Insuman Basal OPTIPEN 300 IU 3 ml
Insuman Basal OPTIPEN 300 IU 3 ml
Insuman Basal WHAT IS AND WHAT IT IS USED
Insuman Basal is a liquid (suspension) for injection under the skin. Insulin, which is contained in Insuman Basal is produced by biotechnology process and is identical to the body's own insulin. Insuman Basal insulin preparation is gradual in onset and duration of action. Insulin is in the form of tiny crystals of insulin protamine.
Insuman Basal used to lower high blood sugar in patients with diabetes mellitus. Diabetes is a disease in which the body does not produce enough insulin to control blood sugar.
BEFORE YOU USE Insuman Basal
Do not use Insuman Basal
If you are allergic (hypersensitive) to insulin or any of the other ingredients of Insuman Basal
Do not inject Insuman Basal vein (blood vessel). Do not use Insuman Basal insulin pump, for these devices have special insulin preparations.
Take special care with Insuman Basal
Follow these instructions for dosage, monitoring (blood and urine), diet and physical activity (physical work and exercise) as it
discussed with your doctor.
If you have liver or kidney problems or are elderly, speak to your doctor as you may need a lower dose of insulin
Before traveling consult your doctor. You may need to talk about:
Availability of your insulin in the country you are visiting,
Enough insulin, syringes, etc.
More correct storage of your insulin while traveling,
Timing of meals and insulin administration while traveling,
Possible effects of changing time zones,
Possible new health risks in the countries to be visited,
What to do in cases of emergency, when you feel unwell or become ill.
Illnesses and injuries
In these situations, the management of your diabetes may require a lot of care:
If you are ill or have a major injury, your blood sugar may
If you do not eat enough, your blood sugar may become too low
In most cases you will need a doctor. Contact your doctor early. If you have diabetes type I (insulin-dependent diabetes mellitus), do not stop your insulin and continue to get enough carbohydrates. I always tell people who are caring for you or treating you that you require insulin. Some patients with longstanding 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 signs of heart failure such as unusual shortness of breath or rapid increase in weight or localized swelling (edema).
Taking other medicines
Some medicines cause changes in blood sugar levels (decrease or increase or both depending on the situation). In any case, you may need to adjust your insulin dosage to avoid too low or too high blood sugar levels. Be careful when you start or stop taking any medicine. Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Ask your doctor before taking any medicine if it can affect your blood sugar and how to take action if necessary.
Medicines that can cause drop your blood sugar (hypoglycemia) include:
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 diseases)
Fluoxetine (used to treat depression)
Fibrates (used to lower high levels of blood lipids), monoamine oxidase inhibitors (MAOI) (used to treat depression), pentoxifylline, propoxyphene, salicylates (such as aspirin, used to relieve pain and lower fever) ,
Drugs that may cause increased your blood sugar (hyperglycemia) include:
Corticosteroids (such as "cortisone" used to treat inflammation)
Danazol (medicine acting on ovulation),
Diazoxide (used to treat high blood pressure)
Diuretics (used to treat high blood pressure or excessive fluid retention)
Glucagon (pancreas hormone used to treat severe hypoglycaemia)
Isoniazid (used to treat tuberculosis)
Oestrogens and progestogens (eg contraceptive pill used for birth control)
Phenothiazine derivatives (used to treat psychiatric disorders)
Somatropin (growth hormone)
Sympathomimetic drugs (such as epinephrine [adrenaline] or salbutamol, terbutaline used to treat asthma)
Thyroid hormones (used to treat thyroid narusheniyana)
Protease inhibitors (used to treat HIV),
Atypical antipsychotic medications (eg olanzapine and clozapine).
Your blood sugar level may either fall or rise if you take:
Beta-blockers (used to treat high blood pressure)
Clonidine (used to treat high blood pressure)
Lithium salts (used to treat mental disorders).
Pentamidine (used to treat certain infections caused by parasites) may cause hypoglycaemia which may sometimes be followed by hyperglycaemia. Beta-blockers like other sympatholytic medicines (such as clonidine, guanethidine, and reserpine) may weaken or suppress entirely the first warning symptoms which help you to recognize hypoglycaemia. If you are not sure whether you are taking any of these medicines, ask your doctor or pharmacist.
