Humalog

Insulin lispro (recombinant DNA origin produced in E.coli).

Each ml contains 100 units of insulin lispro* (equivalent to 3.5 mg).
*produced in E. coli by recombinant DNA technology.
Vial: Each vial contains 1000 units insulin lispro in 10 ml solution.
Cartridge: Each container includes 3ml equivalent to 300 units insulin lispro.
KwikPen: Humalog 100 units/ml KwikPen solution for injection is a sterile, clear, colourless, aqueous solution and contains 100 units of insulin lispro in each millilitre (100 units/ml) solution for injection. Each Humalog KwikPen contains 300 units (3 millilitres).
The active substance is insulin lispro. Insulin lispro is made in the laboratory by a 'recombinant DNA technology' process. It is a changed form of human insulin and so is different from other human and animal insulins. Insulin lispro is closely related to human insulin, which is a natural hormone made by the pancreas.
Excipients/Inactive Ingredients: m-Cresol [3.15 mg/ml], Glycerol, Dibasic sodium phosphate·7H₂O, Zinc oxide and Water for injections. Hydrochloric acid and sodium hydroxide may be used to adjust pH to 7.0-7.8.

Pharmacotherapeutic group: Drugs used in diabetes, insulins and analogues for injection, fast-acting. ATC code: A10AB04.
Pharmacology: Pharmacodynamics: The primary activity of insulin lispro is the regulation of glucose metabolism.
In addition, insulins have 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.
Insulin lispro has a rapid onset of action (approximately 15 minutes), thus allowing it to be given closer to a meal (within zero to 15 minutes of the meal) when compared to soluble insulin (30 to 45 minutes before). Insulin lispro takes effect rapidly and has a shorter duration of activity (2 to 5 hours) when compared to soluble insulin.
Clinical trials in patients with type 1 and type 2 diabetes have demonstrated reduced postprandial hyperglycaemia with insulin lispro compared to soluble human insulin.
As with all insulin preparations, the time course of insulin lispro action may vary in different individuals or at different times in the same individual and is dependent on dose, site of injection, blood supply, temperature and physical activity. The typical activity profile following subcutaneous injection is illustrated as follows. (See figure.)

Click on icon to see table/diagram/image

The previous representation reflects the relative amount of glucose over time required to maintain the subject's whole blood glucose concentrations near fasting levels and is an indicator of the effect of these insulins on glucose metabolism over time.
Clinical trials have been performed in children (61 patients aged 2 to 11) and children and adolescents (481 patients aged 9 to 19 years), comparing insulin lispro to human soluble insulin. The pharmacodynamic profile of insulin lispro in children is similar to that seen in adults.
When used in subcutaneous infusion pumps, treatment with insulin lispro has been shown to result in lower glycosylated haemoglobin levels compared to soluble insulin. In a double-blind, crossover study, the reduction in glycosylated haemoglobin levels after 12 weeks dosing was 0.37 percentage points with insulin lispro, compared to 0.03 percentage points for soluble insulin (p = 0.004).
In patients with type 2 diabetes on maximum doses of sulphonyl urea agents, studies have shown that the addition of insulin lispro significantly reduces HbA_1c compared to sulphonyl urea alone. The reduction of HbA_1c would also be expected with other insulin products e.g. soluble or isophane insulins.
Clinical trials in patients with type 1 and type 2 diabetes have demonstrated a reduced number of episodes of nocturnal hypoglycaemia with insulin lispro compared to soluble human insulin. In some studies, reduction of nocturnal hypoglycaemia was associated with increased episodes of daytime hypoglycaemia.
The glucodynamic response to insulin lispro is not affected by renal or hepatic function impairment. Glucodynamic differences between insulin lispro and soluble human insulin, as measured during a glucose clamp procedure, were maintained over a wide range of renal function.
Insulin lispro has been shown to be equipotent to human insulin on a molar basis but its effect is more rapid and of a shorter duration.
Pharmacokinetics: The pharmacokinetics of insulin lispro reflect a compound that is rapidly absorbed, and achieves peak blood levels 30 to 70 minutes following subcutaneous injection. When considering the clinical relevance of these kinetics, it is more appropriate to examine the glucose utilisation curves (as previously discussed in Pharmacodynamics).
Insulin lispro maintains more rapid absorption when compared to soluble human insulin in patients with renal impairment. In patients with type 2 diabetes over a wide range of renal function the pharmacokinetic differences between insulin lispro and soluble human insulin were generally maintained and shown to be independent of renal function. Insulin lispro maintains more rapid absorption and elimination when compared to soluble human insulin in patients with hepatic impairment.
Toxicology: Preclinical safety data: In in vitro tests, including binding to insulin receptor sites and effects on growing cells, insulin lispro behaved in a manner that closely resembled human insulin. Studies also demonstrate that the dissociation of binding to the insulin receptor of insulin lispro is equivalent to human insulin. Acute, one month and twelve month toxicology studies produced no significant toxicity findings.
Insulin lispro did not induce fertility impairment, embryotoxicity or teratogenicity in animal studies.

