Octaplex Caution For Usage

One package of Octaplex contains: Powder in a vial (type I glass) with a stopper (halobutyl rubber) and a flip off cap (aluminium); 20 ml of Water for Injections in a vial (type I) with a stopper (halobutyl rubber) and a flip off cap (aluminium); 1 transfer set (1 double-ended needle and 1 filter needle); 1 Disposable syringe; 1 Infusion set; 2 Alcohol swabs.
Incompatibilities: This medicinal product must not be mixed with other medicinal products.
Instructions for use and handling and disposal: Read all the instructions and follow them carefully!
During the procedure described as follows, aseptic technique must be maintained!
The product reconstitutes quickly at room temperature.
The solution should be clear or slightly opalescent. Do not use solutions that are cloudy or have deposits. Reconstituted products should be inspected visually for particulate matter and discoloration prior to administration.
After reconstitution, the solution must be used immediately.
Any unused product or waste material should be disposed of in accordance with local requirements.
Instructions for reconstitution: 1. If necessary, allow the solvent (Water for Injections) and the powder in the closed vials to reach room temperature. This temperature should be maintained during reconstitution. If a water bath is used for warming, care must be taken to avoid water coming into contact with the rubber stoppers or the caps of the vials. The temperature of the water bath should not exceed 37°C.
2. Remove the caps from the powder vial and the water vial and clean the rubber stoppers with an alcohol swab.
3. Remove the protective cover from the short end of the double-ended needle, making sure not to touch the exposed tip of the needle.
Then perforate the centre of the water vial rubber stopper with the vertically held needle.
In order to withdraw the fluid from the water vial completely, the needle must be introduced into the rubber stopper in such a way that it just penetrates the stopper and is visible in the vial.
4. Remove the protective cover from the other, long end of the double-ended needle, making sure not to touch the exposed tip of the needle.
Hold the water vial upside-down above the upright powder vial and quickly perforate the centre of the powder vial rubber stopper with the needle. The vacuum inside the powder vial draws in the water.
5. Remove the double-ended needle with the empty water vial from the powder vial, then slowly rotate the powder vial until it is completely dissolved. Octaplex dissolves quickly at room temperature to a colourless to slightly blue solution.
If the powder fails to dissolve completely or an aggregate is formed, do not use the preparation.
Instructions for infusion: As a precautionary measure, the patient's pulse rate should be measured before and during the infusion. If a marked increase in the pulse rate occurs, the infusion speed must be reduced or the administration must be interrupted.
1. After the powder has been reconstituted in the manner previously described, remove the protective cover from the filter needle and perforate the rubber stopper of the powder vial.
2. Remove the cap of the filter needle and attach a 20 ml syringe.
3. Turn the vial with the attached syringe upside-down and draw up the solution into the syringe.
4. Disinfect the intended injection site with an alcohol swab.
5. After removing the filter, inject the solution intravenously at a slow speed: Initially 1 ml per minute, not faster than 2-3 ml per minute.
The filter needle is for single use only. Always use a filter needle when drawing up the preparation into a syringe. No blood must flow into the syringe due to the risk of formation of fibrin clots.