Label: information for the user

Prismasol 2 mmol/lPotassium solution for hemodialysis and hemofiltration.

Calcium chloride dihydrate / Magnesium chloride hexahydrate / Glucose monohydrate / Lactic acid solution 90% / Sodium chloride / Potassium chloride / Sodium hydrogen carbonate

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

1.What is Prismasol and how it is used.

2.What you need to know before starting to use Prismasol.

3.How to use Prismasol

4.Possible adverse effects

5.Storage of Prismasol

6.Contents of the package and additional information

Primasol contains the following active principles: calcium chloride, dihydrate; magnesium chloride, hexahydrate; glucose monohydrate, 90% lactic acid solution; sodium chloride; potassium chloride and sodium hydrogen carbonate.

Prismasolis used in the treatment of renal insufficiency as a solution for continuous hemofiltration or hemodiafiltration (as a substitute for the loss of fluid produced by the passage of blood through the filter) and continuous hemodialysis or hemodiafiltration (blood passes through one side of the dialysis membrane while the dialysis solution passes through the other side of the same membrane).

Prismasolmay also be used in cases of intoxication with dialyzable or filterable substances.

Prismasol 2 mmol/l potassium is especially indicated in patients with a tendency to hyperkalemia (high potassium level in the blood)

Do not use Prismasol 2 mmol/l potassium in the following cases:

• allergy to any of the active principles or to any of the other components (listed in section 6),
• low blood potassium level (hypokalemia),
• high blood bicarbonate concentration (metabolic alkalosis).

It cannot be ruled out that there is a maize antigen derivative in Prismasol.

Do not use hemofiltration or dialysis treatment in the following cases:

• renal insufficiency with pronounced hypercatabolism (abnormally increased catabolism), if uremic symptoms (symptoms caused by high urea concentration in blood) cannot be corrected with hemofiltration.
• insufficient blood pressure in the vascular access.
• systemic anticoagulation (reduced blood coagulation) if there is a high risk of hemorrhage (bleeding)

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to use Prismasol

The solution can only be used by or under the supervision of a competent doctor in renal insufficiency treatments using hemofiltration, hemodiafiltration and continuous hemodialysis techniques.

Before and during treatment, your blood state will be monitored, for example, the acid-base balance and electrolyte concentrations (salts in the blood) will be followed, as well as all liquids administered (intravenous perfusion) and produced (diuresis), even those not directly related to the treatment.

Your blood glucose concentration should be closely monitored, especially if you are diabetic.

Other medications and Prismasol

Inform your doctor or pharmacist if you are taking, have taken recently or may have taken other medications

The blood concentration of some of the other medications may be reduced during treatment. Your doctor will decide if your medication should be changed.

In particular, inform your doctor in the following cases:

•digitalis medications (for the treatment of some heart insufficiencies) since the risk of arrhythmias (irregular or rapid heartbeats) induced by these medications increases during hypokalemia (low potassium concentration in the blood).

•vitamin D and medications containing calcium, since they may increase the risk of hypercalcemia (elevated calcium concentration in the blood).

•any bicarbonate of sodium supplement (or other tamponed source), since it may increase the risk of metabolic alkalosis (excess bicarbonate in the blood).

•when citrate is used as an anticoagulant (as a protector in dialysis equipment), it may reduce plasma calcium levels.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

If you are pregnant or breastfeeding, your doctor will decide if you should be given Prismasol.

Driving and operating machines

There is no information that Prismasol affects the ability to drive or operate machines.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The volume of Prismasol to be administered will depend on your clinical conditions and the desired fluid balance. Therefore, the volume of the dose will depend on your doctor's judgment.

Administration route: intravenous and hemodialysis.

If you think you are using more Prismasol than you should:

Your fluid, acid-base, and electrolyte balance must be carefully controlled.

In the unlikely event of an overdose, your doctor will take the necessary corrective measures to adjust the dose.