For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Humalog is also indicated for the initial stabilisation of diabetes mellitus.
KwikPen: Humalog KwikPen is used to treat diabetes. It works more quickly than normal human insulin because the insulin molecule has been changed slightly.
Diabetes is developed if the pancreas does not make enough insulin to control the level of glucose in the blood. Humalog is a substitute for the patient's own insulin and is used to control glucose in the long term. It works very quickly and lasts a shorter time than soluble insulin (2 to 5 hours). The patient should normally use Humalog within 15 minutes of a meal.
The doctor may advise to use Humalog KwikPen as well as a longer-acting insulin. Each kind of insulin comes with another patient information leaflet. Do not change the insulin unless advised by the doctor. Be very careful if there is a change in insulin.
Humalog is suitable for use in adults and children.

Posology: The dose should be determined by the physician, according to the requirement of the patient.
Humalog may be given shortly before meals. When necessary Humalog can be given soon after meals.
Humalog preparations should be given by subcutaneous injection or by continuous subcutaneous infusion pump (see Dosage & Administration) and may, although not recommended, also be given by intramuscular injection.
Humalog takes effect rapidly and has a shorter duration of activity (2 to 5 hours) given subcutaneously as compared with soluble insulin. This rapid onset of activity allows a Humalog injection (or, in the case of administration by continuous subcutaneous infusion, a Humalog bolus) to be given very close to mealtime. The time course of action of any insulin may vary considerably in different individuals or at different times in the same individual. The faster onset of action compared to soluble human insulin is maintained regardless of injection site. As with all insulin preparations, the duration of action of Humalog is dependent on dose, site of injection, blood supply, temperature, and physical activity.
Humalog can be used in conjunction with a longer-acting insulin or oral sulphonylurea agents, on the advice of a physician.
Special populations: Renal impairment: Insulin requirements may be reduced in the presence of renal impairment.
Hepatic impairment: Insulin requirements may be reduced in patients with hepatic impairment due to reduced capacity for gluconeogenesis and reduced insulin breakdown; however, in patients with chronic hepatic impairment, an increase in insulin resistance may lead to increased insulin requirements.
Paediatric population: Humalog can be used in adolescents and children (see Pharmacology: Pharmacodynamics under Actions).
How to use Humalog KwikPen: Always use Humalog KwikPen exactly as prescribed. Advise the patient to check with a doctor if not sure. To prevent the possible transmission of disease, each pen must be used only by the patient, even if the needle is changed.
Dose: Humalog are normally injected within 15 minutes of a meal. It can be injected soon after a meal, if necessary. The doctor will inform exactly how much to use, when to use it, and how often. These instructions are for each individual patient only. The patient should follow them exactly and visit diabetes clinic regularly.
In changing the type of insulin used (for example from a human or animal insulin to a Humalog product), the patient may have to take more or less than before. This might just be for the first injection or it may be a gradual change over several weeks or months.
Humalog KwikPen is only suitable for injecting just under the skin. Advise the patient to speak to a doctor if there's a need to inject insulin by another method.
If the patient forgets to use Humalog: If the patient takes less Humalog than needed or is unsure how much he/she has injected, a high blood sugar may occur. The blood sugar must be checked.
If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated, they can be very serious and cause headaches, nausea, vomiting, dehydration, unconsciousness, coma or even death (see Side Effects).
