Polhumin Mix-2

Leaflet attached to the packaging: patient information

Polhumin Mix-2, 100 IU/ml, suspension for injection
Human insulin

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Polhumin Mix-2 and what is it used for
• 2. Important information before using Polhumin Mix-2
• 3. How to use Polhumin Mix-2
• 4. Possible side effects
• 5. How to store Polhumin Mix-2
• 6. Contents of the packaging and other information

1. What is Polhumin Mix-2 and what is it used for

Polhumin Mix-2 is human insulin used to treat diabetes. This insulin is produced using genetic engineering techniques (DNA recombination) in Escherichia colibacteria. It is identical to the insulin produced by the human body.
Insulin is a hormone produced in the human body by the pancreas. It is involved in carbohydrate, fat, and protein metabolism, causing, among other things, a decrease in blood glucose levels.
The cause of diabetes is the pancreas' inability to produce insulin in quantities that allow for blood glucose control.
Polhumin Mix-2 is a medium-acting insulin. This means that the onset of action, which is the reduction of blood sugar levels, occurs about 30 minutes after injection, the maximum effect occurs after 2-8 hours, and the total duration of action is up to 24 hours.
The medicine is available in a 3 ml cartridge and is intended for use with an injector.
Warning!Other products must not be mixed with insulin in the cartridge. Insulin must not be administered with other medicines in the same syringe.

2. Important information before using Polhumin Mix-2

When not to use Polhumin Mix-2

• if the patient is allergic to this insulin or any of the other ingredients of this medicine (listed in section 6).
• if the patient has symptoms that may indicate impending hypoglycemia (low blood sugar levels).

Warnings and precautions

• If the current treatment provides good diabetes control, warning signs of excessive blood sugar reduction (hypoglycemia - see below) may not be felt. It is necessary to plan meals, physical activity, and overall activity level carefully. It is also necessary to monitor blood sugar levels by performing frequent blood glucose tests.

and overall activity level. It is also necessary to monitor blood sugar levels by performing frequent blood glucose tests.

• Some people who have changed from animal insulin to human insulin and have experienced hypoglycemia (low blood sugar) have reported that the warning signs of hypoglycemia were less pronounced or different from before. If hypoglycemia occurs frequently or there are difficulties in recognizing the warning signs of hypoglycemia, consult a doctor.
• The need for insulin may also change after consuming alcohol.
• If the patient plans to travel abroad, they should inform their doctor. The time difference may require injections and meals to be taken at different times.
• If the patient has kidney or liver disease, they should inform their doctor. The doctor will adjust the insulin dose accordingly. It should be remembered that in many disease states (e.g., liver disease, kidney disease, adrenal gland disease, pituitary disease, colds) and stressful situations, significant fluctuations in blood sugar levels may occur, which can lead to complications of insulin therapy: hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar).

Polhumin Mix-2 in cartridges is intended for subcutaneous injection only using a reusable injector. If it is necessary to administer insulin by another method, consult a doctor.
Skin changes at the injection site
It is necessary to change the injection site to prevent skin changes, such as lumps under the skin. Insulin injected into an area with lumps may not work properly (see "How to use Polhumin Mix-2"). If insulin is currently being injected into an area with lumps, consult a doctor before changing the site. The doctor may recommend more frequent blood glucose monitoring and adjusting the insulin dose or other anti-diabetic medicines.

• Hypoglycemia(low blood sugar) may be caused by administering too much insulin, delaying or missing a meal, reducing carbohydrate intake, increasing physical activity, or increasing the rate of insulin absorption (e.g., due to increased skin temperature during sunbathing or taking a hot bath). The symptoms of hypoglycemia are: excessive sweating, weakness, hunger, palpitations, feeling cold, feeling anxious, trembling hands, vision disturbances, headaches, and in more severe cases - disorientation, convulsions, loss of consciousness. Warning!In case of recurring hypoglycemia, consult a doctor to determine the cause of the low blood sugar and possible adjustment of the insulin dose. Do not give anything to eat or drink to an unconscious person, as they may choke. An unconscious person should be placed on their side and immediate medical attention should be sought. If treatment for severe hypoglycemia is not started, it may cause temporary or permanent brain damage or death.
• Hyperglycemia.Abnormal, elevated blood glucose levels that occur during insulin treatment are usually due to: not following a diabetic diet, inadequate insulin therapy (too low a dose of insulin), increased demand for insulin (infectious diseases, surgery, injuries), changes in lifestyle (reduced physical activity), as well as taking other medicines, such as oral contraceptives, glucocorticosteroids, or thiazide diuretics. The symptoms of hyperglycemia include: excessive thirst, loss of appetite, frequent urination, feeling tired, sleepiness, dry skin and mucous membranes. Prolonged hyperglycemia can cause the development of ketoacidosis (acetone smell from the mouth, rapid and deep breathing, presence of ketone bodies in the urine) or coma. If the above symptoms occur, immediate medical attention is required.

