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INFUTRAZE CONCENTRATE FOR PERFUSION SOLUTION

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Rita Isabel Calero Garcia

General medicine 2 years exp.

Dr. Rita Isabel Calero Garcia is a physician with extensive experience in emergency medical care, general medicine, and healthcare assistance in various clinical and out-of-hospital settings.

She currently works as a physician at the Canary Islands Emergency Service (Servicio de Urgencias Canario – SUC), where she is responsible for the assessment and care of patients in medical emergency situations, performing the initial diagnosis, patient stabilization, and coordination with hospital services when necessary.

She has also developed her professional activity within the Primary Care Management Service, providing consultations in general medicine. In this setting she is responsible for patient follow-up, management of acute and chronic conditions, as well as health promotion and disease prevention.

She has also worked as a physician in a mobile ICU unit, providing medical assistance in out-of-hospital emergencies, treating critical patients and participating in medicalized patient transport.

In addition, she has collaborated with the Red Cross, participating in healthcare support units, providing medical assistance at events and supporting emergency interventions.

Furthermore, she has provided medical services in the private sector with Salvaser, conducting clinical assessments of patients and providing healthcare services within private medical services.

This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.
About the medicine

How to use INFUTRAZE CONCENTRATE FOR PERFUSION SOLUTION

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 paciente

Infutraze concentrado para solución para perfusión

Lea todo el prospecto detenidamente antes de empezar a usar 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 su hijo/a 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 Infutraze y para qué se utiliza
  2. Qué necesita saber antes de empezar a usar Infutraze
  3. Cómo usar Infutraze
  4. Posibles efectos adversos
  5. Conservación de Infutraze
  6. Contenido del envase e información adicional

1. Qué es Infutraze y para qué se utiliza

Infutraze es una mezcla de oligoelementos que se administra en la sangre por goteo (perfusión intravenosa). Infutraze contiene cinco oligoelementos (zinc, cobre, manganeso, selenio y yodo) en cantidades muy pequeñas que normalmente se absorben de los alimentos. Estos oligoelementos son necesarios para el funcionamiento normal del organismo.

Infutraze se utiliza para cubrir las necesidades básicas de oligoelementos de los recién nacidos prematuros y a término, lactantes, niños y adolescentes que no pueden comer o absorber suficientes alimentos a través de la alimentación por sonda y, por tanto, necesitan alimentos perfundidos por vía intravenosa (lo que se denomina nutrición intravenosa o nutrición parenteral). Infutraze se añade a la nutrición parenteral conteniendo todos los nutrientes que el organismo necesita.

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2. Qué necesita saber antes de empezar a usar Infutraze

No use Infutraze si su hijo/a:

  • es alérgico a los principios activos o a alguno de los demás componentes de este medicamento (incluidos en la sección 6).
  • tiene la enfermedad de Wilson.

Advertencias y precauciones

Consulte a su médico antes de empezar a usar Infutraze si su hijo/a tiene:

  • problemas renales
  • problemas hepáticos
  • excreción biliar reducida
  • problemas de tiroides (hipertiroidismo)

Durante el tratamiento, su médico controlará periódicamente los niveles de oligoelementos en sangre. Su médico adaptará la dosis de Infutraze en consecuencia.

Niños y adolescentes

Infutraze está indicado para recién nacidos prematuros y a término, lactantes, niños y adolescentes.

Otros medicamentos y Infutraze

Informe a su médico si su hijo/a está tomando, ha tomado recientemente o pudiera tener que tomar cualquier otro medicamento.

Embarazo y lactancia

Si está embarazada o en período de lactancia, consulte a su médico antes de utilizar Infutraze.

Infutraze contiene sodio y potasio

Este medicamento contiene menos de 23 mg de sodio (1 mmol) por ampolla de 10 ml; esto es, esencialmente «exento de sodio».

Este medicamento contiene menos de 39 mg (1 mmol) de potasio por ampolla de 10 ml, por lo que se considera esencialmente «exento de potasio».

3. Cómo usar Infutraze

Infutraze le será administrado a su hijo/a en forma de perfusión intravenosa (en la sangre mediante un goteo) por un profesional sanitario. Infutraze se administrará siempre diluido en otra solución de nutrición parenteral.

