Država: Australija
Jezik: engleski
Izvor: Department of Health (Therapeutic Goods Administration)
anagrelide hydrochloride, Quantity: 0.57 mg (Equivalent: anagrelide, Qty 0.5 mg)
Southern Cross Pharma Pty Ltd
Anagrelide hydrochloride
Capsule, hard
Excipient Ingredients: povidone; magnesium stearate; Gelatin; lactose monohydrate; croscarmellose sodium; titanium dioxide; microcrystalline cellulose; lactose
Oral
100
(S4) Prescription Only Medicine
ANAGRELIDE Lupin capsules are indicated for the treatment of essential thrombocythaemia
Visual Identification: A capsule with an opaque white body and cap, filled with white to off-white powder.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2017-08-03
ANAGRELIDE SCP/JULY2017/CMI-00 1 Anagrelide SCP _contains the active ingredient ANAGRELIDE (as hydrochloride monohydrate) _ CONSUMER MEDICINE INFORMATION What is in this leaflet This leaflet answers some common questions about ANAGRELIDE SCP. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking ANAGRELIDE SCP against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. Keep this leaflet with your medicine. You may need to read it again. What ANAGRELIDE SCP is used for ANAGRELIDE SCP capsules contain a medicine called anagrelide (as hydrochloride monohydrate) which acts upon the bone marrow and prevents it from producing too many of the blood cells known as ‘platelets’. In a disease such as ‘thrombocythaemia’, the bone marrow produces too many of these cells, and the very large numbers of platelets in the blood can cause serious problems with blood circulation. ANAGRELIDE SCP capsules can help prevent these problems. Before you take ANAGRELIDE SCP _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE ANAGRELIDE SCP IF YOU: • have an allergy to anagrelide or any of the ingredients listed at the end of this leaflet • have severe liver problems • are pregnant or breast feeding. DO NOT TAKE ANAGRELIDE SCP IF THE EXPIRY DATE (EXP.) PRINTED ON THE PACK HAS PASSED. DO NOT TAKE ANAGRELIDE SCP IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. DO NOT USE ANAGRELIDE SCP TO TREAT ANY OTHER COMPLAINT UNLESS YOUR DOCTOR TELLS YOU TO. _BEFORE YOU START TO TAKE IT _ TELL YOUR DOCTOR IF YOU HAVE ANY OF THE FOLLOWING: • you have any allergies, • you have had or now have any liver or kidney disease • you have heart disease, heart failure or are at high risk of vascular events (thrombosis or bleeding). TELL YOUR DOCTOR IF YOU ARE ALLERGIC TO ANY OTHER MEDICINES, FOODS, DYES OR PRESERVATIVE Pročitajte cijeli dokument
AUSTRALIAN PRODUCT INFORMATION ANAGRELIDE SCP, (ANAGRELIDE AS HYDROCHLORIDE MONOHYDRATE) CAPSULES _ _ 1. NAME OF THE MEDICINE Anagrelide. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Anagrelide capsules contain the active ingredient anagrelide (as hydrochloride monohydrate) equivalent to 0.5 mg of anagrelide. Excipients with known effect: lactose & lactose monohydrate. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM ANAGRELIDE SCP is a capsule with an opaque white body and cap Each ANAGRELIDE SCP capsules contain 0.5 mg of anagrelide as the active ingredient. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS ANAGRELIDE SCP capsules are indicated for the treatment of essential thrombocythaemia. 4.2. DOSE AND METHOD OF ADMINISTRATION Treatment with ANAGRELIDE SCP capsules should be initiated under close medical supervision. The recommended starting dosage of ANAGRELIDE SCP for adult patients is 1 mg /day, which should be administered orally in two divided doses (0.5 mg/dose). The starting dose should be maintained for at least a week. The dose should then be adjusted to the lowest effective dose required to reduce and maintain platelet count below 600 x 10 9 /L and ideally at levels between 150-400 x 10 9 /L. The dose should be increased by not more than 0.5 mg/day in any one week. For patients with moderate hepatic impairment, the recommended starting dose is 0.5 mg/day, to be maintained for a minimum of one week with close monitoring of cardiovascular effects. ANAGRELIDE SCP is not recommended for patients with severe hepatic impairment. Dosage should not exceed 10 mg/day or 2.5 mg in a single dose because of the hypotensive effect of anagrelide see Section 5.1 PHARMACODYNAMIC PROPERTIES. The decision to treat asymptomatic young adults with essential thrombocythaemia should be individualised. To monitor the effect of anagrelide and prevent the occurrence of thrombocytopenia, platelet counts should be performed every two days during the first week of treatment and at l Pročitajte cijeli dokument