To avoid hypoglycemia or hyperglycemia:

• Always carry a spare injector and Polhumin Mix-2 cartridge with you.
• Always carry something that informs others that you have diabetes.
• Always carry sugar cubes with you.

Children

The doctor will recommend the appropriate dosage to achieve normal blood sugar levels (normoglycemia), according to the patient's physiological needs.

Polhumin Mix-2 and other medicines

Tell your doctor about all the medicines you are currently taking or have recently taken
and about the medicines you plan to take.
It is essential to inform your doctor about taking insulin if you visit them for any reason other than diabetes.
The body's need for insulin may change when taking such medicines as:

• estrogens (including oral contraceptives, hormone replacement therapy),
• thyroid hormones,
• lithium compounds (used to treat certain mental illnesses),
• danazol (used to treat, among other things, benign breast diseases (fibrocystic breast disease), endometriosis (growth of the uterine lining outside the uterus)),
• sympathomimetic agents (e.g., epinephrine, terbutaline used to treat asthma),
• nicotinic acid,
• steroids (used in inflammatory conditions),
• phenytoin (an antiepileptic drug)

Medicines that enhance the effect of insulin:

• beta-blockers (used to treat heart disease, high blood pressure - e.g., propranolol),
• certain antidepressants (e.g., monoamine oxidase inhibitors, e.g., iproniazid),
• salicylates (e.g., aspirin),
• somatostatin analogs (e.g., octreotide),
• ethyl alcohol. Oral anti-diabetic medicines reduce the need for insulin. Warning!Other medicines must not be mixed with insulin in the cartridge. Insulin must not be administered with other medicines in the same syringe.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
In women with diabetes, during the reproductive period, it is essential to strive for normal blood sugar levels during insulin treatment.
Insulin does not pass through the placenta into the fetus's blood.
The need for insulin decreases in the first trimester of pregnancy and increases in the next two trimesters. In the final stage of pregnancy, the need for insulin is about twice as high as before pregnancy.
The need for insulin decreases during childbirth and after delivery (the insulin dose is similar to that used in non-pregnant women with diabetes).
Insulin does not pass into breast milk. Patients treated with insulin can breastfeed. Often, a change in insulin dose or diet is necessary.

Driving and using machines

Be aware of the possible symptoms of hypoglycemia. The ability to concentrate and react is usually impaired during hypoglycemia. Never drive a vehicle if symptoms indicate impending hypoglycemia. Consult your doctor to carefully consider the possibility of driving a vehicle or operating machinery in case of frequent episodes of hypoglycemia or difficulties in recognizing its symptoms.

Polhumin Mix-2 contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose unit, which means the medicine is considered "sodium-free".

3. How to use Polhumin Mix-2

This medicine should always be used according to the doctor's recommendations. In case of doubts, consult your doctor.
The insulin dosage is individual for each patient. The insulin dose is determined based on the patient's age, physical activity, health status (e.g., presence of kidney failure), as well as the use of other medicines. The exact dose of insulin should be determined based on regular monitoring of blood glucose and urine levels.
During each change of insulin: e.g., from mixed (porcine-bovine) or bovine insulin to human insulin, change of form, as well as change of manufacturer, a change in dosage may be necessary, which should be done under medical supervision.
In patients who have well-controlled blood sugar levels with highly purified porcine or human insulin, no other changes in dosage are expected than routine ones, aimed at constant monitoring of the patient's condition.
It is essential to follow the scheduled control visits recommended by the doctor.
During treatment, systematic monitoring of blood glucose or urine levels is necessary.
Polhumin Mix-2 in a filled injector is intended for subcutaneous injection only. If it is necessary to administer insulin by another method, consult a doctor.
Subcutaneous injection should be performed in the abdominal area, buttocks, thigh, or upper arm.
It is necessary to change the injection sites to avoid thickening.
Preparing the insulin in cartridges
Before inserting the cartridge containing insulin into the injector, the cartridge should be turned upside down and back several times, so the glass ball can move freely from one end of the cartridge to the other. This action should be performed several times (about 10 times) until a uniform, cloudy or milky suspension is obtained. If the cartridge is already in the injector, it should be turned several times as described above.
These actions should be performed before each insulin injection.
Performing the injection

• hold the skin between two fingers, then insert the needle into the skin fold at an angle of about 45° and inject the insulin under the skin;
• withdraw the needle and gently press the injection site for a few seconds to prevent insulin from leaking out. The injection site should be changed according to the doctor's recommendation. Do not reuse used needles. The needle should be removed in a safe manner. Do not share needles and injectors with other people. The cartridge can be used until its contents are used up, and then it should be removed in a safe manner. If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

