Vivanat Rompharm solution 1mg/ml 3ml syringe, 1pc

Composition

1 ml: sodium ibandronate monohydrate – 1.125 mg, which corresponds to the content of ibandronic acid 1 mg. Auxiliary substances: sodium acetate trihydrate-0.2 mg, glacial acetic acid-0.5 mg, sodium chloride-8.6 mg, acetic acid 1% solution – up to pH 3.7-4.0, d/i water – up to 1 ml

Pharmacological action

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 suppresses bone resorption and has no direct effect on bone formation.

Ibandronic acid prevents bone destruction caused by the termination of the function of the gonads, retinoids, tumors and tumor extracts in vivo.

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

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

Indications

Postmenopausal osteoporosis to prevent fractures.

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

Hypercalcemia in malignant neoplasms.

Use during pregnancy and lactation

It is contraindicated for use during pregnancy and lactation.

Contraindications

For oral and intravenous use: hypocalcemia, severe renal impairment (CC

For oral use: lesions of the esophagus that lead to delayed emptying, such as stricture or achalasia; inability to stay in a sitting or standing position 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; infrequently when taken orally-esophagitis, including esophageal ulceration or strictures, dysphagia, vomiting; rarely-duodenitis. Nervous system and mental disorders:  often – headache, dizziness, insomnia.

Skin and subcutaneous tissue disorders:  often-a rash.

Allergic reactions:  rarely-angioedema, facial edema, urticaria.

Musculoskeletal disorders:  often-arthralgia, myalgia, pain in the extremities, osteoarthritis, back pain, musculoskeletal pain; infrequently-bone pain; rarely-atypical subtrochanteric and diaphyseal femoral fractures (characteristic of the class of bisphosphonates); very rarely – osteonecrosis of the jaw.

From the side of the visual organ:  rarely-inflammatory eye diseases.

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

Other services:  often-nasopharyngitis, cystitis, urinary tract infections, bronchitis, upper respiratory tract infections, arterial hypertension, hypercholesterolemia; infrequently-injection site reactions, phlebitis, thrombophlebitis; rarely-hypersensitivity reactions; with intravenous use, a short-term decrease in serum calcium levels is possible.

Interaction

When used concomitantly with aminoglycosides, hypocalcemia may develop (since these active substances reduce the level of calcium in the serum for a long time); hypomagnesemia is possible.

How to take, course of use and dosage

Apply orally or intravenously.

The dose and schedule of use depend on the indications and clinical situation.

Special instructions

Use with caution in patients with hypersensitivity to other bisphosphonates.

During treatment, renal function and plasma levels of calcium, phosphorus and magnesium should be monitored. It is recommended to avoid excessive hydration 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 hypersensitivity to acetylsalicylic acid.

Avoid intra-arterial use.

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

Form of production

Solution for intravenous use

Active ingredient

Ibandronic Acid

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection

Description

For adults as directed by your doctor

Indications

Osteoporosis, Bone Fractures