Humulin 70/30

Humulin 70/30

Manufacturer:

Eli Lilly

Distributor:

Zuellig
/
Agencia Lei Va Hong
Full Prescribing Info
Contents
Human insulin isophane, human insulin (recombinant DNA origin).
Description
Humulin 70/30 is a premixed suspension which contains 30% insulin dissolved in water and 70% insulin with protamine sulphate.
Humulin 70/30 is a sterile suspension of human insulin in the proportion of 30% soluble insulin to 70% isophane insulin.
Cartridge: A suspension for injection in a cartridge.
One cartridge contains 3 mL equivalent to 300 IU of biphasic isophane insulin - 30% soluble insulin/70% isophane insulin.
Vial: A suspension for injection in a vial.
One vial contains 10 mL equivalent to 1000 IU of biphasic isophane insulin - 30% soluble insulin/70% isophane insulin.
KwikPen: Each Humulin 70/30 KwikPen contains 300 units equivalent to 3 mL.
Excipients/Inactive Ingredients: Protamine sulphate, metacresol, phenol, glycerol, dibasic sodium phosphate 7H2O, zinc oxide, water for injection. The following may be used to adjust pH: hydrochloric acid and/or sodium hydroxide.
Action
Pharmacotherapeutic Group: Humulin 70/30. ATC Code: A10A D01.
Humulin 70/30 is an intermediate acting insulin preparation. It is a premixed suspension of rapid and long acting insulin. Its action is prolonged by the inclusion of protamine sulphate in the suspension.
Pharmacology: Pharmacodynamics: The prime activity of insulin is the regulation of glucose metabolism.
In addition insulin has several anabolic and anti-catabolic actions on a variety of different tissues. Within muscle tissue this includes increasing glycogen, fatty acid, glycerol and protein synthesis and amino acid uptake, while decreasing glycogenolysis, gluconeogenesis, ketogenesis, lipolysis, protein catabolism and amino acid output.
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. (See figure.)

