NovoRapid
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Summary of Product characteristics
(SPC)
14-05-2024
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Active ingredient:
Insulin aspart
Available from:
Novo Nordisk Pharmaceuticals Pty Ltd
Class:
Medicine Registered
Summary of Product characteristics
Product Information
NovoRapid-NovoMix pi3a.doc
Page 1 of 17
PRODUCT INFORMATION
INSULIN ASPART
NOVORAPID
®
10ML VIAL
NOVORAPID
®
PENFILL
®
3ML
NOVORAPID
®
FLEXPEN
®
3ML
NOVOMIX
®
30
PENFILL
®
3ML
NOVOMIX
®
30
FLEXPEN
®
3ML
NAME OF THE MEDICINE
Insulin aspart
Insulin aspart (rys) has the empirical formula C
256
H
381
N
65
O
79
S
6
and a molecular weight of 5825.8.
CAS No.: 116094-23-6
DESCRIPTION
Insulin aspart is a rapid-acting analogue of human insulin that
rapidly lowers blood glucose. Insulin
aspart is homologous with human insulin with the exception of a
substitution of the amino acid proline
by aspartic acid at position 28 on the B-chain. The unique
structure of insulin aspart increases the rate
of absorption from a subcutaneous injection site, giving a faster
onset of action, an earlier peak effect
and a shorter duration of action than soluble human insulin.
Insulin aspart should be given immediately
before a meal or, when necessary, after the start of a meal.
Insulin aspart is produced by recombinant
DNA technology using _Saccharomyces cerevisiae_. One unit
of insulin aspart corresponds to 6 nmol, 0.035 mg salt-free
anhydrous insulin aspart.
NovoRapid
®
is a sterile, clear, colourless, aqueous, neutral solution of
insulin aspart (B28 Asp) 100
U/mL. NovoRapid is a solution for injection.
Product Information
NovoRapid-NovoMix pi3a.doc
Page 2 of 17
NovoRapid also contains the following
inactive ingredients: glycerol, phenol, meta-cresol, zinc
chloride, dibasic sodium phosphate dihydrate, sodium chloride,
sodium hydroxide, hydrochloric acid
and water for injections.
NovoMix
®
30 is a white suspension for subcutaneous injection consisting of
30% soluble insulin aspart
and 70% protamine-crystallised insulin aspart. This is a biphasic
insulin preparation (NovoMix 30)
which produces insulin pl
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