Open the outer wrap immediately before use, break the center seal between the two chambers, and mix the two solutions thoroughly. The solution in one chamber should not be administered alone without mixing it with the solution in the other chamber.
Method of mixing two solutions (Never fail to mix two solutions): Be sure to press the lower chamber to break the center seal between the two chambers. When the upper chamber is pressed, the checker does not open. (See Table 8.)
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Precautions at the time of preparation:
1) Physicochemical changes in the solution, such as precipitation, may occur if this product is combined with the following drugs. The product should be carefully observed for such changes.
a) Drugs that are stable under acidic or alkaline conditions.
b) Drugs that are slightly soluble in water.
c) Drugs that contain calcium salt or phosphate.
2) Since the solution contains calcium salt, blood coagulation may occur if it is mixed with citrated blood.
3) After opening the outer wrap and mixing the two solutions, the mixed solution should be used promptly.
Precautions before administration:
1) Be sure to confirm that the center seal between the two chambers has been broken.
2) When administering BFLUID Injection, it is recommended that urine output be maintained at more than 500 mL per day or more than 20 mL per hr.
3) To minimize the risk of infection, perform all procedures under aseptic conditions (disinfection of patient's skin and devices).
4) Use the solution after warming it to near body temperature if it is to be used under cold environmental conditions.
5) After use, discard all unused solution.
Precautions during administration:
1) The usual adult dose is 500 mL administered over 120 min. The administration rate should be reduced in the elderly and in seriously ill patients.
2) If vascular pain occurs, use an alternate infusion site or discontinue administration.
3) Since skin necrosis and ulceration, which are considered to be caused by extravasation of the solution, have been reported, observe the injection site carefully. After confirming the clinical signs of extravasation (e.g., redness, infiltration, or swelling) at the injection site, immediately discontinue administration and institute appropriate treatment.
4) A light-resistant cover should be used or other appropriate measures should be taken to avoid photochemical decomposition of the vitamin B1
in the solution, although such photochemical decomposition does not occur in a very short time.
When other vitamins are added, a light-resistant cover should also be used or other appropriate measures should be taken to avoid photochemical decomposition of vitamins.
PRECAUTIONS FOR HANDLING:
1. An oxygen absorbent is enclosed between the bag and the outer wrap to maintain stability of the product. Do not remove the outer wrap until immediately before use.
2. A crystalline precipitate may form in the upper chamber solution (amino acid solution) due to changes in environmental temperature. Shake the solution at a temperature of 15°C-25°C to dissolve all precipitate before use.
3. Do not use the solution if the outer wrap covering the product has been damaged, the solution is discolored, or a precipitate that cannot be dissolved by shaking has formed.
4. If the two solutions contained in the chambers have already been mixed together for any reason or if the center seal between the two chambers appears white in color (the seal appears white if it is not intact), do not use the product.
5. Puncture the rubber stopper vertically with a needle in the marked circle. If the stopper is not pierced vertically, the needle may pass through the neck of the container, resulting in leakage of the contents.
6. Soft bag products may not be infused in tandem using a connection tube.
7. If droplets of water or leakage of the contents is noted inside the outer wrap or if the solution is discolored or cloudy, do not use the solution.
8. The volume markings on the container may not be accurate. Use them only as a rough guide.