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Zoledronovy acid monohydrate, a citrate sodium dihydrate, Mannitolum, water for injections.
Concentrate for infusion solution in glass or plastic bottles on 5 and 6.25 ml in a cardboard pack No. 1 or 5.
Inhibiting a bone resorption.
Pharmacodynamics and pharmacokinetics
Drug selectively affects a bone, inhibiting process of a resorption of a bone tissue. The inhibiting effect is had on a resorption indirectly — osteoclasts.
Selective effect of bisfosfonat on a bone is caused by high degree of affinity to the mineralized bone tissue. Zoledronovy acid stops process of proliferation and induces process of apoptosis, possesses antineoplastic and anti-metastatic action, similar properties concerning cells of an oncological tumor of a mammary gland and a myeloma of the person. These properties of zolendronovy acid provide medical effect in the presence of bone metastasises. Clinical suppression of a bone resorption is followed by decrease in pain.
After the beginning of intravenous infusion of drug its concentration in blood serum quickly increases, reaching peak values at the end of infusion, then, concentration quickly decreases (after 4 h by 10%) and to (1% — after 24 h). Communication with blood proteins low. The main amount generally of drug contacts a bone tissue. The system metabolism of drug does not occur, drug is removed in 3 stages through kidneys in an invariable look.
Indications to use
- In the combined treatment of the hypercalcemia caused by a malignant tumor;
- Bone metastasises (osteoblastic, osteolytic) solid tumors at a multiple myeloma.
High sensitivity to drug, pregnancy, the lactation period.
- Dryness in a mouth, anorexia, diarrhea, vomiting, a lock, pains in a stomach, nausea, dyspepsia;
- weakness, headache, tremor, hyperesthesia, paresthesias, change of flavoring feelings;
- thrombocytopenia, anemia, leukopenia;
- frustration of a dream, alarm, the confused consciousness;
- conjunctivitis, dispnoe, cough;
- rash and itch of skin, perspiration;
- mialgiya, spasms, ostealgias, arthralgia;
- proteinuria, dysfunction of kidneys, hamaturia;
- hypersensitivity reactions;
- heat, grippopodobny syndrome, adynamy, thorax pain, peripheral hypostases, increase in weight;
- irritation, swelling, pain and formation of infiltrate on skin in the place of a prick;
- increase in blood serum of indicators of creatinine and urea.
Zoleriks, application instruction (Way and dosage)
Zoleriks enter kapelno intravenously, for not less than 15 min. Before administration of drug it is necessary to define a creatinine indicator in blood serum.
Hypercalcemia at malignant new growths
The recommended Zoleriks's dose makes 4 mg. At an aggravation of symptoms after the expressed effect additional introduction of Zoleriks in a dose of 4 mg is shown. The drug is repeatedly administered in a dosage of 8 mg for not 15 minutes. The period between the first and repeated introduction has to be not less than 7 days as this time is necessary for receiving clinical effect of an initial dose.
After Zoleriks's introduction it is necessary to carry out a constant control behind creatinine level. At development of a hypocalcemia, hypomagnesiemia, hypophosphatemia it is necessary to carry out in short term maintenance therapy.
Contents of a bottle of a concentrate of Zoleriks 4mg/5ml or 5 mg / 6,25 ml dissolve in 100 ml of sodium of chloride (0.9%) or 5% dextrose solution. Ready solution is recommended to be used right after preparation. Infusion solution has to be room temperature. Solution, unused it is necessary to store no more days in the refrigerator at 2 to 80 C at once.
At overdose of drug renal failures, changes of electrolytic structure and concentration of calcium, magnesium and phosphates in blood can be observed.
At co-administration of drug with other HP (diuretics, antineoplastic means, analgetics antibiotics) any clinically expressed interaction is noted.
It is not recommended to administer the drug with the HP having nephrotoxic effect. To enter carefully at a concomitant use of aminoglycosides and bisfosfonat as such combinations cause more long decrease in level of calcium in blood. Divorced drug cannot be mixed with solutions as a part of which to contain calcium ions (Ringer's solution).
Terms of sale
According to the recipe.
At a temperature not above 25 °C.
Period of validity
Coincidence on the ATH code of the 4th level:
Zoledronat-Teva, Aklasta, Veroklast, Zoledreks, Rezoskan, Zometa, Blaztera, Rezoklastin of FS, Rezorba.
About drug are various: "… Found not a hormonedependent breast cancer on 3 stages in my sister five flyings ago. Completed several courses himioprotsedur. Recently in bones of a skeleton numerous metastasises are found. The doctor appointed medicine of Zoleriks. But after administration of drug there was very strong weakness, dizziness, a headache, a fever, zanyl fingers, short wind developed. The sister refuses to accept drug repeatedly". Other patients, despite side effects feel better. Many ask, Zoleriks or Zometa, what is better? There are no basic distinctions between these drugs except that they are made by various companies.
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