Mixtard is human insulin to treat diabetes. Mixtard is a mixture of fast-acting insulin and long-acting insulin. This means that it will start to lower your blood sugar about half an hour after you take it, and the effect will last for approximately 24 hours.
Do not use Mixtard
Take special care with Mixtard
Using other medicines
Many medicines affect the way glucose works in your body and they may influence your insulin dose. Listed below are the most common medicines which may affect your insulin treatment. Talk to your doctor or pharmacist if you take or have recently taken any other medicines, even those not prescribed.
Your need for insulin may change if you also take: oral antidiabetic products; monoamine oxidase inhibitors (MAOI); beta-blockers; ACE-inhibitors; acetylsalicylic acid; anabolic steroids;
sulphonamides; oral contraceptives; thiazides; glucocorticoids; thyroid hormone therapy; beta-sympathomimetics; growth hormone; danazol; octreotide or lanreotide.
Pioglitazone (oral antidiabetic medicine used for the treatment of type 2 diabetes mellitus)
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. Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).
Pregnancy and breast-feeding
If you are pregnant, planning a pregnancy or breast-feeding: please contact your doctor for advice.
Driving and using machines
If you drive or use tools or machines: watch out for signs of a hypo. Your ability to concentrate or to react will be less during a hypo. Never drive or use machinery if you feel a hypo coming on. Discuss with your doctor whether you can drive or use machines at all, if you have a lot of hypos or if you find it hard to recognise hypos.
Talk about your insulin needs with your doctor and nurse. Follow their advice carefully. This leaflet is a general guide.
If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor.
Eat a meal or snack containing carbohydrates within 30 minutes of the injection.
It is recommended that you measure your blood glucose regularly.
See overleaf for detailed instructions.
Before using Mixtard
Do not use Mixtard
Mixtard is for injection under the skin (subcutaneously). Never inject your insulin directly into a vein or muscle. Always vary the sites you inject, to avoid lumps (see 5 Possible side effects). The best places to give yourself an injection are: the front of your waist (abdomen); your buttocks; the front of your thighs or upper arms. Your insulin will work more quickly if you inject it around the waist.
Like all medicines, Mixtard can cause side effects, although not everybody gets them. Mixtard may cause hypoglycaemia (low blood sugar). See the advice in 4 What to do in an emergency.
Side effects reported uncommonly (in less than 1 patient in 100)
Changes at the injection site (Lipodystrophy). If you inject yourself too often at the same site, fatty tissue under the skin at this site may shrink (lipoatrophy) or thicken (lipohypertrophy). Changing the site with each injection may help to prevent such skin changes. If you notice your skin pitting or thickening at the injection site, tell your doctor or nurse because these reactions can become more severe, or they may change the absorption of your insulin if you inject in such a site.
Signs of allergy. Reactions (redness, swelling, itching) at the injection site may occur (local allergic reactions). These usually disappear after a few weeks of taking your insulin. If they do not disappear, see your doctor.
Seek medical advice immediately:
- if signs of allergy spread to other parts of the body, or
- if you suddenly feel unwell and you start sweating; start being sick (vomiting); have difficulty in breathing; have a rapid heart beat; feel dizzy; feel like fainting. You may have a very rare serious allergic reaction to Mixtard or one of its ingredients (called a systemic allergic reaction). See also warning in 2 Before you use Mixtard.
Diabetic retinopathy (eye background changes). If you have diabetic retinopathy and your blood glucose levels improve very fast, the retinopathy may get worse. Ask your doctor about this.
Swollen joints. When you start taking insulin, water retention may cause swelling around your ankles and other joints. This soon disappears.
Painful neuropathy (nerve related pain). If your blood glucose levels improve very fast it may cause a burning, tingling or electric pain. This is called acute painful neuropathy and it usually disappears. If it does not disappear, see your doctor.
Side effects reported very rarely (in less than 1 patient in 10,000)
Vision problems. When you first start your treatment, it may disturb your vision, but the reaction usually disappears.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
Keep out of the reach and sight of children.
