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APIROSERUM SODIUM CHLORIDE 2% SOLUTION FOR INFUSION

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About the medicine

How to use APIROSERUM SODIUM CHLORIDE 2% SOLUTION FOR INFUSION

Translated with AI

This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introducción

Prospecto:información para el usuario

APIROSERUM CLORURO SÓDICO 2% solución para perfusión

Cloruro de sodio

Lea todo el prospecto detenidamente antes de empezar ausar este medicamento,porque contiene información importante para usted.

  • Conserve este prospecto, ya que puede tener que volver a leerlo.
  • Si tiene alguna duda, consulte a su médico o enfermero.
  • Si experimenta efectos adversos, consulte a su médico o enfermero, incluso si se trata de efectos adversos que no aparecen en este prospecto. Ver sección 4.

Contenido del prospecto:

  1. Qué es APIROSERUM CLORURO SÓDICO 2% y para qué se utiliza
  2. Qué necesita saber antes de empezar a usar APIROSERUM CLORURO SÓDICO 2%
  3. Cómo usar APIROSERUM CLORURO SÓDICO 2%
  4. Posibles efectos adversos

5 Conservación de APIROSERUM CLORURO SÓDICO 2%

  1. Contenido del envase e información adicional

1. Qué es APIROSERUM CLORURO SÓDICO y para qué se utiliza

APIROSERUM CLORURO SÓDICO 2% es una solución restauradora, para uso intravenoso, principalmente indicada en el tratamiento de los siguientes trastornos causados por grandes depleciones salinas (pérdida de sales), sin pérdida de agua:

  • Síntomas de la intoxicación acuosa.
  • Hiponatremias relativas (descenso del cociente sodio/agua, por hidratación) cuando se presentan los síntomas de intoxicación acuosa (convulsión, vómitos, cefaleas graves) y no puede esperarse a la espontánea eliminación de agua.
  • Hiperpotasemias (niveles elevados de potasio en sangre) asociadas a hiponatremia (niveles bajos de sodio en sangre), cuando está contraindicada la administración de grandes volúmenes de líquido.
Doctor consultation

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Discuss your symptoms and treatment with a doctor online.

2. Qué necesita saber antes de empezar a usar APIROSERUM CLORURO SÓDICO 2%

No use APIROSERUM CLORURO SÓDICO 2%

En situaciones en las que la administración de una solución hipertónica pueda agravar la situación clínica mediante el incremento de líquido, tales como:

  • Edemas (hinchazón causado por acumulación de líquidos en los tejidos de su cuerpo),
  • Hipertensión (tensión arterial elevada),
  • Hiposistolia (fuerza de contracción del corazón disminuida),
  • Acidosis metabólica hiperclorémica (exceso de ácido en el metabolismo).

Advertencias y precauciones

Consulte a su médico o enfermero antes de empezar a usar APIROSERUM CLORURO SÓDICO 2%.

Si padece insuficiencia cardíaca congestiva (fallo del corazón con encharcamiento pulmonar), disfunción renal (mal funcionamiento del riñón), preeclampsia (subida de tensión ocasionada por el embarazo) u otras alteraciones asociadas con la retención de sodio.

Niños

El uso de APIROSERUM CLORURO SÓDICO 2% en niños debe realizarse bajo estricto control de las cifras de sodio en sangre.

Uso de APIROSERUM CLORURO SÓDICO 2% con otros medicamentos

Comunique a su médico, si está utilizando, ha utilizado recientemente o pudiera tener que utilizar cualquier otro medicamento.

APIROSERUM CLORURO SÓDICO 2% puede disminuir la acción terapéutica de las sales de litio (medicamento antidepresivo).

Embarazo,lactanciay fertilidad

Si está embarazada o en periodo de lactancia, cree que podría estar embarazada o tiene intención de quedarse embarazada, consulte a su médico antes de utilizar este medicamento.

Conducción y uso de máquinas

La influencia de este medicamento sobre la capacidad para conducir y utilizar máquinas es nula.

3. Cómo usar APIROSERUM CLORURO SÓDICO 2%

APIROSERUM CLORURO SÓDICO 2% se administra por perfusión (inyección intravenosa gota a gota). La posología será determinada por el médico en función del estado del paciente.

