NOVORAPID FLEXTOUCH insulin aspart (rys) 300U / 3mL injection multidose cartridge

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Insulin aspart, Quantity: 100 U/mL

Available from:

Novo Nordisk Pharmaceuticals Pty Ltd

INN (International Name):

Insulin aspart

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: glycerol; hydrochloric acid; water for injections; phenol; sodium chloride; sodium hydroxide; zinc chloride; dibasic sodium phosphate dihydrate; metacresol

Administration route:

Subcutaneous, Intravenous

Units in package:

5 x 3 mL Flex Touch

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of diabetes mellitus.

Product summary:

Visual Identification: Clear colourless solution; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 30 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2012-08-07

Summary of Product characteristics

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_Page 1 of 19 _
AUSTRALIAN PRODUCT INFORMATION
NOVORAPID
® (INSULIN ASPART)
NOVOMIX
® (SOLUBLE INSULIN ASPART/INSULIN ASPART CRYSTALISED WITH PROTAMINE)
1.
NAME OF THE MEDICINE
NovoRapid
®
(insulin aspart (rys)) 100 U/mL solution for injection 10mL Vial
NovoRapid
®
Penfill
®
(insulin aspart (rys)) 100 U/mL solution for inejction 3mL cartridge
NovoRapid
®
FlexPen
®
(insulin aspart (rys)) 100 U/mL solution for injection 3mL cartridge
NovoRapid
®
FlexTouch
®
(insulin aspart (rys)) 100 U/mL solution for inejction 3mL cartridge
NovoMix
®
30 Penfill
®
(30% soluble insulin aspart (rys) and 70% insulin aspart (rys)
crystallised with
protamine) 100 U/mL suspension for inejction 3mL cartridge
NovoMix
®
30 FlexPen
®
(30% soluble insulin aspart (rys) and 70% insulin aspart (rys)
crystallised with
protamine) 100 U/mL suspension for injection 3mL cartridge
NovoMix
®
50 FlexPen
®
(50% soluble insulin aspart (rys) and 50% insulin aspart (rys)
crystallised with
protamine)100 U/mL suspension for injection 3mL cartridge
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
3.
PHARMACEUTICAL FORM
NovoRapid is a sterile, clear, colourless, aqueous, neutral solution
of insulin aspart (B28 Asp) 100
U/mL. NovoRapid is a solution for injection.
NovoMix