Table 1 Classification of excipients to which studied neonates were exposed according to available safety data †
From: Hospitalised neonates in Estonia commonly receive potentially harmful excipients
Category | Safety status | Description | No of excipients identified |
|---|---|---|---|
1 | Potentially safe | No adverse reactions reported | 42 |
2 | Potentially harmful and known to be harmful | Adverse reactions reported | 47 |
3 | No safety data found | No data found in the literature on human exposure and toxicity | 19 |
4 | Description of the excipient in SPC or PIL unspecific | Description does not allow a specific literature search | 15 |
Total | 123 |