Bfluid

Amino acid, glucose, electrolytes, vitamin B₁.

Composition: The upper chamber contains an amino acid solution with electrolytes and the lower chamber contains a glucose solution with electrolytes and vitamin B₁. This product contains the following ingredients.
Upper chamber (amino acid solution with electrolytes): See Table 1.

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Lower chamber (glucose solution with electrolytes and vitamin B₁): See Table 2.

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After the two solutions are mixed: See Table 3.

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Product Description: See Table 4.

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Pharmacology: Glucose + Amino Acids + Electrolytes + Vitamin B₁ (BFLUID) was administered to intact rats and dogs and laparotomized vitamin B₁-starved rats, and its effects in the provision of vitamin B₁ and electrolytes and its nutritional effects were compared against those of AMINOFLUID. In intact rats and dogs, blood levels of vitamin B₁ remained at preadministration levels in the Glucose + Amino Acids + Electrolytes + Vitamin B₁ (BFLUID) group. In laparotomized vitamin B₁-starved rats, recovery of vitamin B₁ levels to the normal range was observed after Glucose + Amino Acids + Electrolytes + Vitamin B₁ (BFLUID). Therefore, it was concluded that Glucose + Amino Acids + Electrolytes + Vitamin B₁ (BFLUID) is useful for the provision of vitamin B₁. Glucose + Amino Acids + Electrolytes + Vitamin B₁ (BFLUID) and AMINOFLUID were found to be comparable in terms of the provision of electrolytes and nutrition.
Pharmacodynamics: Clinical Studies: A comparative clinical study of Glucose + Amino Acids + Electrolytes + Vitamin B₁ (BFLUID) was conducted at 16 institutions in Japan. This study included a total of 110 patients who had undergone gastrointestinal surgery. The clinical effects were evaluated in 97 of the 110 patients (46 patients in the Glucose + Amino Acids + Electrolytes + Vitamin B₁ (BFLUID) group and 51 patients in the control group).
Blood levels of vitamin B₁ were maintained in the Glucose + Amino Acids + Electrolytes + Vitamin B₁ (BFLUID) group, in contrast to the decreased levels of vitamin B₁ observed in the control group. Levels of serum proteins (total protein, albumin, prealbumin, transferrin, and retinol-binding protein) showed similar trends in both groups. Safety was evaluated in 102 of the 110 patients (50 patients in the Glucose + Amino Acids + Electrolytes + Vitamin B₁ (BFLUID) group and 52 patients in the control group). Adverse events were defined as findings related to signs and symptoms, abnormal changes in vital signs, abnormal changes in laboratory data, and metabolic acidosis. Adverse events for which a relationship to administration of the study drug could not be ruled out were defined as adverse reactions. For vital signs and laboratory data, adverse events were also defined as values outside the normal range (the standard range for healthy subjects at each facility) after the start of infusion in comparison with postoperative preinfusion values. In addition, if the Investigator or the Co-investigators noted any abnormal changes in outcome variables not specified in the protocol, the changes were handled as adverse events. A total of 17 (34.0%) of the 50 patients in the Glucose + Amino Acids + Electrolytes + Vitamin B₁ (BFLUID) group experienced 32 adverse reactions, showing no statistically significant difference with the findings in the control group (17 of 52 subjects [32.7%], 36 adverse reactions).
Adverse events are also commonly observed after surgical procedures for gastrointestinal diseases, and their frequencies were comparable to the results for the control group. (Refer to the tables as follows.)
Vitamin B deficiency was not observed in either the Glucose + Amino Acids + Electrolytes + Vitamin B₁ (BFLUID) group or the control group during the 5-day infusion period. (See Tables 5a and 5b.)

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With special regard to the deviations of laboratory values shown in Table 5 previously, all deviations cannot be judged to be "medically significant adverse reactions" because postoperative fluctuations in laboratory values were not taken into consideration. Therefore, an "abnormal value for which treatment was required" was defined as a "medically significant adverse reaction". A total of 8 (16.0%) of the 50 patients in the Glucose + Amino Acids + Electrolytes + Vitamin B₁ (BFLUID) group experienced 11 medically significant adverse reactions, showing no statistically significant difference with the findings in the control group (8 of 52 patients [15.4%], 10 adverse reactions). (See Table 6.)

