Vivanat Romfarm solution for infection. 3mg/3ml syringe of 3 ml No. 1

Vivanat Romfarm - the means affecting structure and a mineralization of bones. Bisfofonata.

Indications - treatment of osteoporosis at women during the post-menopausal period with the increased risk of changes.

Structure

• 1 previously filled syringe (3 ml) contains ibandronovy acid 3 mg in the form of sodium of the ibandronat of monohydrate of 3.375 mg;
• excipients: sodium acetate, trihydrate; ice acetic acid; sodium chloride, acetic acid solution of 1%; water for injections.

Contraindication

Hypersensitivity to ibandronovy acid or any of excipients.

Hypocalcemia.

Route of administration

Recommended dose of ibandronovy acid makes 3 mg in the form of an intravenous injection lasting 15-30 seconds, each 3 months.

Should be observed strictly an intravenous way of introduction.

to Patients needs to accept calcium and vitamin D in addition.

in case of the admission of a dose at once as soon as it is possible. Further the injection should carry out each 3 months from the moment of the last administration of drug.

. It is necessary to reconsider periodically a question of need of continuation of treatment taking into account advantage and potential risks of use of the medicament Vivanat Romfarm for each patient separately, especially after 5 or more years of use of drug.

Feature of use

Error of input

Should be careful and avoid administration of the medicament Vivanat Romfarm vnutriarterialno or in perivenous space as it can lead to damage of fabrics.

Hypocalcemia

can lead Use of the medicament Vivanat Romfarm, as well as use of other bisfosfonat entered intravenously to temporary decrease in serumal levels of calcium.

Prior to therapy existing hypocalcemias. Other disturbances of metabolism of a bone tissue and a mineral metabolism it is also necessary to treat effectively.

All patients have to receive enough calcium and vitamin D.

Anaphylactic reaction / shock

At the patients receiving treatment of Ibandronovaya acid intravenously was reported about cases of anaphylactic reaction / shock, including with a lethal outcome.

Drug Vivanat Romfarm is intended by

for use only to women in a postmenopause. Drug should not be used to women of reproductive age.

do not have

appropriate data on use of ibandronovy acid to pregnant women. In researches on rats a certain reproductive toxicity was observed. The potential risk for the person is unknown. The medicament Vivanat Romfarm should not be used during pregnancy.

Children

Are not present the corresponding experience on use of the medicament Vivanat Romfarm to children (aged up to 18 years). Use of medicament in this population of patients Drivers did not study

Considering features of a pharmacodynamics, a pharmacokinetic profile and popularity side reactions, it is expected that the medicament Vivanat Romfarm has no or has insignificant influence on ability to run vehicles or to work with mechanisms.

Overdose

Specific information on treatment of overdose of Ibandronovy acid - is not present

.

Considering the available knowledge of it a class of connections, the overdose at intravenous administration can lead to a hypocalcemia, a hypophosphatemia and a hypomagnesiemia. Clinically significant decrease in serumal levels of calcium, phosphorus and magnesium should be adjusted administration of calcium of a gluconate, potassium phosphate or sodium and magnesium sulfate respectively.

Side effects

Most serious side reactions about which reported is anaphylactic reactions / shock, atypical fractures of a hip, an osteonecrosis of jawbones, inflammations of an eye.

Most frequent side reactions about which reported. These symptoms usually were associated with the first dose, in most cases were short-term, easy or moderately severe and usually disappeared at continuation of treatment and did not demand medicamentous intervention

Storage conditions

to Store in original packing out of children's reach at a temperature not above 25 °C.