Table 2 |
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Features of packaging and labeling for oral artemisinin-containing pharmaceutical products at pharmacies in Dar-es-Salaam, Tanzania |
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Feature |
Frequency |
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General features |
|
|
Packaged and sold as a unit dose |
19 (100%) |
|
Package insert included |
19 (100%) |
|
Image of mosquito appears on package |
7 (37%) |
|
|
|
|
TFDA Package and labeling requirements |
|
|
International non-proprietary name included |
19 (100%) |
|
Non-proprietary name is printed larger or bolder* |
0 |
|
Strength of active ingredient identified |
19 (100%) |
|
Name and address of registrant identified |
17 (89%) |
|
Name and address of manufacturer other than registrant identified |
7 (37%) |
|
Labeled "Keep out of reach of children" |
10 (53%) |
|
Lot or batch number |
19 (100%) |
|
Expiry date |
19 (100%) |
|
Date of manufacture |
18 (95%) |
|
TFDA Registration number |
6 (32%) |
|
TFDA Package insert requirements |
|
|
Indication (uncomplicated malaria) |
19 (100%) |
|
Dosage regimen |
19 (100%) |
|
Contraindications |
12 (63%) |
|
Side effects |
19 (100%) |
|
Drug interactions |
11 (58%) |
|
Precautions and warnings |
18 (95%) |
|
Symptoms and treatment of overdose |
11 (58%) |
|
Presentation (e.g. "12 tablets of 100 mg each") |
19 (100%) |
|
Storage instructions |
13 (68%) |
|
Shelf life |
14 (74%) |
|
Name and address of manufacturer other than registrant identified |
6 (32%) |
|
Date of publication of package insert |
9 (47%) |
|
|
|
|
Appropriateness of recommended dose |
|
|
Recommended total adult dose consistent with international standards** |
4 (21%) |
|
Recommended duration consistent with international standards*** |
5 (26%) |
|
Mentions that non-immune patients may require additional doses |
2 (13%) |
|
Gives dosages for children |
17 (89%) |
|
Specifically formulated for children |
4 (21%) |
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|
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*Excludes one generic product. **At least 16 mg/kg for artesunate, artemether or dihydroartemisinin monotherapies; 9 mg/kg artemether combined with 72 mg/kg lumefantrine; or 12 mg/kg artesunate combined with 32 mg/kg mefloquine. ***At least 7 days for artemisinin monotherapies, 6 doses of artemether/lumefantrine over 3 days, or 3 daily doses for artesunate + mefloquine. |
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Kachur et al. Malaria Journal 2006 5:25 doi:10.1186/1475-2875-5-25 |
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