Iksdzheva solution for infection. 70mg/ml fl. 1.7 ml (120 mg) No. 1

Solution for Iksgev's injections are shown for prevention of bone events (a pathological change, radiations of bones, a compression of a spinal cord or surgical intervention on bones) at adult patients with a late stage of the malignant tumors affecting bones.

Treatment of adults and teenagers with the ripened skeletal system who have a giant-cell tumor of bones it cannot be removed or if the surgical resection, most likely, leads to serious consequences.

Structure

Active ingredient: denosumab;

1 ml of solution; 1 bottle (1.7 ml) contains 120 mg of a denosumab;

Excipients: sorbite (E 420), ice acetic acid, sodium hydroxide, polysorbate 20, water for injections.

Contraindication

• Hypersensitivity to active ingredient or to any excipient.
• Not treated hypocalcemia of heavy degree.
• Defeat after dental or surgical interventions in an oral cavity that do not heal.

Route of administration

Drug should be used under observation of the doctor.

Before administration of medicament solution needs to be checked visually. Solution may contain insignificant quantity of transparent or white belkovopodobny particles.

not to enter solution if it dimmed or changed color. Not to stir up.

to avoid discomfort in the injection site, a bottle it is necessary to heat to room temperature (up to 25 °C) and to enter slowly.

to Enter all contents of a bottle.

For input of a denosumab recommends a needle of caliber 27.

not to enter a needle into a bottle repeatedly.

Feature of use

Pregnant

it is not applied.

Children

it is not applied.

Drivers

does not influence or has insignificant impact on speed of response at control of motor transport or work with other mechanisms.

Overdose

Experience of overdose in clinical trials is absent. The medicament was administered in clinical trials in doses up to 180 mg each 4 weeks and to 120 mg there are each 3 weeks.

Side effects

it was Very often reported about a hypocalcemia which arose after administration of drug, mainly within the first two weeks. As a rule, decrease in level of calcium in blood serum effectively was eliminated by addition of medicaments of calcium and vitamin D. Skeletal and muscular pain was the most frequent side reaction at use of drug. At the patients receiving medicament it was often reported about jaw osteonecrosis cases.

Interaction

Research of interaction was not conducted.

to Store

in the fridge at a temperature of 2-8 °C in original packing for protection against light. Not to freeze.

not to stir up

.

to Store

out of children's reach.

After extraction from the fridge the medicament Iksdzheva® can be stored at the room temperature (25 °C) in original packing no more than 30 days and it is necessary to use during these 30 days.

Expiration date - 3 years.