SYNTHAMIN 17 Amino acid 10% with Electrolytes 500mL injection bottle AHA6921, Baxter Healthcare Pty Ltd , CON-691
Product name
SYNTHAMIN 17 Amino acid 10% with Electrolytes 500mL injection bottle AHA6921
Sponsor name
Baxter Healthcare Pty Ltd
Consent start
Consent no.
CON-691
Standard
Paragraph 9(3)(a), 9(3)(b) and 10(2)(c) of Therapeutic Goods Order No. 91 '“ Standard for labels of prescription and related medicines.
Non-compliance with standard
Name of the medicine and name and quantities of each active ingredient are
separated by text'“ 9(3)(a). The names and quantities of each active ingredient
are not placed on separate lines underneath the name of the medicine '“ 9(3)(b).
The name of the dosage form is not completely described and should be 'injection
solution for intravenous infusion' '“ 10(2)(c).
Therapeutic product type
Prescription medicines