Concentrated Bicarbonate Solution - BASIC Component

Presentation PE-HD Canister (4–10.5 L)

Packaging White/Translucent, Blue Cap

Certifications CE NB 2292, ISO 13485

Product Range & Composition

ID	Name	Qty(L)	UDI-DI	Na⁺ (mmol/L)	HCO₃^- (mmol/L)	NaHCO₃^- (mmol/L)	Cl^- (mmol/L)	NaCl (mmol/L)
1	TERUSOL B-35	5	5940597530007	35.00	35.00	84.25	-	-
1	TERUSOL B-35	10	5940541537373	35.00	35.00	84.25	-	-
2	TERUSOL B-39	10	5940541537366	65.00	39.00	66 g/l	26.00	30.6 g/l

Instructions for Use (IFU) — TERUSOL BASIC Hemodialysis Concentrate

Intended Purpose & Clinical Benefits

Intended purpose: Dialysate preparation. It is used by diluting with acidic 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.

Basic hemodialysis concentrate TERUSOL is used in extracorporeal dialysis with sodium bicarbonate. Basic hemodialysis concentrate is the major component of the system designed for hemodialysis. Only used in combination with purified water for hemodialysis and acidic concentrate for hemodialysis 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: The basic concentrate is only used for hemodialysis/hemofiltration treatment. Do not use as an infusion solution! To be used only in combination with acid 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 basic concentrate for hemodialysis TERUSOL will be used only under medical supervision.
TERUSOL basic hemodialysis concentrate should only be used with acidic hemodialysis concentrate and should be diluted with purified hemodialysis water shortly before use.
1+34: 1.225 L. Basic concentrate + 1 L. Acidic concentrate + 32.775 L. purified water for hemodialysis
1+44: 1.575 L. Basic concentrate + 1 L. Acidic concentrate + 42.425 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: 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 basic hemodialysis concentrate container is blue, so as not to be confused with other concentrates.
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.