Šalis: Naujoji Zelandija
kalba: anglų
Šaltinis: Medsafe (Medicines Safety Authority)
Apremilast 30mg;
Amgen New Zealand Limited
Apremilast 30 mg
30 mg
Film coated tablet
Active: Apremilast 30mg Excipient: Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry beige 85F17424 Purified water
Prescription
Celgene Chemicals GmbH
For the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phytotherapy or systemic therapy.
Package - Contents - Shelf Life: Blister pack, PVC blisters with aluminium push through foil 30mg - 56 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC blisters with aluminium push through foil 30mg - 168 tablets - 36 months from date of manufacture stored at or below 30°C
2015-06-17
Otezla ® (apremilast) film coated tablets 1 NEW ZEALAND CONSUMER MEDICINE INFORMATION OTEZLA ® (APREMILAST) FILM COATED TABLETS WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Otezla. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Otezla against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT OTEZLA IS USED FOR Otezla is used to treat adults with the following conditions: • Moderate to severe plaque psoriasis (an inflammatory disease of the skin, which can cause red, scaly, thick, itchy, painful patches on your skin, and can also affect your scalp and nails) • Psoriatic arthritis (an inflammatory disease of the joints, often accompanied by psoriasis) Psoriasis and psoriatic arthritis are usually lifelong conditions and there is currently no cure. Otezla works by reducing the activity of a natural substance in the body’s cells called ‘phosphodiesterase 4’. This helps regulate the immune response associated with psoriasis and psoriatic arthritis. By regulating the immune response, Otezla can help to control the signs and symptoms of these conditions. In psoriasis, treatment with Otezla results in a reduction in psoriatic skin plaques and other signs and symptoms of the disease. In psoriatic arthritis, treatment with Otezla results in an improvement in swollen and painful joints, and can improve your general physical function. Otezla has also been shown to improve the quality of life in patients with psoriasis or psoriatic arthritis. This means that the impact of your condition on daily activities, relationships and other factors should be less than it was before. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT HOW OTEZLA WORKS, OR WHY THIS MEDICINE HAS BEEN PRE Perskaitykite visą dokumentą
NEW ZEALAND DATA SHEET OTEZLA DATA SHEET PAGE 1 OF 29 1. PRODUCT NAME Otezla ® 30 mg tablets Otezla titration pack 10 mg, 20 mg, 30 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 10 mg tablet contains 10 mg apremilast. Each 20 mg tablet contains 20 mg apremilast. Each 30 mg tablet contains 30 mg apremilast. For the full list of excipients, see section 6.1 List of excipients. Excipient(s) with known effect Otezla 10 mg, 20 mg and 30 mg tablets contain lactose. 3. PHARMACEUTICAL FORM Otezla 10 mg Tablets: Pink, diamond shaped 10 mg film-coated tablet with “APR” engraved on one side and “10” on the opposite side. Otezla 20 mg Tablets: Brown, diamond shaped 20 mg film-coated tablet with “APR” engraved on one side and “20” on the opposite side. Otezla 30 mg Tablets: Beige, diamond shaped 30 mg film-coated tablet with “APR” engraved on one side and “30” on the opposite side. Description Apremilast is a white to pale yellow non-hygroscopic powder with a melting point of approximately 156.1°C. It is practically insoluble in water, slightly soluble in ethanol, and soluble in acetone. Apremilast is the S-enantiomer with a specific rotation of +28.1° in acetonitrile at a concentration of 20 mg/mL. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Otezla is indicated for: • The treatment of signs and symptoms of active psoriatic arthritis in adult patients. • The treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. NEW ZEALAND DATA SHEET OTEZLA DATA SHEET PAGE 2 OF 29 4.2 DOSE AND METHOD OF ADMINISTRATION Treatment with Otezla should be initiated by specialists experienced in the diagnosis and treatment of psoriasis or psoriatic arthritis. Dose The recommended dose of Otezla is 30 mg twice daily taken orally approximately 12 hours apart. An initial titration schedule is required as shown below in Table 1. No re-titration is required after initial titration. TABLE 1: DOSE TITRATION SCHEDULE DAY 1 DAY2 DAY 3 DAY 4 DAY Perskaitykite visą dokumentą