Click on icon to see table/diagram/image

Pharmacokinetics: 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 previously) when considering the activity of insulin.
Toxicology: Preclinical Safety Data: Humulin is human insulin produced by recombinant technology. No serious events have been reported in subchronic toxicology studies. Human insulin was not mutagenic in a series of in vitro and in vivo genetic toxicity assays.
Indications/Uses
For the treatment of patients with diabetes mellitus who require insulin for the maintenance of glucose homeostasis.
Humulin 70/30 is used to control glucose in the long term.
Dosage/Direction for Use
The dosage should be determined by the physician, according to the requirement of the patient.
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 70/30 should be given by subcutaneous injection but may although not recommended, also be given by intramuscular injection. Humulin 70/30 should not be administered intravenously.
Humulin mixture formulation is a ready-made defined mixture of soluble and isophane 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.
Missed Dose: If the patient takes less Humulin 70/30 than needed, the patient's blood sugar levels may increase. Check the patient's blood sugar.
Discontinuing Use of Humulin 70/30: If the patient takes less Humulin 70/30 than needed, the patient's blood sugar levels may become too high. Do not change the insulin unless told by the physician. For any further questions on the use of the product, ask the patient's diabetes specialist nurse, doctor or pharmacist.
Overdosage
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.
Contraindications
Hypoglycaemia. Hypersensitivity to Humulin or to the formulation excipients, unless used as part of a desensitisation programme.
Special Precautions
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, mixture), 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.
The use of dosages which are inadequate or discontinuation of treatment, especially in insulin-dependent diabetics, may lead to hyperglycaemia and diabetic ketoacidosis; conditions which are potentially lethal.
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.
Combination of Human Insulin with Pioglitazone: Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure. This should be kept in mind, if treatment with the combination of pioglitazone and human insulin is considered. If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema. Pioglitazone should be discontinued, if any deterioration in cardiac symptoms occurs.
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 (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.
Use In Pregnancy & Lactation
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.
Careful monitoring of glucose control, as well as general health, is essential in pregnant patients with diabetes.
Patients with diabetes who are lactating may require adjustments in insulin dose and/or diet.
Adverse Reactions
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. No specific frequency for hypoglycaemia is presented, since hypoglycaemia is a result of both the insulin dose and other factors e.g. a patient`s level of diet and exercise.
Local allergy in patients is common (1/100 to <1/10). Redness, swelling, and itching can occur at the site of insulin injection. This condition usually resolves in a few days to a few weeks. In some instances, local reactions may be related to factors other than insulin, such as irritants in the skin cleansing agent or poor injection technique.
Systemic allergy, which is very rare (<1/10,000) 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-threatening.
In the rare event of a severe allergy to Humulin, treatment is required immediately. A change of insulin or desensitisation may be required.
Lipodystrophy at the injection site is uncommon (1/1,000 to < 1/100).
Cases of oedema have been reported with insulin therapy, particularly if previous poor metabolic control is improved by intensified insulin therapy.
Common Problems of Diabetes: Hypoglycaemia: Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This can be caused if the patient: Takes too much Humulin 70/30 or other insulin; misses or delays meals or changes diet; exercises or works too hard just before or after a meal; has an infection or illness (especially diarrhoea or vomiting); has a change in need for insulin; or has trouble with kidneys or liver which gets worse.
Alcohol and some medicines can affect blood sugar levels.
The first symptoms of low blood sugar usually come on quickly and include the following: Tiredness, rapid heartbeat, nervousness or shakiness, feeling sick, headache, cold sweat.
Until the patient becomes confident in recognising warning symptoms, avoid situations such as driving a car, in which the patient or others would be put at risk by hypoglycaemia.
Do not use Humulin 70/30 if the patient thinks hypoglycaemia (low blood sugar) is starting.
If the blood sugar is low, eat glucose tablets, sugar or drink a sugary drink. Then eat fruit, biscuits, or a sandwich, as the doctor has advised and have some rest. This will often get the patient over mild hypoglycaemia or a minor insulin overdose. If the patient gets worse and breathing is shallow and skin gets pale, tell the physician at once. A glucagon injection can treat quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If the patient does not respond to glucagon, the patient will have to go to hospital. Ask the physician about glucagon.
Hyperglycaemia and Diabetic Ketoacidosis: Hyperglycaemia (too much sugar in the blood) means that the body does not have enough insulin. Hyperglycaemia can be brought about by: Not taking Humulin or other insulin; taking less insulin than prescribed; eating a lot more than the diet allows; or fever, infection or emotional stress.
Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many hours or days. The symptoms include the following: Feeling sleepy, no appetite, flushed face, fruity smell on the breath, thirst, feeling or being sick.
Severe symptoms are heavy breathing and a rapid pulse. Get medical help immediately.
If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) are not treated they can be very serious and cause headaches, nausea, vomiting, dehydration, unconsciousness, coma or even death.
Three simple steps to avoid hypoglycaemia or hyperglycaemia are: Always keep spare syringes and a spare vial of Humulin 70/30, always carry something to show that the patient is diabetic, always carry sugar.
