Država: Izrael
Jezik: engleski
Izvor: Ministry of Health
LOMITAPIDE AS MESYLATE
MEDISON PHARMA LTD
C10AX12
CAPSULES
LOMITAPIDE AS MESYLATE 5 MG
PER OS
Required
CATALENT CTS, USA
LOMITAPIDE
An adjunct to a low-fat diet and other lipid-lowering treatments, including LDL apheresis where available, to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B), and non-high-density lipoprotein cholesterol (non-HDL-C) in patients with homozygous familial hypercholesterolemia (HoFH).
2019-10-31
1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986 THIS MEDICINE IS DISPENSED WITH A DOCTOR'S PRESCRIPTION ONLY LOJUXTA 5 MG LOJUXTA 10 MG LOJUXTA 20 MG CAPSULES ACTIVE INGREDIENT: Each capsule of Lojuxta 5 mg contains lomitapide (as mesilate) 5 mg Each capsule of Lojuxta 10 mg contains lomitapide (as mesilate) 10 mg Each capsule of Lojuxta 20 mg contains lomitapide (as mesilate) 20 mg Inactive ingredients and allergens in this medicine: See section 6 ‘Additional information’ and section 2: ‘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, consult your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? Lojuxta is used with a low-fat diet and other lipid lowering treatments, including LDL apheresis in patients with homozygous familial hypercholesterolaemia (HoFH) to lower: LDL cholesterol (“bad " cholesterol) total cholesterol (TC) apolipoprotein-B non-HDL cholesterol THERAPEUTIC GROUP: Lipid-modifying agents. Lojuxta contains the active ingredient called lomitapide which works by blocking the action of “microsomal triglyceride transfer protein” . This protein is located within the liver and the gut cells, where it is involved in assembling fatty substances into larger particles that are then released into the blood stream. By blocking this protein, the medicine decreases the level of fats and cholesterol in the blood. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to the active ingredient (lomitapide) or to any of the other ingredients this medicine contains (see section 6 - ‘Additional information’) • You have liver problems or unexplained abnormal l Pročitajte cijeli dokument
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Lojuxta 5 mg Lojuxta 10 mg Lojuxta 20 mg Capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Lojuxta 5 mg hard capsules Each hard capsule contains lomitapide mesylate equivalent to 5 mg lomitapide. _Excipient with known effect _ Each hard capsule contains 70.12 mg of lactose (as monohydrate) (see section 4.4). Lojuxta 10 mg hard capsules Each hard capsule contains lomitapide mesylate equivalent to 10 mg lomitapide. _Excipient with known effect _ Each hard capsule contains 140.23 mg of lactose (as monohydrate) (see section 4.4). Lojuxta 20 mg hard capsules Each hard capsule contains lomitapide mesylate equivalent to 20 mg lomitapide. _Excipient with known effect _ Each hard capsule contains 129.89 mg of lactose (as monohydrate) (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard, capsule. Lojuxta 5 mg hard capsules The capsule is an orange cap/orange body hard capsule of 19.4 mm, printed with black ink imprinted with “5 mg” on body and “A733” on cap. Lojuxta 10 mg hard capsules The capsule is an orange cap/white body hard capsule of 19.4 mm, printed with black ink imprinted with “10 mg” on body and “A733” on cap. Lojuxta 20 mg hard capsules The capsule is a white cap/white body hard capsule of 19.4 mm, printed with black ink imprinted with “20 mg” on body and “A733” on cap. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lojuxta is indicated as an adjunct to a low-fat diet and other lipid-lowering treatments, including LDL apheresis where available, to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), 2 apolipoprotein B (apo B), and non-high-density lipoprotein cholesterol (non-HDL-C) in patients with homozygous familial hypercholesterolaemia (HoFH). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Lojuxta should be initiated and monitored by a physician experienced in the treatment of lipid disorders. Posology The recommended starting dos Pročitajte cijeli dokument