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Table 2 Features of packaging and labeling for oral artemisinin-containing pharmaceutical products at pharmacies in Dar-es-Salaam, Tanzania

From: Putting the genie back in the bottle? Availability and presentation of oral artemisinin compounds at retail pharmacies in urban Dar-es-Salaam

Feature Frequency
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%)
  1. *Excludes one generic product.
  2. **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.
  3. ***At least 7 days for artemisinin monotherapies, 6 doses of artemether/lumefantrine over 3 days, or 3 daily doses for artesunate + mefloquine.