Three simple ways to avoid hypoglycaemia or hyperglycaemia are: Always keep spare syringes and a spare vial of Humalog, or a spare pen and cartridges, in case the KwikPen is lost or gets damaged.
Diabetics should always carry something to identify their condition.
Sugar must be always on hand.
If the patient stops using Humalog: If the patients takes less Humalog than needed, a high blood sugar may occur. Do not change insulin unless prescribed.
If any further questions may have arise on the use of Humalog KwikPen, patients must be advised by a doctor or pharmacist.
Method of administration: Subcutaneous use.
Humalog preparations should be given by subcutaneous injection.
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 risk of lipodystrophy and cutaneous amyloidosis (see Precautions and Adverse Reactions).
When administered subcutaneously care should be taken when injecting Humalog to ensure that a blood vessel has not been entered. After injection, the site of injection should not be massaged. Patients must be educated to use the proper injection techniques.
Use of Humalog in an insulin infusion pump: For subcutaneous injection of Humalog using a continuous infusion pump, patient may fill the pump reservoir from a Humalog 100 units/ml vial. Some pumps are compatible with cartridges that can be inserted intact into the pump.
Only certain CE-marked insulin infusion pumps may be used to infuse insulin lispro. Before infusing insulin lispro, the manufacturer's instructions should be studied to ascertain the suitability for the particular pump. Use the correct reservoir and catheter for the pump. When filling the pump reservoir avoid damaging it by using the correct needle length on the filling system. The infusion set (tubing and cannula) should be changed in accordance with the instructions in the product information supplied with the infusion set. In the event of a hypoglycaemic episode, the infusion should be stopped until the episode is resolved. If repeated or severe low blood glucose levels occur, notify a health care professional and consider the need to reduce or stop an insulin infusion. A pump malfunction or obstruction of the infusion set can result in a rapid rise in glucose levels. If an interruption to insulin flow is suspected, follow the instructions in the pump product literature. When used with an insulin infusion pump, Humalog should not be mixed with any other insulin.
Intravenous administration of insulin: If necessary, Humalog may also be administered intravenously, for example; for the control of blood glucose levels during ketoacidosis, acute illnesses or during intra and post operative periods.
Humalog 100 units/ml is available in vials if administration of intravenous injection is necessary.
Intravenous injection of insulin lispro should be carried out following normal clinical practise for intravenous injections, for example by an intravenous bolus or by an infusion system. Frequent monitoring of the blood glucose levels is required.
Infusion systems at concentrations from 0.1 units/ml to 1.0 units/ml insulin lispro in 0.9% sodium chloride or 5% dextrose are stable at room temperature for 48 hours. It is recommended that the system is primed before starting the infusion to the patient.

Insulins have 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 activity 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 other sugar or saccharated 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 recur after apparent clinical recovery.
Kwikpen: If Humalog is taken more than necessary, a low blood sugar may occur. The blood sugar should be checked. If the blood sugar is low (mild hypoglycaemia), advise the patient to eat glucose tablets, sugar or drink a sugary drink. Then eat fruit, biscuits, or a sandwich, as the doctor's advice and to have some rest. This will often get the patient over mild hypoglycaemia or a minor insulin overdose. If the patient gets worse and the breathing is shallow and the skin gets pale, advise the patient to inform the doctor immediately. A glucagon injection can treat quite severe hypoglycaemia. Advise the patient to eat glucose or sugar after the glucagon injection. If the patient does not respond to glucagon, the patient will have to go to a hospital. Patients must be advised about glucagon.

