NOVOMIX 50 FlexPen 3mL 50% soluble insulin aspart (rys) and 50% insulin aspart (rys) crystallised with protamine 300U/3mL injection syringe

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Viambatanisho vya kazi:

Insulin aspart, Quantity: 100 U/mL

Inapatikana kutoka:

Novo Nordisk Pharmaceuticals Pty Ltd

INN (Jina la Kimataifa):

Insulin aspart

Dawa fomu:

Injection, suspension

Tungo:

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

Njia ya uendeshaji:

Subcutaneous

Vitengo katika mfuko:

5 x 3 mL

Dawa ya aina:

(S4) Prescription Only Medicine

Matibabu dalili:

Treatment of diabetes mellitus.

Bidhaa muhtasari:

Visual Identification: A white, uniformly cloudy, homogeneous suspension marketed in 3mL cartridges closed with a red plunger.; Container Type: Syringe; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Idhini hali ya:

Registered

Idhini ya tarehe:

2007-05-10

Tabia za bidhaa

_NovoRapid_NovoMix_pi9 _
_ _
_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