1. Name Of The Medicinal Product
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2. Qualitative And Quantitative Composition
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For excipients, see 6.1.
3. Pharmaceutical Form
A solution or suspension for injection in a prefilled/disposable pen injector containing a 3ml cartridge. HumaJect delivers up to 96 units per dose in increments of 2 units.
Humulin Soluble is a sterile, clear, colourless, aqueous solution of human insulin adjusted to a pH range of 7.0 to 7.8.
Humulin Soluble is a rapidly acting insulin preparation.
Humulin Mixture 3 is a sterile suspension of human insulin in the proportion of 30% soluble insulin to 70% isophane insulin, adjusted to a pH range of 6.9 to 7.5.
Humulin Mixture 3 is an intermediate acting insulin preparation.
4. Clinical Particulars
4.1 Therapeutic Indications
For the treatment of patients with diabetes mellitus who require insulin for the maintenance of glucose homeostasis. Humulin is also indicated for the initial control of diabetes mellitus and diabetes mellitus in pregnancy.
4.2 Posology And Method Of Administration
The dosage should be determined by the physician, according to the requirement of the patient.
Humulin Soluble should be given by subcutaneous injection but may, although not recommended, also be given by intramuscular injection. It may also be administered intravenously.
Humulin Isophane, Mixtures, Lente and Zinc in vials and Humulin Isophane and Mixtures in cartridge presentations should be given by subcutaneous injection but may, although not recommended, also be given by intramuscular injection. These formulations 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 Isophane, Humulin Lente and Humulin Zinc may be administered in combination with Humulin Soluble. (See section 6.6 – 'Instructions for use/handling'.)
Humulin Mixture 3 formulation is a ready
4.3 Contraindications
Hypoglycaemia.
Hypersensitivity to Humulin or to the formulation excipients, unless used as part of a desensitisation programme.
Under no circumstances should any Humulin formulation, other than Humulin Soluble in vials, be given intravenously.
4.4 Special Warnings And Precautions For Use
Transferring a patient to another type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), type (soluble, isophane, lente, etc.), species (animal, human, human insulin analogue) and/or method of manufacture (recombinant DNA versus animal
Some patients taking human insulin may require a change in dosage from that used with animal
A few patients who experienced hypoglycaemic reactions after transfer to human insulin have reported that the early warning symptoms were less pronounced or different from those experienced with their previous animal insulin. Patients whose blood glucose is greatly improved, eg, by intensified insulin therapy, may lose some or all of the warning symptoms of hypoglycaemia and should be advised accordingly. Other conditions which may make the early warning symptoms of hypoglycaemia different or less pronounced include long duration of diabetes, diabetic nerve disease, or medications such as beta
The use of dosages which are inadequate, or discontinuation of treatment, especially in insulin
Treatment with human insulin may cause formation of antibodies, but titres of antibodies are lower than those to purified animal insulin.
Insulin requirements may change significantly in diseases of the adrenal, pituitary or thyroid glands and in the presence of renal or hepatic impairment.
Insulin requirements may be increased during illness or emotional disturbances.
Adjustment of insulin dosage may also be necessary if patients change their level of physical activity or change their usual diet.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
The physician should be consulted when using other medications in addition to human insulin.
Insulin requirements may be increased by substances with hyperglycaemic activity, such as oral contraceptives, corticosteroids, or thyroid replacement therapy, danazol, beta-2 stimulants (such as ritodrine, salbutamol, terbutaline).
Insulin requirements may be reduced in the presence of substances with hypoglycaemic activity, such as oral hypoglycaemics, salicylates (for example, acetylsalicylic acid), sulpha antibiotics, certain antidepressants (monoamine oxidase inhibitors), certain angiotensin converting enzyme inhibitors (captopril, enalapril), beta-blockers, octreotide, or alcohol.
4.6 Pregnancy And Lactation
It is essential to maintain good control of the insulin treated (insulin
Careful monitoring of glucose control, as well as general health, is essential in pregnant patients with diabetes.
Diabetic patients who are lactating may require adjustments in insulin dose and/or diet.
4.7 Effects On Ability To Drive And Use Machines
The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia. This may constitute a risk in situations where these abilities are of special importance (eg, driving a car or operating machinery).
Patients should be advised to take precautions to avoid hypoglycaemia whilst driving, this is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia. The advisability of driving should be considered in these circumstances.
4.8 Undesirable Effects
Hypoglycaemia is the most frequent undesirable effect of insulin therapy that a patient with diabetes may suffer. Severe hypoglycaemia may lead to loss of consciousness, and in extreme cases, death.