Hypersensitivity to the active substance or to any of the excipients listed in Description.
Hypoglycaemia.

Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered medicinal product should be clearly recorded.
Transferring a patient to another type or brand of insulin: Transferring a patient to another type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), type (regular/soluble, NPH/isophane, 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. For fast-acting insulins, any patient also on basal insulin must optimise dosage of both insulins to obtain glucose control across the whole day, particularly nocturnal/fasting glucose control.
When mixing Humalog with a longer acting insulin, the shorter-acting Humalog should be drawn into the syringe first, to prevent contamination of the vial by the longer-acting insulin. Mixing of the insulins ahead of time or just before the injection should be on advice of the physician. However, a consistent routine must be followed.
Hypoglycaemia and hyperglycaemia: Conditions which may make the early warning symptoms of hypoglycaemia different or less pronounced include long duration of diabetes, intensified insulin therapy, diabetic nerve disease or medications such as beta-blockers.
A few patients who have experienced hypoglycaemic reactions after transfer from animal-source insulin to human insulin have reported that the early warning symptoms of hypoglycaemia were less pronounced or different from those experienced with their previous insulin. Uncorrected hypoglycaemic or 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.
Injection technique: 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 hypoglycaemia. Blood glucose monitoring is recommended after the change in the injection site, and dose adjustment of antidiabetic medications may be considered.
Insulin requirements and dosage adjustment: Insulin requirements may be increased during illness or emotional disturbances.
Adjustment of dosage may also be necessary if patients undertake increased physical activity or change their usual diet. Exercise taken immediately after a meal may increase the risk of hypoglycaemia. A consequence of the pharmacodynamics of rapid-acting insulin analogues is that if hypoglycaemia occurs, it may occur earlier after an injection when compared with soluble human insulin.
Combination of Humalog 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 Humalog 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.
Avoidance of medication errors: Patients must be instructed to always check the insulin label before each injection to avoid accidental mix-ups.
Patients who are blind or have poor vision must be instructed to always get help/assistance from another person who has good vision and is trained in using the insulin device.
Excipients: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., essentially "sodium-free".
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.
Before using Humalog Kwikpen: Advise the patient to always check the pack and the label of the pre-filled pen for the name and type of the insulin when getting it from a pharmacy. Make sure get the Humalog KwikPen that that was advised by the doctor.
If the blood sugar levels are well controlled by the current insulin therapy, the warning symptoms may not be present when blood sugar is falling too low. Warning signs are listed under Side Effects. Patients should think carefully about when to have meals, how often to exercise and how much to do. Advise the patient to keep a close watch on blood sugar levels by testing the blood glucose often.
A few people who have had hypoglycaemia after switching from animal insulin to human insulin have reported that the early warning symptoms were less obvious or different. If hypoglycaemia often occur or have difficulty recognising it, advise the patient to discuss with a doctor.
The doctor, pharmacist or diabetes nurse must be informed if the patient recently became ill; have kidney or liver problem; or exercising more than usual.
The dose of insulin may change if the patient drinks alcohol.
Advise the patient to inform the doctor, pharmacist or diabetes nurse if there is a plan of going abroad. The time difference between countries may mean to have injections and meals at different times.
Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke, who were treated with pioglitazone and insulin, experienced the development of heart failure. If signs of heart failure is experienced such as unusual shortness of breath, rapid increase in weight or localised swelling (oedema), advise the patient to inform the doctor immediately.
This Pen is not recommended for use by the blind or visually impaired without the help of someone trained to use the Pen.
Skin changes at the injection site: The injection site should be rotated to prevent skin changes such as lumps under the skin. The insulin may not work very well if it's injected into a lumpy area (see Dosage & Administration). Advise the patient to contact a doctor if he/she is currently injecting into a lumpy area before starting to inject into a different area. Blood sugar may be checked more closely, and insulin or other antidiabetic medications dose may be adjusted.
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.

