Bonviva Instructions for Use
- Bonviva Instructions for Use
- Form of preparation, its composition and packaging
- Mechanism of action
- When to take
- When and who should not be taken
- How to take and in what doses
- Drug Interactions
- Period of pregnancy and lactation
- Possible side effects
- How and how much to store
- How to let go of a pharmacy
- Bonviva injections analogs
- Bonviva Syringe Tube Price
Bonviva's preparation containing ibandronic acid is an agent that inhibits the resorption of bone tissue that occurs during the postmenopausal period in women during osteoporosis.
Form of preparation, its composition and packaging
It is available as a clear, colorless solution for intravenous administration. Packing 3 ml in a syringe tube. 1ml the preparation contains ibandronate sodium 1,125 mg and 3,375 mg, which is proportional to ibandronic acid in an amount of 1 and 3 mg.
Also included in the composition are additional substances: sodium chloride 8.6 mg, glacial acetic acid 0.51 mg, sodium acetate 0.204 mg and water for injection up to 1 ml.
A syringe tube, complete with a sterile injection needle, is enclosed in a plastic container, which is packed in a cardboard box.
Mechanism of action
Oppresses bone resorption and osteoclast activity. It is a nitrogen-containing active bisphosphonate. In the process of action ibandronic acid stops the destruction of bones, which occurs due to a decrease in activity and work of the gonads, growth of tumors, retinoids.
The drug in therapeutic doses does not affect the mineralization of bones and does not directly affect the formation of bone tissue, normalizes the rate of bone tissue renewal, bringing it to the level in the reproductive period. All this leads to an increase in bone mass, a decrease in the frequency of fractures.
Due to the high activity and wide therapeutic range, there is the possibility of flexible dosing.
It is not proved that the manifestation of the therapeutic effect of the drug depends on the level of ibandronic acid in the blood plasma. When penetrating into the total blood flow, the substance is rapidly absorbed by the bone tissue or passes to the output through the urinary system. 40-50% of all introduced ibandronic acid immediately go to bone material and there accumulates.
There is no reliable information that ibandronic acid passes the metabolic process, so the amount of substance that does not settle in the bone tissue is excreted unchanged by the kidneys. The half-life of the drug from the body is 10-72 hours. The concentration of the substance in the blood stream decreases very rapidly and drops to 10% of the maximum within the first 3 hours.
The total clearance is 84-160 ml / min, and the renal 50-60% of the total, which is related to the absorption of the drug by the bones.
Pharmacokinetics of the drug does not change with a change in the sex of the patient or his race.
In patients with impaired renal function, a decrease in total and renal clearance is observed, but an increase in the concentration of ibandronic acid in the blood plasma did not adversely affect the tolerability of the drug. Therefore, do not change the standard dosage of the drug.
Since the active substance does not pass the metabolism in the liver and this organ does not have a significant effect on the effectiveness of ibandronic acid, patients who have a violation of liver function do not require dose adjustment.
Kinetic properties of the drug also do not depend on the age of the patient, therefore elderly patients do not need a dose change.
The drug is not used to treat individuals who are under 18 years of age.
When to take
Therapy of osteoporosis in the postmenopausal period in women, correction of the increased risk of fractures. Bonviva reduces the likelihood of vertebral fracture, there is no evidence of an effect on the possibility of a hip fracture.
When and who should not be taken
- a decreased level of calcium in the blood (before the drug is necessary to eliminate this condition)
- severe kidney dysfunction
- period of bearing of the child and lactation
- children under 18 years old
- individual sensitivity to the active ingredient or other ingredients of the drug.
How to take and in what doses
The solution of the drug can be administered only intravenously. Injection should be performed by a specialist who can avoid getting the substance into the artery or surrounding tissue.
A ready-made preparation must be examined before conducting for visually visible inclusions, impurities and discoloration. Needles for injection use those that come complete with syringe tubes in the package. These tools are used only once.
Injection is carried out intravenously, for 15-30 seconds once a month in an amount of 3 mg. Also recommend the addition of drugs containing vitamin D and calcium.
If you missed the next injection, you need to make the drug immediately as it will present such an opportunity and continue treatment with the same frequency - 1 time in 3 months. You can not increase the injection and inject more often than once every 3 months.
During the treatment should be kept under control the work of the kidneys and the content of calcium, phosphorus and magnesium in the blood.
Violation of the functions of the liver and kidneys does not require a change in the dose of the drug.
It is not necessary to adjust the dosage to elderly people.
In case of an overdose, calcium phosphorus and magnesium in the blood decrease.
Assistance with overdose: these phenomena can be corrected by intravenous administration of calcium gluconate, magnesium sulfate and potassium phosphate. If two or more hours have passed since the introduction of the drug, dialysis is not effective.
Since ibandronic acid does not use transport systems, is not metabolized and is excreted only by the kidneys, it is obvious that the drug does not interfere, and does not stimulate the pharmacokinetic processes of other drugs.
Solution for injection Bonviva is incompatible with other solutions for administration, including with calcium-containing drugs.
Period of pregnancy and lactation
There were no clinical trials of Bonviva in pregnant women. There is no evidence of embryotoxicity or teratogenicity. At the same time, tests on animals showed a decrease in the number of embryos, a violation of the birth process, an increase in the anomalies of fruit development.
There is no data on the penetration of ibandronic acid into breast milk of women. In animals, 5% of the maximum concentration in milk is observed after 24 hours.
Possible side effects
Like other drugs of this group Bonviva leads to a drop in the level of calcium in the blood plasma.
Side effects after taking Bonviva usually have mild or moderate severity and did not require withdrawal of treatment. The most commonly developed influenza-like syndrome is myalgia, fever, chills, bone pain, loss of appetite. Usually, this symptomatology occurs after the introduction of the first dose of the drug 3 mg. The duration of this condition is small and it is eliminated independently without correction of therapy.
On the part of the digestive system : dyspepsia, bloating, stool, inflammation of the stomach and intestines.
From the musculoskeletal system : pain in muscles and joints, osteoarthritis.
From the nervous system : headache, sleep disturbance, depressive states, dizziness.
From the skin : an allergic reaction, swelling, urticaria .
On the part of the visual system : inflammatory diseases of the membranes of the eye.
From the skin and its appendages : often - a rash; rarely - angioedema, urticaria, edema of the face.
In general : weakness, infection of the kidneys and the reproductive system, increased blood pressure, increased blood cholesterol levels, bronchitis . Sometimes there is a disruption of the tissue structure at the site of administration - phlebitis, thrombophlebitis , hypersensitivity.
How and how much to store
Bonviva injections should be stored at a temperature of no higher than 30 ° C. Keep away from children. Do not use for more than 2 years from the date of release.
How to let go of a pharmacy
The drug Bonviva refers to the prescription group.
Bonviva injections analogs
Analogues for the pharmacological group (Anti-osteoporosis agents - biophosphonates): Alendrocarn tablets, Alendronate tablets, Bondronate tablets, Bonefos injections, Bonefos tablets, Klobir pricks, Ostalon tablets, Osterepar tablets, Pamidronate medak injections, Tevanat tablets, Forose tablets, Fosamax tablets
Bonviva Syringe Tube Price
Bonviva solution for intravenous injection 3 mg / 3ml - from 4900 rubles.