Zometa Zoledronic acid concentrate for solution for infusion 4mg/5ml vial 5ml №1

Zometa Zoledronic acid concentrate for solution for infusion 4mg/5ml vial 5ml №1

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Composition active ingredient: zoledronic acid; 5 ml of the concentrate containing 4 mg of zoledronic acid anhydrous that meets 4,264 mg of zoledronic acid monohydrate; 1 ml of concentrate contains 0.8 mg of zoledronic anhydrous acid; auxiliary substances: mannitol (E 421), sodium, water for injection. Dosage form Concentrate for preparation of solution for infusions. Pharmacological group Means affecting the structure and mineralization of the bones. Bisphosphonates. PBX code M05V A08. Indications Prevention of symptoms associated with bone lesions (pathological fractures, compression of the vertebral trunk, complications after surgery and radiation therapy or hypercalcemia due to a malignant tumor) in patients with malignant neoplasms at late stages. Treatment of hypercalcemia caused by a malignant tumor. Contraindications Hypersensitivity to the active substance (zoledronic acid), other bisphosphonates or any auxiliary substances that are part of the drug. Pregnancy or breast-feeding. Method of application and doses Zometa is administered only by doctors with experience in the administration of bisphosphonates. Before the introduction of 4 mg concentrate Zometa diluted in 100 ml 0.9% sodium chloride solution or 5% glucose solution. Ready Zometa solution for infusion is administered as a single infusion for at least 15 minutes. Concentrate Zometa should not be mixed with solutions for infusion containing calcium or other divalent cations, such as lactate ringer solution and must be administered in a single infusion through the separate infusion systems. Prevention of symptoms associated with bone lesions in patients with malignant neoplasms at a later stage Adults and elderly patients The recommended dose of Zometa is 4 mg in the form of infusion every 3-4 weeks. Patients also need daily administration of calcium products inside at a dose of 500 mg and 400 IU of vitamin d per day. The decision to treat patients with metastatic bone lesions to prevent symptoms associated with bone lesions should take into account that the beginning of the effect of treatment occurs after 2-3 months. Treatment of hypercalcemia caused by a malignant tumor Adults and elderly patients The recommended dose of Zometa is 4 mg as a single infusion. Before the introduction and during the introduction of Zometa should be ensure adequate hydration of the patient. Violation of kidney function Hypercalcemia caused by a malignant tumor Treatment of hypercalcemia caused by a malignant tumor in patients with severe renal impairment is possible after a thorough assessment of the risk of the drug and the expected benefits. Clinical experience of the drug in patients with serum creatinine levels>400 µmol/l, or>4,5 mg/DL, is absent. Patients with hypercalcemia due to malignant tumor, with the creatinine level in blood serum Prevention of symptoms associated with bone lesions in patients with malignant neoplasms at late stages At the beginning of treatment of patients with multiple myeloma or metastatic bone damage due to a solid tumor should determine the level of serum creatinine and creatinine clearance. KK is calculated by the formula Cockroft-Gault creatinine in the blood serum. Zometa is not recommended for patients with severe renal impairment prior to therapy (creatinine clearance patients with serum creatinine level ? 265 µmol/l, or ? 3 mg/DL, were not carried out. Initial level of creatinine clearance (ml/min)recommended dose of Zometa (mg) * >604 mg 50-603, 5 mg * 40-493, 3 mg * 30-393 mg * Patients with metastatic bone lesions in renal impairment of mild or moderate severity before therapy (creatinine clearance 30-60 ml/min), the following doses are recommended: * Doses calculated with a given assumption AUC = 0,66 mg * h/l (creatinine clearance 75 ml/min). For patients with impaired renal function provides a dose reduction to a level at which such AUC is achieved, as in patients with creatinine clearance of 75 ml/min. After starting therapy, serum creatinine should be measured before administration of each dose of Zometa . In case of violation of renal function, the treatment should be discontinued. In clinical trials, the impaired renal function was defined as follows: for patients with normal baseline creatinine level in the serum (<1.4 mg/DL, or for patients with altered baseline levels of creatinine in the serum (>1.4 mg/DL or>124 µmol/l) increase per 1 mg/DL or 88 µmol/L. During clinical trials, Zometa therapy was restored after the return of creatinine level to the initial level within 10% of the initial value. Zometa therapy should be restored in the same dose as before discontinuation of treatment. paediatric populations The safety and efficacy of zoledronic acid in children from 1 year to 17 years have not been established. There are no recommendations on how to use in children. Instructions for the preparation of doses of Zometa For intravenous administration. 