くすりのしおり

Injection
Revised: 7/2016

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 :
Bonviva Injection 1mg Syringe
 Active ingredient:
Ibandronate sodium hydrate
 Dosage form:
injection
 Print on wrapping:

Effects of this medicine

This medicine suppresses bone resorption by osteoclasts in the bone, thereby increasing bone density and preventing bone fractures.
It is usually used to treat osteoporosis.

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 hypocalcemia or renal disorder.
  • If you are pregnant, possibly 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, inject intravenously once a month.
  • The treatment period with this medicine depends on your response to the treatment.

Precautions while taking this medicine

  • If you become pregnant or may have become pregnant while taking this medicine, consult with your doctor or pharmacist immediately.
  • Try to take enough calcium and vitamin D through meals, etc.
  • Abnormalities in the jaw bone may occur while taking bisphosphonates, including this medicine. Such adverse reactions have been reported often related to dental treatment such as tooth extraction, so receive adequate explanations about the following points from your doctor or pharmacist:
    - Consult with your doctor, and then receive dental checkup before taking this medicine if needed. If possible, have your dental treatment, such as tooth extraction, completed before taking this medicine.
    - Keep your mouth clean by brushing your teeth.
    - Receive dental checkup regularly.
    - When you visit a dentist, tell the dentist that you are taking this medicine.
    - Try to avoid treatments such as tooth extraction as much as possible while taking the medicine.
    - If abnormalities are identified in the teeth/jaw (such as jaw pain, loose teeth or swollen gums), visit a dentist/oral surgery specialist immediately.
  • Abnormalities in the bone of the external ear canal may occur while taking bisphosphonates. According to some cases reporting such an adverse reaction, the development of the reaction has been associated with ear infection or wound. If symptoms such as ear itch, heat sensations inside the ear, strange sensations in the ear, otorrhea and ear pain persist, visit an otolaryngologist.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include back pain, muscle pain or joint pain. 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.
  • general malaise, light headedness, decreased consciousness, impaired mind, hot flush, facial pallor, swelling around eyes and lips, hoarseness, breathing difficulty, shortness of breath, palpitation, hives, impaired judgment  [anaphylactic shock, anaphylactic reaction]
  • sore mouth, swollen mouth, redness, feeling of loose teeth, loose teeth, numbness of jaw, heavy feeling in the jaw, fever, loss of appetite  [jaw bone necrosis/jaw osteomyelitis]
  • ear itch, heat sensations inside the ear, strange sensations in the ear, otorrhea, ear pain  [osteonecrosis of the external ear canal]
  • pain in the thigh or inguinal region  [atypical subtrochanteric and proximal femoral shaft fractures]
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

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.