FARYDAK Hard capsule (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Farydak 10 mg hard capsules. Farydak 15 mg hard capsules. Farydak 20 mg hard capsules.
Qualitative and quantitative composition
Farydak 10 mg hard capsules: Each hard capsule contains panobinostat lactate anhydrous equivalent to 10 mg panobinostat. Farydak 15 mg hard capsules: Each hard capsule contains panobinostat lactate anhydrous ...
Pharmaceutical form
Hard capsule (capsule). Farydak 10 mg hard capsules: Light green opaque hard gelatin capsule (15.6–16.2 mm) containing white to almost white powder, with radial marking LBH 10 mg in black ink on cap and ...
Therapeutic indications
Farydak, in combination with bortezomib and dexamethasone, is indicated for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens ...
Posology and method of administration
Treatment with Farydak should be initiated by a physician experienced in the use of anti-cancer therapies. Posology The recommended starting dose of panobinostat is 20 mg, taken orally once a day, on days ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Breast-feeding (see section 4.6).
Special warnings and precautions for use
Panobinostat is used in combination treatment, therefore the prescribing information of bortezomib and dexamethasone should be consulted prior to initiation of treatment with panobinostat. Decrease in ...
Interaction with other medicinal products and other forms of interaction
Farydak metabolism is through both non-CYP and CYP mediated routes. Approximately 40% of panobinostat is metabolised through CYP3A4. Metabolism via CYP2D6 and 2C19 was minor. Therefore, medicinal products ...
Fertility, pregnancy and lactation
Women of child-bearing potential/Contraception in males and females Based on findings in animals, the likelihood of panobinostat increasing the risk of both foetal death and developmental skeletal abnormalities ...
Effects on ability to drive and use machines
Farydak has a minor influence on the ability to drive and use machines. Dizziness may occur following administration of Farydak (see section 4.8).
Undesirable effects
Summary of the safety profile The safety data of panobinostat have been assessed from a total of 451 patients with multiple myeloma treated with panobinostat in combination with bortezomib and dexamethasone ...
Overdose
Limited experience with overdose has been reported during clinical studies. Adverse reactions observed were consistent with the safety profile, with events primarily involving haematological and gastrointestinal ...
Pharmacodynamic properties
Pharmacotherapeutic group: Other antineoplastic agents ATC code: L01XX42 Mechanism of action Farydak is a histone deacetylase (HDAC) inhibitor that inhibits the enzymatic activity of HDACs at nanomolar ...
Pharmacokinetic properties
Absorption Panobinostat is rapidly and almost completely absorbed with T max reached within 2 hours of oral administration in patients with advanced cancer. The absolute oral bioavailability of panobinostat ...
Preclinical safety data
Repeated dose toxicity studies The primary target organs of toxicity following administration of panobinostat in rats and dogs were identified as the erythropoietic, myelopoietic and lymphatic systems. ...
List of excipients
Capsule content: Magnesium stearate Mannitol Microcrystalline cellulose Pregelatinised starch (maize) Capsule shell: Farydak 10 mg hard capsules: Gelatin Titanium dioxide (E171) Brilliant blue FCF (E133) ...
Incompatibilities
Not applicable.
Shelf life
4 years.
Special precautions for storage
Do not store above 30°C. Store in the original package in order to protect from moisture.
Nature and contents of container
PVC/PCTFE/Alu blister containing 6 capsules. Packs containing 6, 12 or 24 capsules. Not all pack sizes may be marketed.
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
Secura Bio Limited, 32 Molesworth Street, Dublin 2, Ireland
Marketing authorization number(s)
Farydak 10 mg hard capsules: EU/1/15/1023/001-003 Farydak 15 mg hard capsules: EU/1/15/1023/004-006 Farydak 20 mg hard capsules: EU/1/15/1023/007-009
Date of first authorization / renewal of the authorization
Date of first authorisation: 28 August 2015
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