Each ml of the solution contains 100 units of insulin glulisine (equivalent to 3.49 mg).
Excipients/Inactive Ingredients: metacresol (see Precautions), sodium chloride (see Precautions), trometamol, polysorbate 20, concentrated hydrochloric acid, sodium hydroxide, water for injections.
Apidra is an antidiabetic agent, used to reduce high blood sugar in patients with diabetes mellitus; it may be given to adults, adolescents and children, 6 years of age and older. Diabetes mellitus is a disease where the body does not produce enough insulin to control the level of blood sugar.
It is made by biotechnology. It has a rapid onset within 10-20 minutes and a short duration, about 4 hours.
Dose: Always use this medicine exactly as the doctor has instructed. Check with the doctor or pharmacist if not sure.
Based on the life-style and the results of the blood sugar (glucose) tests and the previous insulin usage, the doctor will determine how much Apidra will be needed.
Apidra is a short-acting insulin. The doctor may instruct to use it in combination with an intermediate, long-acting insulin, a basal insulin or with tablets used to treat high blood sugar levels.
When switching from another insulin to insulin glulisine, the doctor may have to adjust the dosage.
Many factors may influence the blood sugar level. These factors should be known so that the patient can react correctly to changes in the blood sugar level and to prevent it from becoming too high or too low.
Method of administration: Apidra is injected under the skin (subcutaneously).
The doctor will show which area of the skin Apidra should be injected. Apidra can be injected in the abdominal wall, the thigh or upper arm or by continuous infusion in the abdominal wall. The effect will be slightly quicker if the insulin is injected into the abdomen. As for all insulins, injection sites and infusion sites within an injection area (abdomen, thigh or upper arm) must be rotated from one injection to the next.
Frequency of administration: Apidra should be taken shortly (0-15 minutes) before or soon after meals.
Instructions for proper use: How to handle SoloStar: SoloStar is a pre-filled disposable pen containing insulin glulisine. Apidra in a pre-filled pen is only suitable for injecting just under the skin. Speak to the doctor if insulin needs to be injected by another method.
Read carefully the Instructions for use under Patient Counselling Information. The pen must be used as described in these Instructions for use.
To prevent the possible transmission of disease, each pen must be used by one patient only.
Before use always attach a new needle, and perform a safety test. Only use needles that are compatible for use with SoloStar (see Instructions for use under Patient Counselling Information).
Look at the cartridge sealed in the disposable pen injector before using it. Only use it if the solution is clear, colourless and has no visible particles in it. Do not shake or mix it before use.
Always use a new pen if the blood sugar control is unexpectedly getting worse. For any problem with SoloStar, please consult the Health Care Professional.
If the patient forgets to use Apidra: If the patient missed a dose of Apidra or has not injected enough insulin, the blood sugar level may become too high (hyperglycaemia). Check the blood sugar frequently.
Do not take a double dose to make up for a forgotten dose.
If the patient stops 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 speaking to a doctor, who will instruct what needs to be done.
For any further questions on the use of this medicine, ask the doctor, pharmacist or nurse.
Insulin mix-ups: Always check the insulin label before each injection to avoid mix-ups between Apidra and other insulins.
If the patient has injected too much Apidra, the blood sugar level may become too low (hypoglycaemia). Check the blood sugar frequently. In general, to prevent hypoglycaemia, eat more food and monitor the blood sugar.
Do not use Apidra: If the patient is allergic to insulin glulisine or any of the other ingredients of this medicine (listed in Description).
If the blood sugar is too low (hypoglycaemia), follow the guidance for hypoglycaemia.
Apidra in a pre-filled pen is only suitable for injecting just under the skin (see Dosage & Administration). Speak to the doctor if insulin needs to be injected by another method.
Talk to the doctor, pharmacist or nurse before using Apidra.
Follow closely the instructions for dose, monitoring (blood tests), diet and physical activity (physical work and exercise) as discussed with the doctor.
