100 units/ml injection solution in the vial
of insulin lispro
What Insulin lispro Sanofi is and what it is used for
Insulin lispro Sanofi is used to treat diabetes. It acts faster than regular human insulin because the insulin molecule has changed slightly.
You get diabetes if your pancreas does not produce enough insulin.
Insulin lispro Sanofi replaces your own insulin and is used to control blood glucose levels for a long time. It works very quickly and for a shorter time than soluble insulin (2-5 hours). You should normally take Insulin lispro Sanofi within 15 minutes before or after a meal.
Your doctor will tell you if you should take Insulin lispro Sanofi with longer-acting insulin. Each type of insulin has its own package leaflet. Do not change your insulin unless your doctor tells you to. Be very careful if you change your insulin.
Insulin lispro Sanofi can be given to both adults and children.
What you need to know before you use Insulin lispro Sanofi
Do not use Insulin lispro Sanofi
- if you have an incipient so-called insulin sensation (low blood sugar). Later on in this leaflet, you will find instructions on how to deal with a mild insulin sensation (see section 3: If you have used too much Insulin lispro Sanofi).
- if you are allergic to insulin lispro or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Enter the product name (“Insulin lispro Sanofi”) and the lot number (found on the outer carton and label of each vial, cartridge, and pre-filled pen ) when reporting adverse reactions.
Skin changes at the injection site
To prevent skin changes, e.g. nodules under the skin, you should constantly change the injection site. It may be that insulin et not work as well if you inject in an area of nodules (see How to use Insulin lispro Sanofi). Contact your doctor before changing the injection site if you are currently injecting in an area with lumps. Your doctor may advise you to check your blood sugar more often and to adjust your insulin dose or the dose of other diabetes medicines.
- If your blood sugar is under good control of your current insulin , you may not be able to detect the warning signs when your blood sugar gets too low. Warning signals are listed later in this leaflet. You should carefully keep track of when you should eat, how often you should exercise and how much you should work. You should also carefully check your blood sugar level by testing your blood sugar frequently.
- Some people who have had insulin sensations after switching from animal insulin to human insulin have reported that the early warning symptoms were less clear or different. If you often have insulin sensations or have difficulty recognizing them, talk to your doctor.
- If you answer YES to any of the following questions, talk to your doctor, pharmacist or diabetes nurse.
- Have you recently become ill?
- Do you have problems with your liver or kidneys?
- Do you train more than usual?
- You should also talk to your doctor, pharmacist or diabetes nurse if you plan to travel abroad. The time difference between countries may mean that you have to take your injections and eat at other times than when you are at home.
- Some patients with long-term type 2 diabetes mellitus and heart disease or previous stroke , developed heart failure during treatment with pioglitazone and insulin . Tell your doctor as soon as possible if you get signs of heart failure such as unexpected shortness of breath, rapid weight gain or local swelling ( edema ).
Other medicines and Insulin lispro Sanofi
Your insulin needs may change if you take
- birth control pills ,
- cortisone ,
- agents for thyroid disease,
- tablets for the treatment of diabetes ,
- acetylsalicylic acid ,
- sulfate antibiotics,
- octreotide,
- beta 2 stimulators (eg ritodrin, salbutamol or terbutaline ),
- beta blockers , or
- certain antidepressants ( monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),
- danazol,
- certain angiotensin converting (ACE) enzyme inhibitors (eg captopril, enalapril ), and
- angiotensin II receptor blockers.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines (see also section “Warnings and precautions”).
Insulin lispro Sanofi with alcohol
Your blood sugar levels may change if you drink alcohol. Therefore, the amount of insulin you need may change when consuming alcohol.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine. Insulin requirements usually decrease during the first 3 months of pregnancy and then increase during the remaining six months.
If you are breastfeeding, adjusting your insulin dose or diet may be necessary.
Driving and using machines
Your ability to concentrate and react may be impaired in hypoglycemia. Keep this in mind in all situations where you may expose yourself or others to risks (eg while driving or using machines). Contact your doctor regarding the suitability of driving if:
- you often suffer from hypoglycemia
- your warning signs of hypoglycaemia are weakened or absent altogether
Insulin lispro Sanofi contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free.
How to use Insulin lispro Sanofi
Always check the name and type of insulin on the package and the label of the vial when you get it from the pharmacy. Make sure you get the Insulin lispro Sanofi prescribed by your doctor.
Always use this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.
