País: Nova Zelanda
Idioma: anglès
Font: Medsafe (Medicines Safety Authority)
Venetoclax 100mg;
AbbVie Limited
Venetoclax 100 mg
100 mg
Film coated tablet
Active: Venetoclax 100mg Excipient: Calcium hydrogen phosphate Colloidal silicon dioxide Copovidone Opadry II yellow 85F32450 Polysorbate 80 Purified water Sodium stearyl fumarate
Prescription
AbbVie Operations Singapore Pte Ltd
VENCLEXTA is indicated for the treatment of patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).
Package - Contents - Shelf Life: Blister pack, PVC/PE/Aclar/Al foil blisters in cardboard carton - 1 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PE/Aclar/Al foil blisters in cardboard carton - 7 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PE/Aclar/Al foil blisters in cardboard wallet - 14 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PE/Aclar/Al foil blisters in cardboard carton - 112 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE bottle with child resistant closure - 120 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE bottle with child resistant closure - 180 tablets - 36 months from date of manufacture stored at or below 30°C
2017-03-13
VENCLEXTA_ CMI - VERSION 11 _ 1 VENCLEXTA ® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about taking this medicine, speak to your doctor or pharmacist. 1. WHY AM I TAKING VENCLEXTA? Venclexta contains the active ingredient venetoclax. Venclexta is used to treat some specific blood cancers, including chronic lymphocytic leukaemia (CLL), small lymphocytic lymphoma (SLL) and acute myeloid leukaemia (AML). For more information, see Section 1. Why am I taking Venclexta? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I TAKE VENCLEXTA? Check the list of ingredients at the end of this CMI. Do not take Venclexta if you have ever had an allergic reaction to any of them. Talk to your doctor before you take this medicine if he/she is not aware that you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I take Venclexta? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Venclexta and affect how it works, or Venclexta may interfere with other medicines and affect how they work. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I TAKE VENCLEXTA? It is very important that you follow all directions carefully, particularly when you first start taking Venclexta. There can be serious consequences if you do not. These instructions can be found in Section 4. How do I take Venclexta? in the full CMI. 5. WHAT SHOULD I KNOW WHILE TAKING VENCLEXTA? THINGS YOU SHOULD DO • Remind any doctor or dentist you visit that you are taking Venclexta. • Drink plenty of water every day when taking Venclexta. • Keep all your appointments, including those for blood tests. THINGS YOU SHOULD NOT DO • Do not stop taking this medicine suddenly without checking with your doctor. DRIVING OR USING MACHINES • Take care when driving or using machinery unt Llegiu el document complet
VENCLEXTA 20 September 2022 Page 1 of 58 Version 15 NEW ZEALAND DATA SHEET 1. VENCLEXTA 10 MG, 50 MG AND 100 MG TABLETS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION VENCLEXTA 10 mg tablets: each film-coated tablet contains 10 mg venetoclax. VENCLEXTA 50 mg tablets: each film-coated tablet contains 50 mg venetoclax. VENCLEXTA 100 mg tablets: each film-coated tablet contains 100 mg venetoclax. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. VENCLEXTA 10 mg tablets: round, biconvex shaped, pale yellow debossed with “V” on one side and “10” on the other side. VENCLEXTA 50 mg tablets: oblong, biconvex shaped, beige debossed with “V” on one side and “50” on the other side. VENCLEXTA 100 mg tablets: oblong, biconvex shaped, pale yellow debossed with “V” on one side and “100” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS VENCLEXTA is indicated for the treatment of patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL). VENCLEXTA is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy. 4.2 DOSE AND METHOD OF ADMINISTRATION METHOD OF ADMINISTRATION VENCLEXTA should be taken orally once daily. Patients should be instructed to take VENCLEXTA tablets with a meal and water at approximately the same time each day. VENCLEXTA tablets should be swallowed whole and not chewed, crushed, or broken prior to swallowing (see section 5.2). CHRONIC LYMPHOCYTIC LEUKAEMIA/SMALL LYMPHOCYTIC LYMPHOMA 5-week Dose Titration Schedule The starting dose of VENCLEXTA is 20 mg once daily for 7 days. The VENCLEXTA dose must be administered according to a weekly dose titration schedule to the daily dose of 400 mg over a period of 5 weeks as shown in Table 1. VENCLEXTA 20 September 2022 Page 2 of 58 Version 15 The 5-week dose titration schedule is designed to gradually reduce tumour burden (debulking) and decrease the risk of tumour lysis syn Llegiu el document complet