Concentrated Bicarbonate Solution - ACID Component

Presentation PE-HD Canister (4–10.5 L)

Packaging White/Translucent, Red Cap

Certifications CE NB 2292, ISO 13485

Product Range & Composition

ID	Name	Qty (L)	UDI-DI	Na⁺ (mmol/L)	K⁺ (mmol/L)	Ca⁺⁺ (mmol/L)	Mg⁺⁺ (mmol/L)	Cl^- (mmol/L)	Acet. (mmol/L)	Gluc. (mmol/L)	HCO₃^- (mmol/L)
1	TERUSOL A 1001	5	5940541537212	138.00	2.00	1.25	0.50	108.5	3.00	-	32.00
1	TERUSOL A 1001	10	5940541537175	138.00	2.00	1.25	0.50	108.5	3.00	-	32.00
2	TERUSOL A 1002	5	5940541537045	138.00	2.00	1.50	0.50	109.0	3.00	-	32.00
2	TERUSOL A 1002	10	5940541537328	138.00	2.00	1.50	0.50	109.0	3.00	-	32.00
3	TERUSOL A 1003	5	5940541537113	138.00	2.00	1.75	0.50	109.5	3.00	-	32.00
3	TERUSOL A 1003	10	5940541537250	138.00	2.00	1.75	0.50	109.5	3.00	-	32.00
4	TERUSOL A 1004	5	5940541537038	138.00	2.00	1.25	0.50	108.5	3.00	5.5 mmol/L (1 g/L)	32.00
4	TERUSOL A 1004	10	5940541537267	138.00	2.00	1.25	0.50	108.5	3.00	5.5 mmol/L (1 g/L)	32.00
5	TERUSOL A 1005	5	5940541537168	138.00	2.00	1.50	0.50	109.0	3.00	5.5 mmol/L (1 g/L)	32.00
5	TERUSOL A 1005	10	5940541537304	138.00	2.00	1.50	0.50	109.0	3.00	5.5 mmol/L (1 g/L)	32.00
6	TERUSOL A 1006	5	5940541537281	138.00	2.00	1.75	0.50	109.5	3.00	5.5 mmol/L (1 g/L)	32.00
6	TERUSOL A 1006	10	5940541537137	138.00	2.00	1.75	0.50	109.5	3.00	5.5 mmol/L (1 g/L)	32.00
7	TERUSOL A 1007	5	5940541537182	138.00	1.00	1.50	0.50	108.0	3.00	5.5 mmol/L (1 g/L)	32.00
7	TERUSOL A 1007	10	5940541537199	138.00	1.00	1.50	0.50	108.0	3.00	5.5 mmol/L (1 g/L)	32.00
8	TERUSOL A 1008	5	5940541537083	138.00	2.00	1.50	0.50	109.0	3.00	11.11 mmol/L (2 g/L)	32.00
8	TERUSOL A 1008	10	5940541537342	138.00	2.00	1.50	0.50	109.0	3.00	11.11 mmol/L (2 g/L)	32.00
9	TERUSOL A 1009	5	5940541537359	138.00	1.00	1.50	0.50	108.0	3.00	-	32.00
9	TERUSOL A 1009	10	5940541537229	138.00	1.00	1.50	0.50	108.0	3.00	-	32.00
10	TERUSOL A 1010	5	5940541537311	138.00	3.00	1.25	0.50	109.5	3.00	-	32.00
10	TERUSOL A 1010	10	5940541537069	138.00	3.00	1.25	0.50	109.5	3.00	-	32.00
11	TERUSOL A 1011	5	5940541537120	138.00	3.00	1.50	0.50	110.0	3.00	-	32.00
11	TERUSOL A 1011	10	5940541537076	138.00	3.00	1.50	0.50	110.0	3.00	-	32.00
12	TERUSOL A 1012	5	5940541537335	138.00	3.00	1.75	0.50	110.5	3.00	-	32.00
12	TERUSOL A 1012	10	5940541537007	138.00	3.00	1.75	0.50	110.5	3.00	-	32.00
13	TERUSOL A 1013	5	5940541537014	138.00	3.00	1.25	0.50	109.5	3.00	5.5 mmol/L (1 g/L)	32.00
13	TERUSOL A 1013	10	5940541537144	138.00	3.00	1.25	0.50	109.5	3.00	5.5 mmol/L (1 g/L)	32.00
14	TERUSOL A 1014	5	5940541537151	138.00	3.00	1.50	0.50	110.0	3.00	5.5 mmol/L (1 g/L)	32.00
