Accusol with potassium: detailed information

Package leaflet: Information for the user

ACCUSOL WITH POTASSIUM

35 Solution for hemofiltration, hemodialysis and hemodiafiltration 2 mmol/L of potassium
Please read this leaflet carefully before you are given this medicine, because it
contains important information for you:

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor.
If you experience any adverse reaction, tell your doctor. This includes any possible adverse reaction not listed in this leaflet. See section 4.

Contents of this package leaflet:

What ACCUSOL WITH POTASSIUM, 35, 2 mmol/L of potassium is and what it is used for
What you need to know before you are given ACCUSOL WITH POTASSIUM, 35, 2 mmol/L of potassium
How you will be given ACCUSOL WITH POTASSIUM, 35, 2 mmol/L of potassium
Possible side effects
How to store ACCUSOL WITH POTASSIUM, 35, 2 mmol/L of potassium
Contents of the pack and other information

1. WHAT ACCUSOL WITH POTASSIUM, 35.2 mmol/l OF POTASSIUM IS AND WHAT IT IS USED FOR

ACCUSOL WITH POTASSIUM, 35.2 mmol/l of potassium, is a solution for hemofiltration,
hemodialysis, and hemodiafiltration.
ACCUSOL WITH POTASSIUM 35.2 mmol/l of potassium is prescribed in cases of temporary or permanent
renal failure.
It purifies the blood from waste products, corrects blood acidity or alkalinity, and restores electrolyte levels. It may also be
used as a source of electrolytes or water for hydration when administered as a replacement fluid in
hemodiafiltration and hemofiltration.
ACCUSOL WITH POTASSIUM solutions are supplied in a non-PVC dual-chamber bag. The two chambers are
separated by a long seal (inter-chamber seal). Prior to use, the two chambers of the ACCUSOL WITH POTASSIUM
solution must first be mixed by activating the long seal (inter-chamber seal), followed by the short SafetyMoon seal
located near the access port.
ACCUSOL WITH POTASSIUM solutions must be administered only by a physician or under medical supervision.

2. WHAT YOU SHOULD KNOW BEFORE BEING ADMINISTERED ACCUSOL WITH POTASSIUM, 35.2 MMOL/L OF POTASSIUM

Before starting therapy, your doctor will check the patency of your venous and arterial access and will also verify that you do not have a high risk of bleeding.
ACCUSOL WITH POTASSIUM solutions are available in various concentrations of potassium and glucose. Your doctor will closely monitor your blood levels of potassium and glucose to ensure that you receive the most appropriate formulation of ACCUSOL WITH POTASSIUM.

Your doctor will not administer ACCUSOL WITH POTASSIUM, 35.2 mmol/l of potassium if:

you do not have adequate venous and/or arterial access.
you are at excessive risk of bleeding.
you have elevated levels of bicarbonate in the blood.
you have low levels of potassium in the blood, unless you are simultaneously receiving potassium supplementation.
you have a clinical condition that could worsen the current acidity or alkalinity of your blood.
you have renal failure such that waste products cannot be removed from the blood by hemofiltration.

Warnings and precautions
ACCUSOL WITH POTASSIUM, 35.2 mmol/l of potassium must be used only by a physician or under the supervision of a physician experienced in hemofiltration, hemodialysis, or hemodiafiltration techniques.
Your doctor must:

measure the acidity, electrolyte concentrations, and levels of waste products in your blood.
ensure these levels are appropriate and monitor them carefully throughout the duration of treatment.
maintain proper fluid balance in the body.
closely monitor blood glucose concentration, especially if you have diabetes.
regularly measure the level of potassium in your blood.
immediately before administration, check that the contents of the two chambers are mixed by activating the long seal (the seal between the chambers), followed by the short SafetyMoon seal located near the access port. Infusion of an unmixed solution may cause an increase in bicarbonate levels in the blood, which in turn may lead to adverse effects such as nausea, drowsiness, headache, irregular heartbeat, and difficulty breathing.

Other medicines and ACCUSOL WITH POTASSIUM, 35.2 mmol/l of potassium
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
The use of ACCUSOL WITH POTASSIUM, 35.2 mmol/l of potassium may affect and interact with other medicines.

If you have diabetes, your blood glucose concentration will be closely monitored. Your insulin dose may be adjusted accordingly, as this solution contains glucose.
If you are taking vitamin D or medications containing calcium, your blood calcium levels may change.
If you are taking additional sodium bicarbonate, there is an increased risk of disturbances in blood electrolyte and alkali levels (alkalosis).
If you are taking medications for the heart, known as cardiac glycosides, you may require potassium supplementation. Your doctor will monitor you closely during treatment.

Pregnancy and Breastfeeding
Inform your doctor if you are pregnant or breastfeeding. Your doctor will evaluate the benefits versus the risks of using ACCUSOL WITH POTASSIUM, 35.2 mmol/l of potassium.

3. HOW ACCUSOL WITH POTASSIUM, 35.2 MMOL/L OF POTASSIUM WILL BE ADMINISTERED TO YOU

Based on your therapy, your doctor will administer ACCUSOL WITH POTASSIUM, 35.2 mmol/L of
potassium via the lines of the dialysis machine.
The treatment of haemofiltration, haemodialysis or haemodiafiltration you will receive depends on your
clinical diagnosis, physical examination, laboratory results and response to treatment.
Your doctor will determine the correct formulation and amount of ACCUSOL WITH POTASSIUM
solution for your clinical condition.