Pregnancy: Data on a large number of exposed pregnancies do not indicate any adverse effect of insulin lispro on pregnancy or on the health of the foetus/newborn.
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 doctor 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.
Breast-feeding: Patients with diabetes who are breast-feeding may require adjustments in insulin dose, diet or both.
Fertility: Insulin lispro did not induce fertility impairment in animal studies (see Pharmacology: Toxicology: Preclinical safety data under Actions).

Summary of safety profile: 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.
Tabulated list of adverse reactions: The following related adverse reactions from clinical trials are listed as follows as MedDRA preferred term by system organ class and in order of decreasing incidence (very common: ≥1/10; common: ≥1/100 to <1/10; uncommon: ≥1/1,000 to <1/100; rare: ≥1/10,000 to <1/1,000; very rare: <1/10,000); not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. (See table.)

Click on icon to see table/diagram/image

Description of selected adverse reactions: Local allergy: Local allergy in patients is common. 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, this condition may be related to factors other than insulin, such as irritants in the skin cleansing agent or poor injection technique.
Systemic allergy: Systemic allergy, which is rare but potentially more serious, is a generalised allergy to insulin. It may cause a 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.
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).
Oedema: Cases of oedema 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 authorisation 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 to the Drug Office, Department of Health.

KwikPen: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Systemic allergy is rare (≥1/10,000 to <1/1,000). The symptoms are as follows: rash over the whole body; blood pressure dropping; difficulty in breathing; heart beating fast; wheezing; sweating
If the patient is having this sort of insulin allergy with Humalog, advise the patient to inform a doctor at once.
Local allergy is common (≥1/100 to <1/10). Some people get redness, swelling or itching around the area of the insulin injection. This usually clears up in anything from a few days to a few weeks. If this happens, advise the patient to inform a doctor.
Lipodystrophy is uncommon (≥1/1,000 to <1/100). If patient injects insulin too often at the same place, the fatty tissue may either shrink (lipoatrophy) or thicken (lipohypertrophy). Lumps under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis). The insulin may not work very well if it's injected into a lumpy area. Change the injection site with each injection to help prevent these skin changes.
Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of insulin therapy or during a change in therapy to improve control of blood glucose.
Reporting of side effects: Patients must be advised by a doctor or pharmacist if they get any side effects. This includes any possible side effects not listed in this monograph. Patients can also report side effects directly via the Drug Office, Department of Health. By reporting side effects, it can help provide more information on the safety of this medicine.
Common problems of diabetes: Hypoglycaemia: Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This can be caused if: patients take too much Humalog or other insulin; patients miss or delay meals or change diet; patients exercise or work too hard just before or after a meal; patients have an infection or illness (especially diarrhoea or vomiting); there is a change in the need for insulin; or patients have 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.
If not confident about recognising warning symptoms, avoid situations, e.g. driving a car, in which would create risks by hypoglycaemia.
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 Humalog or other insulin; taking less insulin than what the doctor's instructed; 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. Advise the patient to get medical help immediately.
Illness: If ill, especially if feel sick or are sick, the amount of insulin need may change. Even when not eating normally, insulin is still needed. Advise the patient to test urine or blood, follow 'sick rules', and inform a doctor.

Insulin requirements may be increased by medicinal products with hyperglycaemic activity, such as oral contraceptives, corticosteroids, or thyroid replacement therapy, danazol, beta₂ stimulants (such as ritodrine, salbutamol, terbutaline).
Insulin requirements may be reduced in the presence of medicinal products with hypoglycaemic activity, such as oral hypoglycaemics, salicylates (for example, acetylsalicylic acid), sulpha antibiotics, certain antidepressants (monoamine oxidase inhibitors, selective serotonin reuptake inhibitors), certain angiotensin converting enzyme inhibitors (captopril, enalapril), angiotensin II receptor blockers, beta-blockers, octreotide or alcohol.
The physician should be consulted when using other medications in addition to Humalog (see Precautions).

