Skip to main content

Advertisement

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
  1. SPC- summary of product characteristics.
  2. PIL - package insert leaflet.
  3. Based on data from Refs [8, 1821], and PubMed searches.