Country: Tanzania
Language: English
Source: Tanzania Medicinces & Medical Devices Authority
Sulfadoxine/Pyrimethamine/Amodiaquine (as Hydrochloride)
Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd, CHINA
Sulfadoxine/Pyrimethamine/Amodiaquine (as Hydrochloride)
250/12.5/76.5
Dispersible Tablets
GUILIN PHARMACEUTICAL CO., LTD, CHINA
Physical description: Amodiaquine tablets: Dispersible tablets, with yellow cores, debossed with “AQ” on one side and a score line on the other side. Sulfadoxine/Pyrimethamine: White, round, dispersible tablets, debossed with “SP” on one side and a score line on the other side; Local technical representative: Tridem Pharma Tanzania Limited (69513)
Registered/Compliant
2022-07-19
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT SPAQ-CO ® DISP Sulfadoxine/Pyrimethamine250mg/12.5mg + Amodiaquine (as Hydrochloride) 76.5mg co- blistered dispersible tablets Sulfadoxine/Pyrimethamine500mg/25mg + Amodiaquine (as Hydrochloride) 153mg co- blistered dispersible tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _SPAQ-CO DISP(AMODIAQUINE (100 MG AS HYDROCHLORIDE) 76.5MG DISPERSIBLE _ _TABLETS+ SULFADOXINE / PYRIMETHAMINE _ _(250/12.5MG) DISPERSIBLE TABLET) _ Each amodiaquine dispersible tablet contains 76.5mg amodiaquine (as hydrochloride). Each sulfadoxine/pyrimethamine dispersible tablet contains 250mg sulfadoxine and 12.5mg pyrimethamine. For a full list of excipients, see section 6.1. _SPAQ-CO DISP(AMODIAQUINE (200 MG AS HYDROCHLORIDE) 153MG DISPERSIBLE _ _TABLETS+ SULFADOXINE / PYRIMETHAMINE _ _(500/25MG) DISPERSIBLE TABLET) _ Each amodiaquine dispersible tablet contains 153mg amodiaquine (as hydrochloride). Each sulfadoxine/pyrimethamine dispersible tablet contains 500 mg sulfadoxine and 25 mg pyrimethamine. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Amodiaquine dispersible tablets are tablets with yellow core debossed with “AM” on one side and a score line on the other side. The score-line is to facilitate breaking for ease of swallowing and not to divide the tablet into equal doses. Sulfadoxine /pyrimethamine dispersible tablets are white round tablets, debossed with “SP” on one side and a score line on the other side. The score-line is to facilitate breaking for ease of swallowing and not to divide the tablet into equal doses. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATION SPAQ-CO Disp is indicated for malaria prevention during the malaria season (seasonal malaria chemoprevention,SMC) in infant aged 3- 12 months and children aged 12–59 months throughout the Sahel sub-region of Africa, provided that amodiaquine and pyrimethamine/sulfadoxine retain sufficient antimalarial efficacy. The most recent official guidelines on the use o Read the complete document