Drug Information Sheet("Kusuri-no-Shiori")
Self-injection
Published: 05/2021
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.	
Brand name:Insulin Aspart BS Injection Cart NR "Sanofi"
Active ingredient:Insulin Aspart(genetical recombination)[insulin aspart biosimilar 1]
Dosage form:clear and colorless injection
Print on wrapping:インスリンアスパルトBS注カートNR「サノフィ」		
Effects of this medicine
This medicine is a human insulin analog (insulin with different amino acid sequence). It lowers blood glucose level through effects including intracellular glucose uptake, inhibition of gluconeogenesis in liver, and promotion of glycogen synthesis in liver and muscle tissue.
It is usually used to treat diabetes mellitus for which insulin therapy is indicated.	
Before using this medicine, be sure to tell your doctor and pharmacist
・If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
If you have hypoglycemic symptoms. 
If you are unable to take sufficient meals due to gastrointestinal disorders such as diarrhea and vomiting, or common cold.
・If you are pregnant or breastfeeding.
・If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)	
Dosing schedule (How to take this medicine)
・Your dosing schedule prescribed by your doctor is((            to be written by a healthcare professional))
・In general, for adults, start with injecting 2 to 20 units of the active ingredient subcutaneously at a time, right before each meals. Although the dosage should be adjusted according to the symptoms and laboratory examination, the maintenance dose including dose of other long-acting insulin preparation(s) is generally 4 to 100 units per day. Strictly follow the instructions.
・Do not share your pen and cartridge with another person.
・Use a type A disposable syringe needle (compliant with JIS T3, 226-2) intended for exclusive use with this
medicine.
・If you find any problem such as leakage of the solution when you attach the type A needle to the pen (itango), change the needle to a new one.
・Attach a new needle every time immediately before injection.
・Inject this medicine subcutaneously into upper arms, thighs, abdomen or buttocks. Because the rate of insulin absorption is affected by the injection part, choose your injection part, and change the injection site for every dosing within the chosen injection part. Injection site should be at least 2 to 3 cm apart from the previously injected point.
・If you miss a dose, consult with your doctor. You should never inject two doses at one time.
・If you accidentally inject more than your prescribed dose, consult with your doctor or pharmacist immediately.
・Do not stop injecting this medicine unless your doctor instructs you to do so.	
Precautions while taking this medicine
・Strictly follow the instructions on dietary/exercise therapy.
・Pay extra attention when you engage in dangerous operations such as working at heights or driving a car as the development of hypoglycemia during such operations may lead to an accident.
・Not eating or heavy exercise may lead to hypoglycemia. Persistent hypoglycemia may result in a fatal
accident.
・Pay close attention to the prevention and treatment methods of hypoglycemia (consuming sugar or juice
immediately after development of the symptoms) and make sure to inform your family and persons around you of these methods.
	
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include hypoglycemia and injection site reaction (swelling, itch, pain, redness). If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
・feeling of excessive hunger, lassitude, tremor (trembling of limbs) [hypoglycemia]
・breathing difficulty, sweating, generalized rash [anaphylactic shock]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.	
Storage conditions and other information
・Keep out of the reach of children.
・Before use, store at 2 to 8 degrees Celsius (in the refrigerator), away from light and freezing.
・After use, do not store in the refrigerator, but store at below 30 degrees Celsius, away from light by using the cap of the injector. Use within 4 weeks.
・Discard the remainder. Do not store them. Ask the pharmacy or medical institution how to discard them.	
For healthcare professional use only      /    /

For further information, talk to your doctor or pharmacist.