Special patient groups: If the patient has liver or kidney problems, speak to the doctor as a lower dose may be needed.
There is insufficient clinical information on the use of Apidra in children younger than the age of 6 years.
Travel: Before travelling consult the doctor. The patient may need to talk about: The availability of the insulin in the country being visited; supplies of insulin, needles, etc; correct storage of the insulin while travelling; timing of meals and insulin administration while travelling; the possible effects of changing to different time zones; possible new health risks in the countries to be visited; what to do in emergency situations when feeling unwell or becoming ill.
Illnesses and injuries: In the following situations, the management of the diabetes may require extra care: If the patient is ill or has a major injury then the blood sugar level may increase (hyperglycaemia).
If the patient is not eating enough, the blood sugar level may become too low (hypoglycaemia).
In most cases, a doctor will be needed. Make sure to contact a doctor early.
If the patient has type 1 diabetes (insulin dependent diabetes mellitus), do not stop the insulin and continue to get enough carbohydrates. Always tell people who are caring or treating the patient that insulin is required.
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. Inform the doctor as soon as possible if the patient experiences signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).
Important information about some of the ingredients of Apidra: This medicine contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially 'sodium-free'.
Apidra contains metacresol: Apidra contains metacresol, which may cause allergic reactions.
Driving and using machines: The ability to concentrate or react may be reduced if: The patient has hypoglycaemia (low blood sugar levels); the patient has hyperglycaemia (high blood sugar levels).
Keep this possible problem in mind in all situations where the patient and others might be put at risk (such as driving a car or using machines).
Contact the doctor for advice on driving if: The patient has frequent episodes of hypoglycaemia; the first warning symptoms which help the patient to recognise hypoglycaemia are reduced or absent.
Pregnancy and breast-feeding: If the patient is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby, ask the doctor or pharmacist for advice before taking this medicine.
Inform the doctor if the patient is planning to become pregnant, or if she is already pregnant. The insulin dose may need to be changed during pregnancy and after giving birth. Careful control of diabetes, and prevention of hypoglycaemia, is important for the health of the baby.
There are no or limited data on the use of Apidra in pregnant women.
If the patient is breast-feeding, consult the doctor as adjustments in insulin doses and diet may be required.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects: Hypoglycaemia (low blood sugar) can be very serious. Hypoglycaemia is a very commonly reported side effect (may affect more than 1 on 10 people). Hypoglycaemia (low blood sugar) means that there is not enough sugar in the blood. If the blood sugar level falls too much the patient may become unconscious. Serious hypoglycaemia may cause brain damage and may be life-threatening. If the patient has symptoms of low blood sugar, take actions to increase the blood sugar level immediately.
If the patient experiences the following symptoms, contact the doctor immediately: Systemic allergic reactions are side effects reported uncommonly (may affect up to 1 in 100 people).
Generalised 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 (angiooedema), shortness of breath, a fall in blood pressure with rapid heart beat and sweating. These could be symptoms of severe cases of generalised allergy to insulin, including anaphylactic reaction, which may be life-threatening.
Hyperglycaemia (high blood sugar) means that there is too much sugar in the blood. The frequency of hyperglycaemia cannot be estimated. If the blood sugar level is too high, more insulin may be needed. This can be serious if the blood glucose level becomes very high.
Other side effects: Common reported side effects (may affect up to 1 in 10 people): Skin and allergic reactions at the injection site: Reactions at the injection site may occur (such as reddening, 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 to a few weeks.
Rare reported side effect (may affect up to 1 in 1,000 people): Skin changes at the injection site (lipodystrophy): If the patient injects the insulin too often at the same skin site, fatty tissue under the skin at this site may either shrink or thicken. Insulin that is injected in such a site may not work very well. Changing the injection site with each injection may help to prevent such skin changes.