4 mg zometa concentrate should be diluted in 100 ml sterile 0.9% sodium chloride solution or 5% glucose for impressive ifusion. Patients with impaired renal function mild or moderate severity recommended reduced doses of zometa . Instructions for preparing reduced doses of Zometa : To recruit the appropriate volume of the concentrate, as indicated below: 4.4 ml corresponds to 3.5 mg 4.1 ml corresponds to 3.3 mg 3.8 ml corresponds to 3 mg. Before the introduction of Zometa and then need to provide sufficient hydration of the patient. Adverse reaction Within three days after application of the drug zometa is usually reported gastropathy reaction, symptoms of which include bone pain, fever, weakness, arthralgia, myalgia, chills and arthritis with swelling of joints. These symptoms usually disappear within a few days. In the case of Zometa identified the following important adverse reactions: the violation of the kidney, necrosis of the jaw, gastropathy reactions, hypocalcemia, blurred vision, atrial fibrillation, anaphylaxis. Information about the frequency of adverse reactions in the application of Zometa dose 4 mg is based mainly on data obtained during long-term therapy. Adverse reactions associated with Zometa , similar to those reported in the application of other bisphosphonates, and can develop in about one third of all patients. Information about the following adverse reactions were collected during clinical studies, mainly after long-term treatment of zoledronic acid. Adverse reactions are classified by frequency of occurrence: very often (?1/10), often (?1/100,<1/10), sometimes (?1/1000,<1/100), rarely (?1/10000,<1/1000), very rarely (<1/10000), unknown (cannot be estimated from the available data). From the blood and lymphatic systems: often - anemia sometimes-thrombocytopenia, leukopenia rarely-pancytopenia. From the nervous system: often - headache; sometimes - paresthesia, dizziness, taste disorders, hypesthesia, hyperesthesia, tremor, drowsiness is very rare - epileptic seizures, numbness and tetany (secondary to hypocalcemia). Psychics: sometimes a concern, sleep disorders; rare - confusion. From the organ of vision: often-conjunctivitis; sometimes-blurred vision, scleritis and inflammation of the orbit; very rarely - uveitis, episcleritis. From the gastrointestinal tract: often-nausea, vomiting, anorexia; sometimes - diarrhea, constipation, abdominal pain, dyspepsia, stomatitis, dry mouth. From the respiratory system: sometimes - shortness of breath, cough, Bronchoconstriction rarely - interstitial lung disease. From the skin and subcutaneous tissues: sometimes itching, rash (including erythematous and macular rash), increased sweating. From the side of musculoskeletal system and connective tissue: often - pain in bones, myalgia, arthralgia, generalized pain; sometimes - muscle cramps, osteonecrosis of the jaw. From the cardiovascular system: sometimes-arterial hypertension, arterial hypotension, atrial fibrillation arterial hypotension, causes fainting and circulatory collapse; rarely-bradycardia, very rarely - arrhythmia (secondary to hypocalcemia). The part of the kidney and genitourinary system : often - kidney failure; sometimes - acute renal failure, hematuria, proteinuria. From the immune system: sometimes-hypersensitivity reactions; rarely-angioedema. General disorders and reactions at the application site of the drug: often - fever, flu-like condition (including fatigue, chills, malaise and flushing) sometimes reactions at the injection site (including pain, irritation, swelling, induration), asthenia, peripheral edema, chest pain, body mass increase, anaphylactic reaction/shock, urticaria and rarely, arthritis and swollen joints as the symptoms of acute-phase reaction. Deviation of laboratory parameters: very often - hypophosphatemia; often - increased creatinine and urea in the blood, sometimes hypocalcemia - hypomagnesemia, hypokalemia rare - hyperkalemia, hypernatremia. Violation of kidney function With the use of Zometa reported a deterioration of kidney function. Based on the analysis of safety data obtained during the registration studies of Zometa for the prevention of adverse events associated with the lesion of bone tissue in patients with common malignant diseases frequency of impaired renal function, which were considered related to Intake : multiple myeloma is 3.2%, prostate cancer is 3.1%, breast cancer by 4.3%, lung cancer and other solid tumors is 3.2%. Factors that may increase the risk of renal impairment include dehydration, previous renal dysfunction, multiple courses of treatment with Zometa or other bisphosphonates, as well as the simultaneous use