Страна: Израиль
Язык: английский
Источник: Ministry of Health
OZANIMOD AS HYDROCHLORIDE
BRISTOL, MYERS SQUIBB (ISRAEL) LIMITED, ISRAEL
L04AA38
CAPSULES
OZANIMOD AS HYDROCHLORIDE 0.23 MG
PER OS
Required
CELGENE CORPORATION, USA
OZANIMOD
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.ZEPOSIA is indicated for the treatment of moderately to severely active ulcerative colitis (UC) in adults.
2021-05-19
Patient leaflet in accordance with the Pharmacists’ Regulations (Preparations) - 1986 This medicine is dispensed with a doctor’s prescription only Zeposia ® 0.23 mg Zeposia ® 0.46 mg Zeposia ® 0.92 mg Active ingredient and its quantity: Zeposia ® 0.23 mg: Each capsule contains 0.23 mg ozanimod (as hydrochloride) Zeposia ® 0.46 mg: Each capsule contains 0.46 mg ozanimod (as hydrochloride) Zeposia ® 0.92 mg: Each capsule contains 0.92 mg ozanimod (as hydrochloride) Inactive ingredients - see section 6 ‘Additional information’ and section 2 under ‘Important information about some of this medicine’s ingredients’. Read the entire leaflet carefully before you start using this medicine. This leaflet contains concise information about this medicine. If you have any further questions, ask the doctor or pharmacist. This medicine has been prescribed to treat you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar to yours. In addition to the leaflet, Zeposia has a patient safety information guide and a patient pregnancy reminder card. The guide and card contain important safety information, which you should know, before starting and during the treatment with Zeposia and which you should follow. Carefully read the patient safety information guide, the patient pregnancy reminder card, and patient leaflet before starting treatment with this medicine. Keep the guide and card for further reference if needed. 1. What is this medicine intended for? • 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. • Zeposia is indicated for the treatment of moderately to severely active ulcerative colitis (UC) in adults. Therapeutic group: selective immunosuppressants. Zeposia contains the active substance ozanimod that belongs to a group of medicines which can reduce the number of white blood cells (lymphocytes) circulating freely round the bo Прочитать полный документ
1 Zeposia_NPI_Dec2023_clean 1. NAME OF THE MEDICINAL PRODUCT Zeposia 0.23 mg Zeposia 0.46 mg Zeposia 0.92 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Zeposia 0.23 mg capsules Each capsule contains ozanimod hydrochloride equivalent to 0.23 mg ozanimod. Zeposia 0.46 mg capsules Each capsule contains ozanimod hydrochloride equivalent to 0.46 mg ozanimod. Zeposia 0.92 mg capsules Each capsule contains ozanimod hydrochloride equivalent to 0.92 mg ozanimod. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule. Zeposia 0.23 mg capsules Size 4 opaque hard shell capsules with light grey body and light grey cap. Imprinted in black ink with “OZA” on the cap and “0.23 mg” on the body. Zeposia 0.46 mg capsules Size 4 opaque hard shell capsules with light grey body and orange cap. Imprinted in black ink with “OZA” on the cap and “0.46 mg” on the body. Zeposia 0.92 mg capsules Size 4 opaque hard shell capsules with orange body and orange cap. Imprinted in black ink with “OZA” on the cap and “0.92 mg” on the body. 2 Zeposia_NPI_Dec2023_clean 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Multiple sclerosis 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. Ulcerative colitis Zeposia is indicated for the treatment of moderately to severely active ulcerative colitis (UC) in adults. 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) or ulcerative colitis (UC). Posology The recommended dose is 0.92 mg ozanimod once daily. The initial dose escalation regimen of ozanimod from Day 1 to Day 7 is required and shown below in Table 1. Following the 7-day dose escalation, the once daily dose is 0.92 mg, starting on Day 8. Table 1: Dose escalation regimen Days 1 – 4 0.23 mg once daily Days 5 – 7 0.46 mg once daily Days 8 and thereafter 0.92 mg onc Прочитать полный документ