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Biphasic isophane insulin injection 100 IU/ml |
Novo Nordisk |
MIXTARD 30 MC is a cloudy or milky suspension containing 30% neutral monocomponent pork insulin and 70% isophane monocomponent pork insulin in 10 ml glass vials. One IU (International Unit) corresponds to 0.035 mg (6.0 nmoles) of porcine insulin.
ATC code A10A D03
The blood glucose lowering effect of insulin is due to the facilitated uptake of glucose following binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver.
Insulin in the blood stream has a half-life of a few minutes. Consequently, the time-action profile of an insulin preparation is determined solely by its absorption characteristics. This process is influenced by several factors (e.g. insulin dosage, injection route and site), which is why considerable intra- and inter-patient variations are seen.
An average action profile after subcutaneous injection indicates:
Onset: within 1/2 hour
Maximum: between 2 and 8 hours
Duration: up to 24 hours
Treatment of diabetes mellitus.
Dosage is individual and determined by the physician in accordance with the needs of the patient.
The average range of total daily insulin requirement for maintenance therapy in type 1 diabetic patients lies between 0.5 and 1.0 IU/kg. However, in pre-pubertal children it usually varies from 0.7 to 1.0 IU/kg, but can be much lower during the period of partial remission. In insulin resistance, e.g. during puberty or due to obesity, the daily insulin requirement may be substantially higher.
Initial dosages for type 2 diabetic patients are often lower, e.g. 0.3 to 0.6 IU/kg/day.
In patients with diabetes mellitus optimised metabolic control delays the onset and slows the progression of late diabetic complications. Optimised metabolic control, including glucose monitoring, is therefore recommended.
In geriatric patients the primary aim of treatment may be symptom relief and avoidance of hypoglycaemic events.
Mixtard 30 is administered subcutaneously in the thigh or abdominal wall. If convenient the gluteal region or deltoid region may be used. Insulin suspensions are never to be administered intravenously. Injection into a lifted skin fold minimises the risk of intramuscular injection. A subcutaneous injection into the abdominal wall results in a faster absorption than from other injection sites.
Injection sites should be rotated within an anatomic region in order to avoid lipodystrophy,
Premixed insulins are usually given once or twice daily when a rapid initial effect together with a more prolonged effect is desired. An injection should be followed by a meal or snack containing carbohydrates within 30 minutes.
Hypoglycaemia.
Hypersensitivity to human insulin or any of the excipients .
Inadequate dosage or discontinuation of treatment, especially in type 1 diabetes, may lead to hyperglycaemia and diabetic ketoacidosis.
Usually the first symptoms of hyperglycaemia set in gradually, over a period of hours or days. They include thirst, increased frequency of urination, nausea, vomiting, drowsiness, flushed dry skin, dry mouth, loss of appetite as well as acetone odour of breath.
In type 1 diabetes, untreated hyperglycaemic events eventually lead to diabetic ketoacidosis which is potentially lethal.
Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.
Renal or hepatic impairment may reduce insulin requirement.
Adjustment of dosage may also be necessary if patients increase their physical activity or change their usual diet.
Transferring a patient to another type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), type (rapid-acting insulin, intermediate-acting insulin, long-acting insulin etc.), species (animal, human insulin analog) and/or method of manufacture (recombinant DNA versus animal source insulin) may result in the need for a change in dose.
Patients switching to Mixtard 30 MC may require a change in dosage from that used with their usual insulin.
If an adjustment is needed, it may occur with the first dose or during the first several weeks or months.
Patients whose blood glucose control is greatly improved e.g. by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia and should be advised accordingly.
There are no restrictions on the treatment of diabetes with insulin during pregnancy as insulin does not pass the placental barrier. Intensified control in the treatment of pregnant women with diabetes is recommended throughout pregnancy and when contemplating pregnancy.
Insulin requirements usually fall in the first trimester and subsequently increase during the second and third trimester.
After delivery, insulin requirements return rapidly to pre-pregnancy values.
There are no restrictions on the treatment of diabetes with insulin during lactation, as insulin treatment of the nursing mother involves no risk to the baby. However, the insulin dosage may need to be reduced.
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.
Hypoglycaemia is a frequently occurring undesirable effect of insulin therapy. Symptoms of hypoglycaemia usually occur suddenly. They may include cold sweat, cool pale skin, nervousness or tremor, anxious feeling, unusual tiredness or weakness, confusion, difficulty in concentration, drowsiness, excessive hunger, temporary vision changes, headache, nausea and palpitation. Severe hypoglycaemia may lead to unconsciousness and may result in temporary or permanent impairment of brain function or even death.
Oedema and refraction anomalies may occur upon initiation of insulin therapy. These symptoms are usually of transitory nature.
Local hypersensitivity reactions (redness, swelling and itching at the injection site) may occur during treatment with insulin. These reactions are usually transitory and normally they disappear during continued treatment.
Generalised hypersensitivity reactions may occasionally occur. They are potentially more serious and may cause generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation and reduction in blood pressure. Generalised hypersensitivity reactions are potentially life threatening.
Lipodystrophy may occur at the injection site as a consequence of failure to rotate injection site within an area.
A number of drugs are known to interact with the glucose metabolism. Possible interactions must therefore be taken into account by the physician.
The following substances may reduce insulin requirement:
Oral hypoglycaemic agents (OHA), octreotide, monoamine oxidase inhibitors (MAOI), non-selective beta-blocking agents, angiotensin converting enzyme (ACE) inhibitors, salicylates, alcohol and anabolic steroids.
The following substances may increase insulin requirement:
Oral contraceptives, thiazides, glucocorticoids, thyroid hormones and sympathomimetics, danazol .
Beta-blocking agents may mask the symptoms of hypoglycaemia.
Alcohol may intensify and prolong the hypoglycaemic effect of insulin.
There are no specific overdose definitions for insulins. However, hypoglycaemia may develop over sequential stages:
Upon regaining consciousness administration of oral carbohydrate is recommended for the patient in order to prevent relapse.
Insulin preparations should be stored at 2°C - 8°C (in a refrigerator in the original container in the carton); not in or near a freezing compartment. Insulin preparations, which have been frozen, must not be used.
Insulin preparations should be protected from excessive heat and sunlight.
Insulin suspensions should not be used if they do not appear uniformly white and cloudy after suspension.
Prescription Medicine
MIXTARD 30 MC® is available in glass vials of 10 ml.
In general terms, insulin should only be added to compounds with which it is known to be compatible. Insulin suspensions should not be added to infusion fluids.
The carton contains a package leaflet with instructions for use and handling. Mixtard 30 MC vials are for use with insulin syringes with the corresponding unit scale.
Novo Nordisk Pharmaceuticals Ltd
PO Box 51-268
Pakuranga
Auckland
Tel: (09) 5790653
Fax: (09) 5790654
28 December 2002
SPC 4.00
Mixtard is a trademark owned by Novo Nordisk A/S, Denmark