ZEPOSIA Hard capsule (2020)
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Περιεχόμενα
1. Name of the medicinal product
Zeposia 0.23 mg hard capsules. Zeposia 0.46 mg hard capsules. Zeposia 0.92 mg hard capsules.
2. Qualitative and quantitative composition
<u>Zeposia 0.23 mg hard capsules:</u> Each hard capsule contains ozanimod hydrochloride equivalent to 0.23 mg ozanimod. <u>Zeposia 0.46 mg hard capsules:</u> Each hard capsule contains ozanimod hydrochloride ...
3. Pharmaceutical form
Hard capsule. <u>Zeposia 0.23 mg hard capsules:</u> Light grey opaque hard capsule, 14.3 mm, imprinted in black ink with OZA on the cap and 0.23 mg on the body. <u>Zeposia 0.46 mg hard capsules:</u> Light ...
4.1. Therapeutic indications
Zeposia is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features.
4.2. Posology and method of administration
Treatment should be initiated under the supervision of a physician experienced in the management of multiple sclerosis (MS). Posology The recommended dose is 0.92 mg ozanimod once daily. The capsules can ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Immunodeficient state (see section 4.4). Patients who in the last 6 months experienced myocardial infarction ...
4.4. Special warnings and precautions for use
Bradyarrhythmia Initiation of treatment with ozanimod Prior to treatment initiation with ozanimod, an ECG in all patients should be obtained to determine whether any pre-existing cardiac abnormalities ...
4.5. Interaction with other medicinal products and other forms of interaction
Effect of inhibitors of the breast cancer resistance protein (BCRP) on ozanimod An inhibitor of the BCRP (ciclosporin) doubled the exposure (AUC) of the minor active metabolites which may subsequently ...
4.6. Fertility, pregnancy and lactation
Women of childbearing potential / Contraception in females Zeposia is contraindicated in women of childbearing potential not using effective contraception (see section 4.3). Therefore, before initiation ...
4.7. Effects on ability to drive and use machines
Zeposia has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile The most commonly reported adverse reactions are nasopharyngitis (11%), alanine aminotransferase increased (5%), and gamma-glutamyl transferase increased (5%). The most common ...
4.9. Overdose
In patients with overdosage of ozanimod, monitor for signs and symptoms of bradycardia, which may include overnight monitoring. Regular measurements of HR and blood pressure are required, and ECGs should ...
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: Immunosuppressants, selective immunosuppressants ATC code: L04AA38 Mechanism of action Ozanimod is a sphingosine 1-phosphate (S1P) receptor modulator, which binds selectively ...
5.2. Pharmacokinetic properties
Ozanimod is extensively metabolised in humans to form a number of circulating active metabolites, including two major active metabolites, CC112273 and CC1084037, with similar activity and selectivity for ...
5.3. Preclinical safety data
In repeated dose toxicology studies in mice (up to 4 weeks), rats (up to 26 weeks) and monkeys (up to 39 weeks), ozanimod markedly affected the lymphoid system (lymphopenia, lymphoid atrophy and reduced ...
6.1. List of excipients
<u>Capsule content:</u> Microcrystalline cellulose Silica, colloidal anhydrous Croscarmellose sodium Magnesium stearate <u>Capsule shell:</u> Zeposia 0.23 mg and 0.46 mg: Gelatin Titanium dioxide (E171) ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Do not store above 25°C.
6.5. Nature and contents of container
Polyvinyl chloride (pVC)/polychlorotrifluoroethylene (PCTFE)/aluminium foil blisters. <u>Treatment initiation pack:</u> Zeposia 0.23 mg and 0.46mg: Pack size of 7 hard capsules (4 0.23 mg, 3 0.46 mg). ...
6.6. Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
8. Marketing authorization number(s)
<u>Treatment initiation pack Zeposia 0.23 mg/0.46 mg hard capsules:</u> EU/1/20/1442/001 (Pack size of 7 hard capsules) <u>Maintenance pack Zeposia 0.92 mg hard capsules:</u> EU/1/20/1442/002 (Pack size ...
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 20 May 2020
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