NovoRapid FlexTouch

Country: Nýja-Sjáland

Tungumál: enska

Heimild: Medsafe (Medicines Safety Authority)

Virkt innihaldsefni:

Insulin aspart 100 U/mL;  

Fáanlegur frá:

Novo Nordisk Pharmaceuticals Ltd

INN (Alþjóðlegt nafn):

Insulin aspart 100 U/mL

Skammtar:

100 U/mL

Lyfjaform:

Solution for injection

Samsetning:

Active: Insulin aspart 100 U/mL   Excipient: Dibasic sodium phosphate dihydrate Glycerol Hydrochloric acid Metacresol Phenol Sodium chloride Sodium hydroxide Water for injection Zinc

Gerð lyfseðils:

Prescription

Framleitt af:

Novo Nordisk A/S

Ábendingar:

Treatment of diabetes mellitus

Vörulýsing:

Package - Contents - Shelf Life: Cartridge, glass, 3ml with bromobutyl rubber piston and bromobutyl/polyisoprene disc closure in FlexTouch injector - 1 dose units - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 1 months opened stored at or below 30°C protect from light 28 days opened stored at 2° to 8°C (Refrigerate, do not freeze) - Cartridge, glass, 3ml with bromobutyl rubber piston and bromobutyl/polyisoprene disc closure in FlexTouch injector - 5 dose units - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 1 months opened stored at or below 30°C protect from light 28 days opened stored at 2° to 8°C (Refrigerate, do not freeze) - Cartridge, glass, 3ml with bromobutyl rubber piston and bromobutyl/polyisoprene disc closure in FlexTouch injector - 10 dose units - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 1 months opened stored at or below 30°C protect from light 28 days opened stored at 2° to 8°C (Refrigerate, do not freeze)

Leyfisdagur:

2012-10-02

Vara einkenni

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NEW ZEALAND DATASHEET
1 PRODUCT NAME
NovoRapid
®
10ml Vial
NovoRapid
®
Penfill
®
3ml
NovoRapid
®
FlexPen
®
3ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Insulin Aspart 100 Units/ml
Recombinant DNA origin: _Saccharomyces cerevisiae_
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.
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.
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.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Treatment of diabetes mellitus.
4.2 Dose and method of administration
NovoRapid has a faster onset and a shorter duration of action than
soluble human insulin. Due
to the faster onset of action, NovoRapid should generally be given
immediately before a meal
or when necessary, soon after the start of a meal.
The dosage of insulin aspart is determined by the physician according
to the patient’s individual
needs. The individual insulin requirement is usually between 0.5 and
1.0 Units/kg/day in adults
and children. In a meal-related treatment 50-70% of this requirement
may be provided by
NovoRapid and the remainder provided by an intermediate-acting or
long-acting insulin given
at least once a day.
The daily insulin requirement may be higher in patients with insulin
resistance (e.g. due to
obesity), and low