Uso en niñosy adolescentes

La administración de APIROSERUM CLORURO SÓDICO 2% en niños debe llevarse a cabo únicamente para el tratamiento inicial de síntomas agudos de hiponatremia (niveles bajos de sodio en sangre).

Uso en personas mayores

Aunque no hay experiencias clínicas que sugieran diferencias en la respuesta terapéutica en ancianos, el ajuste de dosis debe ser cuidadoso, comenzando con la dosis más baja posible y evaluando los posibles riesgos relacionados con otros trastornos que pudiera padecer.

APIROSERUM CLORURO SÓDICO 2% debe inyectarse total o parcialmente una vez conectado al frasco el equipo inyector, para prevenir posibles contaminaciones.

En caso de mezclas múltiples, deberá guardarse la máxima asepsia durante la adición de los medicamentos a los líquidos de uso intravenoso, y emplear estas mezclas dentro de las 6 horas desde su preparación.

Si usa más APIROSERUM CLORURO SÓDICO 2% del que debe

Dada la naturaleza del producto, si su indicación y administración es correcta y controlada, no existe riesgo de intoxicación.

En caso de no cumplirse estos requisitos, si presentara algún síntoma derivado de los efectos adversos, se suspenderá la administración y se recurrirá a tratamiento sintomático.

Si tiene cualquier otra duda sobre el uso de este medicamento, pregunte a su médico o enfermero.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Posibles efectos adversos

Al igual que todos los medicamentos, este medicamento puede producir efectos adversos, aunque no todas las personas los sufran.

Durante el periodo de utilización de sueros hipertónicos, se han observado las siguientes reacciones adversas, cuya frecuencia no se ha podido establecer con exactitud, las cuales derivan del uso inadecuado del medicamento, ya sea por una incorrecta indicación o por usar una posología o técnica de administración inadecuada:

  • Edema pulmonar e insuficiencia cardíaca congestiva.
  • Hipervolemia (aumento anormal del volumen de plasma en el organismo), hipernatremia (niveles elevados de sodio en sangre), disminución en suero de electrolitos, sobrehidratación, hipopotasemia (niveles bajos de potasio en sangre).
  • Trombosis (coágulo en el interior de un vaso sanguíneo), flebitis (inflamación de la pared de una vena), extravasación (escape del medicamento fuera de la vena y dentro de la piel). La perfusión demasiado rápida puede generar dolor local e irritación venosa.

Comunicación de efectos adversos

Si experimenta cualquier tipo de efecto adverso, consulte a su médico, farmacéutico o enfermero, incluso si se trata de posibles efectos adversos que no aparecen en este prospecto. También puede comunicarlos directamente a través del Sistema Español de Farmacovigilancia de Medicamentos de Uso Humano: www.notificaRAM.es. Mediante la comunicación de efectos adversos usted puede contribuir a proporcionar más información sobre la seguridad de este medicamento.

5. Conservación de APIROSERUM CLORURO SÓDICO 2%

Conservar por debajo de 25?C.

Mantener este medicamento fuera de la vista y del alcance de los niños.

No utilice este medicamento después de la fecha de caducidad que aparece en el envase después de “CAD”. La fecha de caducidad es el último día del mes que se indica.

6. Contenido del envase e información adicional

Composición de APIROSERUM CLORURO SÓDICO 2%

  • El principio activo es cloruro de sodio. Cada 100 ml de solución contiene 2 g de cloruro de sodio.

Miliequivalentes/litro: Ion cloruro 342 mEq; Ion sodio 342 mEq

Osmolaridad: 684 mOsmol/litro

pH = 4,5-7,0

Los demás componentes (excipientes) son agua para preparaciones inyectables, ácido clorhídrico e hidróxido de sodio.

Aspecto del producto y contenido del envase

Apiroserum Cloruro Sódico 2% es una solución transparente e incolora.

Frascos de vidrio con 250, 500 y 1000 ml.

Envases clínicos con 12 frascos de 250 y 500 ml.

Puede que solo estén comercializados algunos tamaños de envases.