Su médico decidirá la dosis individual para su hijo/a en función del peso corporal y la actividad.

Se recomienda una perfusión diaria de hierro cuando se administre nutrición parenteral durante más de 3 semanas, y debe administrarse además una perfusión de molibdeno cuando se administre nutrición parenteral durante más de 4 semanas.

Si se le administra más Infutraze del que se debe

Es poco probable que su hijo/a reciba demasiada cantidad de Infutraze, ya que la perfusión estará controlada por un profesional sanitario. Si cree que su hijo/a ha recibido demasiada cantidad de Infutraze, informe a su médico.

Si tiene cualquier otra pregunta sobre el uso de este medicamento, consulte 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

No se han notificado efectos adversos.

Comunicación de efectos adversos

Si su hijo/a experimenta cualquier tipo de efecto adverso, consulte a su médico, farmacéutico o enfermero. 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 Infutraze

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

No conservar a temperatura superior a 25°C. No congelar.

No utilice este medicamento si observa signos visibles de deterioro.

No utilice este medicamento después de la fecha de caducidad que aparece en la caja y en la etiqueta de la ampolla después de CAD. La fecha de caducidad es el último día del mes que se indica.

Periodo de validez tras la mezcla

Se ha demostrado la estabilidad del uso tras la mezcla durante un máximo de 7 días a 2-8°C seguido de 48 horas a 20°C-25°C, incluyendo la duración de la administración. Desde un punto de vista microbiológico, el producto debe usarse inmediatamente. Si no se usa inmediatamente, el tiempo de almacenamiento y las condiciones previas al uso son responsabilidad del usuario y normalmente no deben ser superiores a 24 horas a 2-8°C.

6. Contenido del envase e información adicional

Composición de Infutraze

Los principios activos son:

Infutraze

1 ml

1 ampolla (10 ml)

Cloruro de zinc

1042 microgramos

10420 microgramos

Cloruro de cobre dihidrato

107,4 microgramos

1074 microgramos

Cloruro de manganeso tetrahidrato

3,600 microgramos

36,00 microgramos

Selenito de sodio

15,33 microgramos

153,3 microgramos

Yoduro de potasio

2,567 microgramos

25,67 microgramos

Los principios activos en 1 ml de Infutraze corresponden a:

Zinc (Zn)

7,64 micromoles

500 microgramos

Cobre (Cu)

0,630 micromoles

40,0 microgramos

Manganeso (Mn)

0,0182 micromoles

1,00 microgramos

Selenio (Se)

0,0887 micromoles

7,00 microgramos

Yodo (I)

0,0155 micromoles

1,96 microgramos

Los demás componentes son

Ácido clorhídrico (para ajuste del pH)

Agua para preparaciones inyectables

Aspecto de Infutraze y contenido del envase

Infutraze, concentrado para solución para perfusión es transparente y casi incoloro. Se presenta en ampollas transparentes de 10 ml fabricadas en polipropileno.

Tamaños de envases:

20 x 10 ml en caja de cartón

Titular de la autorización de comercialización y responsable de la fabricación

Responsable de la fabricación:

HP Halden Pharma AS

Svinesundsveien 80

1788 Halden

Noruega

Titular de la autorización de comercialización:

Fresenius Kabi España, S.A.U.

Torre Mapfre-Vila Olímpica

C/Marina 16-18

08005 Barcelona

España

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

Austria

Kidtrayze Konzentrat zur Herstellung einer Infusionslösung

Bélgica

Kidtrayze concentraat voor oplossing voor infusie

Kidtrayze solution à diluer pour perfusion

Kidtrayze Konzentrat zur Herstellung einer Infusionslösung

Bulgaria

????????? ????? ?????????? ?? ?????????? ???????