Using a higher dose of Polhumin Mix-2 than recommended

In case of taking a higher dose of the medicine than recommended, consult your doctor immediately.
As a result of insulin overdose, hypoglycemia may occur (causes and symptoms of hypoglycemia - see section 2 "Important information before using Polhumin Mix-2").
The procedure for insulin overdose depends on the severity of hypoglycemia:

• in cases of mild and moderate hypoglycemia, it is necessary to immediately consume dissolved sugar (2-5 sugar cubes or teaspoons) or a glass of sugary drink. Do not take insulin if symptoms indicate possible hypoglycemia. Always carry sugar, sweets, cakes, or fruit juice with you;
• in severe hypoglycemia, when the patient loses consciousness, a trained person should administer glucagon. As soon as the patient regains consciousness, they should consume sugar or a snack containing sugar. If the patient does not regain consciousness after glucagon administration, they should be treated in a hospital. After each glucagon administration, medical advice should be sought to determine the cause of hypoglycemia and possible ways to prevent it in the future. Inform relatives, friends, and colleagues that in case of loss of consciousness, the unconscious person should be placed on their side and immediate medical attention should be sought. Do not give anything to eat or drink to an unconscious person, as they may choke. In case of hypoglycemia with loss of consciousness or frequent episodes of hypoglycemia, consult the attending doctor, as it may be necessary to adjust the insulin dose and its administration time, as well as change the diet and physical activity.

Missing a dose of Polhumin Mix-2

In case of missing a dose of insulin, consult your doctor.
In case of missing a dose of the medicine, hyperglycemia may occur.
Do not take a double dose to make up for the missed dose.
In case of missing a dose of the medicine at a fixed, specified time, take the medicine as soon as possible, if the time to the next dose is long enough, or take the next dose at the right time and continue regular administration of the medicine.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
As with other insulins, hypoglycemia is the most common complication of insulin therapy.
Side effects reported often(in less than 1 in 10 patients)
Local allergic reaction - symptoms at the injection site (redness, swelling, itching, pain, and bruising at the injection site) may occur during insulin treatment. Most of these symptoms are usually transient and disappear during treatment.
Skin changes at the injection site
If insulin is injected into the same site too frequently, the fatty tissue may shrink (lipoatrophy) or thicken (lipohypertrophy) (not very common - less than 1 in 100 patients). Lumps under the skin can also be caused by the accumulation of a protein called amyloid (cutaneous amyloidosis, frequency of occurrence unknown). Insulin injected into an area with lumps may not work properly. Always change the injection site - this will help prevent these skin changes.
Side effects reported very rarely(in less than 1 in 10,000 patients)
Generalized allergic reaction - may manifest as: generalized skin rash, itching, sweating, gastrointestinal disorders, angioedema, breathing difficulties, palpitations, decreased blood pressure, and fainting/loss of consciousness.
➢ If such symptoms occur during the use of Polhumin Mix-2, consult a doctor immediately.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Polhumin Mix-2

Keep out of sight and reach of children.
Store in a refrigerator (2°C – 8°C).
Do not freeze.
Store in the original packaging to protect from light.
After opening, the cartridge can be stored for a maximum of 28 days at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Do not use this medicine if you notice a change in the appearance of the packaging contents.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Polhumin Mix-2 contains

The active substance of the medicine is biosynthetic, highly purified human insulin.
1 ml of the suspension contains 100 IU of human insulin.
One cartridge for the injector contains 3 ml of the suspension, which corresponds to 300 IU of biphasic insulin in a ratio of 2 parts of soluble insulin and 8 parts of isophane insulin.
Other ingredients of the medicine are protamine sulfate, disodium phosphate dodecahydrate, phenol, metacresol, glycerol, zinc chloride (4% solution), hydrochloric acid (0.1 mol/l solution), sodium hydroxide (0.1 mol/l solution), and water for injections.

What Polhumin Mix-2 looks like and what the packaging contains

White or almost white, neutral, sterile, aqueous suspension of human insulin in a cartridge.

Packaging

5 cartridges of 3 ml each in a PVC/Al blister pack in a cardboard box.
The cartridges are cylindrical glass containers made of neutral, colorless glass, internally siliconized, with a double seal: a rubber stopper and an aluminum cap with a rubber disk. Each cartridge contains 2 glass balls.

Marketing authorization holder and manufacturer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" S.A.
ul. A. Fleminga 2
03-176 Warsaw
Phone number: 22 811-18-14
To obtain more detailed information, contact the representative of the marketing authorization holder.

Date of the last update of the leaflet: