Actrapid Penfill
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Patient Information leaflet
(PIL)
18-01-2021
Summary of Product characteristics
(SPC)
24-11-2020
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:
Cartridge, 3.0mL, 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: Cartridge, 3.0mL - 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:
1985-04-15
Patient Information leaflet
Page 1 of 6
NEW ZEALAND CONSUMER MEDICINE INFORMATION
ACTRAPID
® PENFILL
® 100 IU/ML SOLUTION FOR INJECTION IN CARTRIDGE
Insulin human (rDNA)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING YOUR INSULIN
–
Keep this leaflet. You may need to read it again.
–
If you have any further questions, ask your doctor, nurse or your
pharmacist.
–
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
–
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor, nurse or your pharmacist.
1. WHAT ACTRAPID
® IS AND WHAT IT IS USED FOR
ACTRAPID
® IS HUMAN INSULIN USED TO TREAT DIABETES.
Diabetes mellitus is a disease where your body
does not produce enough insulin to control the level of your blood
sugar. Actrapid
®
is a fast-acting
insulin. This means that it will start to lower your blood sugar about
½ hour after you take it, and the
effect will last for approximately 8 hours. Actrapid
®
is often given in combination with longer-acting
insulin products.
2. BEFORE YOU USE ACTRAPID
®
DO NOT USE ACTRAPID
®
►
IN INSULIN INFUSION PUMPS.
►
IF YOU ARE ALLERGIC (HYPERSENSITIVE)
to human insulin or any of the other ingredients in
Actrapid
®
(see 7 FURTHER INFORMATION).
►
IF YOU SUSPECT HYPOGLYCAEMIA
(low blood sugar) is starting (see 4. WHAT TO DO IN AN
EMERGENCY).
►
IF THE CARTRIDGE OR THE DEVICE CONTAINING CARTRIDGE IS DROPPED,
DAMAGED OR CRUSHED
.
►
IF IT HAS NOT BEEN STORED CORRECTLY
or been frozen (see 6.HOW TO STORE ACTRAPID
®
).
►
IF THE INSULIN DOES NOT APPEAR CLEAR AND COLOURLESS.
BEFORE USING ACTRAPID
®
►
CHECK THE LABEL TO MAKE SURE
it is the right type of insulin.
►
ALWAYS CHECK
the cartridge, including the rubber stopper. Do not use it if any
damage is seen or
if there is a gap between the rubber stopper and the white label band.
Take it back to your
supplier. See your delivery system manual for further instructions.
►
ALWAYS USE
Read the complete document
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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