INFORMATION FOR HEALTH PROFESSIONALS
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Insulin human injection (rbe) 100 IU/mL.
HUMULIN R (Regular)
(also called soluble insulin injection) is a sterile, clear colourless
aqueous solution of human insulin (rbe) adjusted to a pH range of 7.0 to 7.8.
HUMULIN R is a short-acting insulin preparation.
HUMULIN NPH
(also called isophane insulin injection) is a sterile suspension of a white,
crystalline precipitate of isophane human insulin (rbe) in an isotonic phosphate
buffer adjusted to a pH range of 6.9 to 7.5. HUMULIN N is an intermediate-acting
insulin preparation.
HUMULIN 30/70
(also called biphasic isophane insulin injection) is a mixture of human
insulin (70% isophane human insulin (rbe), 30% soluble human insulin (rbe))
adjusted to a pH range of 6.9 to 7.5. HUMULIN Mixture 70/30 is an intermediate
acting insulin preparation.
insulin, human.
The primary activity of human insulin is the regulation of glucose metabolism. In addition, insulin has several anabolic and anti-catabolic actions on many tissues in the body. In muscle and other tissues (except the brain), insulin causes rapid transport of glucose and amino acids intracellularly, promotes anabolism, and inhibits protein catabolism. In the liver, insulin promotes the uptake and storage of glucose in the form of glycogen, inhibits gluconeogenesis, and promotes the conversion of excess glucose into fat.
The typical activity profile (glucose utilisation curves) are 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.
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. Individual variation of blood glucose response profiles are dependent upon factors such as the size of dose, site of injection and physical activity of the patient.
HUMULIN is indicated for the treatment of insulin-requiring diabetes mellitus.
The dosage should be determined by the physician, according to the
requirement of the patient.
HUMULIN R should be given by subcutaneous injection. It may also be administered
intravenously.
HUMULIN NPH and HUMULIN 30/70should be given by subcutaneous 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 preparation 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 NPH and HUMULIN L may be administered in combination with HUMULIN R.
(Instructions for use - Mixing of insulins).
HUMULIN 30/70 formulation is a ready-made defined mixture of HUMULIN R and
HUMULIN NPH insulin designed to avoid the need for the patient to mix insulin
preparations. A patient's treatment regimen should be based on their individual
metabolic requirements.
Vials and cartridges containing HUMULIN R do not require re-suspension. HUMULIN R is a clear and colourless liquid with a water-like appearance and consistency. Do not use HUMULIN R if it appears cloudy, thickened, slightly coloured, or if solid particles are visible.
Carefully shake or rotate the insulin bottle several times to completely mix
the insulin. Insulin should look uniformly cloudy or milky after mixing. If not,
repeat the above step until contents are mixed.
Vials of insulin should be examined frequently.
Do not use if the insulin substance (the white material) remains at the bottom
of the vial after mixing.
Do not use if there are clumps in the insulin after mixing.
Do not use if solid white particles stick to the bottom or wall of the vial,
giving a frosted appearance.
Roll the cartridge between the palms 10 times. Holding the cartridge by one
end, invert it 180° slowly 10 times to allow the glass bead to travel the full
length of the cartridge with each inversion. Insulin should look uniformly
cloudy or milky after mixing. If not, repeat the above steps until the contents
are mixed.
Cartridges of insulin should be examined frequently.
Do not use if the insulin substance (the white material) remains visibly
separated from the liquid after mixing.
Do not use if there are clumps in the insulin after mixing.
Do not use if solid white particles stick to the bottom or wall of the
cartridge, giving a frosted appearance.
Insulin cartridges are not designed to allow any other insulin to be mixed in
the cartridge.
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 R and
HUMULIN NPH, can be used for administration of the correct amount of each
formulation.
To administer insulin, use an insulin syringe marked for the strength of insulin being administered.
To load the cartridge into the device and to attach the needle prior to administration of the insulin, refer to the manufacturer's instruction for the insulin delivery device. For instructions on how to administer insulin, refer to the manufacturer's instruction for the insulin delivery device.
Hypoglycaemia.
Hypersensitivity to HUMULIN or to the formulation excipients (unless used as
part of a desensitisation program).
Under no circumstances should any HUMULIN formulation other than HUMULIN R be
given intravenously.
Transferring a patient to another type or brand of insulin should be done
under strict medical supervision. Changes in strength, brand (manufacturer),
type (Regular, NPH, etc.), species (animal, human, human insulin analogue),
and/or method of manufacture (recombinant DNA versus animal-source insulin) may
result in the need for a change in dosage.
