HUMALOG MIX 25,300 IU 3 ml

HUMALOG MIX25 WHAT IS AND WHAT IT IS USED

Humalog Mix25 is used to treat diabetes. Humalog Mix25 is a premixed suspension. The active substance is insulin lispro. 25% insulin lispro in Humalog Mix25 is dissolved in water and act more quickly than regular insulin because the insulin molecule has been changed slightly. 75% insulin lispro in Humalog Mix25 are in suspension with protamine sulphate, so that its action is prolonged.

You get diabetes if your pancreas does not produce enough insulin to control the level of glucose in the blood. Humalog Mix25 substitute for your own use insulin to control glucose for prolonged periods. Humalog Mix25 run faster and longer time compared to regular insulin. You should normally use Humalog Mix25 within 15 minutes before eating.

Your doctor may advise you to use Humalog Mix25, as well as longer-acting insulin. Each kind of insulin with another leaflet, which explains its properties. Do not change your insulin unless your doctor tells you to. Be very careful if you change your insulin.

 BEFORE YOU USE HUMALOG MIX25

Do not use Humalog Mix25

If you think hypoglycaemia (low blood sugar). Later in this leaflet explains what to do with mild hypoglycaemia.

if you are allergic (hypersensitive) to insulin lispro or any of the other ingredients of Humalog Mix25.

Take special care during treatment with Humalog Mix25

If your blood sugar levels are well controlled by current insulin therapy, you may not feel the warning symptoms when blood sugar levels fall too low. Warning signs are listed later in this leaflet. Must think carefully about when to eat, how often and intensely active. You should carefully monitor the levels of your blood sugar through frequent blood glucose measurement.

Few people who have experienced hypoglycaemia after transfer from animal insulin to human insulin have reported that early warning symptoms were less obvious or different. If you often have hypoglycaemia or have difficulty recognizing it, please discuss this with your doctor.

If you answer YES to any of the following questions, tell your doctor, pharmacist or nurse.

Have you recently become ill?

Do you have problems with your kidneys or liver?

Are you receiving more exercise than usual.

The amount of insulin you need may change if you drink alcohol.

You should also tell your doctor, pharmacist or nurse if you plan to travel abroad. The time difference between countries may mean that you have to have your injections and meals at different times than 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. Tell 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 localized swelling (edema).

Taking other medicines

Your insulin needs may change if you take birth control pills, steroids, hormone replacement therapy thyroid, oral hypoglycaemics, aspirin, antibiotics containing a "sulfa" group, octreotide, "beta-2-stimulant "(eg ritodrine, salbutamol or terbutaline), beta-blockers or certain antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake), danazol, some angiotensin converting (ACE) inhibitors (eg, captopril, enalapril) and angiotensin blockers II receptors.

Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and lactation

Are you pregnant or thinking about becoming pregnant, or breastfeeding? The amount of insulin you need usually falls during the first three months of pregnancy and the remaining six months. If you are breastfeeding you may need to change your insulin intake or diet.

Ask your doctor.

Driving and operating machinery

Ability to concentrate and react may be reduced if you have hypoglycaemia. Please note this in all situations where you might put yourself and others at risk (eg driving a car or operating machinery). You should contact your doctor about the advisability of driving if you have:

frequent episodes of hypoglycemia;

reduced or absent warning signs of hypoglycemia.

 HOW TO USE HUMALOG MIX25

3 ml cartridge for use with pens of 3 ml. They should not be used with pen 1,5 ml.

Always check the packaging and cartridge label for the name and type of insulin when you get it from your pharmacy. Make sure you get the Humalog Mix25, which tells you your doctor.

Always use Humalog Mix25 exactly as your doctor has told you. If you're not sure, ask your doctor.

Dosage

Should normally inject Humalog Mix25 15 minutes before eating. If you need to inject it immediately after eating. But your doctor will tell you exactly how much to use, when to use it and how often. These instructions are only for you. Follow them exactly and visit your diabetes clinic regularly.

