Land: Israel
Sprog: engelsk
Kilde: Ministry of Health
ASCIMINIB AS HYDROCHLORIDE
NOVARTIS ISRAEL LTD
L01EA06
FILM COATED TABLETS
ASCIMINIB AS HYDROCHLORIDE 20 MG
PER OS
Required
NOVARTIS PHARMA STEIN AG, SWITZERLAND
ASCIMINIB
SCEMBLIX is indicated for the treatment of adult patients with:• Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors (TKIs).• Ph+ CML in CP with the T315I mutation
2023-04-30
Artwork Order No.: Artwork Order description: AW identifier No. New: Proof No.: Creation date: Artwork creator: Braille: Printing colours: Print enhancements: AW identifier No. Old: Packaging site: Patient leaflet in accordance with the Pharmacists’ Regulations )PREPARATIONS( - 1986 This medicine is dispensed with a doctor’s prescription only Scemblix ® 20 mg Scemblix ® 40 mg Film-coated tablets Active ingredient Scemblix 20 mg: e a c h f i l m - c o a t e d t a b l e t c o n t a i n s a s c i m i n i b h y d r o c h l o r i d e , e q u i v a l e n t t o a s c i m i n i b 2 0 mg Scemblix 40 mg: e a c h f i l m - c o a t e d t a b l e t c o n t a i n s a s c i m i n i b h y d r o c h l o r i d e , e q u i v a l e n t t o a s c i m i n i b 4 0 mg I n a c t i v e i n g r e d i e n t s a n d a l l e r g e n s i n t h e m e d i c i n e - s e e s e c t i o n 2 u n d e r ‘ I m p o r t a n t i n f o r m a t i o n a b o u t s o m e o f t h i s m e d i c i n e ’ s i n g r e d i e n t s ’ , a n d s e c t i o n 6 ‘ A d d i t i o n a l information’. Read the entire leaflet carefully before you start using this m e d i c i n e . T h i s l e a f l e t c o n t a i n s c o n c i s e i n f o r m a t i o n a b o u t t h i s m e d i c i n e . I f y o u h a v e a n y f u r t h e r q u e s t i o n s , c o n s u l t y o u r d o c t o r o r pharmacist. T h i s m e d i c i n e h a s b e e n p r e s c r i b e d f o r y o u . D o n o t p a s s i t o n t o o t h e r s . I t m a y h a r m t h e m , e v e n i f i t s e e m s t o y o u t h a t t h e i r m e d i c a l c o n d i t i o n i s s i m i l a r t o yours. 1. What is this medicine intended for? For the treatment of adult patients with: Philadelphia chromosome-positive chronic myeloid leukemia )Ph+ CML( in chronic phase )CP(, previously treated with two or more tyrosine kinase inhibitors )TKIs(. Philadelphia chromosome-positive chronic myeloid leukemia )Ph+ CML( in chronic phase )CP( with the T315I mutation. THERAPEUTIC GROUP: Antineoplastic agents, tyrosine kinase inhibi Læs hele dokumentet
SCE API DEC23 V4 FULL PRESCRIBING INFORMATION SCEMBLIX 20 mg SCEMBLIX 40 mg Film coated tablets QUALITATIVE AND QUANTITATIVE COMPOSITION SCEMBLIX 20 mg: each film coated tablet contains 21.62 mg asciminib hydrochloride, equivalent to 20 mg asciminib. Excipient with known effect Each film-coated tablet contains 43 mg lactose monohydrate. SCEMBLIX 40 mg: each film coated tablet contains 43.24 mg asciminib hydrochloride, equivalent to 40 mg asciminib. Excipient with known effect Each film-coated tablet contains 86 mg lactose monohydrate. For the full list of excipients, see section 11. 1. INDICATIONS AND USAGE • SCEMBLIX is indicated for the treatment of adult patients with: Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors (TKIs). • Ph+ CML in CP with the T315I mutation. 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage in Patients with Ph+ CML-CP, Previously Treated with Two or More TKIs The recommended dose of SCEMBLIX is 80 mg taken orally once daily at approximately the same time each day or 40 mg orally twice daily at approximately 12-hour intervals. The recommended dose of SCEMBLIX is taken orally without food. Avoid food consumption for at least 2 hours before and 1 hour after taking SCEMBLIX _[see Clinical Pharmacology _ _(12.2)]_ . Continue treatment with SCEMBLIX as long as clinical benefit is observed or until unacceptable toxicity occurs. 2.2 Recommended Dosage in Patients with Ph+ CML-CP with the T315I Mutation The recommended dose of SCEMBLIX is 200 mg taken orally twice daily at approximately 12-hour intervals. The recommended dose of SCEMBLIX is taken orally without food. Avoid food consumption for at least 2 hours before and 1 hour after taking SCEMBLIX _[see Clinical Pharmacology (12.2)]_ . 2.3 Missed Dose Once Daily Dosage Regimen: If a SCEMBLIX dose is missed by more than approximately 12 hours, skip the dose and take the next dose as scheduled. Twice Daily Dosage Regimens: I f a SCEMBLIX Læs hele dokumentet