Peditrace Novum concentrate for solution for infusion

Croacia

Peditrace Novum koncentrat za otopinu za infuziju

Chipre

Kidtrayze πυκν? δι?λυμα για παρασκευ? διαλ?ματος προς ?γχυση

Chequia

Peditrace Novum

Dinamarca

Peditrace Novum

Estonia

Infutraze

Finlandia

Kidtrayze

Francia

Peditrace solution à diluer pour perfusion

Alemania

Kidtrayze Konzentrat zur Herstellung einer Infusionslösung

Grecia

Kidtrayze πυκν? δι?λυμα για παρασκευ? διαλ?ματος προς ?γχυση

Hungría

Infutraze koncentrátum oldatos infúzióhoz

Islandia

Peditrace Novum

Italia

Kidtrayze

Irlanda

Infutraze concentrate for solution for infusion

Letonia

Infutraze koncentrats infuziju škiduma pagatavošanai

Lituania

Infutraze koncentratas infuziniam tirpalui

Luxemburgo

Kidtrayze

Malta

Kidtrayze

Holanda

Kidtrayze concentraat voor oplossing voor infusie

Noruega

Kidtrayze

Polonia

Peditrace Novum

Portugal

Kidtrayze

Rumanía

Kidtrayze concentrat pentru solutie perfuzabila

Eslovaquia

Peditrace

Eslovenia

KIDTRAYZE koncentrat za raztopino za infundiranje

España

Infutraze

Suecia

Peditrace Novum

Reino Unido

(Irlanda del Norte)

Infutraze concentrate for solution for infusion

Fecha de la última revisión de este prospecto:Octubre 2023

La información detallada 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:

Advertencias y precauciones especiales de empleo

Infutraze debe utilizarse con precaución en pacientes con disfunción renal, en los que la excreción de selenio, zinc y yodo puede disminuir significativamente. Existe un mayor riesgo de acumulación de oligoelementos en estos pacientes.

Infutraze debe utilizarse con precaución en pacientes con disfunción hepática (especialmente colestasis) en los que puede disminuir la excreción de cobre y manganeso.

En pacientes con excreción biliar alterada, la eliminación de manganeso, cobre y zinc puede verse reducida. Los signos clínicos de acumulación de oligoelementos pueden requerir la reducción de la dosis o la interrupción del uso de Infutraze en esos pacientes.

Puede ser necesario ajustar la dosis en pacientes con disfunción renal y disfunción hepática o colestasis leve.

Infutraze debe utilizarse con precaución en pacientes con hipertiroidismo. En esos pacientes, el yodo puede aumentar los síntomas de hipertiroidismo (por ejemplo, bocio).

No es necesario ajustar Infutraze en caso de aporte adicional de yodo a través de antisépticos yodados.

Nutrición parenteral a largo plazo

En pacientes que reciben nutrición parenteral a largo plazo, puede producirse acumulación de oligoelementos, especialmente de manganeso. Si el tratamiento se prolonga durante más de 4 semanas, deben controlarse los niveles de manganeso. La aparición de signos neurológicos (por ejemplo, ansiedad, movimientos oculares rápidos) puede indicar una posible sobrecarga de manganeso, que también puede derivarse de ciertas afecciones médicas y de la nutrición parenteral. La acumulación de manganeso puede requerir la reducción de la dosis o la interrupción del uso de Infutraze.

En los pacientes que reciben nutrición parenteral a largo plazo, puede producirse una deficiencia de oligoelementos, especialmente de cobre, zinc y selenio. En caso de deficiencia, esos oligoelementos individuales deben suministrarse por separado.

Posología

Neonatos prematuros:

Una dosis diaria máxima recomendada de 1,0 ml de Infutraze por kg de peso corporal cubre las necesidades basales de los oligoelementos incluidos.

Neonatos a término, lactantes y niños que pesen menos de 20 kg:

Una dosis diaria máxima recomendada de 0,5 ml de Infutraze por kg de peso corporal cubre las necesidades basales de los oligoelementos incluidos.

Niños que pesen más de 20 kg y adolescentes:

Una dosis diaria máxima recomendada de 10 ml de Infutraze cubre las necesidades basales de los oligoelementos incluidos.

Las siguientes cantidades de oligoelementos están contenidas en 0,5 ml, 1,0 ml y 10 ml de Infutraze:

0,5 ml

1,0 ml

10 ml

Zn

250 microgramos

500 microgramos

5000 microgramos

Cu

20,0 microgramos

40,0 microgramos

400 microgramos

Mn

0,50 microgramos

1,00 microgramos

10,0 microgramos

Se

3,50 microgramos

7,00 microgramos

70,0 microgramos

I

0,98 microgramos

1,96 microgramos

19,6 microgramos

Además de los oligoelementos contenidos en Infutraze, se recomiendan perfusiones diarias de hierro si los pacientes reciben nutrición parenteral durante más de 3 semanas. Se recomienda añadir molibdeno a la nutrición parenteral si los pacientes reciben nutrición parenteral durante más de 4 semanas.

