Humalog Mix25/Humalog Mix50

Humalog Mix25/Humalog Mix50

insulin lispro + insulin lispro protamine

Manufacturer:

Eli Lilly

Distributor:

Zuellig
/
Agencia Lei Va Hong
Full Prescribing Info
Contents
Insulin lispro, insulin lispro protamine.
Description
Humalog Mix25/Humalog Mix50 100 units/ml KwikPen, suspension for injection is a white, sterile suspension and contains 100 units of insulin lispro in each millilitre (100 units/ml) suspension for injection. 25% and 50% of the insulin lispro in Humalog Mix25 and Humalog Mix50, respectively, is dissolved in water. 75% and 50% of the insulin lispro in Humalog Mix25 and Humalog Mix50, respectively, is available in a suspension together with protamine sulphate. Each Humalog Mix25/Humalog Mix50 KwikPen contains 300 units (3 millilitres). The Humalog Mix25/Humalog Mix50 in the KwikPen is the same as the Humalog Mix25/Humalog Mix50, which comes in separate cartridges. The KwikPen simply has a built-in cartridge. When the KwikPen is empty, it cannot be used again.
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: 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.
Indications/Uses
Humalog Mix25/Humalog Mix50 KwikPen is used to treat diabetes. It is a premixed suspension. Its active substance is insulin lispro. 25% or 50% of the insulin lispro in Humalog Mix25 or Humalog Mix50 KwikPen, respectively, is dissolved in water and it works more quickly than normal human insulin because the insulin molecule has been changed slightly. 75% or 50% of the insulin lispro in Humalog Mix25 or Humalog Mix50 KwikPen, respectively, is available in a suspension together with protamine sulphate, so that its action is prolonged.
Diabetes is developed if the pancreas does not make enough insulin to control the level of glucose in the 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. The patient should normally use Humalog Mix25/Humalog Mix50 within 15 minutes of a meal.
The doctor may advise to use Humalog Mix25/Humalog Mix50 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.
The KwikPen is a disposable pre-filled pen containing 3 ml (300 units, 100 units/ml) of insulin lispro. One KwikPen contains multiple doses of insulin. The KwikPen dials 1 unit at a time. The number of units are displayed in the dose window, always check this before injection. Units from 1 to 60 units can be given in a single injection. If the dose is more than 60 units, more than one injection should be given.
Dosage/Direction for Use
Always check the pack and the label of the pre-filled pen for the name and type of the insulin when getting it from the pharmacy.
Always use Humalog Mix25/Humalog Mix50 KwikPen exactly as the doctor's advice. Check with the doctor whenever in doubt. To prevent the possible transmission of disease, each pen must only be used by the patient, even if the needle is changed.
Dosage: Humalog Mix25 and Humalog Mix50 are normally injected within 15 minutes of a meal. It can be injected soon after a meal, if necessary. The doctor will tell 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.
Inject Humalog Mix25/Humalog Mix50 under the skin. It should not be administered using a different administration route. Under no circumstances should Humalog Mix25/Humalog Mix50 be given intravenously.
If the patient forgets to use Humalog Mix25/Humalog Mix50: If Humalog Mix25/Humalog Mix50 is taken less than necessary, a high blood sugar may occur. Check the 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 ways to avoid hypoglycaemia or hyperglycaemia are: Always keep spare syringes and a spare vial of Humalog Mix 25/Humalog Mix 50, 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 Mix25/Humalog Mix50: If Humalog Mix 25/Humalog Mix 50 is taken less than necessary, a high blood sugar may occur. Do not change insulin unless the doctor told so.
If any further questions may have arise on the use of Humalog Mix 25/Humalog Mix 50 KwikPen, ask a doctor or pharmacist.
Overdosage
If Humalog Mix25/Humalog Mix50 is taken more than necessary, a low blood sugar may occur. Check the blood sugar.
If the blood sugar is low (mild hypoglycaemia), eat glucose tablets, sugar or drink a sugary drink. Then eat fruit, biscuits, or a sandwich, as the doctor's advice and 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, tell the doctor immediately. A glucagon injection can treat quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If glucagon has no effect, the patient will have to go to a hospital.
Contraindications
Do NOT use Humalog Mix25/Humalog Mix50 KwikPen: In case hypoglycaemia (low blood sugar) develops (see Dosage & Administration).
If the patient is allergic (hypersensitive) to insulin lispro or any of the other ingredients of this medicine (listed in Description).
Special Precautions
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. Also 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, 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.
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), 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.