Illness: If the patient is ill, especially if the patient feels sick or is sick, the amount of insulin may change. Even when the patient is not eating normally, the patient still needs insulin. Test the urine or blood, follow the 'sick rules', and tell the diabetes specialist nurse or doctor.
Drug Interactions
A number of medicinal products are known to interact with glucose metabolism and therefore the physician should be consulted when using other medications in addition to human insulin (see Precautions). The physician must therefore take possible interactions into account and should always ask his patients about any medicinal products they take.
Insulin requirements may be increased by substances with hyperglycaemic activity, such as glucocorticoids, thyroid hormones, growth hormone, danazol, beta2-sympathomimetic (such as ritodrine, salbutamol, terbutaline), thiazides.
Insulin requirements may be reduced in the presence of substances with hypoglycaemic activity, such as oral hypoglycaemics (OHA), salicylates (for example, acetylsalicylic acid), certain antidepressants (monoamine oxidase inhibitors), certain angiotensin converting enzyme (ACE) inhibitors (captopril, enalapril), angiotensin II receptor blockers, non-selective beta-blocking agents and alcohol.
Somatostatin analogues (octreotide, lanreotide) may both decrease or increase insulin dose requirements.
Caution For Usage
Incompatibilities: Humulin preparations should not be mixed with insulins produced by other manufacturers or with animal insulin preparations.
Special Precautions for Disposal and Other Handling: Do not reuse needles. Dispose of the needle in a responsible manner. Needles and pens must not be shared. Cartridges can be used until empty, then properly discard. Any unused product or waste material should be disposed of in accordance with local requirements.
Instructions for Use and Handling: Cartridge: A suspension for injection in a 3 mL cartridge to be used with a CE marked pen as recommended in the information provided by the device manufacturer.
Preparing a Dose: Cartridges containing Humulin 70/30 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 uniform 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 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.
The manufacturer's instructions with each individual pen must be followed for loading the cartridge, attaching the needle and administering the insulin injection.
Injecting a Dose: Inject the correct dose of insulin.
Use of the injection sites should be rotated so that the same is not used more than approximately once a month.
Vial: A suspension for injection in a 10 mL vial to be used in conjunction with an appropriate syringe (100 IU/mL markings).
Preparing a Dose: Vials containing Humulin 70/30 formulation should be rotated several times in the palms of the hands before use to completely resuspend the insulin, until it appears uniform 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.
Prepare the syringe prior to injection, as directed by the doctor or diabetes specialist nurse.
Use an insulin syringe marked for the strength of insulin being administered.
Injecting a Dose: Inject the correct dose of insulin, as directed by the 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.
KwikPen: Preparing Humulin 70/30: The KwikPen should be rotated in the palms of the hands 10 times and inverted 10 times immediately before use to resuspend insulin until it appears uniformly cloudy or milky. If not, repeat the above procedure until contents are mixed. Cartridges in the pen 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 in the pen 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 sides of the cartridge, giving it a frosted appearance. Check in each time of injection.
Getting the KwikPen Ready to Use: First wash hands.
Read the instructions on how to use the pre-filled insulin pen. Please follow the instructions carefully.
Here are Some Reminders: Use a clean needle. (Needles are not included).
Prime the KwikPen before each use. This checks that insulin comes out and clears the air bubbles from the KwikPen. There may still be some small air bubbles left in the KwikPen, these are harmless, but if the air bubble is too big, it may make the dose of the injection less accurate.
Injecting Humulin 70/30: Before the patient makes an injection, clean the skin as instructed.
Inject under the skin, as was taught. Do not inject directly into a vein.
After the injection, leave the needle in the skin for 5 seconds to make sure the patient has taken the whole dose. Do not rub the area of injection. Make sure that the patient injects at least half an inch (1 cm) from the last site of injection and that the patient 'rotates' the places of injection, as was taught.
After Injecting: As soon as the patient has done the injection, unscrew the needle from the KwikPen using the outer needle cap. This will keep the insulin sterile and prevent leaking. It will also stop air from going back into the KwikPen and the needle clogging up. Do not share needles or KwikPen. Replace the cap on the KwikPen.
Further Injections: Every time the patient uses a KwikPen the patient must use a new needle. Before every injection, clear any air bubbles. The patient can see how much insulin is left by holding the KwikPen with the needle pointing down. The scale on the cartridge shows about how many units are left.
Do not mix any other insulin in the disposable pen. Once the KwikPen is empty, do not use it again. Please get rid of it carefully. The diabetes specialist nurse or pharmacist will advise how to do this.
Storage
Cartridge: Unused Cartridges: Store in a refrigerator (2°C-8°C). Do not freeze. Do not expose to excessive heat or direct sunlight.
After Cartridges Insertion: Store below 30°C. Do not refrigerate. The pen with the inserted cartridge should not be stored with the needle attached.
Shelf-Life: After Cartridges Insertion: 28 days.
Vial: 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.
Shelf-Life: After First Use: 28 days.
KwikPen: Before First Use: Store Humulin 70/30 KwikPen in a refrigerator (2°C-8°C). Do not freeze. Keep the 'in-use' Humulin 70/30 KwikPen at room temperature (below 30°C) for up to 28 days. Do not keep the 'in-use' pen in the fridge. Do not put it near heat or in the sun.
ATC Classification
A10AD01 - insulin (human) ; Belongs to the class of intermediate-acting combined with fast-acting insulins and analogues. Used in the treatment of diabetes.
Presentation/Packing
Cartridge 100 IU/mL (sterile suspension) x 3 mL x 5's. Vial 100 IU/mL (sterile suspension) x 10 mL x 1's. KwikPen pre-filled pen 100 IU/mL (white, sterile suspension) x 3 mL x 5's.
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