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Rhenium Sulfide (186Re) Colloidal CIS BIO INTERNATIONAL 148-370 MBq/mL Injectable Suspension

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About the medicine

How to use Rhenium Sulfide (186Re) Colloidal CIS BIO INTERNATIONAL 148-370 MBq/mL Injectable Suspension

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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

Sulfuro de renio (186Re) coloidal CIS bio international 148-370 MBq/ml suspensión inyectable

Sulfuro de renio (186Re)

Lea todo el prospecto detenidamente antes de empezar a usar este medicamento.

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

Contenido del prospecto:

  1. Qué es Sulfuro de renio (186Re) coloidal CIS bio international y para qué se utiliza
  2. Qué necesita saber antes de empezar a usar Sulfuro de renio (186Re) coloidal CIS bio international
  3. Cómo usar Sulfuro de renio (186Re) coloidal CIS bio international
  4. Posibles efectos adversos
  5. Conservación de Sulfuro de renio (186Re) coloidal CIS bio international
  6. Contenido del envase e información adicional

1. Qué es Sulfuro de renio (186Re) coloidal CIS bio international y para qué se utiliza

Este medicamento es un radiofármaco únicamente para uso terapéutico.

La sustancia activa es sulfuro de renio (186Re).

Sulfuro de renio (186Re) coloidal CIS bio international está indicado en el tratamiento de la enfermedad reumatoide que afecta a las articulaciones de hombros, codos, muñecas, tobillos y caderas.

La administración de Sulfuro de renio (186Re) CIS bio international implica recibir una pequeña cantidad de radiactividad. Su médico y el médico nuclear han considerado que el beneficio clínico que usted obtendrá de este procedimiento con el radiofármaco supera el riesgo de la radiación.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. Qué necesita saber antes de empezar a utilizar Sulfuro de renio (186Re) CIS bio international

No use Sulfuro de renio (186Re) coloidal CIS bio international:

Si es alérgico al sulfuro de renio (186Re) o a cualquiera de los demás componentes de este medicamento (incluidos en la sección 6).

Advertencias y precauciones

Tenga especial cuidado con Sulfuro de renio (186Re) CIS bio international:

  • Si está embarazada o cree que puede estarlo
  • Si está en período de lactancia.
  • En niños y jóvenes durante el crecimiento óseo
  • Si sufre artritis séptica
  • Si tiene una rotura de la cápsula sinovial.
  • Si se le va a tratar la cadera y se le ha administrado un corticosteroide de liberación prolongada.

Antes de la administración de Sulfuro de renio (186Re) CIS bio international,

  • debe evitar el embarazo mediante un método anticonceptivo efectivo mantenido durante varios meses después del tratamiento.

Niños y adolescentes

Consulte con su médico nuclear si tiene menos de 18 años.

Uso de Sulfuro de renio (186Re) CIS bio international con otros medicamentos

Informe a su médico nuclear si está tomando ha tomado recientemente o podría tener que tomar cualquier otro medicamento, incluso los adquiridos sin receta.

Embarazo y lactancia

Si está embarazada o en período de lactancia, cree que podría estar embarazada o tiene intención de quedarse embarazada, consulte al médico nuclear antes de utilizar este medicamento.

Debe informar al médico nuclear antes de la administración de Sulfuro de renio (186Re) CIS bio international si existe alguna posibilidad de que esté embarazada, si tiene un retraso en la menstruación o si está en período de lactancia.

Si usted es una mujer en edad fértil debe utilizar medidas contraceptivas eficaces antes de la administración de este medicamento y mantenerlas varios meses después del tratamiento.

En caso de duda, es importante que consulte al médico especialista en medicina nuclear que supervisará el procedimiento.

Si está embarazada o en período de lactancia, no debe recibir este medicamento.

Si usted está amamantando a su hijo/a debe considerarse la posibilidad de retrasar razonablemente la prueba con este medicamento hasta que usted haya suspendido la lactancia.

Conducción y uso de máquinas

No se han observado efectos sobre la capacidad para conducir y manejar máquinas.