Incompatibilities: This medicinal product must not be mixed with other medicinal products except those mentioned in Special precautions for disposal and other handling as follows.
Special precautions for disposal and other handling: Instructions for use and handling: Vial: To prevent the possible transmission of disease, Patients using vials must never share needles or syringes. The patient should discard the needle after every injection.
The Humalog solution should be clear and colourless. Humalog should not be used if it appears cloudy, thickened, or slightly coloured or if solid particles are visible.
Do not mix insulin in vials with insulin in cartridges. See Incompatibilities as previously mentioned.
Preparing a dose: The vial is to be used in conjunction with an appropriate syringe (100 unit markings).
i) Humalog: 1. Wash hands.
2. If using a new vial, flip off the plastic protective cap, but do not remove the stopper.
3. If the therapeutic regimen requires the injection of basal insulin and Humalog at the same time, the two can be mixed in the syringe. If mixing insulins, refer to Mixing Humalog with longer-acting Human Insulins as follows and Incompatibilities as previously mentioned.
4. Draw air into the syringe equal to the prescribed Humalog dose. Wipe the top of the vial with an alcohol swab. Put the needle through the rubber top of the Humalog vial and inject the air into the vial.
5. Turn the vial and syringe upside down. Hold the vial and syringe firmly in one hand.
6. Making sure the tip of the needle is in the Humalog, withdraw the correct dose into the syringe.
7. Before removing the needle from the vial, check the syringe for air bubbles that reduce the amount of Humalog in it. If bubbles are present, hold the syringe straight up and tap its side until the bubbles float to the top. Push them out with the plunger and withdraw the correct dose.
8. Remove the needle from the vial and lay the syringe down so that the needle does not touch anything.
ii) Mixing Humalog with longer-acting Human Insulins (see Incompatibilities as previously mentioned): 1. Humalog should be mixed with longer-acting human insulins only on the advice of a doctor.
2. Draw air into the syringe equal to the amount of longer-acting insulin being taken. Insert the needle into the longer-acting insulin vial and inject the air. Withdraw the needle.
3. Now inject air into the Humalog vial in the same manner, but do not withdraw the needle.
4. Turn the vial and syringe upside down.
5. Making sure the tip of the needle is in the Humalog, withdraw the correct dose of Humalog into the syringe.
6. Before removing the needle from the vial, check the syringe for air bubbles that reduce the amount of Humalog in it. If bubbles are present, hold the syringe straight up and tap its side until the bubbles float to the top. Push them out with the plunger and withdraw the correct dose.
7. Remove the needle from the vial of Humalog and insert it into the vial of the longer-acting insulin. Turn the vial and syringe upside down. Hold the vial and syringe firmly in one hand and shake gently. Making sure the tip of the needle is in the insulin, withdraw the dose of longer-acting insulin.
8. Withdraw the needle and lay the syringe down so that the needle does not touch anything.
Injecting a dose: 1. Wash hands.
2. Choose a site for injection.
3. Clean the skin as instructed.
4. Stabilise the skin by spreading it or pinching up a large area. Insert the needle and inject as instructed.
5. Pull the needle out and apply gentle pressure over the injection site for several seconds. Do not rub the area.
6. Dispose of the syringe and needle safely. For an injection device use the outer needle cap, unscrew the needle and dispose of it safely.
7. Use of the injection sites should be rotated so that the same is not used more than approximately once a month.
Any unused product or waste material should be disposed of in accordance with local requirements.
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.
Humalog cartridges are to be used with a CE marked pen as recommended in the information provided by the device manufacturer.
a) Preparing a dose: Inspect the Humalog solution. It should be clear and colourless. Do not use Humalog if it appears cloudy, thickened, or slightly coloured or if solid particles are visible.
The following is a general description. 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: 1. Wash hands.
2. Choose a site for injection.
3. Clean the skin as instructed.
4. Remove outer needle cap.
5. Stabilise the skin by spreading it or pinching up a large area. Insert the needle as instructed.
6. Press the knob.
7. Pull the needle out and apply gentle pressure over the injection site for several seconds. Do not rub the area.