Driving and using machines: The patient's ability to concentrate and react may be reduced 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).
Contact the doctor about the advisability of driving in case of: frequent episodes of hypoglycaemia; reduced or absent warning signs of hypoglycaemia.
Use In Pregnancy & Lactation
Pregnancy and breast-feeding: The amount of insulin needed usually falls during the first three months of pregnancy and increases for the remaining six months. Alter insulin intake or diet when breast-feeding.
Ask the doctor for advice.
Side Effects
Like all medicines, Humalog Mix25/Humalog Mix50 can cause side effects, although not everybody gets them.
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, tell the doctor.
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 Mix25/Humalog Mix50, tell the doctor at once.
Lipodystrophy (thickening or pitting of the skin) is uncommon (≥1/1,000 to <1/100). If there is skin thickening or pitting at the injection site, tell the doctor.
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 the patient gets any side effects, talk to the doctor or pharmacist. This includes any possible side effects not previously listed. The patient 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: The patient takes too much Humalog Mix25/Humalog Mix50 or other insulin; the patient misses or delays meals or change of diet; the patient exercises or works too hard just before or after a meal; the patient has an infection or illness (especially diarrhoea or vomiting); there is a change in the need for insulin; or the patient has trouble with 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.
While the patient is not confident about recognising any warning symptoms, avoid situations, e.g. driving a car, in which the patient 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 the doctor prescribed; eating a lot more than the diet allows; or fever, infection or hormonal 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 rapid pulse. Get medical help immediately.
Illness: If the patient is ill, especially if feeling sick or is sick, the amount of insulin needed may change. Even when the patient is not eating normally, insulin is still needed. Urine or blood tests should be done, 'sick rules' should be followed, and inform the doctor.
Drug Interactions
Insulin needs may change if taken with the contraceptive pills, steroids, thyroid hormone replacement therapy, oral hypoglycaemics, acetyl salicylic acid, sulpha antibiotics, octreotide, beta2-stimulants (for example ritodrine, salbutamol or terbutaline), beta-blockers, or 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.
If any of these drugs are being taken or have recently been taken, including medicines obtained without prescription, inform the doctor (see Precautions).
Caution For Usage
Preparing Humalog Mix25/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. Check each time of injection.
Getting the KwikPen ready to use: First, wash hands.
Read the instructions on how to use the pre-filled 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 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 that the whole dose was delivered. Do not rub the site of injection. Make sure that the injection is at least half an inch (1 cm) from the last site and a rotation in injection site should be made.
After injection: Unscrew the needle from the KwikPen using the outer needle cap, as soon as the injection is done. This will keep the insulin sterile and stop it from leaking. It also stops air entering the pen and the needle from clogging. Do not share needles. Do not share the pen. Replace the cap on the pen.
Futher injections: Always use a new needle for every use. Before every injection, clear any air bubbles. The insulin doses left can be seen 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. Discard it carefully, the pharmacist or diabetes nurse will instruct how to do this.
Do not use Humalog Mix25/Humalog Mix50 KwikPen, 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. Check each time of injection.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist on how to dispose of medicines no longer required. These measures will help to protect the environment.
Storage
Before the first use, store Humalog Mix25/Humalog Mix50 KwikPen in a refrigerator (2°C-8°C). Do not freeze.
Keep the used Humalog Mix25/Humalog Mix50 KwikPen at room temperature (15°-30°C) and discard after 28 days. Do not put near heat or in the sun. Do not keep in the fridge. The KwikPen should not be stored with the needle attached.
ATC Classification
A10AD04 - insulin lispro ; Belongs to the class of intermediate-acting combined with fast-acting insulins and analogues. Used in the treatment of diabetes.
Presentation/Packing
Humalog Mix25 susp for inj (pre-filled pen) 100 u/mL (white, sterile suspension) x 3 mL x 5's. Humalog Mix50 susp for inj (pre-filled pen) 100 u/mL (white, sterile suspension) x 3 mL x 5's.
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