GILENYA Hard capsule (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Gilenya 0.25 mg hard capsules. Gilenya 0.5 mg hard capsules.
Qualitative and quantitative composition
Gilenya 0.25 mg hard capsules: Each 0.25 mg capsule contains 0.25 mg fingolimod (as hydrochloride). Gilenya 0.5 mg hard capsules: Each 0.5 mg capsule contains 0.5 mg fingolimod (as hydrochloride). For ...
Pharmaceutical form
Hard capsule. Gilenya 0.25 mg hard capsules: Capsule of 16 mm with ivory opaque cap and body, with black radial imprint FTY 0.25mg on cap and black radial band on body. Gilenya 0.5 mg hard capsules: Capsule ...
Therapeutic indications
Gilenya is indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult patients and paediatric patients aged 10 years and older: ...
Posology and method of administration
The treatment should be initiated and supervised by a physician experienced in multiple sclerosis. Posology In adults, the recommended dose of Gilenya is one 0.5 mg capsule taken orally once daily. In ...
Contraindications
Immunodeficiency syndrome. Patients with increased risk for opportunistic infections, including immunocompromised patients (including those currently receiving immunosuppressive therapies or those immunocompromised ...
Special warnings and precautions for use
Bradyarrhythmia Initiation of Gilenya treatment results in a transient decrease in heart rate and may also be associated with atrioventricular conduction delays, including the occurrence of isolated reports ...
Interaction with other medicinal products and other forms of interaction
Anti-neoplastic, immunomodulatory or immunosuppressive therapies Anti-neoplastic, immunomodulatory or immunosuppressive therapies should not be co-administered due to the risk of additive immune system ...
Fertility, pregnancy and lactation
Women of childbearing potential/Contraception in females Fingolimod is contraindicated in women of childbearing potential not using effective contraception (see section 4.3). Therefore, before initiation ...
Effects on ability to drive and use machines
Gilenya has no or negligible influence on the ability to drive and use machines. However, dizziness or drowsiness may occasionally occur when initiating therapy with Gilenya. On initiation of Gilenya treatment ...
Undesirable effects
Summary of the safety profile Adverse reactions reported with Gilenya 0.5 mg in Studies D2301 (FREEDOMS) and D2309 (FREEDOMS II) are shown below. Adverse reactions derived from post-marketing experience ...
Overdose
Single doses up to 80 times the recommended dose (0.5 mg) were well tolerated in healthy adult volunteers. At 40 mg, 5 of 6 subjects reported mild chest tightness or discomfort which was clinically consistent ...
Pharmacodynamic properties
Pharmacotherapeutic group: Immunosuppressants, selective immunosuppressants ATC code: L04AA27 Mechanism of action Fingolimod is a sphingosine 1-phosphate receptor modulator. Fingolimod is metabolised by ...
Pharmacokinetic properties
Pharmacokinetic data were obtained in healthy adult volunteers, in renal transplant adult patients and in multiple sclerosis adult patients. The pharmacologically active metabolite responsible for efficacy ...
Preclinical safety data
The preclinical safety profile of fingolimod was assessed in mice, rats, dogs and monkeys. The major target organs were the lymphoid system (lymphopenia and lymphoid atrophy), lungs (increased weight, ...
List of excipients
Gilenya 0.25 mg hard capsules <u>Capsule fill:</u> Mannitol Hydroxypropylcellulose Hydroxypropylbetadex Magnesium stearate <u>Capsule shell:</u> Gelatin Titanium dioxide (E171) Yellow iron oxide (E172) ...
Incompatibilities
Not applicable.
Shelf life
Gilenya 0.25 mg hard capsules: 18 months. Gilenya 0.5 mg hard capsules: 2 years.
Special precautions for storage
Do not store above 25°C. Store in the original package in order to protect from moisture.
Nature and contents of container
Gilenya 0.25 mg hard capsules: PVC/PVDC/aluminium blister packs containing 28 hard capsules. PVC/PVDC/aluminium perforated unit dose blister packs containing 7x 1 hard capsules. Gilenya 0.5 mg hard 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
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Marketing authorization number(s)
Gilenya 0.25 mg hard capsules: EU/1/11/677/007-008 Gilenya 0.5 mg hard capsules: EU/1/11/677/001-006
Date of first authorization / renewal of the authorization
Date of first authorisation: 17 March 2011 Date of latest renewal: 23 November 2015
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