Drug Information Sheet("Kusuri-no-Shiori")
Injection
Published: 08/2013
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval
details may vary by country. Medicines have adverse effects (risks) as well as efficacies (benefits). It is
important to minimize adverse effects 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 increases bone mineral density and prevents bone fracture by suppressing bone resorption by
osteoclasts.
It is usually used for the treatment of 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 possibly become pregnant, consult your doctor or pharmacist immediately.
・Try to ingest enough calcium and vitamin D through meals, etc.
・Abnormality in jaw bone may occur while taking bisphosphonates including this medicine. This adverse reaction is
often related to dental treatment such as tooth extraction. Receive adequate explanation about the following
points from doctors or pharmacists:
If possible, receive dental treatment such as tooth extraction prior to taking the medicine, after consultation with
your doctor.
Keep your mouth clean by brushing your teeth while taking the medicine.
Receive an oral or dental checkup regularly while taking the medicine.
Inform your dentist that you are taking the medicine when you receive dental treatment.
Avoid any treatments such as tooth extraction while taking the medicine.
If abnormalities in teeth/jaw such as jaw pain, loose teeth or swollen gums occur, see a dentist/oral surgery
specialist.
Possible adverse effects of 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 effects indicated in
brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
・lassitude, lightheadedness, decreased consciousness, impaired mind, glow, pale face, swelling around the eyes/lips,
hoarseness, breathlessness, shortness of breath, palpitation, urticaria, impaired judgment [anaphylactic shock,
anaphylactic reaction]
・sore/swollen mouth, redness, loose teeth, numbness of jaw, heavy feeling in jaw, fever, loss of appetite
[osteonecrosis of the jaw, osteomyelitis of the jaw]
・pain of thigh or inguinal region [atypical subtrochabteric and diaphyseal femoral 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
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For healthcare professional use only
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For further information, talk to your doctor or pharmacist.
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