How much and how often?
Your doctor will decide and adjust the flow rate and volume of the solution to be administered.
The required amount of fluid depends on the mode of use of ACCUSOL WITH POTASSIUM, 35.2
mmol/L of potassium.

If you are an adult or elderly patient and

you are being treated for chronic renal failure with ACCUSOL WITH POTASSIUM, 35.2 mmol/L of potassium as replacement solution, you should receive 7 to 35 mL/kg/hour or a higher dose.
you are being treated for temporary renal failure with ACCUSOL WITH POTASSIUM, 35.2 mmol/L of potassium as replacement solution, you should receive 20 to 35 mL/kg/hour or a higher dose.
you are being treated for chronic or temporary renal failure with ACCUSOL WITH POTASSIUM, 35.2 mmol/L of potassium as dialysis solution, the amount of solution will be determined by the frequency and duration of treatment.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The possible adverse reactions of ACCUSOL WITH POTASSIUM, 35, 2 mmol/l of potassium, which occur very rarely ( less than 1 in 1,000 patients ), may include:

low blood glucose concentration (hypoglycaemia).

You may experience other possible adverse reactions. Not all of these may be caused by the solutions or the treatment. The possible adverse reactions you may experience are:

reduction (hypovolaemia) or increase (hypervolaemia) in body fluid volume,
decrease (hypotension) or increase (hypertension) in blood pressure,
very low blood phosphate concentration (hypophosphataemia),
alteration in blood alkaline level (alkalosis),
nausea,
vomiting,
muscle cramps,
haemorrhage,
infection,
shortness of breath, irregular breathing (caused by air bubbles in the bloodstream),
alteration in levels of various blood salts (e.g. changes in sodium, potassium, calcium levels in the blood),
increased blood coagulation.

Reporting of adverse reactions
If you experience any adverse reaction, inform your doctor. This includes any possible adverse reaction not listed in this leaflet. You may also report adverse reactions directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ACCUSOL WITH POTASSIUM, 35.2 MMOL/L OF POTASSIUM

Do not refrigerate or freeze.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the carton after Exp.. The expiry date refers to the last day of that month.
The doctor will not use ACCUSOL WITH POTASSIUM if the solution is not clear or if the container is damaged.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

Name of the medicinal product
ACCUSOL WITH POTASSIUM, 35 Solution for hemofiltration, hemodialysis and hemodiafiltration 2 mmol/L of potassium
Composition of the solution ACCUSOL WITH POTASSIUM, 35, 2 mmol of potassium is:

Active ingredients	Per 1000 ml of ACCUSOL WITH POTASSIUM, 2 mmol/l K+
Large chamber "A"
Calcium chloride dihydrate	0.343 g
Magnesium chloride hexahydrate	0.136 g
Sodium chloride	7.52 g
Potassium chloride	0.199 g
Glucose monohydrate	1.47 g
Small chamber "B"
Sodium bicarbonate	13.4 g

Mixing 3750 ml of solution "A" with 1250 ml of solution "B" yields the final solution of 5000 ml.

Ion composition of the final solution	Per 1000 ml of ACCUSOL WITH POTASSIUM
Calcium (Ca++)	1.75 mmol
Magnesium (Mg++)	0.5 mmol
Sodium (Na+)	140 mmol
Potassium (K+)	2 mmol
Chloride (Cl-)	111.3 mmol
Anhydrous glucose	5.55 mmol
Bicarbonate (HCO3-)	35 mmol
Theoretical osmolarity	296 mOsm/l

The other components are: Water for injections, hydrochloric acid, sodium hydroxide, and
disodium phosphate dihydrate.
Description of the appearance of ACCUSOL WITH POTASSIUM, 35.2 mmol/l of potassium, and pack contents
ACCUSOL WITH POTASSIUM, 35.2 mmol/l of potassium is supplied in cardboard boxes containing
two non-PVC dual-chamber bags of 5 litres each.
Each bag is individually packed in its outer wrapper.
The solution in the bag is clear and colourless.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Nikkiso Belgium BV
Industriepark 6
3300 Tienen
Belgium
Tel (Belgium): +32 (0)16 781770
Tel (Italy): +39 800 969203
Manufacturers:
Serumwerk Bernburg AG
Hallesche Landstrasse 105b
06406 Bernburg
Germany

The following information is intended exclusively for doctors or healthcare professionals

INFORMATION FOR HEALTHCARE PROFESSIONALS
ACCUSOL WITH POTASSIUM
35 Solution for hemofiltration, hemodialysis and hemodiafiltration 2 mmol/l of potassium.

