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Humalog Mix50 100 units/ml suspension for injection in cartridge
Humalog® Mix50™ 100 units/ml suspension for injection in cartridge
1. What Humalog Mix50 is and what it is used for
2. What you need to know before you use Humalog Mix50
3. How to use Humalog Mix50
4. Possible side effects
5. How to store Humalog Mix50
6. Contents of the pack and other information
Humalog Mix50 is used to treat diabetes. Humalog Mix50 is a premixed suspension. Its active substance is insulin lispro. 50 % of the insulin lispro in Humalog Mix50 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 is available in a suspension together with protamine sulphate, so that its action is prolonged.
You get diabetes if your pancreas does not make enough insulin to control the level of glucose in your blood. Humalog Mix50 is a substitute for your own insulin and is used to control glucose in the long term. Humalog Mix50 works very quickly and longer than soluble insulin. You should normally use Humalog Mix50 within 15 minutes of a meal.
Your doctor may tell you to use Humalog Mix50 as well as a longer-acting insulin. Each kind of insulin comes with another patient information leaflet to tell you about it. Do not change your insulin unless your doctor tells you to. Be very careful if you do change insulin.
The injection site should be rotated to prevent skin changes such as lumps under the skin. The insulin may not work very well if you inject into a lumpy area (See How to use Humalog Mix50). Contact your doctor if you are currently injecting into a lumpy area before you start injecting a different area. Your doctor may tell you to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medications dose.
Your insulin needs may change if you are taking
Please tell your doctor, if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription (see section “Warnings and precautions”).
Are you pregnant or thinking about becoming pregnant, or are you breast-feeding? The amount of insulin you need usually falls during the first three months of pregnancy and increases for the remaining six months. If you are breast-feeding, you may need to alter your insulin intake or diet. Ask your doctor for advice.
Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving a car or operating machinery). You should contact your doctor about the advisability of driving if you have:
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
The 3 ml cartridge is only for use in Lilly 3 ml pens. It is not for use in 1.5 ml pens.
Always use Humalog Mix50 exactly as your doctor has told you. You should check with your doctor if you are not sure. To prevent the possible transmission of disease, each cartridge must be used by you only, even if the needle on the delivery device is changed.
Do not mix any other insulin in a Humalog Mix50 cartridge. Once the cartridge is empty, do not use it again.
If you use more Humalog Mix50 than you need or are unsure how much you have injected, a low blood sugar may occur. Check your blood sugar.
If your blood sugar is low (mild hypoglycaemia), eat glucose tablets, sugar or drink a sugary drink. Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest. This will often get you over mild hypoglycaemia or a minor insulin overdose. If you get worse and your breathing is shallow and your skin gets pale, tell your doctor at once. A glucagon injection can treat quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If you do not respond to glucagon, you will have to go to hospital. Ask your doctor to tell you about glucagon.
If you take less Humalog Mix50 than you need or are unsure how much you have injected, a high blood sugar may occur. Check your 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 A and B in section 4 “Possible Side Effects”).
Three simple steps to avoid hypoglycaemia or hyperglycaemia are:
If you take less Humalog Mix50 than you need, a high blood sugar may occur. Do not change your insulin unless your doctor tells you to.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
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:
If you think you are having this sort of insulin allergy with Humalog Mix50, tell your 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 to you, tell your doctor.
Lipodystrophy is uncommon (≥ 1/1,000 to < 1/100). If you inject 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 you inject 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 your blood glucose.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This can be caused if:
Alcohol and some medicines can affect your blood sugar levels.
The first symptoms of low blood sugar usually come on quickly and include the following:
While you are not confident about recognising your warning symptoms, avoid situations, e.g. driving a car, in which you or others would be put at risk by hypoglycaemia.
B. Hyperglycaemia and diabetic ketoacidosis
Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin. Hyperglycaemia can be brought about by:
Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many hours or days. The symptoms include the following:
Severe symptoms are heavy breathing and a rapid pulse. Get medical help immediately.
If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change. Even when you are not eating normally, you still need insulin. Test your urine or blood, follow your ‘sick rules’, and tell your doctor.
Before the first use store your Humalog Mix50 in a refrigerator (2° C – 8° C). Do not freeze.
Keep your cartridge in use at room temperature (below 30° C) and discard after 28 days. Do not put it near heat or in the sun. Do not keep your pen or the cartridges you are using in the fridge. The pen with the inserted cartridge should not be stored with the needle attached.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and the carton. The expiry date refers to the last day of that month.
Do not use this medicine if you 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. Check each time you inject yourself.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Humalog Mix50 100 units/ml suspension for injection is a white, sterile suspension and 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 cartridge contains 300 units (3 millilitres). The cartridges come in packs of 5 or 10 cartridges. Not all pack sizes may be marketed.
Humalog Mix50 100 units/ml suspension for injection in cartridge is made by:
The product licence is held by:
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in January 2021.