Insuman Basal use with food and drink
Your blood sugar may rise or fall if you drink alcohol.
Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine. Tell your doctor if you become pregnant or are already pregnant. During pregnancy and postpartum insulin requirements may change. Careful control of your diabetes, and prevention of hypoglycaemia, is essential for the health of your baby. But no experience with the use of 1pzitap Vase! in pregnant women. If you are breastfeeding, consult your doctor as you may require adjustments in your insulin doses and your diet.
Driving and operating machinery
Your ability to concentrate or react may be reduced if:
You have hypoglycemia (low blood sugar)
Have hyperglycemia (high blood sugar)
You have eyesight problems.
Keep this possible problem in all situations where you compromise yourself and others (such as driving a car or operating machinery).
You should consult with your doctor whether it is legal to drive if:
You have frequent episodes of hypoglycaemia
The first warning symptoms which help you to recognize hypoglycaemia are reduced or absent.
Important information about some of the ingredients of Insuman Basal
This medicinal product contains less than 1 mmol (23 mg) sodium per dose t.e.prakticheski sodium-
HOW TO USE Insuman Basal
Based on your lifestyle and results of your blood sugar (glucose), your doctor will:
Determine how much Insuman Basal you need a day
Tell you when you can explore your blood sugar and that studies are needed to
Tell you when you may need to inject a higher or lower dose Insuman Basal.
Many factors can affect your blood sugar. You must be aware of these factors so that you can react correctly to changes in your blood sugar and prevent excessive "high or lower. See the box at the end of this leaflet for more information.
Frequency of use
Insuman Basal is injected under the skin 45 to 60 minutes before meals.
Route of administration
Do NOT inject Insuman Basal vein. Your doctor will show you in which area of the skin to inject insulin. With each injection, change the puncture site within the particular area of skin where you inject insulin.
How to work with patrons
Use bullets with Insuman Basal only OptiPen, ClikSTAR, Autopen 24 or Tactipen, to make sure that you get the correct dose. Not all of these pens may be marketed in your country.
The pen should be used as recommended by the manufacturer of the product in the information provided. Manufacturer's instructions for using the pen must be followed carefully for loading the cartridge, attaching the injection needle and administering the insulin injection.
Leave the cartridge at room temperature for 1 -2 hours before you put it in the pen. Insulin Mix well and check it before you put it in the pen. Later, you re good to mix it immediately before each injection.
Mixing is best done slowly turn pen or cartridge (the cartridge in it) up and down at least 10 times. For ease of shuffling in the cartridge has three small metal balls.
After mixing the suspension should be milky evenly. It should not be used if you stay clear or if, for example, has lumps, particles or clumps of material in the insulin or stick it on the walls and bottom of the cartridge. In such cases it is necessary to use a new cartridge even suspension. Always use a new cartridge if you notice that control your blood sugar deteriorates unexpectedly. This is because insulin may have lost some of its effectiveness. If you think you may have a problem with your insulin, check it with your doctor or pharmacist.
Special care before injection
Before injection remove any air bubbles (see instructions for using the pen). Make sure that neither alcohol nor other disinfectants contaminate the insulin.
Do not re-fill and re-use empty cartridges.
Do not add any other insulin in the cartridge.
Do not mix insulin with any other medicines.
Problems with the 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 has to be thrown away and use a new pen.
If the pen does not work well, you can draw the insulin from the cartridge into a syringe for injection. Therefore, keep the same needle. However, use only those syringes are designed for an insulin concentration of 100 IU (International Units) per ml.
Errors in dosing
If you use more than the amount Insuman Basal
If you have injected too much Insuman Basal, your blood sugar may become too low (hypoglycaemia). Explore your blood sugar frequently. In general, to prevent hypoglycaemia you must eat more and to monitor your blood sugar. For information on the treatment of hypoglycaemia, see box at the end of this leaflet.
