Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Eli Lilly and Company Limited, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL
For the treatment of patients with diabetes mellitus who require insulin for the maintenance of glucose homeostasis.
The dosage should be determined by the physician, according to the requirement of the patient.
No data are available.
Humulin I should be given by subcutaneous injection but may, although not recommended, also be given by intramuscular injection. This formulation should not be administered intravenously.
Subcutaneous administration should be in the upper arms, thighs, buttocks or abdomen. Use of injection sites should be rotated so that the same site is not used more than approximately once a month.
Care should be taken when injecting any Humulin insulin preparations to ensure that a blood vessel has not been entered. After any insulin injection, the injection site should not be massaged. Patients must be educated to use proper injection techniques.
Humulin I (Isophane) may be administered in combination with Humulin S (Soluble). (See Instructions for use and handling for Mixing of Insulins).
Each pack contains a patient information leaflet with instructions on how to inject insulin.
Insulin has no specific overdose definitions, because serum glucose concentrations are a result of complex interactions between insulin levels, glucose availability and other metabolic processes. Hypoglycaemia may occur as a result of an excess of insulin relative to food intake and energy expenditure.
Hypoglycaemia may be associated with listlessness, confusion, palpitations, headache, sweating and vomiting.
Mild hypoglycaemic episodes will respond to oral administration of glucose or sugar products.
Correction of moderately severe hypoglycaemia can be accomplished by intramuscular or subcutaneous administration of glucagon, followed by oral carbohydrate when the patient recovers sufficiently. Patients who fail to respond to glucagon must be given glucose solution intravenously.
If the patient is comatose, glucagon should be administered intramuscularly or subcutaneously. However, glucose solution must be given intravenously, if glucagon is not available or if the patient fails to respond to glucagon. The patient should be given a meal as soon as consciousness is recovered.
Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may occur after apparent clinical recovery.
Unopened vials: 3 years.
After first use: 28 days.
Do not freeze. Do not expose to excessive heat or direct sunlight.
Unopened vials: Store in a refrigerator (2°C-8°C).
After first use: Store below 30°C.
10 ml of suspension in a vial (type I glass) with a stopper (rubber) sealed with a seal (aluminium) combined with a flip top (plastic). Pack size 1 or 2 or 5 (5 × 1). Not all pack sizes may be marketed.
Do not reuse needles. Dispose of the needle in a responsible manner. Needles must not be shared. Vials can be used until empty, then properly discard. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
A suspension for injection in a 10ml vial to be used in conjunction with an appropriate syringe (100 IU/ml markings).
a) Preparing a dose
Vials containing Humulin I formulation should be rotated several times in the palms of the hands before use to completely resuspend the insulin, until it appears uniformly cloudy or milky. If not, repeat the above procedure until contents are mixed.
Do not shake vigorously as this may cause frothing, which may interfere with the correct measurement of the dose.
The vials should be examined frequently and should not be used if clumps of material are present or if solid white particles stick to the bottom or wall of the vial, giving a frosted appearance.
Mixing of insulins: The shorter acting insulin should be drawn into the syringe first, to prevent contamination of the vial by the longer acting preparation. It is advisable to inject directly after mixing. However, if a delay is necessary, a consistent routine must be followed.
Alternatively a separate syringe or, separate cartridges of Humulin S and I, can be used for administration of the correct amount of each formulation.
Prepare your syringe prior to injection, as directed by your doctor or diabetes specialist nurse. Use an insulin syringe marked for the strength of insulin being administered.
b) Injecting a dose
Inject the correct dose of insulin, as directed by your doctor or diabetes specialist nurse. Use of the injection sites should be rotated so that the same is not used more than approximately once a month.
Each pack contains a patient information leaflet with instructions on how to inject insulin.
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