Страна: Австралія
мова: англійська
Джерело: Department of Health (Therapeutic Goods Administration)
primaquine phosphate, Quantity: 13.2 mg (Equivalent: primaquine, Qty 7.5 mg)
Boucher & Muir Pty Ltd
Primaquine phosphate
Tablet, uncoated
Excipient Ingredients: wheat starch; povidone; purified water; lactose monohydrate; purified talc; Gelatin; magnesium stearate; glycerol
Oral
28 tablets, 56 tablets
(S4) Prescription Only Medicine
Prevention of relapses (radical cure) of malaria caused by P.vivax and P. ovale. Adjunctive therapy in the treatment of gametocytemia due to P.falciparum in patients resident in areas receptive to malaria.
Visual Identification: Orange tablets, 6mm diameter, flat without breakline or logo; Container Type: Bottle; Container Material: HDPE; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2014-11-10
PRIMACIN _TABLETS 7.5 MG_ _Primaquine phosphate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start taking Primacin. This leaflet answers some common questions about Primacin. It does not contain all the available information. The most up-to-date Consumer Medicine Information can be downloaded from www.ebs.tga.gov.au. Reading this leaflet 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 Primacin 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 want to read it again. WHAT PRIMACIN IS USED FOR Primacin contains primaquine phosphate. It works by killing the malarial parasite at different stages of its life cycle, both in the blood and in the liver. Primacin is used to treat the vivax and ovale forms of malaria following an attack. It is also used to aid in the treatment of falciparum malaria. Your doctor may have prescribed this medicine for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. Primacin is only available with a doctor's prescription. Primacin is not addictive. BEFORE YOU TAKE PRIMACIN Primacin is not suitable for everyone. _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE PRIMACIN IF YOU: • have severe glucose-6-phosphate (G6PD) deficiency • You may not know if you have this deficiency but your doctor can do a quick blood test to check. • are pregnant • have rheumatoid arthritis or lupus erythematosus • are taking quinacrine hydrochloride to treat malaria • are taking other medicines that affect your red blood cells or bone marrow. DO NOT TAKE PRIMACIN IF YOU ARE ALLERGIC TO ANY MEDICINE CONTAINING PRIMAQUINE OR OTHER 8- AMINOQUINOLINES OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. DO NOT TAKE IT AFTER THE EXPIRY DATE ('EXPIRY') PRINTED ON T Прочитайте повний документ
PRIMACIN ® 1 AUSTRALIAN PRODUCT INFORMATION PRIMACIN ® PRIMAQUINE PHOSPHATE TABLETS 1 NAME OF THE MEDICINE Primaquine phosphate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Primacin tablet contains 7.5 mg primaquine base as 13.2 mg primaquine phosphate. Excipients with known effect: Lactose monohydrate. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Primacin tablets are orange tablets, 6mm diameter, flat without breakline or logo. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ▪ Prevention of relapses (radical cure) of malaria caused by _P. vivax_ and _P. ovale._ ▪ Adjunctive therapy in the treatment of gametocytemia due to _P. falciparum_ in patients resident in areas receptive to malaria. 4.2 DOSE AND METHOD OF ADMINISTRATION Primaquine should be taken with food. Radical treatment (a) 15 mg daily for 14 days. (b) Up to 30 mg daily for 14 days in areas where resistant malaria strains occur or where treatment has failed with lower doses. (c) The WHO advises that the treatment period of 21 days should be employed to achieve radical cure in most of South East Asia and the Pacific regions. Other antimalarial agents may be used concomitantly. (d) For patients with G6PD deficiency: up to 45 mg once weekly for 8 weeks with monitoring for the development of haemolysis. PRIMACIN ® 2 (e) Paediatric dose: 0.3 mg/kg/day. (f) For the reduction of gametocytes of P. falciparum: 45 mg as a single dose for adults and 0.7 to 1.0 mg/kg for children. 4.3 CONTRAINDICATIONS ▪ Hypersensitivity to primaquine or other 8-aminoquinolines ▪ Hypersensitivity to other ingredients in Primacin tablets ▪ Severe glucose-6-phosphate dehydrogenase (G6PD) deficiency ▪ Pregnant women ▪ Acutely ill patients with any serious systemic diseases characterised by a tendency to granulocytopenia, such as rheumatoid arthritis or lupus erythematosus ▪ Patients receiving concurrently other potentially haemolytic medicines or depressants of myeloid elements of the bone marrow 4.4 SPECIAL WARN Прочитайте повний документ