14	TERUSOL A 1014	10	5940541537243	138.00	3.00	1.50	0.50	110.0	3.00	5.5 mmol/L (1 g/L)	32.00
15	TERUSOL A 1015	5	5940541537090	138.00	3.00	1.75	0.50	110.5	3.00	5.5 mmol/L (1 g/L)	32.00
15	TERUSOL A 1015	10	5940541537274	138.00	3.00	1.75	0.50	110.5	3.00	5.5 mmol/L (1 g/L)	32.00
16	TERUSOL A 1016	5	5940541537106	138.00	2.00	1.50	1.00	110.0	3.00	-	32.00
16	TERUSOL A 1016	10	5940541537021	138.00	2.00	1.50	1.00	110.0	3.00	-	32.00
17	TERUSOL A 1017	5	5940541537205	138.00	2.00	1.50	1.00	111.0	3.00	5.5 mmol/L (1 g/L)	32.00
17	TERUSOL A 1017	10	5940541537236	138.00	2.00	1.50	1.00	111.0	3.00	5.5 mmol/L (1 g/L)	32.00
18	TERUSOL A 1018	5	5940541537052	138.00	3.50	1.25	0.50	110.0	3.00	5.5 mmol/L (1 g/L)	32.00
18	TERUSOL A 1018	10	5940541537298	138.00	3.50	1.25	0.50	110.0	3.00	5.5 mmol/L (1 g/L)	32.00
19	TERUSOL A 1019	5	5940541537892	138.00	3.50	1.50	0.50	110.5	3.00	5.5 mmol/L (1 g/L)	32.00
19	TERUSOL A 1019	10	5940541537564	138.00	3.50	1.50	0.50	110.5	3.00	5.5 mmol/L (1 g/L)	32.00
20	TERUSOL A 1020	5	5940541537823	138.00	4.00	1.25	0.50	110.5	3.00	5.5 mmol/L (1 g/L)	32.00
20	TERUSOL A 1020	10	5940541537687	138.00	4.00	1.25	0.50	110.5	3.00	5.5 mmol/L (1 g/L)	32.00
21	TERUSOL A 1021	5	5940541537618	138.00	4.00	1.50	0.50	111.0	3.00	5.5 mmol/L (1 g/L)	32.00
21	TERUSOL A 1021	10	5940541537854	138.00	4.00	1.50	0.50	111.0	3.00	5.5 mmol/L (1 g/L)	32.00
22	TERUSOL A 1022	5	5940541537786	138.00	2.50	1.25	0.50	109.0	3.00	5.5 mmol/L (1 g/L)	32.00
22	TERUSOL A 1022	10	5940541537465	138.00	2.50	1.25	0.50	109.0	3.00	5.5 mmol/L (1 g/L)	32.00
23	TERUSOL A 1023	5	5940541537397	138.00	2.50	1.50	0.50	109.5	3.00	5.5 mmol/L (1 g/L)	32.00
23	TERUSOL A 1023	10	5940541537441	138.00	2.50	1.50	0.50	109.5	3.00	5.5 mmol/L (1 g/L)	32.00
24	TERUSOL A 1024	5	5940541537540	138.00	2.00	1.50	0.50	109.0	2.00	-	33.00
24	TERUSOL A 1024	10	5940541537908	138.00	2.00	1.50	0.50	109.0	2.00	-	33.00
25	TERUSOL A 1025	5	5940541537427	139.00	2.00	1.50	0.50	106.0	3.00	-	36.00
25	TERUSOL A 1025	10	5940541537717	139.00	2.00	1.50	0.50	106.0	3.00	-	36.00
26	TERUSOL A 1026	4.2	5940541537380	138.00	2.00	1.25	0.50	108.5	3.00	-	32.00
		5	5940541537731
		10.5	5940541537779
27	TERUSOL A 1027	4.2	5940541537960	138.00	2.00	1.50	0.50	109.0	3.00	-	32.00
		5	5940541537861
		10.5	5940541537601
28	TERUSOL A 1028	4.2	5940541537489	138.00	2.00	1.75	0.50	109.5	3.00	-	32.00
		5	5940541537458
		10.5	5940541537885
29	TERUSOL A 1029	4.2	5940541537670	138.00	2.00	1.25	0.50	108.5	3.00	5.5 mmol/L (1 g/L)	32.00
		5	5940541537793
		10.5	5940541537991
