Apidra 300 IU SOLOSTAR 3 ml. 5
Apidra 300 IU SOLOSTAR 3 ml. 5
WHAT APIDRA IS AND WHAT IT IS USED
Apidra is an antidiabetic agent, which is used to reduce high blood sugar in patients with diabetes mellitus : it can be used in adults, adolescents and children aged 6 years and older . Diabetes mellitus is a disease in which the body does not produce enough insulin to control blood sugar.
Produced by biotechnological processes. Begins to act quickly, within 10-20 minutes and has a short duration of action, about 4 hours.
2 . BEFORE YOU USE APIDRA
Do not use Apidra
If you are allergic (hypersensitive ) to insulin glulisine or any of the other ingredients of Apidra.
If your blood sugar is too low ( hypoglycaemia), follow the guidance for hypoglycaemia (see box at the end of this leaflet) .
Take special care with Apidra
Follow closely the instructions for dosage , monitoring (blood tests ), diet and physical activity ( physical work and exercise ) as discussed with your doctor .
If you have liver or kidney problems , talk to your doctor as you may need less insulin .
There is insufficient clinical information on the use of Apidra in children younger than 6 years.
Before traveling, check with your doctor. You may need to talk about :
the availability of your insulin in the country you are visiting ;
supplies of insulin , syringes , etc.;
correct storage of your insulin while traveling ;
timing of meals and insulin administration while traveling;
the possible effects of changing time zones ;
possible new health risks in the countries to be visited ;
what to do in emergency situations when you feel unwell or become ill .
Illnesses and injuries
In these situations, the management of your diabetes may require extra care :
if you are ill or have a major injury , your blood sugar may increase (hyperglycaemia) ;
If you do not eat enough , your blood sugar 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 get enough carbohydrates. Always tell people who are caring for you or treating you that you require 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 signs of heart failure such as unusual shortness of breath or rapid increase in weight or localized swelling ( edema) .
Using other medicines
Some drugs cause changes in the blood sugar level (decrease, 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 another 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 may cause drop your blood sugar (hypoglycaemia ) include:
other medications for treating diabetes ;
angiotensin converting enzyme ( ACE) inhibitors ( used in the treatment of certain heart conditions or high blood pressure ) ;
disopyramide (used for the treatment of certain heart conditions) ;
fluoxetine (used to treat depression) ;
fibrates ( used to reduce high levels of lipids in the blood) ;
monoamine oxidase inhibitors (MAOI ) (used to treat depression) ;
pentoxifylline, propoxyphene, salicylates (such as aspirin , used to relieve pain and lower temperature ) ;
sulfonamide antibiotics .
Drugs that may cause increased levels of blood sugar ( hyperglycemia ) include:
corticosteroids (such as "cortisone " used for the treatment of 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 (such as in the 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 for the treatment of disorders of the thyroid gland ) ;
protease inhibitors (used in the treatment of AIDS ) ;
atypical antipsychotic medications (such as clozapine and olanzapine) .
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 psychiatric 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.
Using Apidra 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 after birth may need insulin dose change. Careful control of your diabetes, and prevention of hypoglycaemia, is important for the health of your baby.
There are no adequate data from the use of Apidra in pregnant women.
If you are breastfeeding , consult your doctor as you may require adjustments in your insulin doses and your diet .
Driving and using machines
Your ability to concentrate or react may be reduced if:
you have hypoglycaemia ( low blood sugar) ;
have hyperglycemia ( high blood sugar).
Keep this possible problem in all situations where you jeopardize yourself and others (such as driving a car or operating machinery).
You should consult with your doctor whether it is permissible to drive if:
you have frequent episodes of hypoglycaemia ;
first warning symptoms which help you to recognize hypoglycaemia are reduced or absent.
Important information about some of the ingredients of Apidra
This product contains less than 1 mmol ( 23 mg) of sodium per dose, i.e. essentially sodium .
Apidra contains metacresol, which may cause allergic reactions.
3 . HOW TO USE APIDRA
Based on your lifestyle and the results of blood sugar (glucose) and your previous insulin usage , your doctor will determine how much Apidra will need
Always use Apidra exactly as your doctor tells you . If you are not sure, ask your doctor.
Apidra is a short -acting insulin. Your doctor may advise you when to use it in combination with an intermediate or long -acting insulin or with tablets used to treat high blood sugar levels .
If you switch from another insulin to insulin glulisine may be necessary for your doctor to adjust your dose .
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 too high or too low. See the box at the end of this leaflet for more information .
Method of administration
Apidra is injected under the skin ( subcutaneously). It can also be applied intravenously by a medical professional closely monitored by a physician.
Your doctor will show you in which area of the skin to inject Apidra. Apidra can be injected in the abdomen , thigh or upper arm or by continuous infusion in the abdominal wall. The effect will be a little faster if the insulin is injected into the abdominal wall. As with all insulins, injection sites and infusion should be rotated within the same injection site ( abdomen, thigh , upper arm) injection.
Frequency of administration
Apidra should be taken slightly (0-15 minutes) before or soon after meals.