Forma de administración

Infutraze no debe administrarse sin diluir. Infutraze se administrará en perfusión intravenosa, diluido en una solución/emulsión de nutrición parenteral. La velocidad y la duración de la perfusión vienen determinadas por la velocidad y la duración de la perfusión de la solución de nutrición parenteral.

Infutraze sólo puede mezclarse con otros productos nutricionales cuya compatibilidad haya sido documentada, véase la sección Compatibilidad más adelante.

Precauciones especiales de eliminación y otras manipulaciones

Antes de su uso, compruebe visualmente que el concentrado para solución para perfusión sea transparente y esté libre de partículas.

Compatibilidad

Diluir antes de usar.

Infutraze se utiliza como aditivo para mezclas de nutrición parenteral cuando se dispone de datos de compatibilidad.

Se dispone de datos de compatibilidad con los productos de marca Aminoven Infant, Vaminolact, Vamin 14, Vamin 18, Smoflipid, Intralipid, Vitalipid adulto, Vitalipid infantil, Soluvit N, Addiphos y Glycophos en cantidades definidas, combinados con genéricos de glucosa y electrolitos en cantidades definidas. Infutraze también puede añadirse a SmofKabiven y SmofKabiven EF con o sin Vitalipid N Infant/Adult y Soluvit N y electrolitros. Los datos generados apoyan las adiciones de acuerdo con la tabla resumen siguiente:

Infutraze

Mezcla

0-10 ml/l

Mezclas acuosas de PN con los componentes enumerados anteriormente.

0-10 ml/l

Mezclas de PN que contienen lípidos con los componentes enumerados anteriormente

0-10 ml

SmofKabiven y SmofKabiven EF (bolsa activada de 986 ml, 1477 ml, 1970 ml o 2463 ml) con electrolitos y vitaminas como se indica anteriormente

0-5 ml

SmofKabiven y SmofKabiven EF (bolsa activada de 493 ml) con electrolitos y vitaminas como se indica anteriormente

Infutraze nunca debe añadirse directamente a una emulsión lipídica debido a sus efectos desestabilizadores. Se recomienda mezclar primero los macronutrientes (solución de aminoácidos y glucosa con o sin emulsión lipídica) antes de añadir los micronutrientes. Las adiciones deben realizarse de forma aséptica.

La eliminación del medicamento no utilizado y de todos los materiales que hayan estado en contacto con él, se realizará de acuerdo con la normativa local.

Período de validez tras la mezcla

La estabilidad en uso tras la mezcla (ver sección compatibilidad) se ha demostrado durante un máximo de 7 días a 2-8°C seguido de 48 horas a 20°C-25°C,incluyendo la duración de la administración. Desde un punto de vista microbiológico, el producto debe usarse inmediatamente. Si no se usa inmediatamente, el tiempo de almacenamiento y las condiciones previas al uso son responsabilidad del usuario y normalmente no deben ser superiores a 24 horas a 2-8°C.

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Nuno Tavares Lopes

Family medicine 18 years exp.

Dr. Nuno Tavares Lopes is a licensed physician in Portugal with 17 years of experience in emergency medicine, family and general practice, and public health. He is the Director of Medical and Public Health Services at an international healthcare network and serves as an external consultant for the WHO and ECDC.

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Rita Isabel Calero Garcia

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Dr. Rita Isabel Calero Garcia is a physician with extensive experience in emergency medical care, general medicine, and healthcare assistance in various clinical and out-of-hospital settings.

She currently works as a physician at the Canary Islands Emergency Service (Servicio de Urgencias Canario – SUC), where she is responsible for the assessment and care of patients in medical emergency situations, performing the initial diagnosis, patient stabilization, and coordination with hospital services when necessary.

She has also developed her professional activity within the Primary Care Management Service, providing consultations in general medicine. In this setting she is responsible for patient follow-up, management of acute and chronic conditions, as well as health promotion and disease prevention.

She has also worked as a physician in a mobile ICU unit, providing medical assistance in out-of-hospital emergencies, treating critical patients and participating in medicalized patient transport.