Dosage instructions
- You should normally inject Insulin lispro Sanofi within 15 minutes before a meal. If you need to, you can inject shortly after the meal. Dose one is determined by your doctor who adjusts it individually for you. These instructions are personal and just for you. Follow them closely and visit your diabetes clinic regularly.
- If you change the type of insulin (eg from human or animal insulin to an Insulin lispro Sanofi product) you may need to take more or less than before. This may appear at the first injection one or it may be a gradual change over several weeks or months.
- Inject Insulin lispro Sanofi under the skin ( subcutaneous use or “sc”). You should inject it into a muscle only if your doctor tells you to.
Preparation of Insulin lispro Sanofi
- Insulin lispro Sanofi is already dissolved in water so you do not need to mix it. You may only use it if it looks like water. The solution must be clear, colorless and not contain solid particles. Check this before each injection .
Injection of Insulin lispro Sanofi
- Wash your hands.
- Clean the skin as instructed before injecting. Clean the rubber membrane on the bottle, but do not remove the membrane .
- Use a clean, sterile syringe and needle and insert the rubber membrane and suck up the amount of Insulin lispro Sanofi you need. Your doctor or diabetes nurse will show you how to do this. Do not share needles or syringes with anyone else.
- Inject under the skin as instructed. Do not inject directly into a blood vessel. Wait 5 seconds after finishing the injection before pulling out the needle, then you are sure that you have received the full dose one. Do not massage the injection site. Make sure that you have a margin of at least 1 cm to the previous injection site and that you change the injection site as instructed. Insulin lispro Sanofi injection works faster than soluble human insulin, regardless of injection site (upper arm, thigh, buttocks or abdomen).
- Your doctor will tell you if you should mix Insulin lispro Sanofi with any human insulin. If you have to inject a mixture , first inject the insulin lispro Sanofi into the syringe and then the longer-acting insulin . Inject the solution as soon as you have mixed it. Do the same thing every time.
- Normally Insulin lispro Sanofi should not be mixed with any mixed insulin. You should never mix Insulin lispro Sanofi with insulin produced by other manufacturers or animal insulin.
- You should not inject Insulin lispro Sanofi intravenously (iv). Inject Insulin lispro Sanofi exactly as your doctor or diabetes nurse has told you. Only your doctor can give Insulin lispro Sanofi intravenously . Your doctor will only do this in special circumstances such as surgery or if you are ill and your blood sugar levels are too high.
How to use Insulin lispro Sanofi in an infusion pump
- Only certain CE marked insulin pumps may be used for insulin lispro infusion . Before administering insulin lispro infusion , the manufacturer’s instructions should be read to verify that the pump in question is appropriate. Read and follow the instructions provided with the infusion pump.
- Make sure you use the correct reservoir and catheter for your pump.
- The infusion set (tubing and needle) should be replaced according to the instructions in the instructions for use that come with the infusion set.
- In the event of a hypoglycaemic reaction, the infusion should be stopped until the reaction has ceased. In case of repeated or severely low blood sugar levels, consult your doctor or diabetes clinic and consider the need to discontinue or reduce the insulin infusion.
- A malfunctioning pump or a blockage in the infusion set can cause a rapid rise in blood sugar levels. If a disturbance in insulin flow is suspected, follow the instructions in the instructions for use and, if deemed necessary, consult a doctor or diabetes clinic.
- When used in an insulin pump, Insulin lispro Sanofi must not be mixed with any other insulin .
If you use more Insulin lispro Sanofi than you should
You may get low blood sugar if you take too much Insulin lispro Sanofi. Check your blood sugar. If your blood sugar is low ( mild hypoglycemia), take glucose tablets, sugar, or a sweet drink. Then take fruit, biscuits, or a sandwich according to your doctor’s instructions and rest for a while. Often, mild hypoglycemia or a slight overdose of insulin disappears with this treatment. If you get worse, have shortness of breath, and turn pale, contact your doctor immediately. Quite severe hypoglycemia can be treated with a glucagon injection. Eat glucose or sugar after the glucagon injection. If you are not improved by glucagon, you should be treated in a hospital. Ask your doctor to tell you about glucagon.
If you forget to use Insulin lispro Sanofi
You may get high blood sugar if you take too little Insulin lispro Sanofi. Check your blood sugar.
Failure to treat hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar) can have serious consequences and can lead to headaches, nausea, vomiting, dehydration, unconsciousness, coma, and even death (see Hypoglycaemia and Hyperglycaemia and diabetic ketoacidosis in section 4. ” Possible side effects”).
Three simple tips to avoid hypoglycemia or hyperglycemia:
- Always have a spare syringe and spare bottle of Insulin lispro Sanofi with you.
