Instructions for preparation and introduction:
1. Observe proper asepsis rules when preparing Sigris® for intravenous administration.
2. Calculate the dose and the required number of Sigris® vials. Each Sigris® vial contains 5 mg or 20 mg of the drug.
3. Before administration, the contents of the 5 mg vial should be diluted with 2.5 ml of sterile water for injection; the contents of the 20 mg bottle should be diluted with 10 ml of sterile water for injection.The concentration of the preparation in the solution thus obtained is approximately 2 mg / ml. Slowly add sterile water for injection to the contents of the vial, without flipping or shaking it. Carefully shake each bottle until the lyophilizate contained in it is completely dissolved.
4. The Sigris® solution must be further diluted with sterile 0.9% sodium chloride solution for intravenous administration to a concentration of 100 μg / ml to 200 μg / ml. Slowly draw the appropriate amount of Sigris® solution from the vial and add Zigris® solution to the dropper container containing 0.9% sterile sodium chloride solution. When adding Zigris®, direct the spray of solution to the wall of the dropper container so as to reduce the shaking of the solution. Carefully flip over container, that homogenize solution. Not transport container with a dropper using mechanical systems delivery.
5. Due to the fact that antibacterial preservatives are not included in Sigris®, the solution for intravenous administration should be prepared immediately after diluting Sigris® in the vial (s).If bottles with dilute Zigrisom® not used immediately, they can be stored at room temperature of from 15 ° to 30 ° C, however, these vials must be used during the next 3 hours.
6. Before use, preparations for parenteral administration should be carefully inspected for visible suspended particles and discoloration of the solution.
7. When using a pump for intravenous administration Zigrisa® solution is typically diluted in sterile sodium chloride solution 0.9 for intravenous administration to a concentration of 100 .mu.g / ml to 200 mcg / ml. After preparation, the solution for intravenous administration should be used at room temperature (15 - 30 ° C) for 12 hours. If the intravenous solution has not been used immediately, it should be stored in the refrigerator (2 - 8 ° C) for 12 hours. If the prepared solution was stored in the refrigerator before use, the maximum time during which it is possible to use it, including preparation, storage in the refrigerator and the introduction is 24 hours.
8. When using a syringe pump for administering the drug, the solution of Sigris® is diluted with a sterile 0.9 % solution of sodium chloride for injection to a concentration of 100 μg / ml to 200 μg / ml.In the case when Sigris® is administered at a low rate (less than 5 ml / h), the infusion rate in the first 15 minutes should be about 5 ml / h. After preparation in a syringe solution for intravenous administration should be used at room temperature (15 - 30 ° C) for 12 hours. The maximum time to use the solution, including preparation and administration, is 24 hours.
9. Sigris® should be injected through a separate intravenous port or through an isolated lumen of a multi-lumen central catheter. Via the same port, you can enter only 0.9% solution of sodium chloride for injection, Ringer's injection, dextrose or a mixture of dextrose and 0.9% sodium chloride solution.
10. Sigris® solution should be protected from exposure to high temperatures and / or direct sunlight. It was not revealed incompatibility between Zigris® and glass droppers, as well as droppers and syringes made of polyvinyl chloride, polyethylene, polypropylene or polyolefin.