LYNPARZA Film-coated tablet (2019)
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Περιεχόμενα
Name of the medicinal product
Lynparza 100 mg film-coated tablets. Lynparza 150 mg film-coated tablets.
Qualitative and quantitative composition
Lynparza 100 mg film-coated tablets: Each film-coated tablet contains 100 mg olaparib. Lynparza 150 mg film-coated tablets: Each film-coated tablet contains 150 mg olaparib. Excipient with known effect: ...
Pharmaceutical form
Film-coated tablet (tablet). Lynparza 100 mg film-coated tablets: Yellow to dark yellow, oval, bi-convex tablet, debossed with OP100 on one side and plain on the other side. Lynparza 150 mg film-coated ...
Therapeutic indications
Ovarian cancer Lynparza is indicated as monotherapy for the: maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ...
Posology and method of administration
Treatment with Lynparza should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. Detection of BRCA1/2 mutations Before Lynparza treatment is initiated ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Breast-feeding during treatment and for 1 month after the last dose (see section 4.6).
Special warnings and precautions for use
Haematological toxicity Haematological toxicity has been reported in patients treated with Lynparza, including clinical diagnoses and/or laboratory findings of generally mild or moderate (CTCAE grade 1 ...
Interaction with other medicinal products and other forms of interaction
Pharmacodynamic interactions Clinical studies of olaparib in combination with other anticancer medicinal products, including DNA damaging agents, indicate a potentiation and prolongation of myelosuppressive ...
Pregnancy and lactation
Women of childbearing potential/contraception in females Women of childbearing potential should not become pregnant while on Lynparza and not be pregnant at the beginning of treatment. A pregnancy test ...
Effects on ability to drive and use machines
Lynparza has moderate influence on the ability to drive and use machines. Patients who take Lynparza may experience fatigue, asthenia or dizziness. Patients who experience these symptoms should observe ...
Undesirable effects
Summary of the safety profile Lynparza monotherapy has been associated with adverse reactions generally of mild or moderate severity (CTCAE grade 1 or 2) and generally not requiring treatment discontinuation. ...
Overdose
There is limited experience of overdose with olaparib. No unexpected adverse reactions were reported in a small number of patients who took a daily dose of up to 900 mg of olaparib tablets over two days. ...
Pharmacodynamic properties
Pharmacotherapeutic group: antineoplastic agents, other antineoplastic agents ATC code: L01XX46 Mechanism of action and pharmacodynamic effects Olaparib is a potent inhibitor of human poly (ADP-ribose) ...
Pharmacokinetic properties
The pharmacokinetics of olaparib at the 300 mg tablet dose are characterised by an apparent plasma clearance of ~7 L/h, an apparent volume of distribution of ~158 L and a terminal half-life of 15 hours. ...
Preclinical safety data
Genotoxicity Olaparib showed no mutagenic potential, but was clastogenic in mammalian cells in vitro. When dosed orally to rats, olaparib induced micronuclei in bone marrow. This clastogenicity is consistent ...
List of excipients
Tablet core: Copovidone Silica, colloidal anhydrous Mannitol Sodium stearyl fumarate Tablet coating: Hypromellose Macrogol 400 Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide black (E172) (150 ...
Incompatibilities
Not applicable.
Shelf life
4 years.
Special precautions for storage
Store in the original package in order to protect from moisture. This medicinal product does not require any special temperature storage conditions.
Nature and contents of container
Alu/Alu non-perforated blister containing 8 film-coated tablets. Pack sizes: 56 film-coated tablets (7 blisters). Multipack containing 112 (2 packs of 56) film-coated tablets. Not all pack sizes may be ...
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
AstraZeneca AB, SE-151 85 Södertälje, Sweden
Marketing authorization number(s)
EU/1/14/959/002 EU/1/14/959/003 EU/1/14/959/004 EU/1/14/959/005
Date of first authorization / renewal of the authorization
Date of first authorisation: 16 December 2014
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