An overdose may cause:

• fluid overload in the blood,
• increase in blood bicarbonate levels (metabolic alkalosis),
• and/or reduction in blood electrolyte levels (hypophosphatemia, hypokalemia)

An overdose could lead to severe consequences such as congestive heart failure, electrolyte imbalance, or acid-base imbalance.

For use instructions, see the section “This information is intended solely for healthcare professionals”.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

The following adverse effects have been reported:

Unknown: the frequency cannot be estimated from the available data

• Changes in blood electrolyte levels (electrolyte imbalances such as hypophosphatemia or hypokalemia)
• Elevated or reduced plasma bicarbonate concentration (metabolic alkalosis or acidosis)
• Abnormally high or low body water volume (hyper or hypovolemia)
• Abnormally high blood glucose concentration (hyperglycemia)

• Nausea
• Vomiting
• Muscle cramps
• Hypotension (low blood pressure)

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is an adverse effect not listed in this prospectus.

You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not store at a temperature below + 4º C.

Do not use this medication after the expiration date indicated on the label and packaging after CAD. The expiration date is the last day of the month indicated.

The chemical and physical stability of the reconstituted solution has been demonstrated for 24 hours at a temperature of +22°C. If the solution is not used immediately, the storage time in use and the conditions before use are the responsibility of the user and should not exceed 24 hours including the duration of treatment.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of PRISMASOL

Active principles are:

Before reconstitution:

1000 ml of Electrolyte Solution (Small Compartment A) contains:

Calcium chloride dihydrate 5,145 g

Magnesium chloride hexahydrate 2,033 g

Glucose 22,000 g

(S)-Lactic acid 5,400 g

1000 ml. of Buffer Solution (Large Compartment B) contains:

Sodium chloride 6,450 g

Sodium hydrogen carbonate 3,090 g

Potassium chloride 0,157 g

After reconstitution:

The solution from Compartment A (250 ml) and Compartment B (4750 ml) is mixed to produce a reconstituted solution (5000 ml) with the following composition:

Other components are:carbon dioxide (E-290), water for injection.

pH of the reconstituted solution: 7.0 – 8.5

Product appearance and packaging content

Prismasol is presented in a bicompartimental bag, containing the small Compartment A the electrolyte solution and the large Compartment B the buffer solution. The final reconstituted solution is obtained after breaking the breakable vial and mixing both solutions. The reconstituted solution is transparent and slightly yellow. Each bag (A+B) contains 5000 ml of solution for hemodialysis and hemofiltration. The bag is covered with a transparent overbag.

Each box contains two bags and a leaflet.

Marketing authorization holder:

Vantive Belgium SRL

Boulevard d´Angleterre 2

1420 Braine-l´Alleud

Belgium

Manufacturer:

Bieffe Medital S.p.A.

Via Stelvio 94

23035 Sondalo (SO)

Italy

Ó

Vantive Manufacturing Limited

Moneen Road,

Castlebar

County Mayo

F23 XR63

Ireland

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Germany, Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Slovakia, Slovenia, Estonia, Spain, Finland, France, Greece, Netherlands, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Sweden, United Kingdom (Northern Ireland): Prismasol 2

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Vantive Health, S.L.

Industrial sector 14

C/ Pouet de Camilo nº2

46394 Ribarroja del Turia

Valencia

Spain

Last revision date of this leaflet: 03/2018

The detailed and updated information about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es

--------------------------------------------------------------------------------------------------------------------

This information is intended solely for healthcare professionals

Prismasol 2 mmol/lPotassium solution for hemodialysis and hemofiltration

Precautions

Follow exactly the instructions for use and handling of Prismasol.

The solutions from the two compartmentsmust be mixed before use.

The use of contaminated hemofiltration and hemodialysis solutions may cause sepsis, shockand conditions that can cause death.