of other nephrotoxic agents or reduction of the recommended infusion time. Reported cases of worsening of renal function, progression to renal failure and required hemodialysis during the first or single use of alendronova acid at a dose of 4 mg. the osteonecrosis of the jaw Cases of osteonecrosis (primarily of the jaw) has been reported predominantly in patients with cancer treated with Zometa . Many of these patients had manifestations of local infection, including osteomyelitis. Most cases were associated with dental procedures such as tooth extraction. Jaw osteonecrosis has many established risk factors, in particular cancer, concomitant therapy (e.g. chemotherapy, radiation therapy, corticosteroids) and concomitant diseases (e.g. anemia, coagulopathy, infections, oral diseases) are diagnosed. Although a causal relationship has not been confirmed, these patients are advised to avoid invasive dental procedures. atrial fibrillation In a randomized double-blind controlled clinical trial, which assessed the efficacy and safety of zoledronic acid in patients with postmenopausal osteoporosis, the overall incidence of atrial fibrillation was 2.5% in the group of patients receiving Zometa at a dose of 5 mg, and 1.9% in the placebo group. The cause of the increased frequency of atrial fibrillation is unknown. acute-phase reactions These adverse reactions include fever, myalgia, headache, pain in the extremities, nausea, vomiting, diarrhea and arthralgia, which can begin within the first 3 days after infusion of Zometa . Atypical fractures of the femur During the period of post-registration use, reactions such as acute edwardlucas and dietisalvi fractures of the femur (the undesirable reaction to bisphosphonates). Adverse reactions due to hypocalcemia Hypocalcemia is an important identicaland the risks involved in the use of Zometa was indicated. Data from clinical trials and post-marketing studies about the relationship between therapy Intake , reports of hypocalcemia and secondary development of cardiac arrhythmias. In addition, there is evidence of a link between hypocalcemia and reports of secondary neurological reactions, including epileptic seizures, numbness and tetany. Overdose Clinical experience in the treatment of acute overdose Zometa limited. It was reported that the erroneous use of zoledronic acid at a dose of 48 mg .Patients who used a dose that exceeds the recommended dose should be under constant control, since there may be a violation of kidney function (including renal failure), changes in the electrolyte composition of serum (including calcium, phosphate and magnesium concentrations). When hypocalcemia occurs, calcium gluconate infusion is shown to be performed according to clinical indications. Treatment is symptomatic. Application during pregnancy and lactation The drug is contraindicated during pregnancy and lactation. gestation period There is insufficient data on the use of zoledronic acid in pregnant women. The reproduction studies in animals have shown reproductive toxicity. The potential risk to humans is unknown. lactation Unknown Zometa gets into breast milk. Children The safety and efficacy of alendronova acid children not established. Application features general Before administration Zometa it is necessary to be convinced of sufficient hydration of all patients, including patients with mild and moderate renal impairment. You should avoid fluid overload in patients with risk of development of heart failure. Standard metabolic parameters associated with hypercalcemia, such as calcium, phosphate and magnesium levels, should be carefully checked after starting Zometa therapy . If there is hypocalcemia, hypophosphatemia or hypomagnesemia, short-term corrective therapy may be necessary. Untreated patients with hypercalcemia usually have some renal impairment, so it is necessary to carefully monitor kidney function. Zometa contains the same active substance as Aklasta (zolotendronovu acid). Patients receiving therapy cycle with zometa should not simultaneously take other medications containing alendronova acid. Patients receiving therapy with Zometa , also should not use any other bisphosphonates. Violation of kidney function When deciding on the use of Zometa in patients with hypercalcemia due to malignant tumor, against violations of kidney function should assess the patient's condition and concluded that is dominated by the potential benefits of treatment on possible risks. When deciding on the treatment of patients with bone metastases in order to prevent symptoms associated with diseases of the spine, it should be borne in mind that the effect of the drug appears after 2-3 months. There were reports of renal dysfunction associated with the use of bisphosphonates. Factors that increase the possibility of renal impairment include dehydration, pre-existing renal impairment, multiple cycles of Zometa or