30	TERUSOL A 1030	4.2	5940541537755	138.00	2.00	1.50	0.50	109.0	3.00	5.5 mmol/L (1 g/L)	32.00
		5	5940541537694
		10.5	5940541537748
31	TERUSOL A 1031	4.2	5940541537649	138.00	2.00	1.75	0.50	109.5	3.00	5.5 mmol/L (1 g/L)	32.00
		5	5940541537519
		10.5	5940541537762
32	TERUSOL A 1032	4.2	5940541537656	138.00	3.00	1.25	0.50	109.5	3.00	-	32.00
		5	5940541537472
		10.5	5940541537533
33	TERUSOL A 1033	4.2	5940541537724	138.00	3.00	1.50	0.50	110.0	3.00	-	32.00
		5	5940541537984
		10.5	5940541537526
34	TERUSOL A 1034	4.2	5940541537953	138.00	3.00	1.75	0.50	110.5	3.00	-	32.00
		5	5940541537434
		10.5	5940541537410
35	TERUSOL A 1035	4.2	5940541537700	138.00	3.00	1.25	0.50	109.5	3.00	5.5 mmol/L (1 g/L)	32.00
		5	5940541537571
		10.5	5940541537816
36	TERUSOL A 1036	4.2	5940541537595	138.00	3.00	1.50	0.50	110.0	3.00	5.5 mmol/L (1 g/L)	32.00
		5	5940541537946
		10.5	5940541537830
37	TERUSOL A 1037	4.2	5940541537915	138.00	3.00	1.75	0.50	110.5	3.00	5.5 mmol/L (1 g/L)	32.00
		5	5940541537632
		10.5	5940541537625
38	TERUSOL A 1038	4.2	5940541537403	138.00	2.00	1.50	0.50	109.0	2.00	11.11 mmol/L (2 g/L)	32.00
		5	5940541537496
		10.5	5940541537663
39	TERUSOL A 1039	4.2	5940541537922	138.00	2.00	1.50	0.50	109.0	2.00	-	33.00
		5	5940541537557
		10.5	5940541537588
40	TERUSOL A 1040	4.2	5940541537878	138.00	2.00	1.50	1.00	110.0	2.00	-	33.00
		5	5940541537847
		10.5	5940541537502
41	TERUSOL A 1041	4.2	5940541537977	138.00	2.00	1.25	1.00	109.5	3.00	-	32.00
		5	5940541537939
		10.5	5940541537809
42	TERUSOL A 1042	4.2	5940597530250	138.00	2.00	1.50	1.00	110.0	3.00	-	32.00
		5	5940597530113
		10.5	5940597530281
43	TERUSOL A 1043	4.2	5940597530182	138.00	2.00	1.75	1.00	110.5	3.00	-	32.00
		5	5940597530120
		10.5	5940597530205
44	TERUSOL A 1044	4.2	5940597530090	138.00	2.00	1.50	1.00	110.0	3.00	5.5 mmol/L (1 g/L)	32.00
		5	5940597530069
		10.5	5940597530175
45	TERUSOL A 1045	4.2	5940597530151	140.00	2.00	1.25	0.50	110.5	3.00	-	32.00
		5	5940597530137
		10.5	5940597530021
46	TERUSOL A 1046	4.2	5940597530267	140.00	2.00	1.50	0.50	111.0	3.00	-	32.00
		5	5940597530168
		10.5	5940597530199
47	TERUSOL A 1047	4.2	5940597530045	140.00	2.00	1.75	0.50	111.5	3.00	-	32.00
		5	5940597530083
		10.5	5940597530243
48	TERUSOL A 1048	4.2	5940597530212	140.00	2.00	1.50	0.50	111.0	3.00	5.5 mmol/L (1 g/L)	32.00
		5	5940597530106
		10.5	5940597530038
49	TERUSOL A 1049	4.2	5940597530144	140.00	3.00	1.50	0.50	112.0	3.00	-	32.00
		5	5940597530274
		10.5	5940597530236
50	TERUSOL A 1050	4.2	5940597530052	140.00	3.00	1.50	0.50	112.0	3.00	5.5 mmol/L (1 g/L)	32.00
		5	5940597530076
		10.5	5940597530229