Side effects where the frequency cannot be estimated from the available data: Eye reactions: A marked change (improvement or worsening) in the blood sugar control can disturb the vision temporarily. If the patient has proliferative retinopathy (an eye disease related to diabetes) severe hypoglycaemic attacks may cause temporary loss of vision.
Reporting of side effects: If any side effects occur, talk to the doctor, pharmacist or nurse. This includes any possible side effects not previously listed. By reporting side effects, the patient can help provide more information on the safety of this medicine.
Some medicines cause changes in the blood sugar level (decrease, increase or both depending on the situation). In each case, it may be necessary to adjust the insulin dose to avoid blood sugar levels that are either too low or too high. Be careful when starting or stopping another medicine.
Tell the doctor or pharmacist if the patient is taking, has recently taken or might take any other medicines. Before taking a medicine, ask the doctor if it can affect the blood sugar level and what action, if any, needs to be taken.
Medicines that may cause the blood sugar level to fall (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 blood lipids); monoamine oxidase (MAO) inhibitors (used to treat depression); pentoxifylline, propoxyphene, salicylates (such as aspirin, used to relieve pain and lower fever); sulfonamide antibiotics.
Medicines that may cause the blood sugar level to rise (hyperglycaemia) 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 (such as in the contraceptive pill used for birth control); phenothiazine derivatives (used to treat psychiatric disorders); somatropin (growth hormone); sympathomimetic medicines (such as epinephrine [adrenaline], salbutamol, terbutaline used to treat asthma); thyroid hormones (used to treat thyroid gland disorders); protease inhibitors (used to treat HIV); atypical antipsychotic medicines (such as olanzapine and clozapine).
The blood sugar level may either rise or fall if the patient takes: 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) 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 recognise a hypoglycaemia.
If not sure whether the patient is taking one of those medicines, ask the doctor or pharmacist.
Apidra with alcohol: The blood sugar levels may either rise or fall with alcohol intake.
Do not use this medicine if it does not appear clear and colourless.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help protect the environment.
Not in-use pens: Store in a refrigerator (2°C-8°C).
Do not freeze.
Do not put SoloStar next to the freezer compartment or a freezer pack.
Keep the pre-filled pen in the outer carton in order to protect from light.
In-use pens: Pre-filled pens in use (or carried as a spare) may be stored for a maximum of 4 weeks below 25°C and away from direct heat or direct light. The pen in use must not be stored in a refrigerator.
Do not use it after this time period.
Instructions for Use: SoloStar is a pre-filled pen for the injection of insulin. Your doctor has decided that SoloStar is appropriate for you based on your ability to handle SoloStar. Talk with your doctor, pharmacist or nurse about proper injection technique before using SoloStar.
Read these instructions carefully before using your SoloStar. If you are not able to use SoloStar or follow all the instructions completely on your own, you must use SoloStar only if you have help from a person who is able to follow the instructions completely. To ensure that you read the dose correctly, hold the pen horizontally, with the needle on the left and the dosage selector to the right.
You can set doses from 1 to 80 units in steps of 1 unit. Each pen contains multiple doses.
If you have any questions about SoloStar or about diabetes, ask your doctor, pharmacist or nurse or call the local sanofi-aventis number.
Important information for use of SoloStar: Always attach a new needle before each use. Only use needles that are compatible for use with SoloStar.
Do not select a dose and/or press the injection button without a needle attached.
Always perform the safety test before each injection.
This pen is only for your use. Do not share it with anyone else.
If your injection is given by another person, special caution must be taken by this person to avoid accidental needle injury and transmission of infection.
Never use SoloStar if it is damaged or if you are not sure that it is working properly.
Always have a spare SoloStar in case your SoloStar is lost or damaged.
Step 1. Check the insulin: A. Check the label on your SoloStar to make sure you have the correct insulin. The Apidra SoloStar is blue. It has a dark blue injection button with a raised ring on the top.
B. Take off the pen cap.
C. Check the appearance of your insulin. Apidra is a clear insulin. Do not use this SoloStar if the insulin is cloudy, coloured or has particles.