Do not use Mixtard after the expiry date which is stated on the label and the carton. The expiry date refers to the last day of that month.
The FlexPen that is not being used is to be stored in a refrigerator (2°C - 8°C).
Do not store them in or too near the freezer section or cooling element.
Do not freeze.
The FlexPen that is being used, about to be used or carried as a spare is not to be kept in a refrigerator. After removing theFlexPen from the refrigerator it is recommended to let it reach room temperature before resuspending the insulin as instructed for the first time use. See 3 How to use Mixtard. You can carry it with you and keep it at room temperature (not above 30-C) for up to 6 weeks. Always keep the pen cap on your FlexPen when you’re not using it in order to protect it from light.
Mixtard must be protected from excessive heat and sunlight.
Mixtard 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.
Mixtard is a range of insulin suspensions for injection. Mixtard is supplied in vials, cartridges (PenFill) or pre-filled pens (NovoLet, FlexPen or InnoLet). Mixtard contains the active substance insulin human (rDNA). Mixtard contains both fast-acting (soluble) and long-acting (isophane) insulin:
- Mixtard 10: soluble insulin 10% and isophane insulin 90%,
- Mixtard 20: soluble insulin 20% and isophane insulin 80%,
- Mixtard 30: soluble insulin 30% and isophane insulin 70%,
- Mixtard 40: soluble insulin 40% and isophane insulin 60%,
- Mixtard 50: soluble insulin 50% and isophane insulin 50%.
Mixtard is used in patients with diabetes.
The medicine can only be obtained with a prescription.
Mixtard is given subcutaneously (under the skin) by injection, usually in the abdominal wall (tummy). If convenient it may also be given in the gluteal region (buttocks) or the deltoid region (shoulder). The patient's blood glucose (sugar) should be tested regularly to find the lowest effective dose. The usual dose is between 0.3 and 1.0 international units (IU) per kilogram body weight per day. Mixtard is usually given once or twice a day when a rapid initial effect together with a more long-lasting effect is needed.
Diabetes is a disease in which the body does not produce enough insulin to control the blood glucose. Mixtard is a replacement insulin which is identical to the insulin made by the pancreas. The active substance in Mixtard, insulin human (rDNA), is produced by a method known as ‘recombinant technology’: the insulin is made by a yeast that has received a gene (DNA), which makes it able to produce insulin. Mixtard contains insulin in two forms: the soluble form, which acts quickly (within 30 minutes of injection) and the ‘isophane’ form which is absorbed much more slowly during the day.
This gives Mixtard a longer duration of action. The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood. By controlling the blood glucose, the symptoms and complications of diabetes are reduced.
Mixtard has been studied in a total of 294 patients with type 1 diabetes,when the pancreas cannot produce insulin, and type 2 diabetes, when the body is unable to use insulin effectively. About one-third of the patients had type 1 diabetes and the remainder had type 2 diabetes. The study compared Mixtard 30 to a similar mix, but made up using an insulin analogue (insulin aspart). The study measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c) after 12 weeks, which gives an indication of how well the blood glucose is controlled.
Mixtard led to a decrease in the level of HbA1c, indicating that blood glucose levels had been controlled to a similar level to that seen with other human insulin. Mixtard was effective for both type 1 and type 2 diabetes.
As with all insulins, Mixtard may cause hypoglycaemia (low blood glucose). For the full list of all side effects reported with Mixtard, see the Package Leaflet.
Mixtard should not be used in people who may be hypersensitive (allergic) to insulin human (rDNA) or to any of the other ingredients. Mixtard doses might also need to be adjusted when given with a number of other medicines which may have an effect on blood glucose. The full list is available in the Package Leaflet.
The Committee for Medicinal products for Human Use (CHMP) decided that Mixtard’s benefits are greater than its risks for the treatment of diabetes. The Committee recommended that Mixtard be given marketing authorisation.
The European Commission granted a marketing authorisation valid throughout the European Union, for Mixtard to Novo Nordisk A/S on 7 October 2002. The marketing authorisation was renewed on 7 October 2007.