SCEMBLIX Film-coated tablet (2022)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Scemblix 20 mg film-coated tablets. Scemblix 40 mg film-coated tablets.
2. Qualitative and quantitative composition
Scemblix 20 mg film-coated tablets Each film-coated tablet contains 21.62 mg asciminib hydrochloride, equivalent to 20 mg asciminib. <u>Excipient with known effect:</u> Each film-coated tablet contains ...
3. Pharmaceutical form
Film-coated tablet (tablet). <u>Scemblix 20 mg film-coated tablets:</u> Pale yellow, round, biconvex film-coated tablets with bevelled edges of approximately 6 mm diameter, debossed with company logo on ...
4.1. Therapeutic indications
Scemblix is indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase (Ph+ CML-CP) previously treated with two or more tyrosine kinase ...
4.2. Posology and method of administration
Treatment should be initiated by a physician experienced in the diagnosis and treatment of patients with leukaemia. Posology The recommended dose is 40 mg twice daily at approximately 12-hour intervals. ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Myelosuppression Thrombocytopenia, neutropenia and anaemia occurred in patients receiving asciminib. Severe (NCI CTCAE grade 3 or 4) thrombocytopenia and neutropenia were reported during treatment with ...
4.5. Interaction with other medicinal products and other forms of interaction
Medicinal products with known risk of torsades de pointes Caution should be exercised during concomitant administration of asciminib and medicinal products with known risk of torsades de pointes, including, ...
4.6. Fertility, pregnancy and lactation
Women of childbearing potential/Contraception The pregnancy status of women of childbearing potential should be verified prior to starting treatment with asciminib. Sexually-active women of childbearing ...
4.7. Effects on ability to drive and use machines
Asciminib has no or negligible influence on the ability to drive and use machines. However, it is recommended that patients experiencing dizziness, fatigue or other undesirable effects (see section 4.8) ...
4.8. Undesirable effects
Summary of the safety profile The most common adverse reactions of any grade (incidence ≥20%) in patients receiving asciminib were musculoskeletal pain (37.1%), upper respiratory tract infections (28.1%), ...
4.9. Overdose
In clinical studies, asciminib has been administered at doses up to 280 mg twice daily with no evidence of increased toxicity. General supportive measures and symptomatic treatment should be initiated ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antineoplastic agents, protein kinase inhibitors <b>ATC code:</b> L01EA06 Mechanism of action Asciminib is a potent inhibitor of ABL/BCR::ABL1 tyrosine kinase. Asciminib ...
5.2. Pharmacokinetic properties
Absorption Asciminib is rapidly absorbed, with median maximum plasma level (T<sub>max</sub>) reached 2 to 3 hours after oral administration, independent of the dose. The geometric mean (geoCV%) of C<sub> ...
5.3. Preclinical safety data
Safety pharmacology Moderate cardiovascular effects (increased heart rate, decreased systolic pressure, decreased mean arterial pressure, and decreased arterial pulse pressure) were observed in <em>in ...
6.1. List of excipients
<u>Scemblix 20 mg and 40 mg film-coated tablets:</u> Lactose monohydrate Microcrystalline cellulose (E460i) Hydroxypropylcellulose (E463) Croscarmellose sodium (E468) Polyvinyl alcohol (E1203) Titanium ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
2 years.
6.4. Special precautions for storage
Do not store above 25°C. Store in the original package in order to protect from moisture.
6.5. Nature and contents of container
Scemblix is supplied in PCTFE/PVC/Alu blisters containing 10 film-coated tablets. <u>The following pack sizes are available:</u> Packs containing 20 or 60 film-coated tablets. Not all pack sizes may be ...
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
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
8. Marketing authorization number(s)
EU/1/22/1670/001-004
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