1. NAME OF THE MEDICINAL PRODUCT

ACCUSOL WITH POTASSIUM
35 Solution for hemofiltration, hemodialysis and hemodiafiltration 2 mmol/l potassium.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Composition	Per 1000 ml of ACCUSOL WITH POTASSIUM
Large chamber “A”
Calcium chloride dihydrate	0.343 g
Magnesium chloride hexahydrate	0.136 g
Sodium chloride	7.52 g
Potassium chloride	0.199 g
Glucose monohydrate	1.47 g
Small chamber “B”
Sodium bicarbonate	13.4 g
Final solution after mixing	Per 1000 ml of ACCUSOL WITH POTASSIUM
Calcium chloride dihydrate	0.257 g
Magnesium chloride hexahydrate	0.102 g
Sodium chloride	6.12 g
Potassium chloride	0.149 g
Anhydrous glucose	1.0 g
Sodium bicarbonate	2.94 g

Equivalent to the following ionic composition:

Ion composition of the final solution	Per 1000 ml of ACCUSOL WITH POTASSIUM
Calcium (Ca++)	1.75 mmol
Magnesium (Mg++)	0.5 mmol
Sodium (Na+)	140 mmol
Potassium (K+)	2 mmol
Chloride (Cl-)	111.3 mmol
Anhydrous glucose	5.55 mmol
Bicarbonate (HCO3-)	35 mmol
Theoretical osmolarity	296 mOsm/l

The final solution volume is 5000 ml and results from mixing 3750 ml of solution "A" with 1250 ml of solution "B".
The pH of the final solution ranges between 7.0 and 7.5.
The number "35" in the name indicates the buffer concentration in the solution (bicarbonate = 35 mmol/l).

3. PHARMACEUTICAL FORM

Solution for hemofiltration, hemodialysis, and hemodiafiltration.
ACCUSOL WITH POTASSIUM is a sterile, non-pyrogenic, clear, and colorless solution.

4. CLINICAL INFORMATION

4.1. THERAPEUTIC INDICATIONS
ACCUSOL WITH POTASSIUM is indicated for the treatment of acute and chronic renal failure,
as replacement fluid in hemofiltration and hemodiafiltration, and as dialysis solution in
hemodialysis and hemodiafiltration.

4.2. DOSAGE AND ADMINISTRATION
Solution for hemofiltration, hemodialysis, and hemodiafiltration.

ACCUSOL WITH POTASSIUM as replacement solution
The volume of replacement solution to be administered to adult patients is determined by the ultrafiltration rate and is established on a case-by-case basis to ensure adequate electrolyte balance in body fluids.

Adults:

Chronic renal failure: 7 to 35 ml/kg/hour
Acute renal failure: 20 to 35 ml/kg/hour
Elderly: as in adults

Recommendations regarding fluid volumes may be adjusted by the physician according to the patient's clinical condition.
According to the physician’s prescription, ACCUSOL WITH POTASSIUM may be infused into the extracorporeal blood circuit in predilution and/or postdilution mode.

ACCUSOL WITH POTASSIUM as dialysis solution
The prescription and amount of solution to be used in dialysis treatment depend on the therapeutic modality, treatment frequency, and duration, and will be determined by the physician according to the patient's clinical condition.

Administration:
Hemodialysis: through the dialysate compartment of the dialyzer.
Hemofiltration: through the arterial or venous blood line.

After removing the overpouch, immediately open the long seal (seal between the chambers) to mix the two solutions, then open the short SafetyMoon seal (seal near the access port) to allow administration of the mixed solution. For instructions on use and handling, refer to section 5.5.

4.3. CONTRAINDICATIONS
Contraindications related to the solution:

Hypokalemia, when controlled potassium supplementation is not concurrently provided.
Metabolic alkalosis.

Contraindications related to technical procedures of hemofiltration/hemodialysis/hemodiafiltration:

Renal failure associated with increased hypercatabolism when uremic symptoms can no longer be relieved by hemofiltration.
Inadequate blood flow through the vascular access.
High risk of bleeding due to systemic anticoagulant therapy.

4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE

ACCUSOL WITH POTASSIUM solution must be administered directly by a physician or under the supervision of a physician experienced in hemofiltration, hemodialysis, or hemodiafiltration techniques.
Rarely, the solution may precipitate several hours after the start of treatment. If precipitate forms, Accusol 35 solution and the circuit must be immediately replaced, with careful monitoring of the patient.
Fluid balance must be closely monitored.
Acid-base balance must be closely monitored.
Similarly, electrolyte balance (chloride, phosphate, calcium, magnesium, and sodium levels) must be monitored at regular intervals to detect any potential imbalance.
Serum potassium levels must be monitored regularly before and during treatment. If hypokalemia is present or impending, potassium supplementation and/or switching to a replacement solution with a higher potassium concentration may be necessary. If hyperkalemia begins to develop, increasing the filtration rate and/or switching to a replacement solution with a lower potassium concentration, in addition to standard intensive care measures, may be indicated.
Blood glucose levels must be closely monitored, especially in diabetic patients.
Alkalosis may occur if the long seal (seal between chambers) is not opened (i.e., only the short SafetyMoon seal near the access port is open) and only the solution from the small chamber “B” is administered. The most common clinical symptoms/signs of alkalosis are nausea, lethargy, headache, arrhythmia, and respiratory depression.