8. Using the outer needle cap, unscrew the needle and dispose of it safely.
9. Use of injection sites should be rotated so that the same site is not used more than approximately once a month.
c) Mixing insulins: Do not mix insulin in vials with insulin in cartridges. See Incompatibilities as previously mentioned.
KwikPen: Preparing Humalog KwikPen: Humalog is already dissolved in water, no need to mix it. But use it only if it looks like water. It must be clear, have no colour and no solid pieces in it. Check each time the patient injects himself/herself.
Getting the KwikPen ready to use (See user manual): First wash the hands. Read the instructions on how to use the pre-filled insulin pen. Follow the instructions carefully.
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 pen, these are harmless. But if the air bubbles are too large it may affect the insulin dose.
Injecting Humalog: Before making an injection, clean the skin as instructed. Inject under the skin, as instructed. Do not inject directly into a vein. After the injection, leave the needle in the skin for five seconds to make sure the patient has taken the whole dose. Do not rub the area of injection. Make sure to inject at least half an inch (1 cm) from the last injection and that the patient 'rotates' the places of injection, as what has been taught. It doesn't matter which injection site the patient uses, either upper arm, thigh, buttock or abdomen, the Humalog injection will still work quicker than soluble human insulin.
Do not administer Humalog by the intravenous route. Inject Humalog as the physician or nurse has taught. Only the physician can administer Humalog by the intravenous route. He will only do this under special circumstances such as surgery or if the patient is ill and the glucose levels are too high.
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 stop it leaking. It also stops air entering the pen and the needle clogging. Do not share the needles. Do not share the pen. Replace the cap on the pen.
Further injections: Every time the patient uses a KwikPen, 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 up. 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. Get rid of it carefully, the pharmacist or diabetes nurse will tell the patient how to do this.
Using Humalog in an infusion pump: Only certain CE-marked insulin infusion pumps may be used to infuse insulin lispro. Before infusing insulin lispro, the manufacturers instructions should be studied to ascertain the suitability or otherwise for the particular pump. Read and follow the instructions in the product literature supplied with the infusion pump.
Be sure to use the correct reservoir and catheter for the pump.
Change the infusion set every 48 hours. Use aseptic technique when inserting the infusion set.
In the event of a hypoglycaemic episode, the infusion should be stopped until the episode is resolved. If repeated or severe low blood glucose levels occur, notify the physician or clinic and consider the need to reduce or stop the insulin infusion.
A pump malfunction or obstruction of the infusion set can result in a rapid rise in glucose levels. If an interruption to insulin flow is suspected, follow the instructions in the product literature and if appropriate, notify the physician or clinic.
When used with an insulin infusion pump, Humalog should not be mixed with any other insulin.

Vial: Do not freeze. Do not expose to excessive heat or direct sunlight.
Before use: Store in a refrigerator at (2°C-8°C).
After first use: Store in a refrigerator (2°C-8°C) or below 30°C.
Shelf life: Before use: 3 years.
After first use: 28 days.
Cartridge: Unused cartridge: Store in a refrigerator at (2°C-8°C). Do not freeze. Do not expose to excessive heat or direct sunlight.
After cartridge insertion: Store below 30°C. Do not refrigerate. The pen with the inserted cartridge should not be stored with the needle attached.
Shelf life: Unused cartridge: 3 years.
After cartridge insertion: 28 days.
KwikPen: Before first use: Store in a refrigerator (2°C-8°C). Do not freeze.
In use: Keep at room temperature (15°C-30°C) and discard after 28 days. Do not put it near heat or in the sun. Do not keep the KwikPen in use in the fridge. The KwikPen should not be stored with the needle attached.
Do not use Humalog KwikPen, if the solution is coloured or it has solid pieces in it. Use it only if it looks like water. Check each time of injection.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Insulin Preparations

A10AB04 - insulin lispro ; Belongs to the class of fast-acting insulins and analogues. Used in the treatment of diabetes.

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