If you change the type of insulin you use (for example, from a human or animal insulin product Humalog-ov), maybe you should not take more or less than before. This may be just the first dose or may be a gradual change over several weeks or months.

Inject Humalog Mix25 skin. You should not use it otherwise. Under no circumstances should Humalog Mix25 be given intravenously.

Preparing Humalog Mix25

Before using Humalog Mix25 cartridges should be rotated between the palms of the hands and rotate 180 ° ten times the insulin to be mixed so that it is uniformly cloudy or milky. If not, repeat the above procedure until contents are mixed. Cartridges contain a small glass bead to assist mixing. Do not shake vigorously as this can lead to the formation of foam that will prevent proper titration. Cartridges should be checked frequently and should not be used if there are clumps or on the walls or bottom if solid white particles, giving a frosted appearance. Check each time you inject.

Making use of the pen

First wash your hands. Disinfect the rubber membrane of the cartridge.

You should use Humalog Mix25 cartridges compatible with pen mark. Please make sure that Humalog or Lilly cartridges are mentioned in the leaflet accompanying your pen. 3 ml cartridges are suitable only for pens of 3 ml.

Follow the instructions that come with the pen. Insert the cartridge.

Adjust the dose of 1 or 2 units. Then hold the pen with the needle pointing up and tap the pen so that any bubbles float to the top. As you continue to hold the pen still pointing up, press the injection mechanism. Do this until a drop of Humalog Mix25 needle. There may be still be some small air bubbles in the pen. They are harmless, but if the air bubble is too big, it can make dose injection less accurate.

Injection of Humalog Mix25

Before you make an injection, clean your skin as you were taught. Inject under the skin, as you said. Do not inject directly into a vein. After your injection, leave the needle in the skin for five seconds to make sure that you take the entire dose. Do not rub the area you have just shot. Make sure you inject at least half an inch (1 cm) from the last injection, and that change injection sites, as you have been taught.

After injection

At the moment the injection, unscrew the needle from the pen using the outer needle cap. This will keep the Humalog Mix25 sterile and prevent leaking. It also stops air entering the pen and the needle clogging. Do not share your needles. Do not share your pen. Put the cap back on your pen.

Further injections

Leave cartridge. Before each injection, dial 1 or 2 units and press the pen up until a drop of Humalog Mix25 the needle. You can see how much Humalog is left by looking at the gauge on the side of the cartridge. The distance between the bars is about 20 units. If there is not enough for your dose, change the cartridge.

Do not mix any other insulin in cartridges Humalog Mix25. Once the cartridge is empty, do not use it again.

If you use more than the amount of Humalog Mix25

If you use more Humalog Mix25, than you need may occur lower blood sugar. Check your blood sugar. If your blood sugar is low, eat glucose tablets, sugar or drink a sugary drink. Then eat fruit, biscuits or a sandwich, as your doctor has advised and rest. In most cases, this will help you over mild hypoglycaemia or low insulin overdose. If you feel worse and your breathing is shallow and your skin gets pale, tell your doctor. Too severe hypoglycemia can be treated with glucagon injection. Eat glucose or sugar after the glucagon injection. If you do not respond to glucagon, you will need to go to hospital. Ask your doctor to tell you about glucagon.

If you forget to use Humalog Mix25

If you take less Humalog Mix25, than you need may occur high blood sugar. Check your blood sugar.

If hypoglycaemia (low blood sugar) or hyperglycemia (high blood sugar) are 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").

Always keep a spare syringe and spare bottles with Humalog Mix25, or a spare pen and cartridges, in case you lose your pen or cartridges or they get damaged.

Always carry something to show you are diabetic.

Always carry sugar with you.

If you stop using Humalog Mix25

If you take less Humalog Mix25, than you need may occur high blood sugar. Do not change your insulin you, unless your doctor tells you.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

POSSIBLE SIDE EFFECTS

Like all medicines, Humalog Mix25 can cause side effects, although not everybody gets them.