4.5. INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
When prescribing ACCUSOL WITH POTASSIUM, 35, containing 2 mmol/l of potassium, potential interactions between this treatment and other concomitant therapies prescribed for pre-existing conditions should be considered:

The blood concentration of other medicinal products may be altered during hemodialysis, hemofiltration, and hemodiafiltration.
In patients receiving cardiac glycosides, plasma potassium levels should be closely monitored due to an increased risk of arrhythmias associated with hypokalemia.
Vitamin D and medicinal products containing calcium may increase the risk of hypercalcemia (e.g., calcium carbonate acting as a potassium chelator).
Additional sodium bicarbonate supplementation may increase the risk of metabolic alkalosis.

4.6. FERTILITY, PREGNANCY, AND LACTATION
No clinical or preclinical data are available on the use of ACCUSOL WITH POTASSIUM during pregnancy and breastfeeding. ACCUSOL WITH POTASSIUM should be administered to pregnant and breastfeeding women only if clearly necessary.

4.7. EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Not applicable.

4.8. UNDESIRABLE EFFECTS
The reported undesirable effects refer both to adverse events reported during clinical trials and considered by the investigator as related to ACCUSOL WITH POTASSIUM (point 1), and to a review of the literature (point 2).
Frequency has been assessed according to the following criteria: very common (>1/10), common (>1/100, <1/10), uncommon (>1/1,000, <1/100), rare (>1/10,000, <1/1,000), and very rare (<1/10,000).

Clinical trials

S.O.C.	Adverse Events	Frequency	Procedure-related	Solution-related
Metabolism and nutrition	Hypoglycemia NOS	Rare	Yes	Yes

Literature
The adverse effects listed below reflect the type of adverse effects that may be reported
with haemodialysis or haemofiltration solutions:

Potential adverse reactions related to the treatment include nausea, vomiting, muscle cramps, hypotension, bleeding, clot formation, infections and gas embolism.
Potential adverse reactions related to the product include metabolic alkalosis, electrolyte disturbances and/or fluid imbalance: hypophosphataemia, hypoglycaemia, hypo- and hypervolaemia, hypo- and hypertension.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions occurring after marketing authorisation of the medicinal product is important, as it enables continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are required to report any suspected adverse reaction via the national reporting system at the Italian Medicines Agency website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
4.9. OVERDOSAGE
Overdose should not occur if fluid and electrolyte balances are monitored at regular intervals as recommended in section 4.4 "SPECIAL WARNINGS AND PRECAUTIONS FOR USE". An overdose may cause hypervolaemia and electrolyte imbalances. These symptoms can be corrected by adjusting the ultrafiltration rate and the volume of solution administered.
Electrolyte imbalances should be treated according to the specific electrolyte disturbance identified.

5. PHARMACEUTICAL INFORMATION

5.1. INCOMPATIBILITIES
The medicinal product must not be mixed with other medicinal products, except those mentioned in
paragraph 5.5 “Instructions for use and handling”.

5.2. SHELF LIFE
Shelf life
2 years if stored in the outer protective bag.

Shelf life after mixing
ACCUSOL CON POTASSIO, once removed from the outer protective bag and mixed, must be used within 24 hours.

5.3. SPECIAL PRECAUTIONS FOR STORAGE
Do not refrigerate or freeze.

5.4. NATURE AND CONTENTS OF THE CONTAINER
ACCUSOL CON POTASSIO is supplied in a non-polyvinylchloride (PVC) dual-chamber bag made from a co-extruded film composed of polypropylene, polyamide, and a blend of polypropylene, SEBS, and polyethylene (Clear-Flex). A long seal (inter-chamber seal) separates the two chambers.

The larger chamber "A" is equipped with an injection port for adding medicinal products, while the smaller chamber "B" has an access port for connection to a suitable administration device. To allow administration of the mixed solution, a short SafetyMoon seal (located near the access port) must be opened.

The dual-chamber bag is packaged in a transparent outer protective bag made of copolymers.

The container volume after mixing is 5000 ml (3750 ml in the large chamber and 1250 ml in the small chamber).

ACCUSOL CON POTASSIO is available in packs of 2 bags of 5000 ml per box.

5.5. SPECIAL PRECAUTIONS FOR DISPOSAL AND HANDLING

Check the integrity of the product. Do not use the bag if any of the seals are already open. If damaged, the bag must be discarded.
Administer only if the solution is clear.
Use aseptic technique throughout the entire procedure.
Concomitantly administered medicinal products may be added through the injection port located in the large chamber. Before mixing, verify compatibility of the medicinal products. Add the medicinal product and immediately break the long seal (inter-chamber seal). The product must be used immediately after any medicinal product additions.
Once the outer protective bag has been removed, immediately break the long seal (inter-chamber seal) to mix the two solutions. Ensure that the long seal (inter-chamber seal) is completely opened and that the two solutions are fully mixed. Then open the short SafetyMoon seal (located near the access port) to allow administration of the mixed solution. Connect the bag to the patient’s administration line and activate the access port. The solution must be used within 24 hours of mixing.
Discard any unused portion of the solution.
For single use only. ACCUSOL CON POTASSIO must be used only with appropriate equipment capable of monitoring the therapy.

