くすりのしおり

Self-injection
Revised: 3/2019

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 Glargine BS Injection Kit[FFP]
 Active ingredient:
Insulin glargine (genetical recombination) [insulin glargine biosimilar 2]
 Dosage form:
limpid and colorless injection
 Print on wrapping:

Effects of this medicine

This medicine lowers blood glucose levels by glucose uptake into cells, inhibiting glucose production in the liver and promoting glycogen synthesis in the liver and the muscle.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, gastrointestinal disorder such as diarrhea and vomiting, insufficient dietary intake due to cold etc.
  • 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, in the early phase, subcutaneously inject 4 to 20 units once a day. In some cases, this medicine may be used in combination with other insulin preparations. The timing of injection should be either before breakfast or at bedtime, but it should be injected at the same time every day. Although the dose of injection may be adjusted according to the symptoms or examination findings of the patient, the maintenance dose, including that of other insulin preparations, is generally 4 to 80 units a day. However, the dose may exceed 80 units if necessary. Strictly follow the instructions.
  • Confirm the label of the insulin preparations before using, and take care not to confuse the medicine with other insulin preparations.
  • Use a type A disposable syringe needle (compliant with JIS T3226-2) intended for exclusive use with this medicine.
  • If you find any problem, such as leakage of the solution...change the needle to a new one.
  • Attach a new needle every time immediately before injection.
  • Inject this medicine subcutaneously into the upper arm, femoral region, abdomen or lumbar region. Injection site should be at least 2 to 3 cm apart from the previously injected site in the same area. Do not inject into the vein.
  • Do not share your injection with another person.
  • If you miss a dose, consult with your doctor or pharmacist. You should never inject two doses at one time.
  • If you accidentally inject more than your prescribed dose, consult with your doctor or pharmacist.
  • 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, since 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.
  • You should pay close attention to the prevention and treatment methods...inform your family and persons around you about these methods.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include hypoglycemia and manifestation or worsening of diabetic retinopathy.
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.
  • cold sweat, feeling of excessive hunger, shaking of hands or feet, consciousness disturbed [hypoglycemia]
  • redness, dyspnoeas, blood pressure decreased, loss of consciousness, chest pain [shock, anaphylaxis]
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 the reach of children.
  • Store away from light and do not freeze this medicine. Store this medicine in the refrigerator (at 2 to 8 degrees Celsius). After the use of this medicine is started, store away from light and at room temperature.
  • Before use, this (unused) medicine should be stored in the refrigerator (at 2 to 8 degrees Celsius) away from freeze and light. When you get this medicine out of the refrigerator for subcutaneous injection, use after warming it to room temperature.
  • After using of this medicine, do not store in the refrigerator and store away from light and freeze.
  • Dispose all injections used for more than 4 weeks.
  • Consult with your dispensing pharmacy or medical institution how to discard the medicine.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.