other bisphosphonates, as well as the use of nephrotoxic agents or infusion in a shorter time than recommended. Although the injection of Zometa in a dose of 4 mg over at least 15 minutes the risk is reduced, deterioration of renal function is possible. An increase in serum creatinine levels is also observed in some patients who constantly take the drug in recommended doses to prevent the onset of symptoms associated with spinal diseases, although this is quite rare. Before each dose of Zometa in patients need to evaluate the level of creatinine in the blood serum. After the start of treatment for patients with bone metastases and women with early-stage breast cancer in postmenopausal during treatment with aromatase inhibitors (AIs) to prevent loss of bone mass and of bone fractures with little or moderate renal impairment are recommended lower doses of Zometa (cm . the table in the section "Method of application and dosage"). Patients who have a deterioration in renal function during treatment, taking the drug can be restored only when the level of creatinine returns to its original value within 10% of its initial value. For the possible effect of bisphosphonates, including Zometa , on kidney function, due to the lack of detailed data on clinical safety in patients with severe renal failure creatinine serum>400 µmol/l, or>4.5 mg/DL, for patients with hypercalcemia that induced tumor, and creatinine serum>265 µmol/l, or>3 mg/DL, for patients with bone metastases and in women with early stage breast cancer in the postmenopausal period in the treatment of aromatase inhibitors (AIs) to prevent loss of bone mass and bone fractures, respectively) and only limited pharmacokinetic data for patients with severe renal failure (creatinine clearance patients with severe renal failure is not recommended. Impaired liver function There are no specific recommendations for patients with severe hepatic insufficiency, as only limited clinical data are available. the osteonecrosis of the jaw It was reported on osteonecrosis of the jaw mainly in cancer patients receiving treatment regimens including bisphosphonates, including Zometa . Many of these patients also received chemotherapy and corticosteroids. Most of the reported cases were related to dental procedures such as tooth extraction. Many of the patients showed signs of local infection, including osteomyelitis. The following risk factors should be considered to assess the individual risks of jaw osteonecrosis The activity of bisphosphonates (greater risk for the more active components), route of administration (higher risk for parenteral administration) and cumulative dose, Cancer, chemotherapy, radiotherapy, corticosteroid therapy, Smoking, Dental diseases in history, insufficient oral hygiene, periodontal disease, invasive dental procedures but not tightly adjacent denture. Before the start of treatment with bisphosphonates, it is necessary to examine the oral cavity with appropriate dental prevention. During therapy, these patients should avoid invasive dental procedures if possible. Dental surgery can worsen the condition of patients who have developed jaw osteonecrosis during therapy with bisphosphonates. There is no evidence of patients requiring dental procedures to assume reduces the risk of jaw osteonecrosis stopping treatment with bisphosphonates or not. The physician, in making a clinical assessment, should be guided by each patient's management plan, based on an individual assessment of benefit/risk. Musculoskeletal pain During post-marketing studies have reported strong, sometimes invalidusername pain in bones, joints and/or muscles of the patients who take bisphosphonates. However, such reports were isolated. This category of drugs includes Zometa (Zometa). The time before the onset of symptoms varied from one day to several months from the start of treatment. In most patients, the severity of symptoms decreased after the termination of treatment. In this category, patients noted a relapse of symptoms if treatment was resumed with the same drug or other bisphosphonates. Atypical femoral fracture Edwardlucas and atypical diaphyseal femur fractures were registered during therapy, bisphosphonates, first of all, in patients receiving long-term treatment of osteoporosis. These transverse or short oblique fractures are possible anywhere along the femur from just below the small trochanter to just above the epicondyle. These fractures occur after or without minimal injury, and some patients experience hip or groin pain, often associated with x-ray signs of a stress fracture, a few weeks or months before a complete hip fracture occurs. Fractures are often bilateral, therefore, the second thigh should be tested in patients receiving bisphosphonate therapy and have suffered a femur fracture. Poor healing of these fractures was also reported. On the basis of an individual assessment of