In addition, she has collaborated with the Red Cross, participating in healthcare support units, providing medical assistance at events and supporting emergency interventions.

Furthermore, she has provided medical services in the private sector with Salvaser, conducting clinical assessments of patients and providing healthcare services within private medical services.

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Dr. Jorge Correa Bellido is a Spanish physician who offers online consultations in Spanish and English. He graduated from the University of La Laguna and has a solid background in clinical practice and international research.

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Daniel Cichi

Family medicine 24 years exp.

Dr Daniel Cichi is a family medicine doctor with over 20 years of clinical experience. He provides online consultations for adults, supporting patients with acute symptoms, chronic conditions, and everyday health concerns that require timely medical guidance. His background includes work in emergency care, ambulance services, and family medicine, which allows him to assess symptoms quickly, identify warning signs, and help patients choose the safest next steps – whether that means home care, treatment adjustment, or in-person evaluation. Patients commonly consult Dr Daniel Cichi for: 

  • acute symptoms: fever, infections, flu-like illness, cough, sore throat, shortness of breath;
  • chest discomfort, palpitations, dizziness, fatigue, and blood pressure concerns;
  • digestive problems: abdominal pain, nausea, diarrhoea, constipation, reflux;
  • sexually transmitted infections, erectile dysfunction;
  • muscle, joint, and back pain, minor injuries, post-traumatic symptoms;
  • chronic conditions: hypertension, diabetes, high cholesterol, thyroid disorders, weight loss, hair loss;
  • review and interpretation of lab tests, imaging reports, and medical documents;
  • medication review and treatment adjustment;
  • medical advice while travelling or living abroad;
  • second opinions and guidance on whether in-person care is needed.

Dr Cichi’s consultations are structured and practical. He focuses on clear explanations, risk assessment, and actionable recommendations, helping patients understand their symptoms and make informed decisions about their health.

Get INFUTRAZE CONCENTRATE FOR PERFUSION SOLUTION Prescription Online

1

Fill in a 2-min form

Tell us your symptoms, history, and what medicine you're requesting.

2

Pick a doctor or let us assign

Choose a specialist or we'll match you with the next available doctor.

3

Doctor reviews your case

Usually within 30 minutes. They may ask follow-up questions via chat.

4

Collect from any pharmacy

Electronic prescription sent to your email — valid across Spain.

Frequently Asked Questions

Is a prescription required for INFUTRAZE CONCENTRATE FOR PERFUSION SOLUTION?

INFUTRAZE CONCENTRATE FOR PERFUSION SOLUTION 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 INFUTRAZE CONCENTRATE FOR PERFUSION SOLUTION?

The active ingredient in INFUTRAZE CONCENTRATE FOR PERFUSION SOLUTION is electrolytes in combination with other drugs. This information helps identify medicines with the same composition but different brand names.

Who manufactures INFUTRAZE CONCENTRATE FOR PERFUSION SOLUTION?

INFUTRAZE CONCENTRATE FOR PERFUSION SOLUTION 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 INFUTRAZE CONCENTRATE FOR PERFUSION SOLUTION 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 INFUTRAZE CONCENTRATE FOR PERFUSION SOLUTION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.

How to buy INFUTRAZE CONCENTRATE FOR PERFUSION SOLUTION in Spain?

Spain has a well-developed healthcare infrastructure across major cities such as Madrid, Barcelona, Valencia, and Seville. Pharmacies are widely available and operate under strict regulations, ensuring access to prescribed medications.

You can buy INFUTRAZE CONCENTRATE FOR PERFUSION SOLUTION in Madrid, Barcelona, Seville, or Valencia at any local pharmacy with a valid prescription.

To obtain a prescription, you can use Oladoctor:

What are the alternatives to INFUTRAZE CONCENTRATE FOR PERFUSION SOLUTION?

Other medicines with the same active substance (electrolytes in combination with other drugs) include SUPLIVEN CONCENTRADO FOR PERFUSION SOLUTION, POTASSIUM ACETATE B.BRAUN 1 mEq/ml CONCENTRATE FOR INFUSION SOLUTION, SODIUM BICARBONATE 1/6 M MEIN SOLUTION FOR INFUSION. 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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