6. MARKETING AUTHORISATION HOLDER

Nikkiso Belgium BV
Industriepark 6, 3300 Tienen, Belgium
Tel (Belgium): +32 (0)16 781770
Tel (Italy): +39 800 969203

7. MARKETING AUTHORIZATION NUMBERS

AIC No. 037201035 "35 solution for hemofiltration, hemodialysis and hemodiafiltration 2 mmol/l potassium" 2 double-chamber bags with double seal, 5000 ml each

Package leaflet: Information for the user

ACCUSOL WITH POTASSIUM

35 Solution for haemofiltration, haemodialysis and haemodiafiltration 4 mmol/L potassium
Please read this leaflet carefully before this medicine is administered to you, because
it contains important information for you:

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor.
If you experience any adverse reaction, inform your doctor. This includes any possible adverse reaction not listed in this leaflet. See section 4.

Contents of this package leaflet:

What ACCUSOL WITH POTASSIUM, 35, 4 mmol/L potassium is and what it is used for
What you need to know before being administered ACCUSOL WITH POTASSIUM, 35, 4 mmol/L potassium
How ACCUSOL WITH POTASSIUM, 35, 4 mmol/L potassium will be administered to you
Possible side effects
How to store ACCUSOL WITH POTASSIUM, 35, 4 mmol/L potassium
Contents of the pack and other information

1. WHAT ACCUSOL WITH POTASSIUM, 35.4 mmol/l OF POTASSIUM IS AND WHAT IT IS USED FOR

ACCUSOL WITH POTASSIUM, 35.4 mmol/l of potassium is a solution for hemofiltration,
hemodialysis, and hemodiafiltration.
ACCUSOL WITH POTASSIUM, 35.4 mmol/l of potassium is prescribed in cases of temporary or permanent
renal failure.
It purifies the blood from waste products, corrects blood acidity or alkalinity, and balances electrolyte levels. It may also be
used as a source of salts or water for hydration when administered as a replacement fluid in hemodiafiltration and hemofiltration.
ACCUSOL WITH POTASSIUM solutions are supplied in a non-PVC dual-chamber bag. The two chambers are separated by a long seal (inter-chamber seal). Before use, the two chambers of ACCUSOL WITH POTASSIUM solutions must be mixed by first activating the long seal (inter-chamber seal), followed by the short SafetyMoon seal located near the access port.
ACCUSOL WITH POTASSIUM, 35.4 mmol/l of potassium is particularly indicated for patients with low
potassium levels.
ACCUSOL WITH POTASSIUM solutions must be administered only by a physician or under medical supervision.

2. WHAT YOU SHOULD KNOW BEFORE BEING ADMINISTERED ACCUSOL WITH

POTASSIUM, 35.4 MMOL/L OF POTASSIUM
Before starting treatment, your doctor will check the adequacy of your venous and arterial access, and will also verify that you do not have a high risk of bleeding.
ACCUSOL WITH POTASSIUM solutions are available in various concentrations of potassium and glucose. Your doctor will closely monitor your blood levels of potassium and glucose to ensure that you receive the most appropriate formulation of ACCUSOL WITH POTASSIUM.
Your doctor will not administer ACCUSOL WITH POTASSIUM, 35.4 mmol/l of potassium to you:

if you do not have adequate venous and/or arterial access.
if you have an excessive risk of bleeding.
if you have high levels of bicarbonate in the blood.
if you have abnormally high levels of potassium in the blood.
if you have a clinical condition that could worsen the current acidity or alkalinity of your blood.
if you have renal failure such that waste products cannot be removed from the blood by hemofiltration.

Warnings and precautions
ACCUSOL WITH POTASSIUM, 35.4 mmol/l of potassium must be used only by a physician or under the supervision of a physician experienced in hemofiltration, hemodialysis, or hemodiafiltration techniques.
Your doctor must:

measure the acidity, electrolyte concentrations, and levels of waste products in your blood.
ensure these levels are appropriate and monitor them carefully throughout treatment.
check that fluid balance in the body is maintained.
monitor blood glucose concentration very closely, especially if you have diabetes.
regularly measure blood potassium levels.
immediately before administration, ensure the contents of the two chambers are mixed by activating the long seal (the seal between the chambers), followed by the short SafetyMoon seal located near the access port. Infusion of an unmixed solution may cause an increase in bicarbonate levels in the blood, which in turn may lead to adverse effects such as nausea, drowsiness, headache, irregular heartbeat, and difficulty breathing.

Other medicines and ACCUSOL WITH POTASSIUM, 35.4 mmol/l of potassium
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
The use of ACCUSOL WITH POTASSIUM, 35.4 mmol/l of potassium may affect and interact with other medicines.

If you are diabetic, your blood glucose concentration will be closely monitored. Your insulin dose will be adjusted accordingly, as this solution contains glucose.
If you are taking vitamin D or medicines containing calcium, your blood calcium levels may change.
If you are taking additional sodium bicarbonate, there is an increased risk of disturbances in blood salt and alkali levels (alkalosis).
If you are taking heart medications known as cardiac glycosides, you may require potassium supplementation. Your doctor will monitor you closely during treatment.

Pregnancy and Breast-feeding
Inform your doctor if you are pregnant or breast-feeding. Your doctor will evaluate the benefits versus the risks of using ACCUSOL WITH POTASSIUM, 35.4 mmol/l of potassium.

