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About the medicine

How to use GALLIAD 0.74 - 1.85 GBq RADIOPHARMACEUTICAL GENERATOR

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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 usuario

Galliad 0,74-1,85 GBq generador de radionúclido

Solución de cloruro de galio (68Ga)

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

  • Conserve este prospecto, ya que puede tener que volver a leerlo.
  • Si tiene alguna duda, consulte al médico nuclear que supervisará 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 Galliad y para qué se utiliza
  2. Qué necesita saber antes de empezar a usar la solución de cloruro de galio (68Ga) obtenida con Galliad
  3. Cómo usar la solución de cloruro de galio (68Ga) obtenida con Galliad
  4. Posibles efectos adversos
  5. Conservación de Galliad
  6. Contenido del envase e información adicional

1. Qué es Galliad y para qué se utiliza

Este medicamento es un radiofármaco que no está indicado para utilizar directamente en los pacientes.

Galliad es un generador de radionúclido de germanio (68Ge) / galio (68Ga), un dispositivo que se utiliza para obtener una solución de cloruro de galio (68Ga).

La solución de cloruro de galio (68Ga) obtenida se utiliza para el marcaje radiactivo, una técnica que consiste en realizar un marcaje (marcaje radiactivo) de una sustancia con un compuesto radiactivo, en este caso el 68Ga.

Galliad se utiliza para marcar ciertos medicamentos que han sido desarrollados y aprobados especialmente para ser utilizados con el principio activo, el cloruro de galio (68Ga). Estos medicamentos actúan como portadores para transportar el 68Ga radiactivo a donde se necesita. Puede tratarse de sustancias diseñadas para reconocer un tipo concreto de células del organismo, como las células tumorales (cáncer). La baja cantidad de radiactividad administrada se puede detectar fuera del cuerpo mediante unas cámaras especiales.

Consulte el prospecto del medicamento que se va a marcar radiactivamente con cloruro de galio (68Ga). El médico nuclear le explicará qué tipo de exploración se realizará con este producto.

La administración de un medicamento marcado con 68Ga implica recibir pequeñas cantidades de radiactividad. Su médico y el médico nuclear han considerado que el beneficio clínico que va a obtener del procedimiento con el radiofármaco es superior al 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 usar la solución de cloruro de galio (68Ga) obtenida con Galliad

La solución de cloruro de galio (68Ga) obtenida con Galliadno se debe usar:

  • si es alérgico al cloruro de galio (68Ga) o a cualquiera de los demás componentes de este medicamento (incluidos en la sección 6).

Si utiliza un medicamento marcado con 68Ga, debe leer la información sobre contraindicaciones del prospecto del producto que se va a marcar radiactivamente.

Advertencias y precauciones

Para obtener información sobre las advertencias y precauciones especiales de empleo de medicamentos marcados con 68Ga, consulte el prospecto del medicamento que se va a marcar radiactivamente.

Niños y adolescentes

Comunique a su médico nuclear si usted o su hijo/a es menor de 18 años.

Uso de la solución de cloruro de galio (68Ga) con otros medicamentos

Informe a su médico nuclear si está tomando, ha tomado recientemente o pudiera tener que tomar cualquier otro medicamento, ya que algunos medicamentos pueden interferir en la interpretación de las imágenes.

Se desconoce si el cloruro de galio (68Ga) puede interactuar con otros medicamentos dado que no se han llevado a cabo estudios específicos.

Para obtener más información sobre las interacciones asociadas con el uso de medicamentos marcados con 68Ga, consulte el prospecto del medicamento que se va a marcar radiactivamente.

Embarazo, lactancia y fertilidad

Si está embarazada o en periodo de lactancia, cree que podría estar embarazada o tiene intención de quedarse embarazada, consulte a su médico nuclear antes de que le administren medicamentos marcados radiactivamente con Galliad.

Debe informar al médico nuclear antes de la administración de medicamentos marcados radiactivamente con Galliad si existe alguna posibilidad de que pueda estar embarazada, si tiene un retraso en la menstruación o si está en periodo de lactancia.

En caso de duda, es importante que consulte a su médico nuclear que supervisará el procedimiento.

Si está embarazada

El médico nuclear solo le administrará este producto durante el embarazo si prevé que obtendrá un beneficio que compense los riesgos.

Si está en periodo de lactancia

Se le pedirá que interrumpa la lactancia. Consulte a su médico nuclear cuándo puede reanudar la lactancia materna.

Conducción y uso de máquinas

Su capacidad para conducir y utilizar máquinas puede verse afectada debido al medicamento utilizado en combinación con Galliad. Lea atentamente el prospecto de ese medicamento.

3. Cómo usar la solución de cloruro de galio (68Ga) obtenida con Galliad

Hay normas estrictas sobre el uso, la manipulación y la eliminación de los radiofármacos. Galliad solo se utilizará en áreas controladas especiales. Este producto solo lo manipulará y administrará personal entrenado y cualificado para utilizarlo de forma segura. Esas personas tendrán especial cuidado a la hora de utilizar este producto de forma segura y le mantendrán informado de sus acciones.

El médico nuclear que supervisa el procedimiento decidirá la cantidad de medicamento marcado radiactivamente con Galliad que debe utilizarse en su caso. Esta será la cantidad más pequeña necesaria para alcanzar el resultado deseado, en función del medicamento que se va marcar y su uso previsto. Para obtener más información, lea el prospecto del medicamento que se va a marcar radiactivamente.

Administración de la solución de cloruro de galio (68Ga) obtenida con Galliad y realización del procedimiento

No recibirá la solución de cloruro de galio (68Ga) tal cual, sino otro producto marcado radiactivamente con Galliad.