risks and benefits should decide the issue of termination bisphosphonate therapy for patients with suspected atypical fractures of the femur. During the treatment with bisphosphonates, patients should inform the doctor about any pain in the pelvis, hip or groin, and each patient with such symptoms should be examined for the presence of an incomplete fracture of the femur. hypocalcemia It was reported hypocalcemia in patients treated with Zometa . Cases of cardiac arrhythmias and neurological reactions (including epileptic seizures, numbness and tetany), secondary to severe hypocalcemia, were reported. Cases of severe hypocalcemia requiring hospitalization were reported. In some cases, hypocalcemia may be life-threatening. The ability to influence the reaction rate when driving motor transport or operating other mechanisms Adverse reactions of the drug, such as dizziness and somnolence may affect the ability to drive vehicles or other mechanisms, so care is needed when driving vehicles or work with machinery during the period of use of Zometa . Interaction with other medicinal products and other forms of interaction During clinical trials simultaneously with the Intake of is often prescribed other drugs - anticancer drugs, antibiotics, analgesics. There were no clinically significant interactions. According to data obtained in vitro studies , Zometa does not bind significantly with blood plasma proteins and does not inhibit the enzymes of the cytochrome P450 system. However special clinical studies of drug interactions have not been conducted. It is recommended to exercise caution while using bisphosphonates and aminoglycosides, as they may exhibit an additive effect, whereby the level of calcium in the serum may remain reduced for longer than necessary. We recommend caution when concomitant use of bisphosphonates and loop diuretics, since they may show an additive effect, resulting in can occur hypocalcemia. Caution must be exercised in the appointment of Zometa and other potentially nephrotoxic drugs. It should also be borne in mind the possibility of the development of hypomagnesemia treatment time. In patients with multiple myeloma with intravenous administration of bisphosphonates in combination with talidomide, no clinically significant interactions were observed. It was reported on osteonecrosis of the jaw in patients receiving concomitant treatment cycle with zometa and anti-angiogenic (reduce the blood supply of a tumor) drugs. Pharmacological properties Pharmacodynamics. Alendronova acid belongs to a new class of bisphosphonates specifically act on bone tissue. It is one of the most potent bone resorption inhibitors known to date. The selective effect of bisphosphonates on bone is based on their high affinity with mineralized bone tissue, but the molecular mechanism leading to inhibition of osteoclasts of activity, today is not clarified. Animal studies have found that Zometa inhibits bone resorption without adversely affecting bone formation, mineralization and mechanical properties. In addition to inhibiting bone resorption osteoclasts, Zometa has a direct antitumor effect on cultured myeloma cells and human breast cancer by inhibiting cell proliferation and apoptosis induction. This indicates that Zometa may have anti-metastatic properties. In vivo - inhibition osteoblast bone resorption, which acts on the structure of the microcrystalline matrix of bone, reduces tumor growth, antiangiogenic effects (effects on blood vessels, which reduces blood supply to tumors), analgesic effect. In vitro inhibition osteoblast proliferation, a cytostatic effect, proapoptotic effect on tumour cells, synergistic cytostatic effect with other anti-tumor drugs, anti-adhesive and antiinvasive action. Pharmacokinetics. Pharmacokinetics data for bone metastases were obtained after a single and repeated 5 - and 15-minute infusion of 2, 4, 8 and 16 mg of zoledronic acid in 64 patients. Pharmacokinetic characteristics do not depend on the dose. After the onset of infusion of zoledronic acid plasma concentrations of the drug increase rapidly, reaching a peak at the end of the infusion, then there is a rapid decrease in the concentration of 10% of the peak value after 4: 00 and<1% of the peak value after 24 hours with a sequentially prolonged period of low concentrations do not exceed 0.1% of the peak to the second infusion on the 28th day. Alendronova acid is introduced intravenously and excreted by the kidneys in 3 phases: rapid biphasic elimination of the drug from the systemic circulation with half-lives of t ?? = 0.24 hours and t ?? = 1.87 hours and a long phase with a finite half-life t ?? = 146 hours. There was no cumulation of the drug in plasma with repeated injections every 28 days. Alendronova acid is not metabolized and is excreted by the kidneys unchanged. During the first 24 hours 39 ± 16% of the administered dose is detected in