3. HOW ACCUSOL WITH POTASSIUM, 35.4 MMOL/L OF

POTASSIUM WILL BE ADMINISTERED TO YOU
Based on your therapy, your doctor will administer ACCUSOL WITH POTASSIUM, 35.4 mmol/l of
potassium through the lines of the dialysis machine.
The hemofiltration, hemodialysis, or hemodiafiltration treatment you will receive depends on your
clinical diagnosis, physical examination, laboratory results, and response to treatment.
Your doctor will determine the appropriate formulation and amount of Accusol and ACCUSOL
WITH POTASSIUM solutions according to your clinical condition.

you have been treated for chronic renal failure with ACCUSOL WITH POTASSIUM, 35.4 mmol/l of potassium as replacement solution, you should receive 7 to 35 ml/kg/hour or a higher dose.
you have been treated for temporary renal failure with ACCUSOL WITH POTASSIUM, 35.4 mmol/l of potassium as replacement solution, you should receive 20 to 35 ml/kg/hour or a higher dose.
you have been treated for chronic or temporary renal failure with ACCUSOL WITH POTASSIUM, 35.4 mmol/l of potassium as dialysis solution, the amount of solution will be determined by the frequency and duration of treatment.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

The possible adverse reactions of ACCUSOL WITH POTASSIUM, 35, 4 mmol/l of potassium, which occur very rarely ( less than 1 in 1,000 patients ), may include:

low blood glucose levels (hypoglycaemia).

You may experience other possible adverse reactions. These may not all be caused by the solutions or the treatment. The possible adverse reactions you may experience include:

reduction (hypovolaemia) or increase (hypervolaemia) in body fluid volume,
decrease (hypotension) or increase (hypertension) in blood pressure,
very low blood phosphate levels (hypophosphataemia),
alteration in the alkaline level of the blood (alkalosis),
nausea,
vomiting,
muscle cramps,
haemorrhage,
infection,
shortness of breath, irregular breathing (caused by air bubbles in the bloodstream),
changes in levels of various electrolytes in the blood (e.g. changes in levels of sodium, potassium, calcium in the blood),
increased blood coagulation.
Reporting of adverse reactions
If you experience any adverse reaction, inform your doctor. This includes any possible adverse reaction not listed in this leaflet. You may also report adverse reactions directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ACCUSOL WITH POTASSIUM, 35.4 MMOL/L OF POTASSIUM

Do not refrigerate or freeze.
Keep this medicinal product out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the label and carton following "Exp.". The expiry date refers to the last day of that month.
The doctor will not use ACCUSOL WITH POTASSIUM if the solution is not clear or if the container is damaged.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

Name of the medicinal product
ACCUSOL WITH POTASSIUM, 35 Solution for hemofiltration, hemodialysis and hemodiafiltration 4 mmol/l of potassium
The composition of the solution ACCUSOL WITH POTASSIUM, 35, 4 mmol/l of potassium is:

Active ingredients	Per 1000 ml of ACCUSOL WITH POTASSIUM, 4 mmol/L K+
Large chamber “A”
Calcium chloride dihydrate	0.343 g
Magnesium chloride hexahydrate	0.136 g
Sodium chloride	7.52 g
Potassium chloride	0.398 g
Glucose monohydrate	1.47 g
Small chamber “B”
Sodium bicarbonate	13.4 g

Mixing 3750 ml of solution "A" with 1250 ml of solution "B" yields the final solution of 5000 ml.

Ion composition of the final solution	Per 1000 ml of ACCUSOL WITH POTASSIUM
Calcium (Ca++)	1.75 mmol
Magnesium (Mg++)	0.5 mmol
Sodium (Na+)	140 mmol
Potassium (K+)	4 mmol
Chloride (Cl-)	113.3 mmol
Anhydrous glucose	5.55 mmol
Bicarbonate (HCO3-)	35 mmol
Theoretical osmolarity	300 mOsm/l

The other components are: water for injections, hydrochloric acid, sodium hydroxide and disodium phosphate
dihydrate.
Description of the appearance of ACCUSOL WITH POTASSIUM, 35.4 mmol of potassium and contents
of the packaging
ACCUSOL WITH POTASSIUM, 35.4 mmol of potassium is supplied in cardboard boxes containing
two non-PVC dual-chamber bags of 5 litres each.
Each bag is individually packaged in its outer wrapper.
The solution in the bag is clear and colourless.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Nikkiso Belgium BV
Industriepark 6
3300 Tienen
Belgium
Tel (Belgium): +32 (0)16 781770
Tel (Italy): +39 800 969203
Manufacturers:
Serumwerk Bernburg AG
Hallesche Landstrasse 105b
06406 Bernburg
Germany

The following information is intended exclusively for doctors or healthcare professionals

INFORMATION FOR HEALTHCARE PROFESSIONALS
ACCUSOL WITH POTASSIUM
35 Solution for hemofiltration, hemodialysis and hemodiafiltration 4 mmol/l of potassium.

