Uni-ibandronate Injection (Ibandronic Acid Sodium Hydrate)

Adult administration

Administer 3mg via intravenous injection every 3 months for 15 - 30 seconds.

This medication must be administered only via intravenous injection; incorrect administration into arteries or near veins can cause tissue damage, so utmost caution is necessary. Patients with allergies to this medication or its ingredients, or those with untreated hypocalcemia should not use it. During treatment with this medication, gastrointestinal symptoms such as gastritis, diarrhea, abdominal pain, indigestion, nausea, and constipation may occur, as well as symptoms such as muscle pain, joint pain, headache, and rash. In some patients, flu-like symptoms, including fever, chills, fatigue, muscle pain, and joint pain, may temporarily occur, but they are usually mild and resolve naturally. Rarely, jaw or ear region osteonecrosis may occur in patients using this medication, so it is important for cancer patients or those receiving steroid or chemotherapy to consult a dentist and maintain good oral hygiene before administration. If dental treatment is needed, it is advisable to avoid excessive procedures during the use of this medication and consult a specialist to plan treatment if necessary. Severe bone, joint, or muscle pain may occur during treatment for osteoporosis with this medication; if such symptoms appear, immediate consultation with medical personnel is required. Long-term use of this medication may present a risk of atypical fractures in the femur or other bones, so any pain in the thigh or groin must be investigated. Women who are pregnant or breastfeeding should avoid this medication as its safety has not been established, particularly since harmful effects on the fetus have been observed in animal studies. This medication is excreted through the kidneys, so patients with impaired kidney function need regular examinations and careful monitoring. In cases of overdose, hypocalcemia and hypophosphatemia may occur, necessitating close observation of kidney and liver functions and appropriate treatment. This medication should not be mixed with calcium-containing solutions or other intravenous drugs and must be administered only with the designated solution. After use, the injection needle and syringe should not be reused and must be disposed of in a safe container, out of reach of children.

Serious side effects

Hives, severe swelling (edema), angioedema, facial swelling/edema, anaphylactic reactions/shock, severe allergic reactions, Stevens-Johnson syndrome, erythema multiforme, bullous dermatitis, severe skin adverse reactions, vasculitis/thrombophlebitis, osteonecrosis (jaw and external auditory canal), acute renal failure, multiple organ failure, death, severe edema or urination abnormalities, dyspnea, worsening of asthma, severe allergic reactions, serious neurological symptoms (dizziness,

Mild side effects

• Gastritis
• diarrhea
• abdominal pain
• indigestion
• nausea
• constipation
• musculoskeletal pain
• joint pain
• muscle pain
• flu-like illness

This medication should be stored in a sealed container to prevent exposure to air or moisture. Additionally, it is important to maintain a storage temperature between 1 to 30 degrees Celsius to preserve the effectiveness of the medication.

Appearance

An injection in a colorless, transparent solution contained in a colorless, transparent glass prefilled syringe, accompanied by a single-use needle.

Package unit

3ml x 1 vial