Palmbiva Injection (Ibandronate Sodium Hemihydrate)

Adult administration

Administer 3mg by intravenous injection every 3 months for 15 - 30 seconds. Patients are advised to take calcium and vitamin D as adjunctive therapy. If a scheduled dose is missed, it should be administered as soon as possible, followed by regular dosing at 3-month intervals.

Child administration

Efficacy and safety in pediatric patients under 18 years have not been studied.

This drug must be administered intravenously, and care should be taken as injuring surrounding tissues may occur if injected intra-arterially or perivenously. This drug should not be used in patients with allergies to this medication or its components, or in untreated hypocalcemia patients. Possible side effects during the use of this drug include gastritis, diarrhea, abdominal pain, indigestion, nausea, constipation, musculoskeletal pain, joint pain, muscle pain, headaches, rash, fatigue, and flu-like symptoms. Influenza-like symptoms may occur initially during intravenous injection, but they are generally mild and temporary. This drug may temporarily lower serum calcium levels, so hypocalcemia and bone and mineral metabolism disorders should be treated before administration, and it's important to ensure adequate intake of calcium and vitamin D. Patients undergoing dental treatments or with poor oral hygiene may have an increased risk of osteonecrosis of the jaw, so a dental examination and preventive care should be considered before administration. Excessive dental treatment should be avoided during administration, and if symptoms of osteonecrosis of the jaw occur, consulting a specialist immediately is advised. Long-term use of this drug may result in atypical fractures of the femur or other bones; therefore, if pain in the thigh or groin occurs, an evaluation should be obtained immediately. Patients with impaired renal function or those taking medications affecting the kidneys require regular check-ups and tests during treatment. If anaphylaxis or severe allergic reactions occur during administration, treatment should be stopped immediately and appropriate care should be received. Pregnant or breastfeeding women should avoid using this drug, and safety and efficacy in children under 18 years have not been established. In the event of overdose, careful monitoring is necessary as it may affect renal and liver function, and appropriate treatment should be received if needed. This drug should not be mixed with calcium-containing solutions or other intravenous medications and must be diluted only with the designated solution. After use, the injection needle and syringe should not be reused and should be disposed of safely.

Serious side effects

Urticaria, angioedema, facial swelling/edema, anaphylactic reaction/shock, exacerbation of asthma, Stevens-Johnson syndrome, erythema multiforme, bullous dermatitis, acute renal failure, dyspnea, multiple organ failure, death, severe allergic reactions, severe skin adverse reactions, severe swelling or urinary abnormalities, serious neurological symptoms, jaundice, vascular abnormalities, phlebitis/thromboembolism, eye inflammation (uveitis, episcleritis, scleritis), osteonecrosis of the jaw

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 and moisture and is best kept at room temperature between 1 to 30 degrees Celsius. Proper storage will maintain the medication's efficacy and safety.

Appearance

A colorless, transparent solution in a colorless, transparent glass prefilled syringe with a single-use injection needle attached.

Package unit

3ml x 1 vial