Sulfuro de renio (186Re) CIS bio international contiene sodio

Este medicamento contiene 12.7 mg de sodio (componente principal de la sal de mesa/para cocinar) en cada ml. Esto equivale al 0,6% de la ingesta diaria máxima de sodio recomendada para un adulto. La cantidad de sodio administrada podría ser en algunos casos mayor de 23 mg. Por lo tanto, se debe tener en cuenta si sigue una dieta pobre en sodio.

3. Cómo se utiliza Sulfuro de renio (186Re) CIS bio international

Hay normas estrictas sobre el uso, la manipulación y la eliminación de radiofármacos. Sulfuro de renio (186Re) CIS bio international se usará únicamente en áreas especiales controladas. Este producto sólo será manejado y le será administrado por personal entrenado y cualificación para usarlo de forma segura. Esas personas pondrán especial cuidado en el uso seguro de este producto y le informarán de sus acciones.

El médico nuclear que supervise el procedimiento decidirá la cantidad de Sulfuro de renio (186Re) coloidal CIS bio international que debe usarse en su caso, que será la cantidad mínima necesaria para obtener el efecto deseado. La cantidad generalmente recomendada para administrar a un adulto es de 70 a 110 MBq (Megabequerelio, la unidad utilizada para expresar la radiactividad) según la articulación a tratar.

Administración de Sulfuro de renio (186Re) CIS bio international y realización del procedimiento

Sulfuro de renio (186Re) CIS bio international se inyecta directamente por su médico nuclear en las articulaciones de hombros, codos, muñecas, tobillos o caderas.

Pueden ser tratadas varias articulaciones de forma simultánea o sucesiva.

En caso de recaída puede plantearse una nueva inyección en la articulación después de un descanso de 6 meses.

Después de la administración de Sulfuro de renio (186Re) CIS bio international debería:

  • Tener la articulación inmovilizada 3 días (férulas o reposo en cama)
  • Usar un método anticonceptivo eficaz durante varios meses después del tratamiento para evitar cualquier embarazo.
  • Debe evitarse el contacto directo con niños pequeños y mujeres embarazadas.

El médico nuclear le informará si necesita tomar alguna precaución especial después de recibir este medicamento. Consulte con su médico nuclear si tiene cualquier duda.

Si se le ha administrado másSulfuro de renio (186Re) CIS bio internationaldel que debie:

Es improbable que se le administre una sobredosis porque usted recibirá una dosis única de Sulfuro de renio (186Re) CIS bio international controlada con precisión por el médico nuclear que supervise el procedimiento.

Si tiene cualquier otra duda sobre el uso de Sulfuro de renio (186Re) CIS bio international, pregunte al médico nuclear que supervisa el procedimiento.

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.

Se han comunicado los siguientes efectos adversos:

Frecuentes (pueden afectar hasta 1 de cada 10 pacientes)

  • Hinchazón por acumulación de líquido (edema)
  • Trastorno de la pigmentación

Poco frecuentes (pueden afectar hasta 1 de cada 100 pacientes)

  • Anomalías cromosómicas

Frecuencia no conocida (no puede estimarse a partir de los datos disponibles)

  • Inflamación de las articulaciones debido a una infección (artritis infecciosa)
  • Náuseas
  • Vómitos
  • Pérdida de flujo de sangre en los huesos que hace que el hueso muera (osteonecrosis)
  • Pérdida de líquido en las articulaciones (derrame articular)
  • Inflamación de las articulaciones
  • Dolor de las articulaciones

Las reacciones adversas más frecuentemente observadas después de la sinoviortesis con renio son:

  • Coloración pardusca de la muñeca en el lugar de la inyección y a veces infiltración y rigidez de los músculos extensores.
  • Hinchazón por acumulación de líquido (edema) del antebrazo tras sinoviortesis de muñeca.
  • Dolor local transitorio o inflamación de la articulación (fenómeno de dilatación) tras la punción de la articulación.
  • Nauseas y vómitos.
  • Infección de las articulaciones.
  • Pérdida de flujo de sangre en los huesos que hace que el hueso muera.