Prismasol may be warmed to 37°C to improve patient well-being.The warming of the solution before use must be performed before reconstitution only with dry heat. Solutions must not be warmed in water or in the microwave. The solution must be visually inspected before administration to detect the presence of particles and a possible color change, when the solution and the packaging allow it. Do not administer if the solution is not transparent or if the seal is not intact.

Prismasol is a solution that contains potassium. Before and during hemofiltration and hemodialysis, the blood potassium concentration must be monitored. Depending on the potassium concentration in the blood before treatment, hypokalemia or hyperkalemia may develop.

If hypokalemia occurs, potassium supplementation and/or administration of a dialysate with a higher potassium concentration may be necessary.

If hyperkalemia develops once treatment has started, the addition of potassium sources that affect the concentrations must be evaluated. When the solution is used as a substitution solution, the perfusion rate must be reduced and it must be confirmed that the desired potassium concentration has been reached. If hyperkalemia is not resolved, perfusion must be stopped immediately.

If hyperkalemia develops when the solution is used as a dialysate, administration of a dialysate without potassium may be necessary to increase potassium elimination.

The inorganic phosphate concentration must be measured regularly. In the case of low inorganic phosphate levels in the blood, they must be restored.A concentration of up to 1.2 mmol/l of phosphates may be added to the solution. If potassium phosphate is added, the total potassium concentration must not exceed 4 mEq/l (4 mmol/l).

Although no severe hypersensitivity reactions to corn have been reported with Prismasol, solutions containing glucosederived from cornstarch hydrolysisshould not be used in patients with known corn allergy or corn-derived products.

If signs or symptoms of suspected hypersensitivity reactions develop, administration must be stopped immediately. Appropriate compensatory therapeutic measures must be initiated as clinically indicated.

Due to the content of glucose and lactate in the solution, it may lead to hyperglycemia, especially in diabetic patients. Blood glucose levels must be monitored regularly. In case of developing hyperglycemia, administration of a substitution solution or dialysate free of dextrose may be necessary. To maintain the desired glycemic control, other corrective measures may be necessary.

Prismasol contains sodium hydrogen carbonate (bicarbonate) and lactate (precursor of bicarbonate) that may affect acid-base balance. If metabolic alkalosis develops or worsens during treatment with the solution, it may be necessary to reduce the administration rate or stop administration.

Before and during treatment, close monitoring of electrolyte and acid-base balance must be performed throughout the procedure.

In case of fluid imbalance, the clinical situation must be carefully controlled and fluid balancemust be corrected as necessary.

Method of administration

Intravenous and for hemodialysis. Prismasol when used as a substitution solution is administered within the circuit before the hemofilter (pre-dilution) or after the hemofilter (post-dilution)

Dosage

The volume and rate of use of Prismasol will depend on the blood electrolyte concentration, acid-base balance, and the general clinical condition of the patient. The administration schedule (dose, perfusion rate, and cumulative volume) of Prismasol should be established by a doctor.

The flow rates used for the substitution solution in hemofiltration and hemodiafiltration are:

Adults:500 - 3000 ml/h

The flow rates used for the dialysis solution (dialysate) in continuous hemodialysis and continuous hemodiafiltration are:

Adults:500 - 2500 ml/h

Normally, the flow rates used in adults are approximately 2000 to 2500 ml/h, corresponding to a daily fluid volume of approximately 48 to 60 liters.

Pediatric population

The flow rate intervals of the substitution solution in hemofiltration and hemodiafiltration and of the dialysis solution(dialysate) in continuous hemodialysis are:

Children (from neonates to adolescents up to 18 years of age): from1000 to2000 ml/h/1.73m2.

Higher flow rates of up to 4000 ml/h/1.73m2, especially in small children (≤10 kg), may be necessary. The absolute flow rate (in ml/h) of the pediatric population should not generally exceed the maximum adult flow rate.

