The information highlighted (if any) are the most recent updates for this brand.
Human insulin (equivalent to 70% isophane insulin, 30% soluble insulin).
Cartridge: Each mL contains 100 IU Human Insulin (produced in E. coli by recombinant DNA technology), Ph. Eur. (70% Isophane Insulin/30% Soluble Insulin), 1.6 mg metacresol distilled and 0.65 mg phenol as preservatives.
Biphasic Isophane Insulin (70% Isophane Insulin/30% Soluble Insulin) is a sterile suspension of human insulin in the proportion of 70% isophane insulin to 30% soluble insulin.
Vial: 1 mL contains 100 IU insulin human, Ph. Eur. (produced in E. coli by recombinant DNA technology).
One vial contains 10 mL equivalent to 1000 IU of biphasic isophane insulin - 70% isophane insulin + 30% soluble insulin.
Insulin Human (rDNA) [Humulin 70/30] is a sterile suspension of human insulin in the proportion of 70% isophane insulin to 30% soluble insulin.
KwikPen: 1 mL contains 100 IU insulin human, (produced in E. coli by recombinant DNA technology).
One prefilled pen contains 3 mL equivalent to 300 IU of soluble insulin.
Insulin Human (Humulin 70/30 KwikPen) is a sterile suspension of human insulin in the proportion of 30% soluble insulin to 70% isophane insulin.
Excipients/Inactive Ingredients: Cartridge: m-cresol, glycerol, phenol, protamine sulfate, dibasic sodium phosphate 7H2O, zinc oxide, water for injections.
The following may be used to adjust pH: hydrochloric acid and/or sodium hydroxide.
Vial and KwikPen: m‑cresol (1.6 mg/mL) as preservative, glycerol, phenol (0.65 mg/mL) as preservative, protamine sulfate, dibasic sodium phosphate 7H2O, zinc oxide, water for injection.
The following may be used to adjust pH: hydrochloric acid and/or sodium hydrochloride (for vial); hydrochloric acid and/or sodium hydroxide (for KwikPen).
Pharmacotherapeutic group: Insulins and analogues for injection, intermediate acting combined with fast acting.
ATC code: A10A D01.
Cartridge: Biphasic Isophane Insulin (70% Isophane Insulin/30% Soluble Insulin) (Humulin 70/30) is a premixed suspension of rapid and intermediate acting insulin.
Vial: Insulin Human (rDNA) is a premixed suspension of intermediate and rapid acting insulin.
KwikPen: Insulin Human (Humulin 70/30 KwikPen) is an intermediate-acting insulin preparation.
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 utilization curve) following subcutaneous injection is illustrated as follows 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.
Cartridge: See Figure 1.
Click on icon to see table/diagram/image
Vial: See Figure 2.
Click on icon to see table/diagram/image
KwikPen: See Figure 3.
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 utilization 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.
For the treatment of patients with diabetes mellitus who require insulin for the maintenance of glucose homeostasis.
Cartridge: The dosage should be determined by the physician, according to the requirement of the patient.
Biphasic Isophane Insulin (70% Isophane Insulin/30% Soluble Insulin) (Humulin 70/30) in cartridges is only suitable for subcutaneous injections from a reusable pen. 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 in order to reduce the risk of lipodystrophy and cutaneous amyloidosis (see Precautions and Special Precautions for Disposal and Other Handling under Cautions for Usage).
Care should be taken when injecting any Insulin Human (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.
Biphasic Isophane Insulin (70% Isophane Insulin/30% Soluble Insulin) (Humulin 70/30) 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.
Vial and KwikPen: Posology: The dosage should be determined by the physician, according to the requirement of the patient.
Pediatric population: No data are available.
Method of administration: Insulin Human (Humulin 70/30) should be given by subcutaneous 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 in order to reduce the risk of lipodystrophy and cutaneous amyloidosis (see Precautions and Adverse Reactions).
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 formulation is a ready-made defined mixture of isophane and soluble 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.
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. Hypoglycemia may occur as a result of an excess of insulin relative to food intake and energy expenditure.
Hypoglycemia may be associated with listlessness, confusion, palpitations, headache, sweating and vomiting.
Mild hypoglycemic episodes will respond to oral administration of glucose or sugar products.
Correction of moderately severe hypoglycemia 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 hypoglycemia may occur after apparent clinical recovery.
Hypoglycemia.
Cartridge and KwikPen: Hypersensitivity to Insulin Human (Humulin) or to the formulation excipients, unless used as part of a desensitization program.
Under no circumstances should any Insulin Human (Humulin) formulation other than Soluble Insulin Human (Humulin R) be given intravenously.
Vial: Hypersensitivity to the active substance or to any of the excipients listed in Description, unless used as part of a desensitization programme.
Under no circumstances should Insulin Human (rDNA) [Humulin 70/30] 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 (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 hypoglycemic 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 hypoglycemia and should be advised accordingly. Other conditions which may make the early warning symptoms of hypoglycemia may be different or less pronounced include long duration of diabetes, diabetic nerve disease, medications such as beta-blockers. Uncorrected hypoglycemic and hyperglycemic 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 hyperglycemia and diabetic ketoacidosis; conditions which are potentially lethal.
Treatment with human insulin may cause formation of antibodies, but titers 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.
Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at sites with these reactions. A sudden change in the injection site to an unaffected area has been reported to result in hypoglycemia. Blood glucose monitoring is recommended after the change in the injection site, and dose adjustment of antidiabetic medications may be considered.
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 edema. Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs.
Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Excipients: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., essentially "sodium-free".
Effects on Ability to Drive and Use Machines: The patient's ability to concentrate and react may be impaired as a result of hypoglycemia. 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 hypoglycemia whilst driving, this is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycemia or have frequent episodes of hypoglycemia. The advisability of driving should be considered in these circumstances.
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.
Hypoglycemia is the most frequent undesirable effect of insulin therapy that a patient with diabetes may suffer. Severe hypoglycemia may lead to loss of consciousness, and in extreme cases, death. No specific frequency for hypoglycemia is presented, since hypoglycemia 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 generalized 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 generalized allergy may be life-threatening. In the rare event of a severe allergy to Insulin Human (Humulin), treatment is required immediately. A change of insulin or desensitization may be required.
Lipodystrophy at the injection site is uncommon (≥1/1,000 to <1/100).
Spontaneous data: Skin and subcutaneous tissue disorders: Frequency "unknown": Cutaneous amyloidosis.
Skin and subcutaneous tissue disorders: Lipodystrophy and cutaneous amyloidosis may occur at the injection site and delay local insulin absorption. Continuous rotation of the injection site within the given injection area may help to reduce or prevent these reactions (see Precautions).
Cases of edema have been reported with insulin therapy, particularly if previous poor metabolic control is improved by intensified insulin therapy.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.
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 hyperglycemic activity, such as oral contraceptives (for KwikPen), glucocorticoids, thyroid hormones, growth hormone, danazol, beta2-sympathomimetics (such as ritodrine, salbutamol, terbutaline), thiazides.
Insulin requirements may be reduced in the presence of substances with hypoglycemic activity, such as oral hypoglycemics (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.
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/prefilled pens (KwikPen)/vials can be used until empty, then properly discard. Any unused product or waste material should be disposed of in accordance with local requirements.
Cartridge: Lilly 3 mL cartridges are designed and tested for use with Lilly pens.
Instructions for use and handling: Cartridge: To prevent the possible transmission of disease, each cartridge must be used by one patient only, even if the needle on the delivery device is changed.
Pens to be used with Biphasic Isophane Insulin (70% Isophane Insulin/30% Soluble Insulin) (Humulin 70/30) Cartridge: The cartridges should only be used in conjunction with a Lilly reusable insulin pen and should not be used with any other reusable pen as the dosing accuracy has not been established with other pens.
a) Preparing a dose: Biphasic Isophane Insulin (70% Isophane Insulin/30% Soluble Insulin) (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 previous 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 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.
b) 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.
Vial: A suspension for injection in a 10 mL vial to be used in conjunction with an appropriate syringe (100 IU/mL markings).
a) Preparing a dose: Vials containing Insulin Human (rDNA) [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 previous 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.
b) 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: To prevent the possible transmission of disease, each pen must be used by one patient only, even if the needle is changed.
A suspension for injection in a prefilled pen injector containing 3 mL cartridge. Insulin Human (Humulin 70/30 KwikPen) delivers up to 60 units per dose in single increments.
a) Preparing a dose: Insulin Human (Humulin 70/30 KwikPen) 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 and milky. If not, repeat the previous 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 bottom or wall of the cartridge, giving a frosted appearance.
Follow the instructions with Insulin Human (Humulin 70/30 KwikPen) for attaching the needle and administering the insulin injection.
Insulin Human (Humulin 70/30 KwikPen) a needle must always be attached before priming dialing and injecting an insulin dose. It should always be primed before each injection. Failure to prime Insulin Human (Humulin 70/30 KwikPen) may result in an inaccurate dose.
b) 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 site is not used more than approximately once a month.
Each pack contains a patient information leaflet with instruction on how to inject insulin.
Cartridge: Unused cartridge: Store unopened containers refrigerated between 2°C - 8°C. Do not freeze. Do not expose to excessive heat or direct sunlight.
After cartridge insertion: Do not refrigerate in-use cartridges in reusable injectors. Store in-use cartridges (after the disc seal has been punctured) unrefrigerated for up to 28 days at a maximum temperature of 30°C. The pen with the inserted cartridge should not be stored with the needle attached.
Shelf Life: Unused cartridge: 24 months.
After cartridge 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: Unopened vials: 3 years.
After first use: 28 days.
KwikPen: Unused prefilled pens: Store in a refrigerator (2°C‑8°C) until time of use.
After first use: Store in‑use drug product (after disc seal has been punctured) unrefrigerated for up to 28 days at a maximum temperature of 30°C.
Do not freeze. Do not expose to excessive heat or direct sunlight.
Shelf‑life: Unused prefilled pens: 2 years.
After first use: 28 days.
A10AD01 - insulin (human) ; Belongs to the class of intermediate-acting combined with fast-acting insulins and analogues. Used in the treatment of diabetes.
Humulin 70/30 (100 IU/mL) inj susp (vial)
10 mL x 1's
Humulin 70/30 (100 u/mL) inj susp (cartridge)
3 mL x 5 × 1's
Humulin 70/30 KwikPen susp for inj 100 IU/mL
3 mL x 5 × 1's