くすりのしおり

Injection
Revised: 6/2017

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 :
ZOLEDRONIC ACID for i.v. infusion 4mg /5mL "Nichiiko"[bone lesion]
 Active ingredient:
Zoledronic acid hydrate
 Dosage form:
injection
 Print on wrapping:

Effects of this medicine

This medicine relieves bone pain or prevents bone fracture associated with bone metastasis of solid tumors or multiple myeloma.
It is usually used to treat bone lesion associated with multiple myeloma and bone metastasis of solid tumors.

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 renal dysfunction.
    If you have recently received dental treatment such as tooth extraction or have a plan to receive it.
  • 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 by intravenous infusion once every 3 to 4 weeks.
  • It may be administered for a long time depending on your response to the treatment.
  • Ask your doctor about your frequency of injection.

Precautions while taking this medicine

  • To prevent hypocalcemia, you may take calcium or vitamin D according to your doctor instructions.
  • Maintain your oral hygiene while using this medicine.
  • Inform your dentist or oral surgeon that you are using this medicine when you receive dental examination.
  • Consult with your doctor and receive your dental examination before treatment of this medicine as needed. You should finish dental treatments such as tooth extraction before treatment of this medicine as much as possible. Receive your dental examination on a regular basis.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include fever, nausea, malaise, headache, anemia, bone pain, joint pain, erythematous skin rash (red rash), macular skin rash (red rash), angioneurotic edema (swelling of eyelid/lip, breathing difficulty, hives), hives, erythema, blister, skin rash, eczema and itch. 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.
  • decreased urine output, edema, hematuria, decreased consciousness, thirst [acute renal failure, interstitial nephritis, fanconi syndrome]
  • general edema, respiratory distress, easy to breathe in sitting position than when lying [congestive heart failure (edema, respiratory distress, pulmonary edema)]
  • convulsion, lassitude in muscle, numbness, unable to recognize place, time or name, palpitation [hypocalcemia]
  • fever, cough, respiratory distress [interstitial pneumonia]
  • pain of jaw/tooth, filling with pus, delay in healing wound after tooth extraction [osteonecrosis and osteomyelitis of the jaw]
  • ear pain, ear discharge [osteonecrosis of the external auditory canal]
  • pain of the thigh/inguinal region [atypical subtrochanteric and proximal femoral fracture]
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.

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