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Pharmacokinetics: (Reference data in rats.): Glucose + Amino Acids + Electrolytes + Vitamin B₁ (BFLUID) containing ¹⁴C-labeled glucose was administered intravenously to intact rats. The radioactivity was rapidly distributed throughout the body, with particularly high levels observed in the liver (which plays an active role in glucose metabolism) and in the brain (which utilizes a large amount of glucose). The main route of excretion of the administered radioactivity was in the expired air as ¹⁴CO₂, accounting for 62.8% of the administered dose up to 24hr. Radioactivity was also excreted in the urine (4.9%). The glucose was utilized mainly as an energy source and expired in the breath.

Provision of amino acids, electrolytes, vitamin B₁, and water via a peripheral vein to patients with mild hypoproteinemia or mild malnutrition due to inadequate oral intake, and before and after surgery.

Immediately before use, break the center seal between the two chambers and mix the two solutions thoroughly. The usual adult dosage is 500 mL per dose, infused via a peripheral vein. The usual infusion rate in adults is 500 mL administered over 120 min. The infusion rate should be reduced in the elderly and in critically ill patients. The dosage should be adjusted according to the patient's condition, body weight, and age. The maximum dosage is 2500 mL per day.

No available information.

Patients with hepatic coma or at risk of developing hepatic coma. [Due to impaired amino acid metabolism, the patient’s clinical condition may deteriorate.]
Patients with serious renal disorder or azotemia (for both, patients on dialysis or hemofiltration are excluded). [The amounts of water and electrolytes may be excessive, causing the patient's clinical condition to deteriorate. Urea and other amino acid metabolites may be retained, which may cause the patient's clinical condition to deteriorate.] (See Precautions.)
Patients with oliguria (patients on dialysis or hemofiltration are excluded). [The patients' clinical condition may deteriorate.] (See Precautions.)
Patients with congestive heart failure. [An increase in the circulating blood volume may cause a burden on the heart, resulting in the patient's clinical condition to deteriorate.]
Patients with severe acidosis (hyperlactacidemia etc). [The patient's clinical condition may deteriorate.]
Patients with hyperkalemia or Addison's disease. [The patient's clinical condition may deteriorate.]
Patients with hyperphosphatemia or hypoparathyroidism. [The patient's clinical condition may deteriorate.]
Patients with hypermagnesemia or hypothyroidism. [The patient's clinical condition may deteriorate.]
Patients with hypercalcemia. [The patient's clinical condition may deteriorate.]
Patients with reduced urine output due to obstructive uropathy. [Water and/or electrolyte overload may occur, causing the patient's clinical condition to deteriorate.]
Patients with abnormal amino acid metabolism. [Since the infused amino acids are not adequately metabolized, the patient's clinical condition may deteriorate.]
Patients with known hypersensitivity to thiamine chloride hydrochloride.

Careful Administration: Glucose + Amino Acids + Electrolytes + Vitamin B₁ (BFLUID) should be administered with care in the following patients: Patients with hepatic dysfunction. [Abnormalities in water and electrolyte metabolism may be exacerbated.]
Patients with renal dysfunction. [Since these patients have impaired water and electrolyte metabolism, the solution should be administered with care.]
Patients on dialysis or hemofiltration with serious renal disorder, azotemia, or oliguria. [The amounts of water and electrolytes may be excessive and urea and other amino acid metabolites may be retained.] (See Important Precautions as follows.)
Patients with cardiovascular dysfunction. [An increase in the circulating blood volume may cause a burden on the heart, resulting in the patient's clinical condition to deteriorate.]
Patients with acidosis. [The patient's clinical condition may deteriorate.]
Patients with diabetes mellitus. [Impaired uptake of glucose into the tissues may result in hyperglycemia, which may cause the patient's clinical condition to deteriorate.]
Patients with known hypersensitivity to drugs.
Important Precautions: Glucose + Amino Acids + Electrolytes + Vitamin B₁ (BFLUID) contains 15 g of amino acids (2.35 g nitrogen) and 150 kcal (nonprotein calories) in 500 mL. However, daily caloric requirements cannot be met by administering this solution as the sole source of nutritional support. This solution should therefore be used only for short-term nutritional therapy.
When used as a nutritional supplement in patients in whom oral intake is inadequate, the solution should be administered based on an overall assessment of the patient's nutritional requirements and oral intake.
When this solution is used alone in postoperative patients, its use should be limited to 3-5 days and oral/enteral nutrition or other regimens should be instituted as soon as it is feasible to do so.
Glucose + Amino Acids + Electrolytes + Vitamin B₁ (BFLUID) contains 0.96 mg of thiamine chloride hydrochloride (vitamin B₁) as a vitamin source in 500 mL. Additional vitamin B₁ or other vitamins should be administered, depending on the patient's condition.
The volume of water, electrolytes, or urea, etc. removed and acummulated in patients on dialysis or hemofiltration with serious renal disorder, azotemia, or oliguria varies depending on the dialysis method and patient's conditions. Initiation and continuation of administration should be determined after the patient's conditions are carefully checked based on assessment of blood biochemistry, acid-base equilibrium, and body-fluid balance, etc.
Use in Children: The safety of this product in children has not been established (no clinical experience).
Use in the Elderly: Since elderly patients often have reduced physiological function and associated hepatic, renal, or cardiac dysfunction, it is advisable to take measures such as reducing the dose by decreasing the infusion rate under careful supervision.