Step 2. Attach the needle: Always use a new sterile needle for each injection. This helps prevent contamination, and potential needle blocks.
A. Remove the protective seal from a new needle.
B. Line up the needle with the pen, and keep it straight as you attach it (screw or push on, depending on the needle type).
If the needle is not kept straight while you attach it, it can damage the rubber seal and cause leakage, or break the needle.
Step 3. Perform a safety test: Always perform the safety test before each injection. This ensures that you get an accurate dose by: Ensuring that pen and needle work properly; removing air bubbles.
A. Select a dose of 2 units by turning the dosage selector.
B. Take off the outer needle cap and keep it to remove the used needle after injection. Take off the inner needle cap and discard it.
C. Hold the pen with the needle pointing upwards.
D. Tap the insulin reservoir so that any air bubbles rise up towards the needle.
E. Press the injection button all the way in. Check if insulin comes out of the needle tip.
You may have to perform the safety test several times before insulin is seen.
If no insulin comes out, check for air bubbles and repeat the safety test two more times to remove them.
If still no insulin comes out, the needle may be blocked. Change the needle and try again.
If no insulin comes out after changing the needle, your SoloStar may be damaged. Do not use this SoloStar.
Step 4. Select the dose: You can set the dose in steps of 1 unit, from a minimum of 1 unit to a maximum of 80 units. If you need a dose greater than 80 units, you should give it as two or more injections.
A. Check that the dose window shows "0" following the safety test.
B. Select your required dose. If you turn past your dose, you can turn back down.
Do not push the injection button while turning, as insulin will come out.
You cannot turn the dosage selector past the number of units left in the pen. Do not force the dosage selector to turn. In this case, either you can inject what is remaining in the pen and complete your dose with a new SoloStar or use a new SoloStar for your full dose.
Step 5. Inject the dose: A. Use the injection method as instructed by your doctor, pharmacist or nurse.
B. Insert the needle into the skin.
C. Deliver the dose by pressing the injection button in all the way. The number in the dose window will return to "0" as you inject.
D. Keep the injection button pressed all the way in. Slowly count to 10 before you withdraw the needle from the skin. This ensures that the full dose will be delivered.
The pen plunger moves with each dose. The plunger will reach the end of the cartridge when the total of 300 units of insulin has been used.
Step 6. Remove and discard the needle: Always remove the needle after each injection and store SoloStar without a needle attached.
This helps prevent: Contamination and/or infection; Entry of air into the insulin reservoir and leakage of insulin, which can cause inaccurate dosing.
A. Put the outer needle cap back on the needle, and use it to unscrew the needle from the pen. To reduce the risk of accidental needle injury, never replace the inner needle cap.
If your injection is given by another person, or if you are giving an injection to another person, special caution must be taken by this person when removing and disposing of the needle. Follow recommended safety measures for removal and disposal of needles (contact your doctor, pharmacist or nurse) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.
B. Dispose of the needle safely, as instructed by your doctor, pharmacist or nurse.
C. Always put the pen cap back on the pen, then store the pen until your next injection.
Storage instructions: If your SoloStar is in cool storage, take it out 1 to 2 hours before you inject to allow it to warm up to room temperature. Cold insulin is more painful to inject.
Discard your used SoloStar as required by your local authorities.
Maintenance: Protect your SoloStar from dust and dirt.
You can clean the outside of your SoloStar by wiping it with a damp cloth.
Do not soak, wash or lubricate the pen as this may damage it.
Your SoloStar is designed to work accurately and safely. It should be handled with care. Avoid situations where SoloStar might be damaged. If you are concerned that your SoloStar may be damaged, use a new one.
A10AB06 - insulin glulisine ; Belongs to the class of fast-acting insulins and analogues. Used in the treatment of diabetes.
Soln for inj (pre-filled pen) (clear, colourless, aqueous with no particles visible) 100 u/mL x 3 mL x 5's.