Local allergy in patients occurs as redness, swelling, and itching at the site of insulin injection. This condition usually resolves in a few days to a few weeks. In some instances, this condition may be related to factors other than insulin, such as irritants in the skin cleansing agent or poor injection technique.
Systemic allergy, less common but potentially more serious, is a generalised allergy to insulin. It may cause rash over the whole body, shortness of breath, wheezing, reduction in blood pressure, fast pulse, or sweating. Severe cases of generalised allergy may be life
Lipodystrophy may occur at the injection site.
4.9 Overdose
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.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmaco-therapeutic group:
Humulin Soluble: A10A B01
Humulin Mixtures: A10A D01
The prime activity of insulin is the regulation of glucose metabolism.
In addition, insulin has several anabolic and anti
The typical activity profile (glucose utilisation curve) following subcutaneous injection is illustrated below by the heavy line. Variations that a patient may experience in timing and/or intensity of insulin activity are illustrated by the shaded area. Individual variability will depend on factors such as size of dose, site of injection, temperature and physical activity of the patient.
5.2 Pharmacokinetic Properties
The pharmacokinetics of insulin do not reflect the metabolic action of that hormone. Therefore, it is more appropriate to examine glucose utilisation curves (as discussed above) when considering the activity of insulin.
5.3 Preclinical Safety Data
Humulin is human insulin produced by recombinant technology. No serious events have been reported in subin vitro and in vivo genetic toxicity assays.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Each prefilled pen will contain human insulin (recombinant DNA origin) and the following excipients:
HumaJect S preparation:
m-cresol distilled, 2.5mg/ml (preservative)
Glycerol (tonicity modifier)
Water for injections (solvent)
The following may be used:
Hydrochloric acid (pH adjustment) and/or
Sodium hydroxide (pH adjustment)
HumaJect M3 preparation:
m-cresol distilled, 1.6mg/ml (preservative)
Glycerol (tonicity modifier)
Phenol 0.65mg/ml (preservative)
Protamine sulphate (complexes with insulin to prolong its action)
Dibasic sodium phosphate (buffer)
Zinc oxide (adjust zinc content)
Water for injections (solvent)
The following may be used:
Hydrochloric acid (pH adjustment) and/or
Sodium hydroxide (pH adjustment).
6.2 Incompatibilities
The effects of mixing human insulin with insulins of animal source or human insulin produced by other manufacturers have not been studied.
6.3 Shelf Life
Two years.
The in
6.4 Special Precautions For Storage
Store at 2°C
Do not freeze. Do not expose to excessive heat or direct sunlight.
Keep the container in the outer carton.
Once in use, HumaJect may be used for up to 28 days. Do not use beyond this period.
When in use, HumaJect should not be stored above 30°C.
6.5 Nature And Contents Of Container
The product is filled in cartridges that comply with the requirements of the Ph. Eur. for Type I flint glass, and sealed with rubber closures consisting of a plunger head at the bottom and a disk seal at the top of the cartridge.
5 X 3ml pens.
6.6 Special Precautions For Disposal And Other Handling
a) Preparing a dose
HumaJect containing Humulin Soluble does not require resuspension and should only be used if it is clear, colourless, with no solid particles visible and if it is of water
HumaJect containing Humulin Mixture formulation should be rolled in the palms of the hands ten times and inverted 180° ten times immediately before use to resuspend the insulin until it appears uniformly cloudy or milky. If not, repeat the above procedure until contents are mixed. Cartridges contain a small glass bead to assist mixing. Do not shake vigorously as this may cause frothing, which may interfere with the correct measurement of the dose.
The cartridges of Humulin Mixture formulation 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 cartridge, giving a frosted appearance.
The cartridges are not designed to allow any other insulin to be mixed in the cartridge. Cartridges are not designed to be refilled.
Follow the instructions with HumaJect for attaching the needle and administering the insulin injection.
For HumaJect, a needle must always be attached before priming, dialling and injecting an insulin dose. HumaJect should always be primed before each injection. Failure to prime HumaJect may result in an inaccurate dose.
b) Injecting a dose
Inject the correct dose of insulin, as directed by your doctor or diabetic 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.
c) Disposal of used containers and needles
Do not reuse needles. Dispose of the needle in a responsible manner. Needles and pens must not be shared. HumaJect can be used until empty, then properly discard.
7. Marketing Authorisation Holder
Eli Lilly and Company Limited
Kingsclere Road
Basingstoke
Hampshire
RG21 6XA
8. Marketing Authorisation Number(S)
HumaJect S pen: PL 0006/0305
HumaJect M3 pen: PL 0006/0309
9. Date Of First Authorisation/Renewal Of The Authorisation
8 March 1995
10. Date Of Revision Of The Text
13 March 2000
LEGAL CATEGORY
POM
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