Zolevista solution for inf. 5mg/100ml Comte. 100 ml No. 1 ***

Zolevista – medicine which affects structure and a mineralization of bones.

Treatment of osteoporosis at women in the postmenopauzny period and men at the increased risk of changes, including persons with a recent low-traumatic fracture of a hip.

Treatment of the osteoporosis connected with long-term system glucocorticoid therapy at women in the postmenopauzny period and at men at the increased risk of changes.

Treatment of a bone disease of Peget at adults.

Structure

• 100 ml of solution 5 mg of zoledronovy acid that corresponds to 5.33 mg of zoledronovy acid of monohydrate;
• other components: citrate trisodium a dihydrate, a mannitol (E 421), Acidum hydrochloricum, sodium hydroxide, water for injections.

Contraindication

Hypersensitivity to active agent or to any component of medicine or hypersensitivity to bisfosfonata.

Hypocalcemia.

Heavy renal failure with clearance of creatinine <35 ml/min.

Pregnancy or the period of feeding by a breast.

Route of administration

Osteoporosis.

Treatment of postmenopauzny osteoporosis, osteoporosis at men, treatment of the osteoporosis connected with long-term system glucocorticoid therapy: the recommended dose – 1 intravenous infusion of 5 mg.

Peget's Disease.

Medicine are appointed only by doctors with experience of treatment of a disease of Peget with damage of bones. The recommended dose – one intravenous infusion of 5 mg of Zolevista.

Repeated medicament treatment of a disease Pedzheta.

After an initiation of treatment of a disease of Peget zoledronovy acid observes the long period of remission at the patients who are responsible for treatment. Repeated treatment includes additional intravenous infusion of 5 mg. Zolevista to patients with a recurrence with an interval of 1 year or longer after an initiation of treatment.

Feature of use

to Patients with a heavy renal failure (clearance of creatinine <35 ml/min.) it is contraindicated in view of risk of failure of kidneys at this category of patients. After administration of zoledronovy acid the renal failure, especially at patients with already existing renal dysfunction or other risk factors including advanced age, a concomitant use of nephrotoxic medicines, simultaneous therapy by diuretics or dehydration which arose after administration of zoledronovy acid was observed.

Zolevista is contraindicated to

during pregnancy.

Children

are not recommended to appoint

children and teenagers (up to 18 years) as there are not enough data on safety and efficiency of use in this age group.

Drivers

Undesirable reactions, such as dizziness, can affect ability to run vehicles or to work with other mechanisms.

Overdose

Patients to whom applied a medicament dose exceeding recommended, have to be under constant control as there can be a renal failure (including a renal failure), change of electrolytic composition of blood serum (including concentration of calcium (clinically). significant hypocalcemia), phosphates and magnesium).

Side effects

Infection and invasion: flu, nasopharyngitis.

from blood and lymphatic system: anemia.

from the immune system: reactions of hypersensitivity, including exceptional cases of a bronchospasm, urticaria and Quincke's disease and very exceptional cases of anaphylactic reactions / shock.

from a metabolism, metabolism: hypocalcemia, reduction of appetite, hypophosphatemia.

from mentality: insomnia.

to Store

in original packing at a temperature not above 25ºС. To store out of children's reach.