Bonviva injections instructions for use
- Bonviva injections instructions for use
- The form of release of the drug, its composition and packaging
- Mechanism of action
- When to take
- When and who can not take
- How to take and in what doses
- Drug interaction
- Period of pregnancy and lactation
- Possible side effects
- How and how much to store
- How to let go from the pharmacy
- Bonviva shots analogues
- Bonviva tube syringe price
Bonviva preparation containing ibandronic acid is an agent that inhibits bone tissue resorption that occurs during the menopausal period in women during osteoporosis.
The form of release of the drug, its composition and packaging
Available as a clear, colorless solution for intravenous administration. Packing 3 ml in a syringe tube. 1 ml of the drug contains ibandronata sodium 1.125 mg and 3.375 mg, which is proportional to ibandronic acid in the amount of 1 and 3 mg.
The following additional substances are also included: sodium chloride 8.6 mg, glacial acetic acid 0.51 mg, sodium acetate 0.204 mg, and water for injection up to 1 ml.
Syringe tubes complete with a sterile needle for injection are enclosed in a plastic container that is packed in a carton box.
Mechanism of action
Inhibits bone resorption and osteoclast activity. Is a nitrogen-containing active bisfosfonatom. In the process of action, ibandronic acid stops the destruction of bones, which occurs due to a decrease in the activity and functioning of the sex glands, the growth of tumors, and retinoids.
The drug in therapeutic doses does not affect bone mineralization and does not directly affect the formation of bone tissue, normalizes the rate of bone tissue renewal, bringing it to the level during the reproductive period. All this leads to an increase in bone mass, a decrease in the frequency of fractures.
Due to its high activity and wide therapeutic range, there is a possibility of flexible selection of doses.
It is not proven that the manifestation of the therapeutic effect of the drug depends on the level of ibandronic acid in the blood plasma. When it enters the general circulation, the substance is quickly absorbed by the bone tissue or goes to the outlet through the urinary system. 40-50% of all injected ibandronic acid immediately goes into the bone material and accumulates there.
There is no reliable information that ibandronic acid undergoes a metabolic process, therefore, the amount of a 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 bloodstream decreases very quickly and during the first 3 hours drops to 10% of the maximum.
The total clearance of 84-160 ml / min, and renal 50-60% of the total, which is associated with the absorption of the drug bones.
The pharmacokinetics of the drug does not change with the gender of the patient or his race.
In patients with impaired renal function, there is a decrease in total and renal clearance, however, an increase in plasma ibandronic acid concentration did not adversely affect the tolerability of the drug. Therefore, do not spend changing the standard dosage of the drug.
Since the active substance does not undergo metabolism in the liver and this organ does not significantly affect the efficacy of ibandronic acid, patients who have impaired liver function do not require dose adjustment.
The kinetic properties of the drug also do not depend on the age of the patient, so the elderly patients do not need to change the dose.
The drug is not used to treat persons whose age has not reached 18 years.
When to take
Therapy of osteoporosis in the postmenopausal period in women, the correction of the increased risk of fractures. Bonviva reduces the likelihood of vertebral fractures, and no impact on the possibility of a hip fracture has been established.
When and who can not take
- low blood calcium levels (this condition must be eliminated before the drug is administered)
- severe renal dysfunction
- period of childbearing and breastfeeding
- children under 18
- individual sensitivity to the active substance or other ingredients of the drug.
How to take and in what doses
The drug solution is allowed to be administered only intravenously. The injection should be carried out by a specialist who can prevent the substance from entering the artery or surrounding tissue.
The finished product must always be examined before maintenance for the presence of visually visible inclusions, impurities and discoloration. Needles for injection use those that come bundled with syringe tubes in the package. These tools are used only once.
The injection is carried out intravenously, for 15-30 seconds 1 time per month in an amount of 3 mg. Also recommend additionally taking medications containing vitamin D and calcium.
If another injection was allowed to pass, it is necessary to administer the drug as soon as such an opportunity presents itself and to continue treatment with the same frequency rate once every 3 months. You can not increase the introduction of the drug and perform the injection more often than 1 time in 3 months.
During the period of treatment should be kept under control the work of the kidneys and the blood levels of calcium, phosphorus and magnesium.
Impaired liver and kidney function does not require changing the dose of the drug.
Elderly people do not need to adjust the dosage.
In case of overdose, a decrease in calcium phosphorus and magnesium in the blood occurs.
Help with overdose: these phenomena can be adjusted by intravenous administration of calcium gluconate, magnesium sulfate and potassium phosphate. If 2 or more hours have passed since the drug was injected, dialysis is not effective.
Since ibandronic acid does not activate the transport systems, does not undergo metabolism and is only excreted by the kidneys, it is obvious that the drug does not interfere, and does not stimulate the pharmacokinetic processes of other drugs.
Bonviva injection solution is incompatible with other injection solutions, including calcium-containing preparations.
Period of pregnancy and lactation
Clinical trials of the drug Bonviva in pregnant women was not conducted. There is no evidence of its embryotoxicity or teratogenicity. At the same time, animal tests showed a decrease in the number of embryos, a violation of the generic process, an increase in fetal anomalies.
There is no data on the penetration of ibandronic acid in the breast milk of women. In animals, after 24 hours, 5% of the maximum concentration in milk is observed.
Possible side effects
Like other drugs in this group Bonviva leads to a drop in calcium levels in the blood plasma.
Side effects after taking the drug Bonviva are usually characterized by mild or moderate severity and did not require cancellation of treatment. The most common flu-like syndrome is myalgia, fever, chills, bone pain, loss of appetite. Usually, this symptom occurs after the first dose of the drug is administered 3 mg. The duration of this condition is small and it is eliminated independently without correction of therapy.
On the part of the digestive tract : dyspeptic symptoms, bloating, impaired stool, inflammation of the lining of the stomach and intestines.
On the part of the musculoskeletal system : pain in muscles and joints, osteoarthritis.
Of the nervous system : headache, sleep disturbance, depressive states, dizziness.
For the skin : an allergic reaction, swelling, urticaria .
On the part of the visual system : inflammatory diseases of the eye membranes.
On the part of the skin and its appendages : often - a rash; rarely - angioedema, urticaria, swelling of the face.
In general : weakness, infections of the kidneys and the reproductive system, increased blood pressure, increased blood cholesterol levels, bronchitis . Sometimes there is a violation of the structure of the tissue at the injection site - phlebitis, thrombophlebitis , hypersensitivity.
How and how much to store
Bonviva injections should be stored at a temperature not higher than 30 ° C. Keep out of the reach of children. Do not use for more than 2 years since the release of the drug.
How to let go from the pharmacy
The drug Bonviva belongs to the prescription group.
Bonviva shots analogues
Analogs of pharmacological group (anti-osteoporosis agents - bisphosphonates) Alendrokern tablet Alendronate tablets Bondronat tablets Bonefos injections, Bonefos tablets Klobir injections Ostalon tablets, pills Osterepar, Pamidronate Medac injections Tevanat tablets Foroza tablets, pills FOSAMAX
Bonviva tube syringe price
Bonviva solution for intravenous injection of 3 mg / 3 ml - from 4900 rubles.