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ABASAGLAR 100 IU / ml. 3 ml. 10 vials

Product Code: ABASAGLAR 100 IU / ml. 3 ml. 10 vials
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What ABASAGLAR is and what it is used for
ABASAGLAR is a solution for injection containing insulin glargine. Insulin glargine is a modified insulin, very similar to human insulin.
ABASAGLAR is used to treat diabetes mellitus in adults, adolescents and children aged 2 years or older.
Diabetes mellitus is a disease in which your body does not produce enough insulin to control blood sugar levels. Insulin glargine has a long-lasting and evenly lowering blood glucose action.

2. What you need to know before using ABASAGLAR
Do not use ABASAGLAR:
If you are allergic to insulin glargine or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using ABASAGLAR.
Always follow the instructions for insulin dosing, blood and urine tracking, diet and exercise (physical work and exercise) as discussed with your doctor.
If your blood sugar is too low (hypoglycaemia), follow the instructions for hypoglycaemia (see box at the end of this leaflet).

Before traveling, consult your doctor. You may need to talk about:
The presence of your insulin in the country you are going to visit;
Sufficient insulin, syringes, etc .;
The correct storage of your insulin while traveling;
Meal times and insulin while traveling;
The possible effects of changing the time zones;
Possible new health risks in the countries you will visit;
What to do in cases of urgency, when you feel bad or get sick.
Diseases and injuries
In the following situations, controlling your diabetes may require a lot of care (eg, adjusting the insulin dose, blood and urine tests):
If you are sick or have a serious trauma, your blood sugar level may rise (hyperglycaemia);
If you do not eat enough, your blood sugar level may become too low (hypoglycaemia).
In most cases you will need a doctor. Contact a doctor early.

If you have type 1 diabetes (insulin-dependent diabetes mellitus), do not stop your insulin and continue to take enough carbohydrates. Always tell people who care for you or treat you that you need insulin.
Some patients with long-standing type 2 diabetes and heart disease or stroke (stroke) treated with pioglitazone and insulin develop heart failure. Tell your doctor as soon as possible if you experience symptoms of heart failure such as unusual shortness of breath or rapid weight gain or localized edema.

Other medicines and ABASAGLAR
Some medicines cause changes in blood sugar (dropping, increasing or, depending on the situation, both). In any case, it may be necessary to adjust the dose of your insulin to avoid either too low or too high blood sugar levels. Be careful when you start or stop taking another medicine.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Ask your doctor before taking any medicine to determine if it can affect your blood sugar level and what action to take if necessary.
Medicines that can cause a fall in your blood sugar (hypoglycaemia) include:
All other medicines to treat diabetes;
Angiotensin-converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood pressure);
Disopyramide (used to treat certain heart conditions);
Fluoxetine (used to treat depression);
Fibrates (used to lower high levels of lipids in the blood);
Monoamine oxidase (MAO) inhibitors (used to treat depression);
Pentoxifylline, propoxyphene, salicylates (such as aspirin used to relieve pain and lower the temperature);
Somatostatin analogues (such as octreotide used to treat a rare condition where you produce too much growth hormone);
Sulfonamide antibiotics.
Medicines that may cause your blood sugar level to rise (hyperglycaemia) include:
Corticosteroids (such as "cortisone" used to treat inflammation);
Danazol (a medicine affecting ovulation);
Diazoxide (used to treat high blood pressure);
Diuretics (used to treat high blood pressure or excessive fluid retention);
Glucagon (pancreatic hormone used to treat severe hypoglycaemia);
Isoniazid (used to treat tuberculosis);
Estrogens and progestogens (e.g., birth control pills used for birth control);
Phenothiazine derivatives (used to treat psychiatric disorders);
Somatropin (growth hormone);
Sympathomimetics (such as epinephrine [adrenaline], salbutamol, terbutaline used to treat asthma);
Thyroid hormones (used to treat thyroid abnormalities);
Atypical antipsychotic medicines (such as clozapine, olanzapine);
Protease inhibitors (used to treat AIDS).
Your blood sugar level may either rise or fall if you take:
Beta-blockers (used to treat high blood pressure);
Clonidine (used to treat high blood pressure);
Lithium salts (used to treat psychiatric disorders).
Pentamidine (used to treat some infections caused by parasites) can cause hypoglycaemia, which can sometimes be followed by hyperglycaemia.
Beta-blockers, as well as other sympatholytic medicines (such as clonidine, guanethidine and reserpine) may weaken or completely suppress the first warning symptoms that help to recognize hypoglycaemia.

