Vivanate Rompharm,1 mg/ml 3 ml

Bone resorption inhibitor, nitrogen-containing bisphosphonate. It has a selective effect on bone tissue, which is due to its high affinity for hydroxyapatite, which constitutes the mineral matrix of bone. Ibandronic acid suppresses bone resorption and has no direct effect on bone formation.

Ibandronic acid prevents bone destruction caused by cessation of glandular function, retinoids, tumors and tumor extracts in vivo.

In postmenopausal women, it reduces the increased rate of bone renewal to reproductive age levels, resulting in a progressive increase in bone mass.

Ibandronic acid prevents the development of new and reduces the growth of existing bone metastases. It has a dose-dependent inhibitory effect on tumor osteolysis.

Indications

Postmenopausal osteoporosis to prevent fractures.

Metastatic bone lesions in order to reduce the risk of hypercalcemia, pathological fractures, reduce pain, reduce the need for radiation therapy for pain and the risk of fractures.

Hypercalcemia in malignant neoplasms.

Pharmacological effect

Bone resorption inhibitor, nitrogen-containing bisphosphonate. It has a selective effect on bone tissue, which is due to its high affinity for hydroxyapatite, which makes up the mineral matrix of bone. Ibandronic acid inhibits bone resorption and has no direct effect on bone formation.

Ibandronic acid prevents bone destruction caused by gonadal suppression, retinoids, tumors and tumor extracts in vivo.

In postmenopausal women, it reduces the increased rate of bone turnover to reproductive age levels, which leads to a progressive increase in bone mass.

Ibandronic acid prevents the development of new bone metastases and reduces the growth of existing bone metastases. It has a dose-dependent inhibitory effect on tumor osteolysis.

Special instructions

Use with caution in patients with hypersensitivity to other bisphosphonates.

During treatment, kidney function, calcium, phosphorus and magnesium levels in the blood plasma should be monitored. It is recommended to avoid overhydration in patients with circulatory insufficiency.

It should be borne in mind that the use of bisphosphonates can cause bronchospasm in patients with bronchial asthma and with hypersensitivity to acetylsalicylic acid.

Avoid intra-arterial administration.

Products containing calcium and other polyvalent cations (for example, aluminum, magnesium, iron), incl. milk and solid foods may interfere with the absorption of ibandronic acid (they should be consumed no earlier than 30 minutes after oral administration of the drug).

Active ingredient

Ibandronic acid

Composition

1 ml:

Pregnancy

Contraindicated for use during pregnancy and lactation.

Contraindications

For oral and intravenous administration: hypocalcemia, severe renal dysfunction (creatinine clearance < 30 ml/min), lesions of the esophagus leading to a delay in its emptying, such as stricture or achalasia (for oral administration), pregnancy, lactation (breastfeeding), children and adolescents under 18 years of age, hypersensitivity to ibandronic acid.

For oral administration: lesions of the esophagus leading to a delay in its emptying, such as stricture or achalasia; inability to sit or stand for 60 minutes.

Side Effects

From the digestive system: often – dyspepsia (nausea, abdominal pain), flatulence, diarrhea, constipation, gastritis, gastroenteritis, when taken orally – esophagitis, gastroesophageal reflux disease; uncommon when taken orally – esophagitis, including esophageal ulceration or stricture, dysphagia, vomiting; rarely – duodenitis.
From the nervous system and psyche: often – headache, dizziness, insomnia.

From the skin and subcutaneous tissues: often – rash.

Allergic reactions: rarely – angioedema, facial swelling, urticaria.

From the musculoskeletal system: often – arthralgia, myalgia, pain in the extremities, osteoarthritis, back pain, musculoskeletal pain; infrequently – bone pain; rarely – atypical subtrochanteric and diaphyseal fractures of the femur (typical of the bisphosphonate class); very rarely – osteonecrosis of the jaw.

From the organ of vision: rarely – inflammatory diseases of the eyes.

From the body as a whole: often – flu-like syndrome, weakness; infrequently – asthenia.

Other: often – nasopharyngitis, cystitis, urinary tract infections, bronchitis, upper respiratory tract infections, arterial hypertension, hypercholesterolemia; uncommon – reactions at the injection site, phlebitis, thrombophlebitis; rarely – hypersensitivity reactions; with intravenous administration, a short-term decrease in the level of calcium in the blood serum is possible.

Interaction

When used simultaneously with aminoglycosides, hypocalcemia may develop (since these active substances reduce serum calcium levels for a long time); hypomagnesemia is possible.

Manufacturer

K.O.Rompharm Company S.R.L., Romania