Ibanel Injection (Sodium Ibandronate Hydrate)

Adult administration

3mg is given intravenously every 3 months for 15 - 30 seconds. Patients are advised to take calcium and vitamin D as an adjunct. If a dose is missed on the regular dosing day, inject as soon as possible, then continue regular dosing every 3 months thereafter.

This medication should only be administered intravenously, as improper injection into arteries or surrounding veins can cause tissue damage. Patients with allergies to this medication or its components, or those with untreated hypocalcemia, should not use this medication. While taking this medication, gastrointestinal symptoms such as indigestion, abdominal pain, nausea, diarrhea, constipation, as well as adverse reactions like muscle pain, joint pain, headache, and rash may occur. Some patients may experience flu-like symptoms such as fever, myalgia, fatigue, and chills, but these are generally mild and resolve without treatment. This medication may temporarily lower serum calcium levels; therefore, hypocalcemia or bone and mineral metabolism disorders must be treated before administration. During treatment, adequate intake of calcium and vitamin D is important, and supplements should be taken if necessary. Serious side effects of osteonecrosis of the jaw have been reported, so it is advisable to have a dental examination before administration and to avoid excessive dental treatment during therapy. The risk of osteonecrosis is particularly high for cancer patients, steroid users, or those with poor oral hygiene, requiring caution. Rarely, cases of necrosis of the bone around the ear have been reported among patients who received this medication, so if there is ear pain or discharge, medical consultation should be sought immediately. Patients who have used this medication long term may experience atypical fractures in the femur or other bones, and if there is pain in the thigh or groin area, evaluation is recommended. Severe allergic reactions or anaphylaxis may occur during treatment, so it is imperative to stop administration and seek emergency treatment if symptoms arise. Women who are pregnant or breastfeeding should preferably avoid this medication as its safety has not been established. This medication is excreted by the kidneys, so patients with renal impairment should be regularly monitored while using it. In cases of overdose, renal and hepatic toxicity may occur, therefore careful observation of renal and liver function should be conducted if overdose is suspected. This medication should not be mixed with solutions containing calcium and must be administered only via intravenous injection. Syringes and needles should not be reused and must be disposed of safely after use.

Serious side effects

• Hives, severe swelling (edema), anaphylactic reaction/shock, hypersensitivity reactions, angioedema, facial swelling/edema, severe allergic reactions
• Stevens-Johnson syndrome, erythema multiforme, bullous dermatitis, severe skin reactions
• Shortness of breath, exacerbation of asthma, difficulty breathing, cough with fever accompanied respiratory abnormalities
• Osteonecrosis (including of the jaw and external ear canal), acute renal failure, multiple organ failure, death, severe neurological symptoms
• Severe edema or

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 tightly sealed container to prevent air or moisture ingress, at a temperature between 1 and 30 degrees Celsius. Proper storage will maintain the medication's efficacy and prevent deterioration.

Appearance

A colorless, clear liquid in a colorless transparent prefilled syringe with a single-use syringe attached.

Package unit

5 prefilled syringes/box [3ml/prefilled syringe], 1 prefilled syringe/box [3ml/prefilled syringe]