Titular de la autorización de comercialización y responsable de la fabricación

Titular de la autorización de comercialización:

Fresenius Kabi España S.A.U.

Torre Mapfre – Vila Olímpica

Marina 16-18,08005-Barcelona (España)

Responsable de la fabricación:

Fresenius Kabi Italia S.r.l.

Via Camagre, 41/43

I - 37063 Isola della Scala (Verona)

Este prospecto ha sido aprobado en Enero 2022

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.gob.es/

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Esta información está destinada únicamente a profesionales del sector sanitario:

Posología

En relación al cálculo del volumen y velocidad de administración de una solución de cloruro de sodio hipertónico, en pacientes con síntomas graves, la corrección puede iniciarse a 1-2 mEq/l/hora, recomendándose detener la corrección rápida al cesar los síntomas que amenazan la vida del paciente, o al alcanzar una concentración sérica de 125-130 mEq/l (o aún menor si el valor de sodio en plasma es inferior a 100 mEq/l), sin superar los 12 mEq/l en las primeras 24 horas.

Para evitar el posible daño que un cambio excesivo puede provocar, la concentración de sodio no debería superar los 25 mEq/l durante las primeras 48 horas del tratamiento.

La velocidad de corrección de la hiponatremia debe ser calculada utilizando la siguiente fórmula:

Conc. de Na en 1 litro de perfusión – Na sérico

Cambio en la concentración de Na sérico = ---------------------------------------------------------

Agua corporal total +1

Uso clínico: Efecto estimado de 1 litro de solución sobre el sodio sérico

Una vez alcanzada la corrección se puede valorar la necesidad de administrar suero salino NO hipertónico.

Población pediátrica

La administración intravenosa de soluciones hipertónicas (>0,9%) debe llevarse a cabo únicamente para el tratamiento inicial de síntomas agudos de hiponatremia; mantenimiento 3-4 mEq/Kg/día; máximo 100-150 mEq/día. En cualquier caso, la dosis varía mucho dependiendo de la condición clínica. La restitución viene determinada por los valores de laboratorio.

Advertencias y precauciones especiales

Se debe monitorizar el volumen de orina y sodio cada 2 h para modificar la pauta de perfusión.

Se debe controlar la respuesta clínica tras la administración del fármaco, vigilando el incremento de volumen intravascular y la elevación de las cifras de sodio (hipernatremia por sobre-corrección).

La solución debe administrarse mediante un equipo estéril y una técnica aséptica. El equipo debe cebarse con la solución para evitar la entrada de aire en el sistema.

Al administrar la solución y en caso de mezclas, deberá usarse una técnica aséptica.

Antes de adicionar medicamentos a la solución o de administrar simultáneamente con otros medicamentos, se debe comprobar que no existen incompatibilidades.

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Frequently Asked Questions

Is a prescription required for APIROSERUM SODIUM CHLORIDE 2% SOLUTION FOR INFUSION?
APIROSERUM SODIUM CHLORIDE 2% SOLUTION FOR INFUSION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in APIROSERUM SODIUM CHLORIDE 2% SOLUTION FOR INFUSION?
The active ingredient in APIROSERUM SODIUM CHLORIDE 2% SOLUTION FOR INFUSION is electrolytes. This information helps identify medicines with the same composition but different brand names.
Who manufactures APIROSERUM SODIUM CHLORIDE 2% SOLUTION FOR INFUSION?
APIROSERUM SODIUM CHLORIDE 2% SOLUTION FOR INFUSION is manufactured by Fresenius Kabi España, S.A.U.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of APIROSERUM SODIUM CHLORIDE 2% SOLUTION FOR INFUSION online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether APIROSERUM SODIUM CHLORIDE 2% SOLUTION FOR INFUSION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to APIROSERUM SODIUM CHLORIDE 2% SOLUTION FOR INFUSION?
Other medicines with the same active substance (electrolytes) include SODIUM ACETATE 1M FRESENIUS KABI CONCENTRATE FOR PERFUSION SOLUTION, APIROSERUM RINGER'S SOLUTION FOR INFUSION, SODIUM CHLORIDE B. BRAUN 20% CONCENTRATE FOR INFUSION SOLUTION. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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