くすりのしおり

Injection
Published: 11/2016

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 :
Reclast for i.v. infusion 5mg
 Active ingredient:
Zoledronic acid hydrate
 Dosage form:
injection
 Print on wrapping:

Effects of this medicine

This medicine is a bisphosphonate preparation. This medicine suppresses bone loss to increase bone density and prevent bone fracture.
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 renal disorder, dehydration (fever, diarrhea, vomiting, etc.) or hypocalcemia.
    If you have recently received dental treatment such as tooth extraction or have a plan to receive it.
  • 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, this medicine is administered by intravenous drip infusion once a year. This medicine should be infused over a period of 15 minutes or longer at a constant infusion rate.
  • The treatment period with this medicine depends on your symptoms.

Precautions while taking this medicine

  • This medicine may cause acute renal failure. Drink sufficient amount of water before injection and early after injection. If dehydration (fever, diarrhea, vomiting, etc.) are seen early after injection, receive medical advice. Renal function tests may be performed before or during use of this medicine.
  • This medicine may cause hypocalcemia. Try to ingest enough calcium and vitamin D through meals, etc.
  • Bisphosphonates may cause osteonecrosis of the jaw/osteomyelitis of the jaw. This adverse reaction is often related to dental treatment such as tooth extraction or local infection.
    - Prior to using the medicine, consult with your doctor, and if necessary, receive dental treatment such as tooth extraction.
    - While taking this medicine (at least for 1 year after injection), maintain your oral hygiene by brushing your teeth and receive dental checkup regularly.
    - If you need to receive any dental treatments while taking this medicine (at least for 1 year after injection), tell the dentist that you are taking this medicine and avoid treatments such as tooth extraction as much as possible.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include fever, joint pain, muscle pain, malaise, influenza-like illness (complicated symptoms of fever/joint pain/muscle pain/malaise /chills/headache, etc.) and headache. 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, see your doctor immediately.
  • decreased urine output, edema, malaise [acute renal failure, interstitial nephritis, Fanconi syndrome]
  • convulsion, weakness of muscles, numbness [hypocalcemia]
  • jaw pain, teeth loose, gums swelling [osteonecrosis of the jaw/osteomyelitis of the jaw]
  • otitis externa (itch/hotness/discomfort of the ear), ear discharge, ear pain [osteonecrosis of the external auditory canal]
  • pain of thigh or inguinal region [atypical subtrochanteric 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

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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