TOnly for hospital use. For intravenous administration only.
The drug should be diluted directly before use.
Instructions for the cultivation of medicinal preparation before administration are given in subsection "Instructions for use".
The contents of the vial are intended only forFor single application.
Before application of the preparation "Reassens", SBP should be stabilized at a level above 125 mm Hg.
The dose of Reasans should be calculated based on the patient's body weight (see Table 1.) The drug should be administered as a continuous intravenous infusion within 48 hours, the recommended dose being 30 μg / kg / day, two consecutive intravenous infusions for 24 hours each at a constant rate of administration of 10 ml / h.
Table 1. The volume of the preparation is Reassins *. concentrate for the preparation of a solution for infusion, which should be diluted in 250 ml of a 5% sterile dextrose (glucose) solution to prepare one 24-hour intravenous infusion
| Weight bodies the patient (kg) | Serelaxin (mg) | Amount of preparation |
| Rheasant, concentrate for the preparation of a sterile solution for infusion (ml) for dilution in 250 ml of a 5% solution of dextrose (glucose) |
|
|
| 40-59 kg | 2.0 mg | 2.0 ml |
| 60-74 kg | 3.0 mg | 3.0 ml |
| 75-114 kg | 3.5 mg | 3.5 ml |
| 115-160 kg | 5.5 mg | 5.5 ml (2 bottles are required) |
It is necessary to regularly monitor blood pressure (BP) during the administration of the drug Reassanz. If the SBP decreases by more than 40 mm Hg. relative to the initial value, but remains at a level above 100 mm Hg.or if the SBP decreases in the patient to a level below 100 mmHg, the following measures should be taken (see Table 2):
Table 2.
| Systolic blood pressure during infusion * | Required dose adjustment |
| Decrease by more than 40 mm Hg. relative to the initial value, but the SBP is above 100 mm Hg. | Reducing the rate of IV infusion of the drug Reassanse "by 50% until the end of the 48-hour infusion (i.e., a decrease in the IV infusion rate from 10 ml / h to 5 ml / h) |
| Below 100 mm of mercury. | Termination of infusion of the drug Reassanz " |
* These values of blood pressure should be confirmed by two dimensions, conducted with an interval of 15 minutes.
Dosing regimen the special groups patients
Patients with impaired renal function
Do not require dose adjustment for use of the drug in patients with disorders of kidney function or patients with terminal stage chronic renal failure.
Patients with impaired hepatic function
Do not require dose adjustment in patients with a violation of the liver.
Elderly age / gender / ethnicity belonging
Do not need dose adjustment in dependence from sex, age or ethnicity. accessories.
Patients under the age of 18 years
Safety and effectiveness of the application of Reassans in children and adolescents in under the age of 18 years are not established.
Instructions for use
Preparation of solution for infusion should be carried out in accordance with the rules of aseptic. Reasans' preparation should not be mixed with furosemide or any other medicines (with the exception of nitroglycerin, a concentrate for the preparation of a solution for infusions, with a concentration of no more than 0.5 mg / ml, with proline glycol and dextrose (glucose) as adjuvants) in an intravenous catheter or an infusion container. Using a sterile syringe, dial the required amount of concentrate to prepare the infusion solution based on the patient's body weight (see Table 3) and enter it into the infusion tank containing 250 ml of a 5% sterile dextrose (glucose) solution.
Table 3. The volume of the preparation of Reasans, a concentrate for the preparation of a solution for infusion, which should be dialed with a sterile syringe.
| Body mass the patient (kg) | Volume of the preparation Reasans, concentrate for solution for infusion (ml), for 24-hour infusion |
| 40-59 kg | 2.0 ml |
| 60-74 kg | 3.0 ml |
| 75-114 kg
115-160 kg | 3.5 ml
5.5 ml (requires 2 bottles) |
Stir the contents of the infusion container, gently rocking it from side to side. Hss shake the container for infusion.
To avoid microbiological contamination, it is necessary to start using the prepared solution no later than 4 hours after its preparation (if stored at room temperature (20-25 ° C)).
Prepare an infusion system with a separate intravenous catheter (you can use a multichannel catheter). Choose an infusion system with a small volume of "dead" space.
It is recommended to supplement the infusion system with an infusion filter Posidyne / Nanodyne ELD (Pall) with holes of 0.2 μm to minimize the risk of bacterial contamination.
Rinse the infusion system and the infusion filter with a prepared solution of the preparation Reasans * (10 ml) from the container for intravenous infusion.
Start the intravenous infusion of the drug, setting the infusion rate at 10 mL / h for 24 hours.
In the same way, prepare a second IV infusion bottle for useshortly before the end of the first intravenous infusion. 8. Start a second 24-hour IV infusion immediately after the end of the first:
If during the first intravenous infusion did not correct the dose, start a second intravenous infusion, setting the infusion rate of 10 ml / h for 24 hours. If the IV infusion rate was reduced from 10 ml / h to 5 ml / h during the first intravenous infusion, start a second intravenous infusion, setting the infusion rate at 5 ml / h for 24 hours.
Unused solution in vial or infusion system should be disposed of after 24 hours.
Avoid exposure to direct sunlight on the prepared solution.
Dispose of unused product or waste in accordance with local regulations.