국가: 나이지리아
언어: 영어
출처: NAFDAC (National Agency for Food and Drugs Administration and Control)
artesunate, sulfamethoxypyrazine, pyrimethamine
Dafra Pharma GmbH
artesunate, sulfamethoxypyrazine, pyrimethamine
TABLETS
ERFA NOV/S.A LANDBOAWERSSTRAAT 25,B-1040/BRUSSEL
CO-ARINATE is used as curative treatment for all forms of malaria, including severe malaria caused by multi drug-resistant strains of Plasmodium falciparum. In case of P. vivax addition of primaquine may be required. CO-ARINATE has been especially designed to treat malaria in children, adolescents and adults.
Each tablet CO-ARINATE® Adult contains 200 mg artesunate, 500 mg sulfamethoxypyrazine and 25 mg pyrimethamine. Box containing 1 blister of 3 tablets. Other pharmaceutical form: CO-ARINATE® Junior: each tablet contains 100 mg artesunate, 250 mg sulfamethoxypyrazine and 12,5 mg pyrimethamine.
Dafra Pharma Dossier: Co-Arinate Adult RA Departement Summary of Product Characteristics SmPC Page 1 of 6 Date: 26/01/2017 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Co-Arinate ® Adult 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet Co-Arinate® Adult contains 200 mg artesunate, 500 mg sulfamethoxypyrazine and 25 mg pyrimethamine. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Box containing 1 blister of 3 tablets. OTHER PHARMACEUTICAL FORM: Co-Arinate® Junior: each tablet contains 100 mg artesunate, 250 mg sulfamethoxypyrazine and 12,5 mg pyrimethamine. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Co-Arinate® is used as curative treatment for all forms of malaria, including severe malaria caused by multi drug-resistant strains of Plasmodium falciparum. In case of P. vivax addition of primaquine may be required. Co-Arinate® has been especially designed to treat malaria in children, adolescents and adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION: The dose for this treatment is based on body weight at 4 mg / kg of Artesunate combined with Sulfamethoxypyrazine and Pyrimethamine. Three consecutive intakes of this dose must be given during 48 hours: A first tablet is taken upon confirmation of malaria diagnosis (at Time 0) A second tablet is taken 24 hours later The final tablet is taken after a further 24 hours have passed; therefore there is an interval of 24 hours between doses which must be adhered to. Dafra Pharma Dossier: Co-Arinate Adult RA Departement Summary of Product Characteristics SmPC Page 2 of 6 Date: 26/01/2017 Dosage scheme for the 48 hour treatment: Presentation Weight (kg) Age (in years) Number of tablets Total course 0 h 24 h 48 h Co-Arinate® Adult > 35 – < 80 kg (> 14 years and adults) 1 1 1 3 tablets Further dose adaptations may be necessary for adults > 80 kg. The tablets should be taken with fluid such as drinking water. In order to facilitate administration they may be crushed if necessary. Note: A full course 전체 문서 읽기