Handling instructions

The electrolyte solution (small Compartment A) is added to the buffer solution (large Compartment B) after breaking the breakable vial just before use to obtain the reconstituted solution.

Only use with suitable renal extracorporeal substitution equipment.

Aseptic technique must be followed throughout the manipulation and administration process to the patient.

Only use if the overbag is intact, all seals are intact, the breakable vial is not broken, and the solution is transparent. Press the bag firmly to ensure that there are no leaks.If leaks are observed, discard the solution immediately, as sterility cannot be guaranteed.

The large Compartment (B) is equipped with an injection port for adding other medications that may be necessary once the solution is reconstituted. It is the responsibility of the doctor to evaluate the compatibility of an added medication with Prismasol, checking for any eventual color change and/or precipitation, insoluble complexes, or crystals. Before adding a medication, verify if it is soluble and stable in water at the pH of Prismasol (the pH of the reconstituted solution is between 7.0 and 8.5).Admixtures may not be compatible. Consult the Instructions for Use of the added medication.

Remove any liquid from the injection port, place the bag in an inverted position, add the medication through the injection port, and mix perfectly. The solution must be administered immediately.The introduction and mixing of additives must always be performed before connecting the solution bag to the extracorporeal circuit.

IRemove the overbag from the bag immediately before use and discard any other packaging material. Break the seal by breaking the breakable vial located between the two compartments of the bag. The vial will remain inside the bag. (See Figure I below).

IIEnsure that all the liquid from the small Compartment A passes tothe large Compartment B. (See Figure II below).

IIIClarifytwicethe small Compartment A by forcing the mixed solution to return to this compartment and then again to the large Compartment B (See Figure III below).

IVOnce the small Compartment A is empty, agitate the large Compartment B to mix its contents completely. The solution is now ready to use and can be hung on the equipment. (See Figure IV below).

VThe dialysis or substitution line can be connected to either of the two access ports.

V.aIf the luer connector is used, remove the cap by rotating and extracting it, and connect the male luer lock connector of the dialysis or substitution line to the female luer receptacle of the bag by rotating and pressing. Ensure that the connection is tight and secure. The connection will open. Check that the solution flows freely. (See Figure Va below).

If the dialysis or substitution line is disconnected from the luer connector, the connector will close, and the solution flow will stop. The luer port is a non-needle port that can be cleaned.

V.bIf the injection port is used, remove the cap first. The injection port is a port that can be disinfected with a swab. Insert the spike through the rubber stopper. Check that the solution flows freely. (See Figure Vb below).

The solution should be used immediately after removing the overbag. If not, the reconstituted solution should be used within 24 hours, including the duration of treatment after adding the electrolyte solution to the buffer solution.

The reconstituted solution is for single use only. Discard any unused solution immediately.

The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.

(FORMATO PVC CON VÁSTAGO ROMPIBLE)

Qué contiene PRISMASOL

Los principios activos son:

Antes de la reconstitución:

1000 ml de Solución de electrolitos (Compartimento A pequeño) contiene:

Cloruro de calcio dihidrato 5,145 g

Cloruro de magnesio hexahidrato 2,033 g

Glucosa 22,000 g

Ácido (S)-Láctico 5,400 g

1000 ml. de solución tampón (Compartimento B grande) contiene:

Cloruro de sodio 6,450 g

Hidrogenocarbonato de sodio 3,090 g

Cloruro de potasio 0,157 g

Después de la reconstitución:

La solución del compartimento A (250 ml) y del compartimento B (4750 ml) se mezclan para originar una solución reconstituida (5000 ml) con la siguiente composición:

Los demás componentes son:dióxido de carbono (E-290), agua para preparaciones inyectables.

pH de la solución reconstituida: 7,0 – 8,5

Aspecto del productoy contenido del envase

Prismasol se presenta en una bolsa bicompartimental, conteniendo el compartimento pequeño A la solución de electrolitos y el compartimento grande B la solución tampón. La solución final reconstituida se obtiene después de romper la pared sellada y mezclar ambas soluciones. La solución reconstituida es transparente y ligeramente amarilla. Cada bolsa (A+B) contiene 5000 ml de solución para hemodiálisis y hemofiltración. La bolsa está recubierta por una sobrebolsa transparente.

