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PLERIXAFOR ACCORD 20 mg/ml INJECTABLE SOLUTION

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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 PLERIXAFOR ACCORD 20 mg/ml INJECTABLE 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 usuario

Plerixafor Accord 20 mg/ml solución inyectable

plerixafor

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 farmacéutico.
  • Este medicamento se le ha recetado solamente a usted, y no debe dárselo a otras personas aunque tengan los mismos síntomas que usted, ya que puede perjudicarles.
  • Si experimenta efectos adversos, consulte a su médico o farmacéutico, incluso si se trata de efectos adversos que no aparecen en este prospecto. Ver sección 4.

Contenido del prospecto

  1. Qué es Plerixafor Accord y para qué se utiliza
  2. Qué necesita saber antes de empezar a usar Plerixafor Accord
  3. Cómo usar Plerixafor Accord
  4. Posibles efectos adversos
  5. Conservación de Plerixafor Accord
  6. Contenido del envase e información adicional

1. Qué es Plerixafor Accord y para qué se utiliza

Plerixafor Accord contiene el principio activo plerixafor que bloquea una proteína de la superficie de células madre hematopoyéticas. Esta proteína “fija" las células madre de la sangre a la médula ósea. Plerixafor mejora la liberación de las células madre al torrente circulatorio (movilización). Las células madre se pueden recoger con un aparato que separa los componentes de la sangre (máquina de aféresis), posteriormente congelarlas y almacenarlas hasta su trasplante.

Si la movilización es escasa, se administra Plerixafor Accord para ayudar a recoger células madre de la sangre del paciente para la recogida, almacenamiento y reintroducción (trasplante),

  • En pacientes adultos con linfoma (un cáncer de glóbulos blancos) o mieloma múltiple (un cáncer que afecta a las células plasmáticas de médula ósea).
  • En niños de 1 a menos de 18 años con linfoma o tumores sólidos.
Doctor consultation

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2. Qué necesita saber antes de empezar a usar Plerixafor Accord

No use Plerixafor Accord

  • si es alérgico a plerixafor o a cualquiera de los demás componentes de este medicamento (incluidos en la sección 6).

Advertencias y precauciones

Consulte a su médico, farmacéutico o enfermero antes de empezar a usar Plerixafor Accord.

Informe a su médico:

  • si tiene o ha tenido cualquier problema de corazón.
  • si tiene problemas de riñón. Su médico puede ajustarle la dosis.
  • si tiene un número alto de glóbulos blancos.
  • si tiene un número bajo de plaquetas.
  • si tiene antecedentes de sensación de desmayo o de mareo estando de pie o sentado o se ha desmayado anteriormente tras las inyecciones.

Su médico puede realizarle análisis de sangre periódicamentepara controlar el número de células de la sangre.

No se recomienda el uso de Plerixafor Accord para la movilización de células madre si tiene leucemia (un cáncer de la sangre o de médula ósea).

Otros medicamentos y Plerixafor Accord

Informe a su médico o farmacéutico si está tomando, ha tomado recientemente o podría tener que tomar cualquier otro medicamento.

Embarazo y lactancia

No debe utilizar Plerixafor Accord si está embarazada, puesto que no se dispone de datos de los efectos de Plerixafor Accord en mujeres embarazadas. Es importante que informe a su médico si está embarazada, cree que podría estarlo o tiene intención de quedarse embarazada. Se recomienda el uso de métodos anticonceptivos si está en edad fértil.

No debe dar el pecho si está usando Plerixafor Accord ya que se desconoce si Plerixafor Accord pasa a la leche materna.

Conducción y uso de máquinas

Plerixafor Accord puede causar mareos y fatiga. Por tanto, debe evitar conducir si se siente mareado, cansado o no se siente bien.

Plerixafor Accord contiene sodio

Este medicamento contiene menos de 1 mmol de sodio (23 mg) por dosis; esto es, esencialmente “exento de sodio”.

3. Cómo usar Plerixafor Accord

Su médico o un enfermero le inyectará su medicamento.

Primero recibirá G-CSF y luego le administrarán Plerixafor Accord

La movilización comenzará administrándole primero otro medicamento llamado G-CSF (factor estimulante de colonias de granulocitos). El G-CSF ayudará a Plerixafor Accord a funcionar apropiadamente en su organismo. Si desea más información acerca de G-CSF, pregunte a su médico y lea el correspondiente prospecto.

¿Cuánto Plerixafor Accord se administra?

La dosis recomendada en adultos es de 20 mg (dosis fija) o 0,24 mg/kg de peso/día.

La dosis recomendada en niños, de 1 a menos de 18 años, es de 0,24 mg/kg de peso corporal/día.

Su dosis dependerá de su peso corporal, que debe medirse la semana anterior a que reciba la primera dosis. Si tiene problemas de riñón moderados o graves, su médico reducirá la dosis.

¿Cómo se administra Plerixafor Accord?

Plerixafor Accord se administra mediante inyección subcutánea (bajo la piel).

¿Cuándo se administra Plerixafor Accord por primera vez?

Recibirá la primera dosis entre 6 y 11 horas antes de la aféresis (recogida de las células madre de su sangre).

¿Cuánto durará la administración de Plerixafor Accord?

El tratamiento dura de 2 a 4 días consecutivos (en algunos casos hasta 7 días), hasta que se hayan recogido suficientes células madre para su trasplante. En algunos casos, no es posible recoger suficiente número de células madres, por lo que se interrumpirá el intento de recogida.

Medicine questions

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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.