If you are not sure if you are taking any of these medicines, ask your doctor or pharmacist.

ABASAGLAR with alcohol
Your blood sugar levels may either rise or fall if you drink alcohol.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Tell your doctor if you are planning a pregnancy or if you are already pregnant. During pregnancy and after birth your dose of insulin may need to be changed. Careful control of your diabetes and prevention of hypoglycemia are especially important for your baby's health.
If you are breast-feeding, talk to your doctor as adjustments of your insulin dose and dietary adjustment may be necessary.

Driving and using machines
Your ability to concentrate or react may be reduced if:
Have hypoglycaemia (low blood sugar);
You have hyperglycaemia (high blood sugar levels);
You have vision problems.
Remember this possible problem in all situations where you can compromise yourself and others (when driving a car or operating machinery). You should consult your doctor if you are allowed to drive if:
Have frequent attacks of hypoglycaemia;
The first warning symptoms that help you recognize hypoglycaemia are weakened or absent.
Important information about some of the ingredients of ABASAGLAR
This medicine contains less than 1 mmol (23 mg) of sodium per dose, ie. Practically "does not contain sodium".

3. How to use ABASAGLAR
Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Based on your lifestyle and the results of your blood glucose (glucose) studies and your previous insulin use, your doctor will:
Determine what quantity of ABASAGLAR you need per day and at what time;
Tell you when to test your blood sugar level and whether urine tests are needed;
Tell you when you may need to inject a higher or lower dose of ABASAGLAR.
ABASAGLAR is a long-acting insulin. Your doctor may advise you to use it in combination with a short acting insulin or with tablets used to treat high blood sugar levels.
Many factors can affect your blood sugar level. You should be aware of these factors so that you can react properly to changes in your blood sugar level and prevent it from increasing or decreasing too much. See the box at the end of this leaflet for more information.

Usage in children and adolescents
ABASAGLAR can be used in adolescents and children aged 2 years or older. There is no experience with the use of ABASAGLAR in children under the age of 2 years.

Frequency of application
You need one injection of ABASAGLAR every day at the same time of the day.

Mode of application
ABASAGLAR is injected under the skin. Do not inject ABASAGLAR into a vein, as this will change its effect and may cause hypoglycaemia.
Your doctor will tell you which area of ​​skin to inject ABASAGLAR. For each injection, change the injection site within the specified area of ​​skin you are using.

How to work with cartridges
Only use the ABASAGLAR cartridges in pens recommended for use with Lilly insulin cartridges to make sure you are getting the right dose. Not all of these pens can be marketed in your country.
The pen should be used as recommended by the device manufacturer in the patient information.
The manufacturer's instructions for use of the pen should be carefully observed with regard to cartridge filling, needle insertion and administration of insulin injection.
To prevent possible transmission of diseases, each pen should only be used by one patient.
Inspect the cartridge before using it. Only use if the solution is clear, colorless and has a water-like consistency and is free of visible particles. Do not shake or mix before use.
Always use a new cartridge if you notice that your blood sugar control unexpectedly gets worse. This is because insulin may have lost some of its effectiveness. If you think you have a problem with ABASAGLAR, check with your doctor or pharmacist.