Cada caja contiene dos bolsas y un prospecto.

Titular de la autorización de comercialización:

Vantive Belgium SRL

Boulevard d´Angleterre 2

1420 Braine-l´Alleud

Bélgica

Fabricante:

Bieffe Medital S.p.A.

Via Stelvio 94

23035 Sondalo (SO)

Italia

Ó

Vantive Manufacturing Limited Moneen Road,

Castlebar

County Mayo

F23 XR63

Irlanda

Este medicamento está autorizado en los estados miembros del Espacio Económico Europeo y en el Reino Unido (Irlanda del Norte) con los siguientes nombres:

Alemania, Austria, Bélgica, Bulgaria, Chipre, República Checa, Dinamarca, Eslovaquia, Eslovenia, Estonia, España, Finlandia, Francia, Grecia, Holanda, Hungría, Islandia, Irlanda, Italia, Letonia, Lituania, Luxemburgo, Malta, Noruega, Polonia, Portugal, Rumania, Suecia, Reino Unido (Irlanda del Norte): Prismasol 2

Pueden solicitar más información respecto a este medicamento dirigiéndose al representante local del titular de la autorización de comercialización:

Vantive Health, S.L.

Polígono industrial sector 14

C/ Pouet de Camilo nº2

46394 Ribarroja del Turia

Valencia

España

Fecha de la última revisión de este prospecto: 03/2018

La información detallada y actualizada de este medicamento está disponible en la página web de la Agencia Española de medicamentos y Productos Sanitarios (AEMPS) http://www.aemps.es

-----------------------------------------------------------------------------------------------------------------------------------

Esta información está destinada únicamente a profesionales del sector sanitario

Prismasol 2 mmol/lPotasio solución para hemodiálisis y hemofiltración

Precauciones

Deben seguirsecon exactitudlas instrucciones de uso y manipulación de Prismasol.

Las soluciones de los dos compartimentosdeben mezclarse antes de usarse.

El uso de soluciones de hemofiltración y hemodiálisis contaminadas puede causar sepsis, shocky condiciones que pueden causar la muerte.

Prismasol puede calentarse a 37°C para mejorar el bienestar del paciente.El calentamiento de la solución antes de su uso debe realizarse antes de su reconstitución solo con calor seco. Las soluciones no deben calentarse en agua ni en el microondas. La solución debe inspeccionarse visualmente antes de la administración para detectar la presencia de partículas y un posible cambio de color, cuando la solución y el envase lo permitan. No administrar si la solución no es transparente o si el precinto no está intacto.

Prismasol es una solución que contiene potasio. Antes y durante la hemofiltración y/o la hemodiálisis, debe hacerse un seguimiento de la concentración sanguínea de potasio. En función de la concentración de potasio en sangre antes del tratamiento, puede desarrollarse hipo o hiperpotasemia.

Si se produce hipopotasemia, puede ser necesaria la adición de potasio y/o la administración de un dializado con una mayor concentración de potasio.

Si se produce hiperpotasemia una vez iniciado el tratamiento, deberá valorarse la adición de fuentes de potasio que afecten a las concentraciones de potasio. Cuando la solución se utiliza como solución de sustitución, se debe disminuir la velocidad de perfusión y confirmar que se ha alcanzado la concentración de potasio deseada. Si no se resuelve la hiperpotasemia, detener la perfusión de inmediato.

Si la hiperpotasemia se desarrolla cuando se utiliza la solución como dializado, puede ser necesario administrar un dializado sin potasio para aumentar la eliminación del potasio.