Some patients taking human insulin may require a change in dosage from that used
with animal-source insulins. If an adjustment is needed, it may occur with the
first dose or during the first several weeks or months.
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, e.g. 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 blockers. Uncorrected
hypoglycaemic and hyperglycaemic reactions can cause loss of consciousness, coma
or death.
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.
Human insulin is produced by recombinant technology. No serious events have been reported in subchronic toxicology studies. Human insulin was not mutagenic in a battery of in vitro and in vivo genetic toxicity assays.
It is essential to maintain good control of the insulin treated
(insulin-dependent or gestational diabetes) patient throughout pregnancy.
Insulin requirements usually fall during the first trimester and increase during
the second and third trimesters. Patients with diabetes should be advised to
inform their doctors if they are pregnant or are contemplating pregnancy.
Diabetic patients who are lactating may require adjustments in insulin dose
and/or diet.
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 (e.g. 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.
Local allergy in patients may occur as redness, swelling, or itching at the
site of injection. These minor reactions usually resolve in a few days to a few
weeks. In some instances, these reactions may be related to factors other than
insulin, such as irritants in the skin cleansing agent or poor injection
technique.
Systemic allergy to insulin is less common but potentially more serious.
Generalised allergy to insulin may cause rash over the whole body, shortness of
breath, wheezing, reduction in blood pressure, rapid pulse or sweating. Severe
cases of generalised allergic reaction may be life-threatening.
Lipodystrophy
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.
The patient should check with their physician when using other medicines in
addition to HUMULIN.
Insulin requirements may be decreased in the presence of medicines with
hypoglycaemic activity e.g. anabolic steroids, guanethidine, propranolol
(masking effect), oral antidiabetic agents, alcohol, sulpha-antibiotics, (e.g.
sulphonamides), octreotide, certain antidepressants (monoamine oxidase
inhibitors), angiotension converting enzyme inhibitors (captopril and
enalapril), angiotensin II receptor blockers and beta-adrenergic blockers, or
salicylates.
Insulin requirements may be increased by medicines with hyperglycaemic activity,
e.g. oral contraceptives, isoniazid, corticosteroids or thyroid hormone
replacement therapy.
Overdose causes hypoglycaemia with accompanying symptoms that may include listlessness, confusion, palpitations, sweating, vomiting and headache. Hypoglycaemia may occur as a result of an excess of human insulin relative to food intake, energy expenditure or both. Mild episodes of hypoglycaemia usually can be treated with oral glucose. Adjustments in medicine dosage, meal patterns, or exercise may be needed. More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular or subcutaneous administration of glucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur after apparent clinical recovery.
HUMULIN preparations should be stored in a refrigerator between 2° and 8° C. HUMULIN preparations should not be frozen or exposed to excessive heat or sunlight.
The shelf life for HUMULIN R, HUMULIN NPH and HUMULIN 30/70 is two years when stored under appropriate conditions.
When in use, all HUMULIN 10 mL vials may be kept at room temperature (30° C)
for up to 28 days.
When in use, all 3 mL cartridges may be kept at room temperature (30° C) for up
to 28 days.
The effects of mixing human insulin with insulins of animal source or human insulin produced by other manufacturers have not been studied.
Prescription Medicine
Vials 10 mL: HUMULIN R, NPH and HUMULIN 30/70are available individually.
Cartridges 3.0 mL: HUMULIN R, NPH and HUMULIN 30/70 are available in packs of
five.
Each vial or cartridge will contain human insulin (recombinant DNA origin)
and the following excipients:
m-cresol distilled 2.5 mg/mL,
glycerol,
water for injections.
Hydrochloric acid and/or sodium hydroxide may have been used during manufacture.
Each vial or cartridge will contain human insulin (recombinant DNA origin)
and the following excipients:
m-cresol distilled 1.6 mg/mL,
glycerol,
phenol 0.65 mg/mL,
protamine sulphate,
dibasic sodium phosphate,
zinc oxide,
water for injections.
Hydrochloric acid and/or sodium hydroxide may have been used during manufacture.
Eli Lilly and Company (NZ) Limited
Level 3, Axon House
414-422 Khyber Pass Road, Newmarket
PO Box 109 197, Newmarket
Auckland
NEW ZEALAND
Telephone (09) 523 9300
26th of September 2006