Humalog Mix25/Humalog Mix50

Insulin lispro, insulin lispro protamine.

Humalog Mix25/Humalog Mix50 suspension for injection is a white, sterile suspension. It is a premixed suspension.
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.
The other ingredients are protamine sulphate, m-cresol, phenol, glycerol, dibasic sodium phosphate 7H₂O, zinc oxide and water for injection. Sodium hydroxide or hydrochloric acid may have been used to adjust the acidity.
The KwikPen is a disposable pre-filled pen. One KwikPen contains multiple doses of insulin. The KwikPen dials 1 unit at a time. The number of units is displayed in the dose window and should always be checked before injection. A single injection can deliver from 1 to 60 units. If the dose is more than 60 units, more than one injection will need to be given.
Humalog Mix25: Humalog Mix25 contains 100 units of insulin lispro in each millilitre (100 units/ml) suspension for injection. 25% of the insulin lispro in Humalog Mix25 is dissolved in water. 75% of the insulin lispro in Humalog Mix25 is available in a suspension together with protamine sulphate. Each Humalog Mix25 KwikPen contains 300 units (3 millilitres).
Humalog Mix50: Humalog Mix50 contains 100 units of insulin lispro in each millilitre (100 units/ml) suspension for injection. 50% of the insulin lispro in Humalog Mix50 is dissolved in water. 50% of the insulin lispro in Humalog Mix50 is available in a suspension together with protamine sulphate. Each Humalog Mix50 KwikPen contains 300 units (3 millilitres).

Humalog Mix25: The active substance of Humalog Mix25 is insulin lispro. 25% of the insulin lispro in Humalog Mix25 KwikPen is dissolved in water and it works more quickly than normal human insulin because the insulin molecule has been changed slightly. 75% of the insulin lispro in Humalog Mix25 KwikPen is available in a suspension together with protamine sulphate, so that its action is prolonged.
Humalog Mix50: The active substance of Humalog Mix50 is insulin lispro. 50% of the insulin lispro in Humalog Mix50 KwikPen is dissolved in water and it works more quickly than normal human insulin because the insulin molecule has been changed slightly. 50% of the insulin lispro in Humalog Mix50 KwikPen is available in a suspension together with protamine sulphate, so that its action is prolonged.

Humalog Mix25 KwikPen/Humalog Mix50 KwikPen is used to treat diabetes.
Patients get diabetes if their pancreas does not make enough insulin to control the level of glucose in their blood. Humalog Mix25/Humalog Mix50 is a substitute for the patient's own insulin and is used to control glucose in the long term. Humalog Mix25/Humalog Mix50 works very quickly and longer than soluble insulin. Humalog Mix25/Humalog Mix50 should normally be used within 15 minutes of a meal.
Patients may be prescribed to use Humalog Mix25 KwikPen/Humalog Mix50 KwikPen as well as a longer-acting insulin. Each kind of insulin comes with another patient information leaflet. Patients should not change their insulin unless advised by their doctor. They should be very careful if they do change insulin.

Patients should always use Humalog Mix25 KwikPen/Humalog Mix50 KwikPen exactly as advised by their doctor. Patients should check with their doctor if they are not sure. To prevent the possible transmission of disease, each pen must be used by one patient only, even if the needle is changed.
Dose: Humalog Mix25/Humalog Mix50 should normally be injected within 15 minutes of a meal. If needed, it can be injected soon after a meal. Patients will be advised exactly how much to use, when to use it, and how often. These instructions are only for the individual patient. Patients should follow them exactly and visit their diabetes clinic regularly.
If patients change the type of insulin they use (for example from a human or animal insulin to a Humalog product), they 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 Mix25 KwikPen/Humalog Mix50 KwikPen is only suitable for injecting just under the skin. Patients should speak to their doctor if they need to inject their insulin by another method.
Preparing Humalog Mix25 KwikPen/Humalog Mix50 KwikPen: The KwikPen should be rotated in the palms of the hands ten times and inverted 180° ten times immediately before use to resuspend insulin until it appears uniformly cloudy or milky. If not, repeat the previously mentioned 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 it a frosted appearance. Patients should check each time they inject themselves.
Getting the KwikPen ready to use: 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 Mix25/Humalog Mix50: Before an injection is made, clean the skin as instructed. Inject under the skin as taught. Do not inject directly into a vein. After the injection, leave the needle in the skin for five seconds to make sure the whole dose has been taken. Do not rub the area just injected. Make sure to inject at least half an inch (1 cm) from where the last injection was and to 'rotate' the places injected, as taught.
After injecting: As soon as the injection has been done, 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 a KwikPen is used, a new needle must be used. Before every injection, clear any air bubbles. Hold the KwikPen with the needle pointing up to see how much insulin is left. The scale on the cartridge shows about how many units there 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 advise on how to do this.
Patients who forget to use Humalog Mix25/Humalog Mix50: If patients take less Humalog Mix25/Humalog Mix50 than they need or are unsure how much they have injected, a high blood sugar may occur. Patients should check their blood sugar.
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 steps to avoid hypoglycaemia or hyperglycaemia: Always keep a spare pen and cartridges, in case of losing or damaging the KwikPen. Always carry something to show diabetic status. Always carry sugar.
Patients who stop using Humalog Mix25/Humalog Mix50: If patients take less Humalog Mix25/Humalog Mix50 than they need, a high blood sugar may occur. Patients should not change their insulin unless their doctor tells them to.

