Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, U.K.
The treatment of insulin dependent diabetes mellitus.
May be used for diabetics requiring a depot insulin of medium duration. Where a more rapid, intense onset is desirable it may be mixed with Hypurin Neutral.
Usually administered subcutaneously but where necessary it may be given intramuscularly in which case onset is more rapid and overall duration shorter. It should not be given intravenously. Onset of action occurs within 2 hours after subcutaneous injection with an overall duration of 18-24 hours. Maximum effect is exerted between 6-12 hours.
Injection sites should always be rotated within the same region in order to reduce the risk of lipodystrophy and cutaneous amyloidosis (see section 4.4 and 4.8).
Overdosage causes hypoglycaemia. Symptoms include yawning, hunger, pallor, restlessness, weakness, sweating, trembling, confusion, anxiety, nervousness, excitement, irritability, aggression, altered behaviour, deep respiration, cramps, headache, paraesthesia and/or numbness of the nose, mouth, fingers or toes, reduced consciousness, visual disturbance, including blurred vision and double vision, slurred speech, difficulty in finding words, difficulty in concentration, drowsiness, fatigue, convulsions, hemiplegia, paralysis, tachycardia and/or palpitations, myocardial ischaemia and cerebral oedema which, if untreated, will lead to collapse, coma and/or irreversible brain damage.
Hypokalaemia may also occur with insulin overdose.
Mild hypoglycaemia will respond to oral administration of glucose or sugar and rest.
Moderately severe hypoglycaemia can be treated by intramuscular, intravenous or subcutaneous injection of glucagon followed by oral carbohydrate when the patient is sufficiently recovered.
For patients who are comatose or who have failed to respond to glucagon injection an intravenous injection of strong Dextrose Injection BP should be given.
36 months.
Following injection of the first dose the product should be used within 28 days. Discard any unused material after this time.
Store at 2°C-8°C.
Do not freeze.
Chemical and physical in-use stability has been demonstrated for 28 days at 25°C.
From a microbiological point of view the opening carries a risk of microbial contamination and aseptic handling is a necessity.
In use storage times and conditions are the responsibility of the user.
10ml neutral glass vial sealed with a rubber bung and metal closure.
Prior to use the vial of Hypurin Porcine Isophane should be rolled gently between the palms or inverted several times.
The vial must not be used if the contents have been frozen or it contains lumps that do not disperse on mixing.
Hypurin Porcine Isophane may be mixed with Hypurin Porcine Neutral in the syringe, in which case Hypurin Porcine Neutral should be the first dose to be withdrawn. The injection should then be made immediately upon withdrawal of the contents.
The use of each vial should be restricted to a single patient.
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