Ibandronate Sodium Hydrate Injection

Adult administration

Administer 3mg by intravenous injection over 15 - 30 seconds once every 3 months. Patients should take supplemental calcium and vitamin D. If a dose is missed on the scheduled dosing date, administer the injection as soon as possible and continue regular dosing at 3-month intervals from that date. Patients with hepatic impairment No dose adjustment is necessary. Patients with renal impairment No dose adjustment is necessary in patients with mild or moderate renal impairment whose serum creatinine is 200 µmol/L(2.3mg/dL) or less, or whose creatinine clearance is 30ml/min or more. There is insufficient clinical experience in patients whose serum creatinine exceeds 200 µmol/L(2.3mg/dL) or whose creatinine clearance is less than 30ml/min; therefore, administration of this medicine is not recommended. Elderly patients No dose adjustment is necessary.

Child administration

Efficacy and safety in children aged 18 years or younger have not been studied.

This medication must be administered intravenously, and care should be taken when administering it intra-arterially or around the vein, as tissue damage may occur. It should not be given to patients who are allergic to this medication or any of its ingredients, or to patients with untreated hypocalcemia. Gastrointestinal symptoms such as gastritis, diarrhea, abdominal pain, dyspepsia, nausea, and constipation may occur while using this medication, and musculoskeletal pain, arthralgia, and myalgia may also develop. Some patients may experience flu-like symptoms such as fever, chills, fatigue, joint pain, and muscle pain, which are generally temporary and mild symptoms. Long-term use of this medication may rarely result in osteonecrosis of the jaw; therefore, prior to any dental treatment, a thorough oral examination and careful treatment planning should be conducted. Additionally, if sudden thigh pain occurs while taking this medication, healthcare professionals should be consulted immediately to consider the possibility of atypical femoral fractures. This medication may temporarily lower serum calcium levels, so it is important to treat hypocalcemia or other metabolic bone disorders before administration and to ensure adequate intake of calcium and vitamin D. Patients with poor kidney function or those taking medications that may affect the kidneys should have regular check-ups by healthcare professionals during treatment. Pregnant or lactating women should not use this medication, as its safety has not been established. In the case of overdose, monitoring should be conducted carefully because it may affect kidney and liver function, and calcium, phosphorus, and magnesium supplementation may be necessary as needed. This medication should not be mixed with calcium-containing solutions or other intravenous medications, and used syringes and needles should not be reused and should be disposed of safely.

• Gastritis
• diarrhea
• abdominal pain
• dyspepsia
• nausea
• constipation
• musculoskeletal pain
• joint pain
• myalgia
• influenza-like illness

This medication should be stored in a sealed container to prevent the ingress of air, and the storage temperature should be maintained between 1 degree and 30 degrees Celsius at room temperature. By storing it this way, the effectiveness of the medication can be safely maintained.

Appearance

A colorless and transparent solution in a colorless and transparent glass pre-filled syringe, with a single-use syringe attached.

Package unit

3ml/unit