Instructions for proper use
How to handle the vials
Apidra vials are for use with insulin syringes with the corresponding unit scale and for use with the insulin pump system .
Look at the vial before use . Only be used if the solution is clear, colorless and without particles . Do not shake or mix it before use.
Always use a new vial if you notice that control your blood sugar is unexpectedly getting worse . This is because the insulin may have lost some of its effectiveness . If you think you have a problem with Apidra, check it with your doctor or pharmacist.
If you need to mix two types of insulin
Apidra must not be mixed with any other drug than NPH human insulin .
If Apidra is mixed with NPH human insulin into the syringe first need to download Apidra. Injection should be made immediately after mixing .
How to handle an infusion pump system
Apidra must not be mixed with diluents or any other insulin when used in a pump .
Before using Apidra in the pump system , you should have detailed instructions for use . In addition, information about actions to be taken in case of illness, too high or too low blood sugar or pump system failure .
Use type pump system recommended by your doctor. Read and follow the instructions that accompany your insulin infusion pump . Follow your doctor's instructions about the basal level infusion and boluses with meals that need to be taken. To benefit of insulin infusion , and to identify possible malfunction of the insulin pump , you should regularly measure their blood sugar.
Infusion set and reservoir should be changed every 48 hours using aseptic technique.
What to do in case of pump system failure ?
Always keep extra insulin for injection under the skin in case of pump system failure .
If you use more than the amount of Apidra
If you have injected too much Apidra, your blood sugar may become too low ( hypoglycaemia). Explore your blood sugar frequently . In general, to prevent hypoglycaemia you must eat more food and monitor your blood sugar. For information on the treatment of hypoglycaemia, see box at the end of this leaflet.
If you forget to use Apidra
If you miss a dose of Apidra or if you have not injected enough insulin , your blood sugar may get too high ( hyperglycaemia). 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 Apidra
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 Apidra 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 in treatment between Apidra and other insulins.
4 . POSSIBLE SIDE EFFECTS
Like all medicines , Apidra can cause side effects, although not everybody gets them .
Hypoglycemia ( low blood sugar) can be very serious. If your blood sugar level falls too much you may lose consciousness. Serious hypoglycaemia may cause brain damage and may be life-threatening . If you have symptoms of low blood sugar, take actions to increase your blood sugar.
If you experience the following symptoms, call your doctor immediately: 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. These may be symptoms of generalized allergy to insulin, including anaphylactic reaction, which can be life-threatening.
The frequency of possible adverse effects listed below is defined using the following convention:
very common ( affects more than 1 user in 10);
common ( affects 1 to 10 users in 100) ;
uncommon ( affects 1 to 10 users in 1000 ) ;
rare (affects 1 to 10 users in 10,000 ) ;
very rare ( affects less than 1 user in 10,000 ) ;
known ( from the available data can not be estimated ) .
Very commonly reported side effects
Hypoglycemia (low blood sugar ) means that there is not enough blood sugar . See the box at the end of this leaflet for important information about hypoglycaemia and its treatment.
Commonly reported side effects
Skin and allergic reactions
Reactions at the injection site (like redness , unusually intense pain on injection , itching, hives, swelling or inflammation) . They can also spread around the injection site . Most minor reactions to insulins usually resolve in a few days or a few weeks.
Uncommon side effects reported
Systemic allergic reactions
Generalized allergy to insulin. 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. Severe cases of generalized reactions , including anaphylactic reaction, which can be life-threatening.
Frequently reported adverse events
Skin changes at the injection site ( lipodystrophy)
If you often take your insulin at the same skin site, fatty tissue of this site may either 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.
Other adverse reactions (frequency not known ) include:
Hyperglycemia (high blood sugar ) means that the blood has too much sugar.
If your blood sugar is too high, this indicates that you may need more insulin than you injected . See the box at the end of this leaflet for more information .
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 .
If any of the side effects gets serious , or you notice other effects not listed in this leaflet , please tell your doctor or pharmacist.
5 . HOW TO STORE APIDRA
Keep out of reach of children.
Do not use Apidra after the expiry date stated on the carton and vial label . Expiry date refers to the last day of that month.
Store in a refrigerator (2 ° C - 8 ° C).
Do not freeze .
Do not put Apidra next to the freezer compartment . Keep the vial in the outer carton to protect from light.
Once opened, the vial may be stored for a maximum of 4 weeks at the carton below 25 ° C, away from direct heat or direct exposure to light. Do not use the vial after this period. Recommended that the date of first use be noted on the label.
Keep the vial in the outer carton in order to protect from light. Do not use Apidra, if it does not appear clear and colorless.
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.
6 . FURTHER INFORMATION
What does Apidra
The active substance is insulin glulisine . Each ml of the solution contains 100 Units of insulin glulisine (equivalent to 3,49 mg). Each vial contains 10 ml of injection solution equivalent to 1000 Units.
Other ingredients are: metacresol , sodium chloride , trometamol , polysorbate 20, concentrated hydrochloric acid, sodium hydroxide, water for injections.
Apidra looks like and contents of the pack