- Always carry something with you that shows that you are diabetic.
- Always have fast-acting carbohydrates (sugar) with you.
If you stop using Insulin lispro Sanofi
You may get high blood sugar if you take too little Insulin lispro Sanofi. Do not change your insulin unless your doctor tells you to.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
General allergies are rare (may affect up to 1 in 1,000 people). The symptoms are:
| itching all over the body | drop in blood pressure |
| breathing difficulties | palpitation |
| hissing breathing | sweating |
If you think you may have this type of insulin allergy with Insulin lispro Sanofi, talk to your doctor straight away.
Local allergy is common (may affect more than 1 user in 10). Some people get redness, swelling, or itching at the injection site. This usually stops after a few days or a few weeks. If you get any of these symptoms, talk to your doctor.
Skin changes at the injection site
If you inject insulin too often in the same place, the adipose tissue may either shrink (lipoatrophy) or thicken (lipohypertrophy) (may affect up to 1 in 100 people). Nodules under the skin can also be caused by the accumulation of a protein called amyloid ( cutaneous amyloidosis. How often this occurs is not known). It may be that insulin et not work as well if you inject in an area with nodules. Change the injection site for each injection to prevent these skin changes.
Edema (swollen arms, ankles; fluid retention ) has been reported, especially when starting insulin therapy or when changing treatment to improve the control of your blood sugar.
Common problems with diabetes
Hypoglycemia
Hypoglycemia (low blood sugar) means that there is not enough sugar in the blood. This can
caused by:
- that you are taking too much Insulin lispro Sanofi or other insulin
- that you skip or postpone meals or change your diet
- that you exercise or work too hard just before or after a meal
- that you have an infection or are ill (especially with diarrhea or vomiting)
- that your insulin needs have changed, or
- that you have problems with your kidneys or liver that have gotten worse
Alcohol and certain medications can affect blood sugar levels (see section 2).
The first symptoms of low blood sugar usually appear quickly and involve
| fatigue | palpitation |
| nervousness and tremors | nausea |
| headache | cold sweats |
If you are not sure about recognizing the warning symptoms, avoid situations, such as driving a car, where you may expose yourself or others to risks due to hypoglycemia.
Hyperglycaemia and diabetic ketoacidosis
Hyperglycemia (too much sugar in the blood) means that your body does not have enough insulin.
Hyperglycaemia can occur if:
- you have not taken your Insulin lispro Sanofi or any other insulin
- you have taken less insulin than your doctor told you to
- you have eaten more than your diet allows, or
- you have a fever, infection or are emotionally stressed
Hyperglycaemia can lead to diabetic ketoacidosis . The first symptoms creep in for several hours or days. They are:
| somnolence | no appetite |
| flushing | the acetone-like odor from the breath |
| thirst | nausea or vomiting |
Serious symptoms are heavy breathing and rapid heartbeat. Seek medical attention immediately.
In case of illness
If you are sick, especially if you feel nauseous or vomit, your insulin needs may change. Even if you do not eat normally, you still need insulin. Test urine or blood, follow the instructions regarding your illness, talk to your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency, By reporting side effects, you can help increase drug safety information.
5. How to store Insulin lispro Sanofi
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.
Before first use, Insulin lispro Sanofi should be stored in a refrigerator (2 ° C – 8 ° C). Do not freeze. Keep the vial in the outer carton. Sensitive to light.
Keep the vial at room temperature (not above 30 ° C) and discard it after 4 weeks. Store in a cool place. Keep the vial in the outer carton. Sensitive to light.
Do not use Insulin lispro Sanofi if the solution is colored or contains solid particles. You may only use it if it looks like water. Check this before each injection.
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. Contents of the packaging and other information
Content declaration
- The active substance is insulin lispro. One ml solution contains 100 units (equivalent to 3.5 mg) of insulin lispro. Each vial contains 10 ml of solution for injection , equivalent to 1000 units.
- The other ingredients are: metacresol, glycerol , disodium hydrogen phosphate heptahydrate, zinc oxide and water for injections. Hydrochloric acid or sodium hydroxide may have been used to adjust the pH .
What the medicine looks like and contents of the pack
Insulin lispro Sanofi injection solution in the vial is a clear, colorless aqueous solution.
Each vial contains 10 ml.
Insulin lispro Sanofi vial is supplied in packs of 1 or 5 vials. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
sanofi-aventis groupe, 54 rue La Boétie, F – 75008 Paris, France
Manufacturer:
Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt, Germany.
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