La concentración de fosfatos inorgánicos debe ser medida con regularidad. En el caso de que los niveles de fosfato inorgánico en sangre, sean bajos, éste debe ser restablecido.Puede añadirse a la solución una concentración de fosfatos de hasta 1,2 mmol/l. Si se añade fosfato potásico, la concentración total de potasio no debería superar los 4 mEq/l (4 mmol/l).

Aunque no se han notificado casos de reacción de hipersensibilidad grave al maíz con Prismasol, las soluciones que contienen glucosaprocedente de almidón de maíz hidrolizadono deberían utilizarse en pacientes con alergia conocida al maíz o a los productos derivados del maíz.

Si se desarrollan signos o síntomas de sospecha de una reacción de hipersensibilidad, la administración debe interrumpirse de inmediato. Deben instaurarse las medidas terapéuticas compensatorias apropiadas que estén clínicamente indicadas.

Debido al contenido de glucosa y lactato de la solución, puede dar lugar a hiperglucemia especialmente en pacientes diabéticos. Los niveles de glucosa en sangre deben ser monitorizados de forma regular. En caso de desarrollar hiperglucemia, puede ser necesario administrar una solución de sustitución o dializado libre de dextrosa. Para mantener el control glucémico deseado, pueden ser necesarias otras medidas correctivas.

Prismasol contiene hidrogenocarbonato de sodio (bicarbonato) y lactato (precursor del bicarbonato) que puede influir en el equilibrio de ácido-base. Si la alcalosis metabólica se desarrolla o empeora durante el tratamiento con la solución, puede que sea necesario reducir la velocidad de administración o detener la administración.

Antes y durante el tratamiento, debe hacerse un seguimiento estrecho del equilibrio electrolítico y de ácido-base durante todo el procedimiento.

En caso de desequilibrio de líquidos, la situación clínica debe ser controlada cuidadosamente y el equilibrio de líquidosdebería corregirse segúnsea necesario.

Método de administración

Vía intravenosa y para hemodiálisis. Prismasol cuando se usa como solución de sustitución se administra dentro del circuito antes del hemofiltro (pre-dilución) ó después del hemofiltro (post-dilución)

Posología

El volumeny la velocidad de uso de Prismasol dependerán de la concentración de electrolitos en sangre, del equilibrio ácido-base y del estado clínico general del paciente. La pauta de administración (dosis, velocidad de perfusión y volumen acumulativo) de Prismasol debería establecerla unmédico.

Las velocidades de flujo utilizadas para la solución de sustitución en hemofiltración y hemodiafiltración son:

Adultos:500 - 3000 ml/h

Las velocidades de flujo utilizadas para la solución de diálisis (dializado) en hemodiálisis continua y hemodiafiltración continua son:

Adultos:500 - 2500 ml/h

Normalmente las tasas de flujo utilizadas en adultos sonde aproximadamente 2000 ml/h a 2500ml/h, lo que corresponde a un volumen de líquido diario de entre 48 y60 litrosaproximadamente.

Población pediátrica

Los intervalos de tasas de flujo de la solución de sustitución en hemofiltración yhemodiafiltración y de la solución de diálisis(dializado) en hemodiálisis continua son:

Niños (de neonatos a adolescentes de hasta 18 años de edad): de1000 a2000 ml/h/1.73m2.

Pueden ser necesarias velocidades de flujo de hasta 4000 ml/h/1.73m2, especialmente en niños pequeños (≤10 kg). La velocidad de flujo absoluta (en ml/h) de la población pediátrica no debería superar por lo general la velocidad de flujo máximade los adultos.

Instrucciones de manipulación

La solución de electrolitos (compartimento pequeño A) se añade a la solución tampón (compartimento grande B) después de romper la pared sellada justo antes de usar para obtener la solución reconstituida.

Utilizar únicamente con equipos de sustitución renal extracorpórea adecuados.

Se deberá seguiruna técnica asépt