Special attention before injection
Remove all air bubbles before injection (see instructions for using the pen).
Make sure that insulin is not contaminated with alcohol, other disinfectants or other substances.
Do not fill or reuse the empty cartridges. Do not add any other insulin to the cartridge. Do not mix ABASAGLAR with any other insulin or medicine. Do not dilute it. Mixing or dilution may alter the effect of ABASAGLAR.

Problems with the insulin pen?
Refer to the manufacturer's instructions for using the pen.
If the insulin pen is damaged or not working properly (due to mechanical defects), it should be discarded and a new insulin pen used.
If the insulin pen does not work well, you can withdraw the insulin from the cartridge in a syringe for injection. Therefore, you should have syringes for injection and needles as well. Use, however, only such syringes that are designed for insulin at a concentration of 100 units per milliliter.

If you use more ABASAGLAR than you should
If you have injected too much ABASAGLAR, your blood sugar level may become too low (hypoglycaemia). Study your blood sugar often. In general, to prevent hypoglycaemia, you should eat more food and monitor your blood sugar. For information on the treatment of hypoglycaemia, see the box at the end of this leaflet.

If you forget to use ABASAGLAR
If you have missed a dose of ABASAGLAR or if you have not injected enough insulin, your blood sugar level may rise significantly (hyperglycaemia). Study your blood sugar often. For information on the treatment of hyperglycaemia, see the box at the end of this leaflet.
Do not take a double dose to make up for the missed dose.

If you stop using ABASAGLAR
This can lead to severe hyperglycaemia (multiple sclerosis)
Other undesirable effects (frequency can not be estimated from the available data):
Insulin treatment can cause the body to produce antibodies to insulin (substances that act against insulin). Very rarely, however, this may necessitate a change in the dose of insulin.
Usage in children and adolescents
In general, adverse drug reactions in children and adolescents 18 years of age or younger are similar to those seen in adults.
Injection site reactions (injection site pain, injection site reaction) and skin reactions (rash, urticaria) have been reported relatively more frequently in children and adolescents 18 years of age or younger than adults.
There are no safety data from clinical studies in children under 2 years of age.

Reporting of side effects
If any of the side effects gets serious, tell your doctor or pharmacist. This includes all possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system. As you report side effects, you can contribute to getting more information about the safety of this medicine.

5. How to store ABASAGLAR
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton and the label of the cartridge, either after "EXP" or "EXP". The expiry date refers to the last day of that month.

Unopened cartridges
Store in a refrigerator (2 ° C - 8 ° C). Do not freeze.
Do not place ABASAGLAR near the freezing chamber or freeze pack. Keep the cartridge in the outer carton in order to protect from light.

Cartridges in use
Cartridges in use (insulin pen) or worn as a spare may be stored for a maximum of 28 days at not more than 30 ° C and protected from direct heat or direct light. Cartridges in use should not be stored in a refrigerator. Do not use after this period.
Do not use ABASAGLAR if you notice particles in it. Only use ABASAGLAR if the solution is clear, colorless and has a water-like consistency.
Do not dispose of medicines in the sewer or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Package Contents and Additional Information
What ABASAGLAR contains
The active substance is: insulin glargine. Each milliliter of the solution contains 100 units of the active substance insulin glargine (equivalent to 3.64 g).
The other ingredients are: zinc oxide, metacresol, glycerol, sodium hydroxide - see section 2 "Important information about some of the ingredients of ABASAGLAR"), hydrochloric acid and water for injections.

What ABASAGLAR looks like and contents of the pack
ABASAGLAR 100 Units / ml solution for injection in a cartridge is a clear and colorless solution.
ABASAGLAR is supplied in a special cartridge that should only be used with pens recommended for use with Lilly insulin cartridges. Each cartridge contains 3 ml of solution for injection (equivalent to 300 units) and is available in packs of 1, 2, 5, 10, and a pack of 2 x 5 cartridges.
Not all pack sizes may be marketed.


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