If patients use more Humalog Mix25/Humalog Mix50 than they need or are unsure how much they have injected, a low blood sugar may occur. Patients should check their blood sugar.
Patients whose blood sugar is low (mild hypoglycaemia) should eat glucose tablets, sugar or drink a sugary drink. Then they should eat fruit, biscuits, or a sandwich, as advised by their doctor, and have some rest. This will often get patients over mild hypoglycaemia or a minor insulin overdose. Patients who get worse and whose breathing is shallow and whose skin gets pale should seek medical advice at once. A glucagon injection can treat quite severe hypoglycaemia. Patients should eat glucose or sugar after the glucagon injection. Patients who do not respond to glucagon will have to go to hospital.

Humalog Mix25 KwikPen/Humalog Mix50 KwikPen should NOT be used in patients who think hypoglycaemia (low blood sugar) is starting. See Overdosage for information on how to deal with mild hypoglycaemia.
Humalog Mix25 KwikPen/Humalog Mix50 KwikPen should NOT be used in patients who are allergic to insulin lispro or any of the other ingredients of this medicine (listed in Description).

Patients should always check the pack and the label of the pre-filled pen for the name and type of the insulin when they get it from their pharmacy. Patients should make sure they get the Humalog Mix25 KwikPen/Humalog Mix50 KwikPen that their doctor has told them to use.
Patients whose blood sugar levels are well controlled by their current insulin therapy may not feel the warning symptoms when their blood sugar is falling too low. Patients must think carefully about when to have their meals, how often to exercise and how much to do. Patients must also keep a close watch on their blood sugar levels by testing their 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. Patients who often have hypoglycaemia or have difficulty recognising them should have a discussion with their doctor.
Patients who have recently become ill, who have trouble with their kidneys or liver, or who are exercising more than usual should seek medical advice from their doctor, pharmacist or diabetes nurse.
The amount of insulin needed may also change if patients drink alcohol.
Patients should also tell their doctor, pharmacist or diabetes nurse if they are planning to go abroad. The time difference between countries may mean that patients have to have their injections and meals at different times from when they are at home.
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. Patients should inform their doctor as soon as possible if they experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).
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 is injected into a lumpy area (see Side Effects). Patients should contact their doctor if they are currently injecting into a lumpy area before they start injecting a different area. Patients may be advised to check their blood sugar more closely, and to adjust the dose of their insulin or other antidiabetic medications.
Humalog Mix25 KwikPen/Humalog Mix50 KwikPen contains sodium: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.
Driving and using machines: The ability to concentrate and react may be reduced in patients who have hypoglycaemia. This possible problem should be kept in mind in all situations where patients might put themselves and others at risk (e.g. driving a car or operating machinery). Patients should contact their doctor about the advisability of driving if they have: frequent episodes of hypoglycaemia; reduced or absent warning signs of hypoglycaemia.

The amount of insulin needed usually falls during the first three months of pregnancy and increases for the remaining six months. Patients who are breast-feeding may need to alter their insulin intake or diet. Seek medical advice.

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 patients think they are having this sort of insulin allergy with Humalog Mix25/Humalog Mix50, they should tell their 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, patients should tell their doctor.
Lipodystrophy is uncommon (≥1/1,000 to <1/100). If insulin is injected 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 is 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 the blood glucose.
Reporting of side effects: If patients get any side effects, they should talk to their doctor or pharmacist. This includes any possible side effects not previously listed. Patients can also report side effects directly via the Drug Office, Department of Health. By reporting side effects patients 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 Mix25/Humalog Mix50 or other insulin; patients miss or delay meals or change their 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 their kidneys or liver which gets worse.
Alcohol and some medicines can affect the 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 patients are not confident about recognising their warning symptoms, they should avoid situations, e.g. driving a car, in which they or others would be put at risk 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 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.
Illness: If patients are ill, especially if they feel sick or are sick, the amount of insulin they need may change. Even when patients are not eating normally, they still need insulin. Patients should test their urine or blood, follow their 'sick rules', and tell their doctor.

Insulin needs may change if patients are taking the contraceptive pill, steroids, thyroid hormone replacement therapy, oral hypoglycaemics, acetyl salicylic acid, sulpha antibiotics, octreotide, "beta₂ stimulants" (for example ritodrine, salbutamol or terbutaline), beta-blockers, some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors), danazol, some angiotensin converting enzyme (ACE) inhibitors (for example captopril, enalapril), and angiotensin II receptor blockers.
Patients should tell their doctor if they are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Patients should not use this medicine if they notice clumps of material are present or if solid white particles stick to the bottom or wall of the cartridge, giving it a frosted appearance. Patients should check each time they inject themselves.
Medicines should not be disposed of via wastewater or household waste. Patients should ask their pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Before the first use store Humalog Mix25 KwikPen/Humalog Mix50 KwikPen in a refrigerator (2°C - 8°C). Do not freeze.
Keep Humalog Mix25 KwikPen/Humalog Mix50 KwikPen in use 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 being used in the fridge. The KwikPen should not be stored with the needle attached.

Insulin Preparations

A10AD04 - insulin lispro ; Belongs to the class of intermediate-acting combined with fast-acting insulins and analogues. Used in the treatment of diabetes.

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