LYNPARZA Hard capsule (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Lynparza 50 mg hard capsules.
Qualitative and quantitative composition
Each hard capsule contains 50 mg of olaparib. For the full list of excipients, see section 6.1.
Pharmaceutical form
Hard capsule. White, opaque, size 0 hard capsule, marked with OLAPARIB 50 mg and the AstraZeneca logo in black ink.
Therapeutic indications
Lynparza is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian ...
Posology and method of administration
Treatment with Lynparza should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. Patients must have confirmation of a deleterious or suspected deleterious ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Breast-feeding during treatment and 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 ...
Fertility, 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
Symptoms of overdose are not established and there is no specific treatment in the event of Lynparza overdose. In the event of an overdose, physicians should follow general supportive measures and should ...
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 400 mg twice daily capsule dose are characterised by an apparent plasma clearance of ~8.6 L/h, an apparent volume of distribution of ~167 L and a terminal half-life ...
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
Capsule content: Lauroyl macrogol-32 glycerides Capsule shell: Hypromellose Titanium dioxide (E171) Gellan gum (E418) Potassium acetate Printing ink: Shellac Iron oxide black (E172)
Incompatibilities
Not applicable.
Shelf life
2 years.
Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. Any capsules that have been frozen must be discarded. Lynparza capsules can be stored for up to 3 months below 30°C. The capsules must be discarded after ...
Nature and contents of container
HDPE plastic bottle with a child-resistant closure containing 112 hard capsules. Pack of 448 capsules (4 bottles of 112 capsules).
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/1/14/959/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 16 December 2014
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