Glucose + Amino Acids + Electrolytes + Vitamin B₁ (BFLUID) should be used in pregnant women and in women who may possibly be pregnant only if the expected therapeutic benefits outweigh the potential risks associated with administration. (The safety of this product in pregnant women has not been established.)
It is advisable to avoid using this product in nursing mothers. If use of this product is judged to be essential, breast feeding should be discontinued during administration. (The safety of this product in nursing mothers has not been established.)

Reported incidence rates are based on the results obtained for 50 patients who had undergone gastrointestinal surgery in a phase III clinical study. With regard to adverse events (clinically significant adverse reactions), a total of 8 patients (16.0%) experienced 11 adverse reactions, including vascular pain (3), phlebitis (4), and chest discomfort (1) in a total of 7 patients as subjective or objective manifestations and elevated serum AST (GOT) levels (1), elevated serum ALT (GPT) levels (1), and elevated serum ALP levels (1) in a total of 1 patient as abnormal changes in laboratory data. (These data were obtained at the time of drug approval in Japan, 2006.) Refer to Pharmacology: Clinical Studies under Actions.
Clinically Significant Adverse Reactions: Shock^[Note] (frequency unknown): Shock may occur. Patients should be closely monitored, and if any signs or symptoms such as decreased blood pressure, chest discomfort, or dyspnea occur, administration should be discontinued immediately and appropriate measures should be taken.
Note: Adverse reactions commonly associated with thiamine chloride hydrochloride injections.
Other Adverse Reactions: If other adverse reactions are observed, take appropriate measures such as discontinuing administration. (See Table 7.)

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No available information.

Precautions Concerning Use: Preparation: 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.
To open the package: Tear outer wrap at notch and remove solution container.
To break the center seal: Press the lower chamber with both hands until the center seal breaks (admix other drugs, when needed, after mixing two solutions).
To mix: Press both chambers alternately to mix the solutions thoroughly.
Precautions at the time of preparation: 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: Drugs that are stable under acidic or alkaline conditions; Drugs that are slightly soluble in water; Drugs that contain calcium salt or phosphate.
Since the solution contains calcium salt, blood coagulation may occur if it is mixed with citrated blood.
After opening the outer wrap and mixing the two solutions, the mixed solution should be used promptly.
Precautions before administration: 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.
If vascular pain occurs, use an alternate infusion site or discontinue administration.
Extravasation of the solution may result in skin necroses and ulceration. After confirming the clinical signs of extravasation (e.g., redness, infiltration, or swelling) at the injection site, immediately discontinue administration and institute appropriate treatment. 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: 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.
A crystalline precipitate may form in the upper chamber solution (amino acid solution with electrolytes) due to changes in environmental temperature. Shake the solution at a temperature of 15°C-25°C to dissolve all precipitate before use.
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 shacking has formed.
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.
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.
Soft bag products may not be infused in tandem using a connection tube.
If droplets of water are noted inside the outer wrap or if the solution is cloudy, do not use the solution.
The volume markings on the container may not be accurate. Use them only as a rough guide.

Store at temperatures not exceeding 30°C, protected from light.
Expiration Date: 24 months from the date of manufacture (as indicated on the container).

Parenteral Nutritional Products

B05BA - Solutions for parenteral nutrition ; Used in I.V. solutions.

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