From: A comparative evaluation of medicine package inserts for oral antidiabetic agents in Palestine
Local Companies | ||||||||
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No. | Criteria | A (n = 3) | B (n = 3) | C (n = 2) | D (n = 2) | Total scores of Local products n = 10 (%) | Total scores of Imported products n = 8 (%) | Total n = 18 (%) |
1. | Brand name | 3 | 3 | 2 | 2 | 10 (100.0) | 8 (100.0) | 18 (100.0) |
2. | Active ingredient | 3 | 3 | 2 | 2 | 10 (100.0) | 8 (100.0) | 18 (100.0) |
3. | Inactive ingredients (excipients) | 0 | 0 | 0 | 0 | 0 (0.0) | 8 (100.0) | 8 (44.4) |
4. | Therapeutic class | 2 | 3 | 1 | 2 | 8 (80.0) | 8 (100.0) | 16 (88.8) |
5. | Mechanism of action | 0 | 0 | 0 | 0 | 0 (0.0) | 3 (37.5) | 3 (16.6) |
6. | Indications | 2 | 3 | 2 | 2 | 9 (90.0) | 8 (100.0) | 17 (94.0) |
7. | Drug dose | 1 | 0 | 0 | 0 | 1 (10.0) | 6 (75.0) | 7 (38.8) |
8. | Duration of use | 0 | 0 | 0 | 0 | 0 (0.0) | 0 (0.0) | 0 (0.0) |
9. | Missing dose | 3 | 3 | 2 | 2 | 10 (100.0) | 8 (100.0) | 18 (100.0) |
10. | Maximum dose | 0 | 0 | 0 | 0 | 0 (0.0) | 5 (62.5) | 5 (27.7) |
11. | Directions for use | 3 | 3 | 2 | 2 | 10 (100.0) | 8 (100.0) | 18 (100.0) |
12. | Overdose and management | 3 | 3 | 2 | 2 | 10 (100.0) | 8 (100.0) | 18 (100.0) |
13. | Warning and precautions | 3 | 3 | 2 | 2 | 10 (100.0) | 8 (100.0) | 18 (100.0) |
14. | Effect on ability to drive and use machines | 0 | 0 | 0 | 2 | 2 (20.0) | 7 (87.5) | 9 (50.0) |
15. | Contraindications | 3 | 3 | 2 | 2 | 10 (100.0) | 8 (100.0) | 18 (100.0) |
16. | Adverse drug reactions | 3 | 3 | 2 | 2 | 10 (100.0) | 8 (100.0) | 18 (100.0) |
17. | Drug-drug interactions | 3 | 3 | 2 | 2 | 10 (100.0) | 8 (100.0) | 18 (100.0) |
18. | Drug-food interactions | 0 | 0 | 0 | 0 | 0 (0.0) | 8 (100.0) | 8 (44.4) |
19. | Pregnancy considerations | 3 | 3 | 2 | 2 | 10 (100.0) | 8 (100.0) | 18 (100.0) |
20. | Lactation considerations | 3 | 3 | 2 | 2 | 10 (100.0) | 8 (100.0) | 18 (100.0) |
21. | Pediatric considerations | 3 | 1 | 0 | 2 | 6 (60.0) | 8 (100.0) | 18 (100.0) |
22. | Geriatric considerations | 1 | 0 | 0 | 0 | 1 (10.0) | 0 (0.0) | 1 (5.6) |
23. | Possibility of tablet splitting | 0 | 1 | 0 | 1 | 2 (20.0) | 6 (75.0) | 8 (44.4) |
24. | Possibility of crushing and mixing with food or beverages | 0 | 1 | 0 | 1 | 4 (40.0) | 6 (75.0) | 10 (56.0) |
25. | Instructions to convert tablets or capsules into liquid forms | 0 | 0 | 0 | 0 | 0 (0.0) | 0 (0.0) | 0 (0.0) |
26. | Pharmacokinetic information | 0 | 0 | 0 | 0 | 0 (0.0) | 0 (0.0) | 0 (0.0) |
27. | Shelf life | 0 | 0 | 0 | 0 | 0 (0.0) | 0 (0.0) | 0 (0.0) |
28. | Storage | 3 | 3 | 2 | 2 | 10 (100.0) | 8 (100.0) | 18 (100.0) |
29. | Name and address of manufacturers/distributors | 3 | 3 | 2 | 2 | 10 (100.0) | 8 (100.0) | 18 (100.0) |
30. | Date of last revision | 0 | 0 | 0 | 0 | 0 (0.0) | 8 (100.0) | 8 (44.4) |
31. | References | 0 | 0 | 2 | 0 | 2 (20.0) | 0 (0.0) | 2 (11.1) |