Actrapid

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

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:

Vial, 10 mL

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: Vial, - 10 mL - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

1983-06-09

Patient Information leaflet

Actrapid Vial PIL 5.docx
Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE USER
ACTRAPID
® 100 IU/ML SOLUTION FOR INJECTION IN VIAL
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 PROTECTIVE CAP IS LOOSE OR MISSING.
Each vial has a protective, tamper-proof plastic cap.
If it is not in perfect condition when you get the vial, return the
vial to your supplier.
►
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.
►
REMOVE THE PROTECTIVE CAP.
TAKE SPECIAL CARE WITH ACTRAPID
®
►
IF YOU HAVE TROUBLE
with your kidneys or liver, or with your adrenal, pituitary or thyroid
g

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