La solución de cloruro de galio (68Ga) solo se debe utilizar en combinación con otro medicamento que haya sido desarrollado específicamente para combinarse (marcaje radiactivo) con Galliad. Solo recibirá el producto final marcado radiactivamente.

Duración del procedimiento

Su médico nuclear le informará sobre la duración habitual del procedimiento tras la administración del medicamento marcado radiactivamente con Galliad.

Después de la administración del medicamento marcado radiactivamente con Galliad

El médico nuclear le informará en caso de que deba tomar alguna precaución especial después de recibir el medicamento marcado radiactivamente con Galliad. Consulte a su médico nuclear si tiene alguna pregunta.

Si se le ha administrado más medicamento marcado radiactivamente con Galliad del que debería

Es improbable que se produzca una sobredosis, dado que solo recibirá el medicamento marcado radiactivamente con Galliad controlado con precisión por el médico nuclear que supervisa el procedimiento. No obstante, en caso de sobredosis, recibirá el tratamiento adecuado.

Si tiene alguna otra duda sobre el uso de este producto, 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, el medicamento marcado radiactivamente con Galliad puede producir efectos adversos, aunque no todas las personas los sufran.

La administración del medicamento marcado radiactivamente con Galliad, implica recibir una pequeña cantidad de radiación ionizante con un riesgo muy bajo de desarrollar cáncer y anomalías hereditarias.

Comunicación de efectos adversos

Si experimenta cualquier tipo de efecto adverso, consulte a su médico nuclear, 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 Galliad

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

La siguiente información está destinada únicamente al especialista:

El generador de radionúclido no se debe utilizar después de la fecha de caducidad que aparece en el envase después de "CAD".

No desmontar la carcasa de plástico. No conservar a temperatura superior a 25°C.

La solución de cloruro de galio (68Ga) obtenida con Galliad se debe utilizar inmediatamente.

6. Contenido del envase e información adicional

Contenido de Galliad

El principio activo es una solución de cloruro de galio (68Ga).

Los demás componentes son:

  • dióxido de titanio (matriz).
  • ácido clorhídrico 0,1 N estéril (solución para elución).

Aspecto de Galliad y contenido del envase

Usted no recibirá ni manipulará este medicamento.

Titular de la autorización de comercialización y responsable de la fabricación

IRE-Elit

Avenue de l'Espérance

B-6220 Fleurus

Bélgica

Este medicamento está autorizado en los Estados miembros del Espacio Económico Europeo con los siguientes nombres:

País

Nombre del producto

Austria

Galli Ad 0,74-1,85 GBq, Radionuklidgenerator

Bélgica

Galli Ad 0,74-1,85 GBq, radionuclidegenerator / générateur radiopharmaceutique / Radionuklidgenerator/

Dinamarca

Galli Ad 0,74-1,85 GBq, radionuklidgenerator

Finlandia

Galliad 0,74-1,85 GBq, radionuklidgeneraattori / radionuklidgenerator

Francia

Galliad 0,74-1,85 GBq, générateur radiopharmaceutique

Alemania

Galli Ad 0,74-1,85 GBq, Radionuklidgenerator

Italia

Germanio cloruro (68Ge)/Gallio cloruro (68Ga) IRE-ELiT

Países Bajos

GalliAd 0,74-1,85 GBq, radionuclidegenerator

Noruega

Galliad

Luxemburgo

Galli Ad 0,74-1,85 GBq, générateur radiopharmaceutique

España

Galliad 0,74-1,85 GBq generador de radionúclido

Suecia

Galliad 0,74-1,85 GBq, radionuklidgenerator

Reino Unido

GalliAd 0.74-1.85 GBq, radionuclide generator

Fecha de la últimarevisión de este prospecto: Mayo2018

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

Esta información está destinada únicamente a profesionales médicos o del sector sanitario:

La ficha técnica completa de Galliad 0,74-1,85 GBq generador de radionúclido, se proporciona en un documento aparte en el envase del producto, con el objetivo de facilitar a los profesionales sanitarios otra información científica y práctica adicional sobre la administración y el uso de este radiofármaco.

Por favor, consulte la ficha técnica.

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Frequently Asked Questions

Is a prescription required for GALLIAD 0.74 - 1.85 GBq RADIOPHARMACEUTICAL GENERATOR?

GALLIAD 0.74 - 1.85 GBq RADIOPHARMACEUTICAL GENERATOR requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.

Who manufactures GALLIAD 0.74 - 1.85 GBq RADIOPHARMACEUTICAL GENERATOR?

GALLIAD 0.74 - 1.85 GBq RADIOPHARMACEUTICAL GENERATOR is manufactured by Ire Elit. Pharmacy brands and packaging may differ depending on the distributor.

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Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether GALLIAD 0.74 - 1.85 GBq RADIOPHARMACEUTICAL GENERATOR 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 GALLIAD 0.74 - 1.85 GBq RADIOPHARMACEUTICAL GENERATOR 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 GALLIAD 0.74 - 1.85 GBq RADIOPHARMACEUTICAL GENERATOR 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 GALLIAD 0.74 - 1.85 GBq RADIOPHARMACEUTICAL GENERATOR?

Other medicines with the same active substance () include GALLIAPHARM 0.74 - 1.85 GBq RADIONUCLIDE GENERATOR, NORCOLESTEROL IODINATED (131 I) CIS BIO INTERNATIONAL 7.5-15 MBq/ml INJECTABLE SOLUTION, ADREVIEW 74 MBq/ml INJECTABLE 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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