Instructions for Vivanat Rompharm (Ibandronic acid)
Solution for intravenous administration in a syringe
Release form:
Solution for in/in introduction
Description
The solution for in/in injection is transparent, colorless.
composition
1 ml:
sodium ibandronate monohydrate - 1.125 mg, which corresponds to the content of ibandronic acid 1 mg.
Excipients:
sodium acetate trihydrate - 0.2 mg,
acetic acid glacial - 0.5 mg,
sodium chloride - 8.6 mg,
acetic acid 1% solution to pH 3.7-4.0,
water d / and - up to 1 ml.
3 ml - single-use syringes (1) - packages of single-use contoured pockets (1) with 1 disposable needle d/i - cardboard packs.
3 ml - single-use syringes (1) - packages of cellular contour (4) with 4 disposable needles d/i - packs of cardboard.
ATC codes
M05BA06 Ibandronic acid
Clinical-pharmacological groups / Group affiliation
Bone tissue resorption inhibitor. Bisphosphonate
Active substance
ibandroic acid
Pharmacotherapy group Vivanat Rompharm:
Ibandronic acid is a highly active nitrogen-containing bisphosphonate, a bone resorption inhibitor. Suppresses osteoclasts. Ibandronic acid prevents bone destruction caused by blockage of genital function, retinoids, tumors or the introduction of in vivo tumor tissue extracts.
Ibandronic acid does not interfere with bone mineralization in therapeutic doses for osteoporosis treatment and does not affect the osteoclastic pool replenishment process. The selective action of ibandronic acid on bone tissue is due to its high affinity for hydroxyapatite, which is the mineral matrix of bone.
Ibandronic acid is a dose-dependent inhibitor of bone resorption and does not directly affect bone tissue formation.
In menopausal women, decreases the increased rate of bone tissue renewal to the level of reproductive age, leading to an overall progressive increase in bone mass, reduced rates of bone collagen cleavage in urine and blood serum, fracture rates, and increased bone mineral density (MPC).
Testimony:
Postmenopausal osteoporosis to prevent fractures.
Metastatic bone lesions in order to reduce the risk of hypercalciemia, pathological fractures, pain reduction, reduction of the need for radiation therapy in case of pain syndrome and the threat of fractures.
Hypercalciemia in malignant neoplasms.
Method of use, course and dosage Ibandronic acid:
Used inwards or inwards.
The dose and application pattern depend on the indications and clinical situation.
Drug Vivanat Rompharm interaction
With simultaneous use with aminoglycosides, hypocalcemia may develop (since these active substances reduce the level of calcium in the serum for a long time); it is possible to use hypomagnesium.
Side Effect Vivanat Rompharm:
On the digestive side: Often - dyspepsia (nausea, abdominal pains), flatulence, diarrhea, constipation, gastritis, gastroenteritis, when taken inwards - esophagitis, gastroesophageal reflux disease; Not often when ingested - esophagitis, including ulceration of the oesophagus or stricture, dysphagia, vomiting; Rarely - duodenite.
On the part of the nervous system and psyche: Often - headache, dizziness, insomnia.
From the skin and subcutaneous tissues: often a rash.
Allergic reactions: Rarely - angioneurotic edema, facial edema, urticaria.
From the side of the musculoskeletal system: Often - arthralgia, myalgia, limb pain, osteoarthritis, back pain, bone and muscle pain; infrequently - bone pain; rare atypical and diaphysial fractures of the femur (characteristic of the bisphosphonates class); Very rarely - osteonecrosis of the jaw.
From the viewpoint of: rarely - inflammatory diseases of the eye.
From the body as a whole: Often flu-like syndrome, weakness; It is not often - asthenia.
Others: Often - nasopharyngitis, cystitis, urinary tract infections, bronchitis, upper respiratory tract infections, arterial hypertension, hypercholesterolemia; infrequently - reactions at the place of introduction, phlebitis, thrombophlebitis; rarely hypersensitivity reactions; A short-term decrease in the blood serum calcium level is possible during the injection.
Application for kidney disorders
It is contraindicated in severe renal failure (serum creatinine levels greater than 5 mg/dL, or 442 μmol/L).
Use in children
There is no clinical experience of use in children.
Nosology Ibandronic acid (ICD codes)
C79.5
Secondary malignancy of bones and bone marrow
E83.5
Calcium metabolism disorders
M80.0
Postmenopausal osteoporosis with pathological fracture
M80.1
Osteoporosis with pathological fracture after ovarian removal
M81.0
Postmenopausal osteoporosis
M81.1
Osteoporosis after ovarian removal