Comunicación de efectos adversos

Si experimenta cualquier tipo de efecto adverso, consulte a su especialista en medicina nuclear, incluso si se trata de cualquier efecto adverso no incluido en este prospecto. También puede comunicarlos directamente a través del Sistema Español de Farmacovigilancia de Medicamentos de Uso Humano: https:// 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 Sulfuro de renio (186Re) coloidal CIS bio International

No tendrá que almacenar este medicamento. Este medicamento se almacena bajo la responsabilidad del especialista en instalaciones adecuadas. El almacenamiento de radiofármacos se realizará conforme a la normativa nacional sobre materiales radiactivos.

6. Contenido del envase y otras informaciones

Composición de Sulfuro de renio (186Re) CIS bio international

  • El principio activo es sulfuro de renio (186Re
  • Los demás componentes son: ácido ascórbico, gelatina, hidróxido de sodio, ácido clorhídrico y agua para preparaciones inyectables.

Aspecto deSulfuro de renio (186Re)CIS bio international y contenido del envase

Este medicamento se presenta en forma de suspensión inyectable en viales multidosis de 15 ml de vidrio incoloro cerrado con tapón de goma y cápsula de aluminio. El vial se acondiciona con un contenedor blindado plomado

Tamaño del envase: Un vial contiene 37 a 3700 MBq de renio(186Re) a una concentración de 148 a 370 MBq/ml en la fecha y hora de calibración.

Titular de la autorización de comercialización y responsable de la fabricación:

CIS bio internacional

RN 306 - Saclay

B.P. 32

F-91192 Gif-sur-Yvette Cedex

FRANCIA

Puede solicitar más información sobre este medicamento dirigiéndose al representante local del Titular de la autorización de comercialización:

Curium Pharma Spain S.A.

Avda. Dr. Severo Ochoa, 29

28100-Alcobendas

Tfno.: 91 4841989

Este prospecto fue revisado por última vez en Febrero 2020

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/

Esta información está destinada únicamente a profesionales sanitarios:

La ficha técnica completa de Sulfuro de renio (186Re) CIS bio international se incluye como documento separado en el envase del producto, con el fin de proporcionar a los profesionales sanitarios otra información científica y práctica adicional sobre la administración y uso de este radiofármaco.

Por favor, consulte la ficha técnica.

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General medicine 6 years exp.

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Frequently Asked Questions

Is a prescription required for Rhenium Sulfide (186Re) Colloidal CIS BIO INTERNATIONAL 148-370 MBq/mL Injectable Suspension?
Rhenium Sulfide (186Re) Colloidal CIS BIO INTERNATIONAL 148-370 MBq/mL Injectable Suspension 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 Rhenium Sulfide (186Re) Colloidal CIS BIO INTERNATIONAL 148-370 MBq/mL Injectable Suspension?
The active ingredient in Rhenium Sulfide (186Re) Colloidal CIS BIO INTERNATIONAL 148-370 MBq/mL Injectable Suspension is rhenium (186Re) sulfide colloid. This information helps identify medicines with the same composition but different brand names.
Who manufactures Rhenium Sulfide (186Re) Colloidal CIS BIO INTERNATIONAL 148-370 MBq/mL Injectable Suspension?
Rhenium Sulfide (186Re) Colloidal CIS BIO INTERNATIONAL 148-370 MBq/mL Injectable Suspension is manufactured by Cis Bio International. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of Rhenium Sulfide (186Re) Colloidal CIS BIO INTERNATIONAL 148-370 MBq/mL Injectable Suspension 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 Rhenium Sulfide (186Re) Colloidal CIS BIO INTERNATIONAL 148-370 MBq/mL Injectable Suspension 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 Rhenium Sulfide (186Re) Colloidal CIS BIO INTERNATIONAL 148-370 MBq/mL Injectable Suspension?
Other medicines with the same active substance (rhenium (186Re) sulfide colloid) include ERBIUM CITRATE (169Er) colloidal CIS BIO INTERNACIONAL 111 MBq/ML INJECTABLE SUSPENSION, Yttrium Citrate (90 Y) Colloidal CIS BIO INTERNATIONAL 37-370 MBq/ml Injectable Suspension, SODIUM IODIDE (I131) CURIUM PHARMA SPAIN 37-7400 MBq CAPSULES. 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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