If you forget to use Insuman Basa
If you miss a dose Insuman Basal or if you have not injected enough insulin, your blood sugar can significantly increase (hyperglycemia). Explore your blood sugar frequently. For information on the treatment of hyperglycaemia, see box at the end of this leaflet.
Do not take a double dose to make up for a missed dose.
If you stop using Insuman Basal
This could lead to severe hyperglycaemia (very high blood sugar) and ketoacidosis (build up of acid in the blood because the body is breaking down fat instead of sugar). Do not stop treatment with Insuman Basal without consulting a doctor, who will tell you what to do.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
You should always check the insulin label before each injection to avoid confusion between the treatment and other Insuman Basal insulins.
POSSIBLE SIDE EFFECTS
Like all medicines, Insuman Basal can cause side effects, although not everybody gets them.
As with any insulin therapy, the most common adverse reaction is hypoglycaemia (low blood sugar). Severe hypoglycemia can cause brain damage and may be life-threatening. For more information about side effects of low blood sugar or high blood sugar, see the box at the end of this leaflet. May lead to serious allergic reactions to insulin, which can become life-threatening. Such reactions to insulin or to the excipients can cause large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angioedema), shortness of breath, spad.v blood pressure with rapid heart beat and sweating.
Commonly reported side effects (occurring in less than 1 in 10
but more than 1 in 100 patients)
Insulin treatment can also lead to a temporary accumulation of water in the body,
swelling of the calves and ankles.
Injection site reactions
Uncommonly reported side effects (occurring in less than 1 in 100 but more than 1 in 1000 patients)
Severe allergic reaction with low blood pressure (shock)
Injection site urticaria (hives).
Other side effects include:
Systemic allergic reactions
Associated symptoms may include large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angioedema), shortness of breath, a fall in blood pressure with rapid heart beat and sweating,
A marked change (improvement or worsening) in control of your blood sugar can disturb your vision temporarily. If you have proliferative retinopathy (an eye disease related to diabetes) severe hypoglycaemic attacks may cause temporary loss of vision.
Skin changes at the injection site (lipodystrophy)
If you often take your insulin at the same skin site, fatty tissue in this place may shrink or thicken. Insulin injected in such a place may not work very well. Changing the site with each injection may help to prevent such skin changes.
Skin and allergic reactions
May be other minor reactions at the injection site (like redness, unusually intense pain at the injection site, itching, swelling, or inflammation at the injection site). They can also spread around the injection site. Most minor reactions to insulins usually resolve in a few days or a few weeks. Insulin treatment can cause the body to produce antibodies to insulin (substances that act against insulin). Very rarely, however, may require a change in dosage of insulin.
Tell your doctor or pharmacist if you notice any of the side effects listed above or any other unwanted or unexpected effects. To prevent serious side effects, immediately call your doctor if any of these effects is severe, occurs suddenly or gets worse rapidly.
HOW TO STORE Insuman Basal
Keep out of reach of children. Do not use Insuman Basal after the expiration date stated on the carton and label of the cartridge. The expiry date refers to the last day of that month.
Store in a refrigerator (2 ° C-8 ° C). Do not freeze. Do not put Insuman Basal the freezer compartment or a freezer bag. Keep the cartridge in the outer carton to protect from light.
In use cartridges
Cartridges in use (in the insulin pen) or kept as a spare may be stored up to 4 weeks at 25 ° C while protected from direct heat (ie heating near the object) or direct light (direct sunlight or near a lamp ). Cartridge in use must be stored in the refrigerator. Do not use the cartridge after this period. 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.
What Insuman Basal
The active substance is insulin human. One ml of Insuman Basal contains 100 IU (International Units) of the active substance insulin human.
The other ingredients are protamine sulphate, m-cresol, phenol, zinc chloride, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide, hydrochloric acid (for pH adjustment), water for injections.
Insuman Basal looks like and contents of pack
After mixing Insuman Basal evenly milky liquid (suspension for injection) with no visible lumps or sediment particles. Insuman Basal comes in cartridges containing H ml (300 IU). Packs of H, 4, 5, 6, 9 and 10 cartridges of 3 ml.