1. NAME OF THE MEDICINAL PRODUCT

ACCUSOL WITH POTASSIUM
35 Solution for hemofiltration, hemodialysis and hemodiafiltration 4 mmol/l of potassium.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Composition	Per 1000 ml of ACCUSOL WITH POTASSIUM
Large chamber “A”
Calcium chloride dihydrate	0.343 g
Magnesium chloride hexahydrate	0.136 g
Sodium chloride	7.52 g
Potassium chloride	0.398 g
Glucose monohydrate	1.47 g
Small chamber “B”
Sodium bicarbonate	13.4 g
Final solution after mixing	Per 1000 ml of ACCUSOL WITH POTASSIUM
Calcium chloride dihydrate	0.257 g
Magnesium chloride hexahydrate	0.102 g
Sodium chloride	6.12 g
Potassium chloride	0.298 g
Anhydrous glucose	1.0 g
Sodium bicarbonate	2.94 g

Equivalent to the following ionic composition:

Ion composition of the final solution	Per 1000 ml of ACCUSOL WITH POTASSIUM
Calcium (Ca++)	1.75 mmol
Magnesium (Mg++)	0.5 mmol
Sodium (Na+)	140 mmol
Potassium (K+)	4 mmol
Chloride (Cl-)	113.3 mmol
Anhydrous glucose	5.55 mmol
Bicarbonate (HCO3-)	35 mmol
Theoretical osmolarity	300 mOsm/l

The final solution volume is 5000 ml and results from mixing 3750 ml of solution "A" with 1250 ml of solution "B".
The pH of the final solution ranges between 7.0 and 7.5.
The number "35" contained in the name indicates the buffer concentration in the solution (bicarbonate = 35 mmol/l).

3. PHARMACEUTICAL FORM

Solution for hemofiltration, hemodialysis, and hemodiafiltration.
ACCUSOL WITH POTASSIUM is a sterile, non-pyrogenic, clear, and colorless solution.

4. CLINICAL INFORMATION

4.1. THERAPEUTIC INDICATIONS
ACCUSOL WITH POTASSIUM is indicated for the treatment of acute and chronic renal failure,
as replacement solution in hemofiltration and hemodiafiltration, and as dialysis solution
in hemodialysis and hemodiafiltration.
ACCUSOL WITH POTASSIUM, 35.4 mmol/L of potassium, is primarily indicated in patients with
hypokalemia and normokalemia.

4.2. DOSAGE AND ADMINISTRATION
Solution for hemofiltration, hemodialysis, and hemodiafiltration.

ACCUSOL WITH POTASSIUM as replacement solution
The amount of replacement solution to be administered to adult patients is determined by the ultrafiltration rate and is established on an individual basis to ensure adequate electrolyte balance in body fluids.

Adults:

Chronic renal failure: 7 to 35 mL/kg/hour.
Acute renal failure: 20 to 35 mL/kg/hour.
Elderly: as for adults.

The physician may adjust fluid volume recommendations according to the patient's clinical condition.
Depending on the physician's prescription, ACCUSOL WITH POTASSIUM may be infused into the extracorporeal blood circuit in predilution and/or postdilution mode.

ACCUSOL WITH POTASSIUM as dialysis solution
The prescription and amount of solution to be used in dialysis treatment depend on the therapeutic modality, treatment frequency and duration, and will be determined by the treating physician according to the patient's clinical condition.

Administration:
Hemodialysis: through the dialysate compartment of the dialyzer.
Hemofiltration: through the arterial or venous blood line.

After removing the outer pouch, immediately open the long seal (seal between the chambers) to mix the two solutions, then open the short SafetyMoon seal (seal near the access port) to allow administration of the mixed solution.
For instructions on use and handling, see section 5.5.

4.3. CONTRAINDICATIONS
Contraindications related to the solution:

Hyperkalemia.
Metabolic alkalosis.

Contraindications related to hemofiltration/hemodialysis/hemodiafiltration procedures:

Renal failure associated with increased hypercatabolism when uremic symptoms can no longer be relieved by hemofiltration.
Inadequate blood flow through the vascular access.
High risk of bleeding due to systemic anticoagulant treatment.

4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE

ACCUSOL WITH POTASSIUM solution must be administered directly by a physician or under the supervision of a physician experienced in hemofiltration, hemodialysis, or hemodiafiltration techniques.
Rarely, the solution may precipitate several hours after the start of treatment. If a precipitate forms, the Accusol 35 solution and the circuit must be immediately replaced, and the patient must be closely monitored.
Fluid balance must be carefully monitored.
Acid-base balance must be carefully monitored.
Similarly, electrolyte balance (chloride, phosphate, calcium, magnesium, and sodium levels) must be monitored at regular intervals to detect any potential imbalance.
Serum potassium levels must be monitored regularly before and during treatment. If hypokalemia is present or imminent, potassium supplementation may be necessary. If hyperkalemia begins to develop, it may be advisable to increase the filtration rate and/or switch to a replacement solution with a lower potassium concentration, in addition to standard intensive therapy measures.
Blood glucose levels must be closely monitored, particularly in diabetic patients.
Alkalosis may occur if the long seal (seal between chambers) is not opened (i.e., only the short SafetyMoon seal near the access port is open) and only the solution from the small chamber “B” is administered. The most common clinical symptoms/signs of alkalosis are nausea, lethargy, headache, arrhythmia, and respiratory depression.

4.5. INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
When prescribing ACCUSOL WITH POTASSIUM, 35.4 mmol/L of potassium, potential interactions between this treatment and other concomitant therapies prescribed for pre-existing conditions must be considered.

