[The microbial count of insulin multiple-dose containers].
In accordance with the Pharmacopoeia of the GDR, from multiple-dose containers containing injection preparations with preservatives added such preparations may be repeatedly withdrawn up to 72 h after opening these containers. Exempted from this limitation are multiple-dose containers containing insulin injection preparations repeatedly used by diabetics for self-injections. Microbiological tests were to contribute to clearing the question whether the period of using these insulin multiple-dose containers can be provided to be maximally 30 d after first use.
Thonke
M
M
Institut für Arzneimittelwesen der DDR, Berlin.
Hildebrandt
R
R
Dressel
H
H
D015169:Colony Count, Microbial; D004340:Drug Contamination; D004349:Drug Packaging; D006801:Humans; D007328:Insulin / Q000008:administration & dosage; D011310:Preservatives, Pharmaceutical
D007328:Insulin; D011310:Preservatives, Pharmaceutical
Uber den Keimgehalt angebrochener Insulin-Mehrdosenbehälter.