Hemodialysis Concentrates Dialysis a&B Solution Liquid

• Quality Guarantee Period: One Year
• Group: Adult
• Logo Printing: Without Logo Printing
• Transport Package: Carton
• Trademark: OEM
• Origin: China
• Model NO.: QDHSK-201225-02
• HS Code: 3004909099
• Production Capacity: 5000000 Pieces/Month

Product Description

1. COMPONENTS

The hemodialysis concentrate (Liquid) is divided into Liquid Acid Concentrate for Bicarbonate Dialysis (Dialysate A Concentrate) and Liquid Bicarbonate Concentrate (Dialysate B Concentrate).
The Liquid Acid Concentrate for Bicarbonate Dialysis is the aqueous solution of glacial acetic acid, sodium chloride, potassium chloride, calcium chloride and magnesium chloride. The Liquid Bicarbonate Concentrate is the aqueous solution of sodium bicarbonate (or sodium bicarbonate and sodium chloride).
The solute concentration of the liquid concentrate is shown in the table below.

Chemical	PRSTXY-A02	PRSTXY-A04	PRSTXY-A06	PRSTXY-B01	PRSTXY-B02	PRSTXY-B03	PRSTXY-B04
NaCl (g/L)	210.68	210.68	166.79	-	-	-	30
KCl (g/L)	5.22	5.49	5.49	-	-	-	-
CaCl2·2H2O (g/L)	7.72	8.12	8.12	-	-	-	-
MgCl2·6H2O (g/L)	3.56	3.74	3.74	-	-	-	-
CH3COOH (g/L)	6.31	6.63	6.63	-	-	-	-
NaHCO3 (g/L)	-	-	-	84	81.68	59.18	59.18

 

1. INDICATION FOR USE

The product is intended for use in extracorporeal bicarbonate hemodialysis for acute and chronic renal failure and to be used with the appropriate 3-stream proportioning hemodialysis machine/monitor and bicarbonate concentrate according to a physician's prescription.

1. SHELF LIFE

12 months.

1. STORAGE

Sealed storage at room temperature with good ventilation. Avoid direct sunshine and protect from freezing.
Avoid mixing storage with toxic, contaminated and odorous substances.

1. COLOUR CODING

Red is used for acid and blue is used for bicarbonate.

1. CONTRAINDICATIONS

Hyperkalaemia (only for hemodialysis concentrates yielding a potassium concentration in the ready-to-use dialysis fluid of 4mmol/L or higher), hypokalaemia (only for hemodialysis concentrates yielding a potassium concentration in the ready-to-use dialysis fluid of 3mmol/L or lower). Potential adverse effects of rapid plasma potassium concentration changes should be considered when prescribing a patient's dialysis fluid potassium concentration. Uncontrollable coagulation anomalies.

1. CAUTIONS

Do not use if the liquid concentrate is discolored or cloudy.
This product has a variety of specifications applicable to different dialysis machine types. Refer to the label for the details of the specifications.
Do not store again for re-use once opened.
If crystallization occurs at an unavoidable low temperature, the concentrate can be placed below 38ºC until the crystals are completely dissolved and then be used.
Proper Dilution: Use purified water that meets or exceeds current ISO 23500-3 hemodialysis water quality standards. Refer to the directions for use provided in the dialysis machine operator's manual. Check conductivity (information is available from manufacturer) and pH of dialyzing fluid before starting treatment and each time solution is added.

1. WARNINGS
   1. For use only with three-stream proportioning systems calibrated to a proper dilution. Use with other equipment or without associated concentrate may cause patient injury or death. NOT FOR PERITONEAL DIALYSIS OR PARENTERAL USE.
   2. This acid concentrate product contains acetic acid and, after mixing, yields 3 milliequivalents per liter of acetate in the dialysate. After diffusion across the dialyzer membrane, acetate is metabolized by the liver to serum bicarbonate and adds to the serum bicarbonate that separately results from the diffusion of dialysate bicarbonate across the dialyzer membrane. During dialysis, the dynamic of diffusion and concentration gradients prevent serum bicarbonate concentration from exceeding the dialysate bicarbonate concentration. The bicarbonate concentration of the dialysate is the bicarbonate setting on the dialysis machine, and is the bicarbonate dose prescribed by the physician. On the hemodialysis machines, the bicarbonate dose may be set in different ranges.

When the dialysis session terminates, acetate that has not yet metabolized may remain in the blood and will be converted to serum bicarbonate after diffusion ceases, without possibility of diffusion out of the blood. The post dialysis metabolism of acetate could thus briefly increase serum bicarbonate concentration above the prescribed bicarbonate concentration of the dialysate. Physicians should consider this possibility in prescribing bicarbonate dose.
Prescription of insufficient bicarbonate may contribute to metabolic acidosis; excessive bicarbonate may contribute to metabolic alkalosis. Both conditions are associated with poor patient outcomes, including increased mortality risk.

1. 1. Use only as directed. Do not use if seals or container are damaged. Mix thoroughly before use. Keep container tightly closed when not in use.
   2. Check the validity period before use.Take care of contaminated by bacteria growth of Bicarbonate Concentrate. Open and use within 24 hours.
   3. Refer to the physician's prescription before dialysis. Refer to instructions provided by the hemodialysis machine manufacturer.
2. ADVERSE REACTIONS

Some undesirable effects related to dialysis can occur, for instance, hypotension, nausea, headache and cramps.

1. REQUIREMENTS

1.   The associated formulas are compatible with the following types of machines.

Collocation No.	Type of Dialysate A Concentrate	Type of Dialysate B Concentrate	Dilution proportion(Acid: bicarbonate: water)	Compatible Machine
1	PRSTXY-A02	PRSTXY-B01	1:1.225:32.775	Fresenius
2	PRSTXY-A02	PRSTXY-B02	1:1.26:32.74	B. Braun, TORAY
3	PRSTXY-A04	PRSTXY-B03	1:1.83:34	Gambro, Baxter.
4	PRSTXY-A06	PRSTXY-B04	1:1.83:34	Gambro, Baxter.

2.   For use only with water that meets current ISO 23500-3 requirements.

1. USE INSTRUCTIONS

Mix liquid acid concentrate, liquid bicarbonate concentrate and dialysis water in proper proportions. The dilution ratio and associated concentrates are shown in the table below.

Collocation No.	Type of Dialysate A Concentrate	Type of Dialysate B Concentrate	Dilution proportion(Acid: bicarbonate: water)	The final dialysate electrolyte concentration(mmol/L)
				Na^+	K^+	Mg^2+	Ca^2+	Cl^-	CH3COO^-	HCO3^-
1	PRSTXY-A02	PRSTXY-B01	1:1.225:32.775	138.0	2.0	0.5	1.50	109.0	3.0	32.0
2	PRSTXY-A02	PRSTXY-B02	1:1.26:32.74	138.0	2.0	0.5	1.50	109.0	3.0	32.0
3	PRSTXY-A04	PRSTXY-B03	1:1.83:34	138.0	2.0	0.5	1.50	109.0	3.0	32.0
4	PRSTXY-A06	PRSTXY-B04	1:1.83:34	138.0	2.0	0.5	1.50	109.0	3.0	32.0