the urine. The rest of the drug is associated with bone tissue. Then slowly there is the reverse release of zoledronic acid from bone tissue into the systemic bloodstream and its excretion by the kidneys. The total clearance in the body is 5,04 ± 2,5 l/h and does not depend on the dose, sex, age, race and body weight of the patient. An increase in infusion time from 5 to 15 minutes leads to a decrease in the concentration of zoledronic acid by 30% at the end of the infusion, but does not affect the curve of concentration versus time in blood plasma (AUC). Variability of pharmacokinetic parameters of zoledronic acid in different patients was high, as in other bisphosphonates. Data on the pharmacokinetics of zoledronic acid in patients with hypercalcemia and liver failure are not available. According to data obtained in vitro , zolendronovaya acid does not inhibit human enzyme R450 and is not subjected to biotransformation; according to experimental studies conducted in animals, with feces derived less than 3% of the dose, which suggests that the state of liver function does not affect the pharmacokinetics of zoledronic acid. Renal clearance of zoledronic acid correlates with creatinine clearance, renal clearance is 5 ± 33% creatinine clearance, reaching an average of 84 ± 29 ml/min (range 22-143 ml/min) in 64 cancer patients included in the study. Analysis of the group of patients showed that patients with creatinine clearance 20 ml/min (acute renal failure) and 50 ml/min (average renal failure) relative clearance of zoledronic acid - 37% and 72%, respectively. However, data from such in patients with acute renal insufficiency ( Discovered low affinity of zoledronic acid for the cellular components of blood. Binding to plasma proteins is low (about 56%) and does not depend on the concentration of zoledronic acid. special populations children Limited pharmacokinetic data for children with severe osteogenesis disorders suggest that the pharmacokinetics of zoledronic acid in children aged 3 to 17 years is similar to those in adults when used in equivalent doses (mg/kg). Age, weight, sex and creatinine clearance, as it turned out, do not affect the systemic exposure of zoledronic acid. Basic physico-chemical properties transparent colorless liquid. Incompatibility Zometa concentrate is to be diluted in a sterile 0.9% sodium chloride solution or 5% glucose solution. Concentrate Zometa should not be mixed with solutions for infusion containing calcium or other divalent cations, such as lactate ringer solution and must be administered in a single infusion using a separate system for infusion. A study with glass vials, as well as several types of infusion bags and infusion systems made of polyvinyl chloride, polyethylene and polypropylene (pre-filled with 0.9% sodium chloride solution or 5% glucose solution), showed no incompatibility with the above packaging materials. Shelf life 3 years. Storage conditions Store at a temperature not exceeding 30 ° C out of reach of children. After dilution in a sterile 0.9% sodium chloride solution or 5% glucose solution, the drug is stable for 24 hours at a storage temperature of 2-8 ° C. After aseptic dilution should be used ready for use immediately. Packaging 5 ml concentrate for preparation of infusion solution in a colorless plastic bottle with a gray rubber stopper and an aluminum lid with a flip-off component. Category home away from home By prescription. Manufacturer Novartis Pharma Stein AG, Switzerland/Novartis Pharma Stein AG, Switzerland. Location Schaffhauserstrasse, 4332 Stein, Switzerland/Schaffhauserstrasse, 4332 Stein, Switzerland. POWDER FOR PREPARATION OF INFUSION ZOMETA 4MG Zometa is a medicinal product, which is a concentrate of highly effective bisphosphonate. The action of the drug is aimed at resorption of processes in the bone system. The active ingredient is zoledronic acid. The substance is involved in the process of mineralization of bones, has a high level of biological accessibility. Indications for appointment The medication is prescribed for: Therapy of hypercalcemia, which is caused by cancer. The implementation of the combined treatment of pathological fractures, including spinal injuries. Reducing the risk of complications after undergoing radiation therapy. Prevention of bone mass reduction during the entry of women into menopause. How to apply The tool is intended for intravenous drip method for 15 minutes. The standard dose for cancer patients – 4 mg, which is re-assigned after 3-4 weeks. The dosage of the drug can be changed based on the severity of the patient's condition and the expressed need for the use of bisphosphonate. For the preparation of medication should be 4 mg of powder to be diluted by adding 5 ml of injectable water. When performing intravenous infusion liquid drug is added to 50 ml of saline.

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