Actrapid Innolet
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Summary of Product characteristics
(SPC)
04-01-2021
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Active ingredient:
Neutral insulin, human, pyr 100 IU/mL;
Available from:
Novo Nordisk Pharmaceuticals Ltd
INN (International Name):
Neutral insulin, human, pyr 100 IU/mL
Dosage:
100 IU/mL
Pharmaceutical form:
Solution for injection
Composition:
Active: Neutral insulin, human, pyr 100 IU/mL Excipient: Glycerol Hydrochloric acid Metacresol Sodium hydroxide Water for injection Zinc
Units in package:
Syringe, 3mL glass cartridge, 5 dose units
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Novo Nordisk A/S
Therapeutic indications:
Treatment of diabetes mellitus. Furthermore indicated for the initial stabilisation of diabetes, during treatment of diabetic ketoacidosis and the hyperosmolar non ketotic syndrome, and during stress situations such as severe infections and major surgery in diabetic patients.
Product summary:
Package - Contents - Shelf Life: Syringe, 3mL glass cartridge - 5 dose units - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 6 weeks opened stored at or below 25°C
Authorization date:
2002-02-26
Summary of Product characteristics
1
NEW ZEALAND DATASHEET
1 PRODUCT NAME
ACTRAPID
®
100 IU/ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Insulin
human,
rDNA
(produced
by
recombinant
DNA
technology
in
_Saccharomyces _
_cerevisiae_).
Neutral insulin 100 IU/ml
3 PHARMACEUTICAL FORM
ACTRAPID is a clear colourless solution containing 100% neutral human
insulin. It is
available in 3 ml Penfill
®
cartridges made of glass, with a plunger (bromobutyl) and a stopper
(bromobutyl/polyisoprene)
in
a
carton,
or
in
10
ml
glass
vials
closed
with
a
disc
(bromobutyl/polyisoprene rubber) and a protective tamper-proof plastic
cap in a carton. One
IU (International Unit) corresponds to 0.035 mg of anhydrous human
insulin.
The Penfill cartridges are designed to be used with Novo Nordisk
insulin delivery systems.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Treatment of diabetes mellitus. Furthermore, indicated for the initial
stabilisation of diabetes,
during treatment of diabetic ketoacidosis and the hyperosmolar non
ketotic syndrome, and
during stress situations such as severe infections and major surgery
in diabetic patients.
4.2 Dose and method of administration
ACTRAPID is a-short-acting insulin and is often used in combination
with intermediate- or
long acting insulins.
Dosage is individual and determined by the physician in accordance
with the needs of the
patient.
The individual insulin requirement is usually between 0.5 and 1.0
IU/kg/day. The daily insulin
requirement may be higher in patients with insulin resistance (e.g.
during puberty in the
young or due to obesity) and lower in patients with residual,
endogenous insulin production.
In patients with diabetes mellitus optimised glycaemic control delays
the onset of late
diabetic complications. Close blood glucose monitoring is recommended.
An injection should be followed by a meal or snack containing
carbohydrates within 30
minutes. _ _
Concomitant illness, especially infections and feverish conditions,
usually increases the
patient’s insulin requirement. Concomitant diseases in the kidney,
liver
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