The blood concentration of other medicinal products may be altered during hemodialysis, hemofiltration, and hemodiafiltration.
In patients receiving cardiac glycosides, serum potassium levels must be closely monitored due to an increased risk of arrhythmias associated with hypokalemia.
Vitamin D and medicinal products containing calcium may increase the risk of hypercalcemia (e.g., calcium carbonate acting as a potassium chelator).
Additional sodium bicarbonate replacement may increase the risk of metabolic alkalosis.

4.6. FERTILITY, PREGNANCY AND LACTATION
No clinical or preclinical data are available on the use of ACCUSOL WITH POTASSIUM during pregnancy and lactation. ACCUSOL WITH POTASSIUM should be administered to pregnant and lactating women only if clearly necessary.

4.7. EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Not applicable.

4.8. UNDESIRABLE EFFECTS
The reported undesirable effects refer both to adverse events reported during clinical trials and considered by the investigator as related to ACCUSOL WITH POTASSIUM (point 1), and to a review of the literature (point 2).
Frequency has been assessed according to the following criteria: very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10,000, <1/1000), and very rare (<1/10,000).

Clinical trials

S.O.C.	Adverse Events	Frequency	Procedure-related	Solution-related
Metabolism and nutrition disorders	Hypoglycemia NOS	Rare	Yes	Yes

Literature
The adverse effects listed below reflect the type of adverse effects that may be reported with dialysis or haemofiltration solutions:

Potential adverse reactions related to the treatment include nausea, vomiting, muscle cramps, hypotension, haemorrhage, clot formation, infections and gas embolism.
Potential adverse reactions related to the product include metabolic alkalosis, electrolyte disturbances and/or fluid imbalances: hypophosphataemia, hypoglycaemia, hypo- and hypervolaemia, hypo- and hypertension.

Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after marketing authorisation is important, as it enables continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are required to report any suspected adverse reactions via the national reporting system at the following website: Italian Medicines Agency:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
4.9. OVERDOSAGE
Overdosage should not occur if fluid and electrolyte balances are monitored at regular intervals as recommended in section 4.4 “SPECIAL WARNINGS AND PRECAUTIONS FOR USE”. Overdosage may cause hypervolaemia and electrolyte imbalances. These symptoms can be corrected by adjusting the ultrafiltration rate and the volume of solution administered.
Electrolyte imbalances must be treated according to the specific electrolyte disturbance identified.

5. PHARMACEUTICAL INFORMATION

5.1. INCOMPATIBILITIES
The medicinal product must not be mixed with other medicinal products except those mentioned in section 5.5 “Instructions for use and handling”.

5.2. SHELF LIFE
Shelf life
2 years if stored in the outer protective pouch.

Shelf life after mixing
ACCUSOL WITH POTASSIUM, once removed from the outer protective pouch and mixed, must be used within 24 hours.

5.3. SPECIAL PRECAUTIONS FOR STORAGE
Do not refrigerate or freeze.

5.4. NATURE AND CONTENTS OF CONTAINER
ACCUSOL WITH POTASSIUM is packaged in a non-polyvinylchloride (PVC) dual-chamber bag made from a co-extruded film composed of polypropylene, polyamide, and a blend of polypropylene, SEBS, and polyethylene (Clear-Flex). The two chambers are separated by a long seal (inter-chamber seal).

The dual-chamber bag is enclosed in a transparent outer protective pouch made of copolymers.

The container volume after mixing is 5000 ml (3750 ml in the large chamber and 1250 ml in the small chamber).
ACCUSOL WITH POTASSIUM is available in packs of 2 bags of 5000 ml per box.

5.5. SPECIAL PRECAUTIONS FOR DISPOSAL AND HANDLING

Check the product's integrity. Do not use the bag if any of the seals are already open. If damaged, the bag must be discarded.
Administer only if the solution is clear.
Use aseptic technique throughout the entire procedure.
Concomitantly administered medicinal products may be added through the injection port located in the large chamber. Before mixing, check compatibility of the medicinal products. Add the medicinal product and immediately break the long seal (inter-chamber seal). The product must be used immediately after any addition of medicinal products.
Once the outer protective pouch has been removed, immediately break the long seal (inter-chamber seal) to mix the two solutions. Ensure that the long seal (inter-chamber seal) is completely opened and that the two solutions are fully mixed. Then open the short SafetyMoon seal (located near the access port) to allow administration of the mixed solution. Connect the bag to the patient’s administration line and activate the access port. The solution must be used within 24 hours after mixing.
Discard any unused portion of the solution.
For single use only. ACCUSOL WITH POTASSIUM must only be used with appropriate equipment capable of monitoring the therapy.

6. MARKETING AUTHORISATION HOLDER

Nikkiso Belgium BV
Industriepark 6, 3300 Tienen, Belgium
Tel (Belgium): +32 (0)16 781770
Tel (Italy): +39 800 969203

7. MARKETING AUTHORIZATION NUMBERS

AIC No. 037201047 "35 solution for hemofiltration, hemodialysis and hemodiafiltration 4 mmol/l of
potassium" 2 dual-chamber bags with double seal, 5000 ml