for up to 6 months in rats and 9 months in dogs, the primary toxicities were identified in the skin/hair (dermal changes in rats and dogs, ...
List of excipients
Tablet core: Lactose monohydrate Microcrystalline cellulose Sodium starch glycolate Magnesium stearate Film coating: Opadry II Blue 85F30716 containing: Polyvinyl alcohol partially hydrolysed (E1203) ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 5 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Aluminium/aluminium blister containing 10 film-coated tablets. Each pack contains 30 film-coated tablets.
Special precautions for disposal and other handling
Dacomitinib has the potential to be a very persistent, bioaccumulative and toxic substance (see section 5.3). Any unused medicinal product or waste material should be disposed of in accordance with local ...
Marketing authorization holder
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Marketing authorization number(s)
EU/1/19/1354/001 EU/1/19/1354/002 EU/1/19/1354/003
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