Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
MEFLOQUINE HYDROCHLORIDE
Roche Products Ltd
250 Base Milligrams
Tablets
1989-12-14
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lariam 250mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 250mg mefloquine (as 274.09 mg mefloquine hydrochloride). Each tablet contains 50.61mg lactose monohydrate For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Tablets White to off-white cylindrical biplanar tablets, cross-scored and imprinted Roche on one face. The tablet can be divided into equal halves to facilitate dosing. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Therapy and prophylaxis of malaria. _Therapy_: Lariam is especially indicated for therapy of _P. falciparum _malaria in which the pathogen has become resistant to other antimalarial agents. Following treatment of _P. vivax _malaria with Lariam, relapse prophylaxis with an 8-amino-quinoline derivative, for example primaquine, should be considered in order to eliminate parasites in the hepatic phase. _Prophylaxis_: Malaria prophylaxis with Lariam is particularly recommended for travellers to malarious areas in which multiple resistant _P. falciparum _strains occur. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _CURATIVE TREATMENT_ The recommended total therapeutic dose of mefloquine for non-immune patients is 20 – 25mg/kg. A lower total dose of 15mg/kg may suffice for partially immune individuals. The recommended total therapeutic dosages of Lariam tablets relative to body weight and immune status are presented in the following table:* NON-IMMUNE PATIENTS PARTIALLY IMMUNE PATIENTS < 20kg ** ¼ tablet / 2.5 – 3kg 1 tablet / 10 – 12 kg ¼ tablet / 4kg 1 tablet / 16kg 20 - 30kg 2 – 3 tablets 1¼ - 2 tablets > 30 - 45kg 3 – 4 tablets 2 – 3 tablets > 45 – 60kg 4 – 5 tablets 3 – 4 tablets > 60kg *** 6 tablets 4 – 6 tablets IRISH MEDICIN Leggi il documento completo