Instructions for Use (IFU) — TERUSOL ACIDIC Hemodialysis Concentrate

Intended Purpose & Clinical Benefits

Intended purpose: Dialysate preparation. The electrolyte concentrations in solution are restoring plasma levels to clinically desired concentrations or maintain plasma levels at the desired concentration. It is used by diluting with Basic hemodialysis concentrates in a proper haemodialysis solution (dialysate) that obtained from applicable dilution provides to be removed the toxics and waste materials in the blood and to be replaced deficient electrolytes through semi-permanent membrane in haemodialysis instrument not directly contacting with blood.

Acidic hemodialysis concentrate TERUSOL is used in extracorporeal dialysis with sodium bicarbonate. Acidic concentrate for hemodialysis is the major component of the system designed for hemodialysis. Only used in combination with purified hemodialysis water and Basic hemodialysis concentrate to prevent inflammation during treatment.

Clinical benefits: The Hemodialysis concentrate solution is prepared according to the individual patient's needs and greatly helps to regulate the electrolyte and acid-base balance to remove all the metabolic wastes.

Intended Patients

Age: 1 day* – to geriatrics
Gender: not relevant
Weight: not relevant
Nationality: Not relevant
Patient state: Not relevant

* Hemodialysis is rarely used in neonates and infants due to the risk of major complications in the very young. Nevertheless, there are clinical situations where hemodialysis is needed and may be helpful in small children.

Indications

Acute renal failure

Severe fluid overload
Refractory hypertension
Uncontrollable hyperkalemia
Nausea, vomiting, poor appetite, gastritis with hemorrhage
Lethargy, malaise, somnolence, stupor, coma, delirium, asterixis, tremor, seizures
Pericarditis (risk of hemorrhage or tamponade)
Bleeding diathesis (epistaxis, gastrointestinal (GI) bleeding and etc.)
Severe metabolic acidosis
Blood urea nitrogen (BUN) > 70–100 mg/dl

Chronic renal failure (CRF)

Pericarditis
Fluid overload or pulmonary edema refractory to diuretics
Accelerated hypertension poorly responsive to antihypertensives
Progressive uremic encephalopathy or neuropathy such as confusion, asterixis, myoclonus, wrist or foot drop, seizures
Bleeding diathesis attributable to uremia

End-stage renal disease (ESRD)

A simple mnemonic is used to remember the indications for dialysis: A-E-I-O-U:

Acid-base problems
Electrolyte problems
Intoxications
Overload (fluid)
Uremic symptoms

Contraindications

There are no absolute contraindications for bicarbonate dialysis.

Relative contraindications

Hyperkalemia, hypocalcemia
Refractory coagulopathy.

Instructions & Precautions for Use

Instructions for use: Acidic concentrate is only used for hemodialysis/hemofiltration treatment. Do not use as an infusion solution! To be used only in combination with basic concentrate and Ph.Eur purified water. Shake well before use.

Precautions for use:

Failure to follow these Instructions for Use may cause patient injury or death.
The acidic concentrate for hemodialysis TERUSOL will only be used under medical supervision.
TERUSOL acidic hemodialysis concentrate should only be used with basic hemodialysis concentrate and should be diluted with purified hemodialysis water shortly before use. (11+34: 1 L Acid concentrate + 1,225 L basic concentrate + 32,775 L purified water for hemodialysis).
This dilution process is applied according to the setting conditions of the hemodialysis machine, including the on-line procedures, for the on-line filtration and the treatment requirements of the patients.
Precautions must be taken during dilution to prevent microbiological contamination.
Before dialysis treatment, check the conductivity of the final solution. Using dialysis solution with incorrect conductivity or pH can cause serious injury or death. Consult the hemodialysis machine manufacturer's instructions to determine the conductivity and pH of the final solution.
Concentrate from opened canisters must be used within 24 hours.

Storage: Protected from moisture and sunlight, in a vertical position. Temperature: between 4-30°C.

Warnings

The use of product is restricted only to practitioners (doctors, dialysis technicians/nurses).
Do not use the product if the packaging is damaged! Do not use concentrate from open containers!
Do not use the product after the expiration date!
The lid of the TERUSOL acidic hemodialysis concentrate container is red, so as not to be confused with other concentrate.
Replace a leaking canister immediately. Spills can cause slips and falls; clean up spills immediately.
Please ensure that your hemodialysis machine is equipped with an endotoxin retention filter (ETRF) to remove bacteria and endotoxins from the dialysis fluid, creating an ultrapure dialysate, essential for patient safety.

Undesirable side-effects

Hypotension, nausea, vomiting or cramps may occur, so the hemodialysis procedure must be performed under medical supervision. For any adverse effects, consult your physician.