Local allergy is common (> = 1/100 to <1/10): Some people experience redness, swelling or itching around the injection of insulin. Usually it clears up in a few days to a few weeks. If this happens to you, tell your doctor.

Systemic allergy is rare (> = 1/10, 000 to <1/1, 000). Symptoms are:

rash all over the body;

difficulty breathing;

wheezy breathing;

drop in blood pressure;

fast heartbeat;

sweating.

If you think you have this type of insulin allergy with Humalog Mix25, tell your doctor immediately.

Lipodystrophy (thickening or pitting of the skin) is uncommon (> = 1/1, 000 to <1/100). If you notice a thickening or pitting at the injection site, tell your doctor.

If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

Problems of diabetes

A. Hypoglycaemia

Hypoglycemia (low blood sugar) means that there is enough sugar in the blood. It can be caused if:

take too much Humalog Mix25 or other insulin;

miss or delay meals or change your diet;

exercise or work too hard just before or after a meal;

you have an infection or illness (especially diarrhea or vomiting);

a change in your insulin;

have problems with your kidneys or liver, which gets worse.

Alcohol and some drugs can affect your levels of blood sugar.

The first symptoms of low blood sugar usually come on quickly and include:

fatigue;

nervousness or tremor;

headache;

fast heartbeat;

feeling sick;

cold sweat.

Until you are confident that you can recognize your warning symptoms, avoid situations such as driving in which you or others would be put at risk by hypoglycaemia.

B. Hyperglycaemia and diabetic ketoacidosis

Hyperglycemia (too much glucose in the blood) means that your body does not have enough insulin. Hyperglycemia may be caused by the fact that:

do not take Humalog, designed for you or other insulin;

taking less insulin than you have been told by your doctor;

Food is much more than your diet allows;

fever, infection or emotional stress.

Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms appear slowly over many hours or days. Symptoms include the following:

drowsiness;

flushed face;

thirst;

lack of appetite;

breath smell of fruit;

feeling sick or vomiting.

Severe symptoms are heavy breathing and a rapid pulse. Seek medical help immediately.

C. Illness

If you are sick / on, especially if you feel sick or are sick /, the amount of insulin you need may change. Even if you are not eating normally, you need insulin. Test your urine or blood, follow your "rules of the disease" and tell your doctor.

 HOW TO STORE HUMALOG MIX25

Before use, store Humalog Mix25, designed for you in a refrigerator (2 ° C - 8 ° C). Do not freeze. Keep the cartridge in use at room temperature (15-30 ° C) and discard after 28 days. Do not put it near sources of heat and light. The pen or the cartridges you are using in the refrigerator. Pen with a cartridge must be stored with the needle attached.

Keep out of reach of children.

Do not use Humalog Mix25 after the expiry date stated on the label and carton. The expiry date refers to the last day of that month.

Do not use Humalog Mix25, if there is a "rags" or if solid white particles stick to the surface or wall of the cartridge looks frosted. Check each time you inject.

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.

 ADDITIONAL INFORMATION

What Humalog Mix25 100U/ml suspension for injection in a cartridge

The active substance is insulin lispro. Insulin lispro is made in the laboratory by a 'recombinant DNA technology' process. This is a modified form of human insulin and is therefore different from other human and animal insulins. Insulin lispro is closely related to human insulin, which is a natural hormone produced 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 be used to adjust acidity.

How does Humalog Mix25 100U/ml, suspension for injection in a cartridge and contents of the pack

Humalog Mix25 100U/ml, suspension for injection is a white, sterile suspension and contains 100 units of insulin lispro in each milliliter (100 U / ml) suspension for injection. 25% insulin lispro in Humalog Mix25 is dissolved in water. 75% insulin lispro in Humalog Mix25 is in suspension with protamine sulfate. Each cartridge contains 300 units (H milliliters). Cartridges come in packs of 5 cartridges or a pack of 2 x 5 cartridges.

Not all pack sizes may be marketed.