Informe a su médico inmediatamente si

  • nada más recibir plerixafor, presenta erupción cutánea, hinchazón alrededor de los ojos, dificultad para respirar o falta de oxígeno, sensación de mareo estando de pie o sentado, sensación de desmayo o se desmaya
  • siente dolor en la parte superior izquierda del abdomen (vientre) o en su hombro izquierdo

Efectos adversos muy frecuentes(pueden afectar a más de 1 de cada 10 personas)

  • diarrea, náuseas, enrojecimiento o irritación en el lugar de inyección
  • recuento bajo de glóbulos rojos en las pruebas de laboratorio (anemia en niños)

Efectos adversos frecuentes(pueden afectar hasta 1 de cada 10 personas)

  • dolor de cabeza
  • mareos, sensación de cansancio o de malestar
  • dificultad para dormir
  • flatulencia, estreñimiento, indigestión, vómitos
  • síntomas estomacales como dolor, hinchazón o molestias
  • sequedad de boca, entumecimiento alrededor de la boca
  • sudoración, enrojecimiento generalizado de la piel, dolor en las articulaciones, dolor muscular y de huesos

Efectos adversos poco frecuentes(pueden afectar hasta 1 de cada 100 personas)

  • reacciones alérgicas como erupción cutánea, hinchazón alrededor de los ojos, dificultad para respirar
  • reacciones anafilácticas, incluyendo shock anafiláctico
  • sueños alterados, pesadillas

En raras ocasiones, los efectos adversos gastrointestinales pueden ser severos (diarrea, vómitos, dolor de estómago y náuseas).

Infarto de miocardio

En los ensayos clínicos, con poca frecuencia, los pacientes con factores de riesgo para padecer un infarto de miocardio padecieron un infarto de miocardio después de la administración de Plerixafor Accord y G- CSF. Informe a su médico inmediatamente si tiene molestias en el pecho.

Hormigueo y entumecimiento

El hormigueo y entumecimiento son frecuentes en pacientes que están recibiendo tratamiento para el cáncer. Aproximadamente uno de cada cinco pacientes los sufren. Sin embargo, estos efectos no parecen ocurrir con más frecuencia cuando se utiliza Plerixafor Accord.

Puede tener también un aumento del número de las células blancas de la sangre (leucocitos), en sus análisis de sangre.

Comunicación de efectos adversos

Si experimenta cualquier tipo de efecto adverso, consulte a su médico, incluso si se trata de posibles efectos adversos que no aparecen en este prospecto. También puede comunicarlos directamente a través del sistema nacional de notificación incluido en el Apéndice V. Mediante la comunicación de efectos adversos usted puede contribuir a proporcionar más información sobre la seguridad de este medicamento.

5. Conservación de Plerixafor Accord

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 la etiqueta después de CAD, La fecha de caducidad es el último día del mes que se indica.

Este medicamento no requiere condiciones especiales de conservación.

Una vez abierto el vial, Plerixafor Accord debe utilizarse inmediatamente.

Los medicamentos no se deben tirar por los desagües ni a la basura. Pregunte a su farmacéutico cómo deshacerse de los envases y de los medicamentos que no necesita. De esta forma, ayudará a proteger el medio ambiente.

6. Contenido del envase e información adicional

Composición de Plerixafor Accord

  • El principio activo es plerixafor. Cada ml de solución inyectable contiene 20 mg de plerixafor.

Cada vial contiene 24 mg de plerixafor en 1,2 ml de solución.

  • Los demás componentes son cloruro sódico, ácido clorhídrico (concentrado) e hidróxido sódico, y agua para preparaciones inyectables (ver sección 2 “Plerixafor Accord contiene sodio”).

Aspecto del producto y contenido del envase

Plerixafor Accord es una solución inyectable transparente incolora o amarilla pálida contenida en un vial de vidrio con un tapón de caucho, sello de aluminio tipo extraíble y tapa de plástico de PP de color azul mate. Cada vial contiene 1,2 ml de solución.

Cada envase contiene 1 vial.

Titular de la autorización de comercialización

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n,

Edifici Est 6ª planta,

08039 Barcelona

España

Responsable de la fabricación

Accord Healthcare Polska Sp.z o.o.

ul. Lutomierska 50,

95-200 Pabianice, Polonia

O

Laboratori Fundació Dau

C/ C, 12-14 Pol. Ind.

Zona Franca, Barcelona, 08040,

España

O

Accord Healthcare B.V.

Winthontlaan 200, 3526KV Utrecht

Países Bajos

O

Pharmadox Healthcare Limited

KW20A KordinIndustrial Park, Paola

PLA 3000, Malta

Fecha de la última revisión de este prospecto:

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Yevgen Yakovenko

General surgery 12 years exp.

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If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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General medicine 6 years exp.

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

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Bulat Garipov

General medicine 15 years exp.

Dr. Bulat Garipov is a radiologist with more than 15 years of experience, specializing in magnetic resonance imaging (MRI). Throughout his professional career, he has worked in leading diagnostic imaging centers, both in on-site practice and teleradiology, which has allowed him to develop a broad and versatile approach to radiology.

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Alina Tsurkan

Family medicine 13 years exp.

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Dmytro Horobets

Family medicine 7 years exp.

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Alexander Nazarchuk

Allergology 7 years exp.

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Frequently Asked Questions

Is a prescription required for PLERIXAFOR ACCORD 20 mg/ml INJECTABLE SOLUTION?
PLERIXAFOR ACCORD 20 mg/ml INJECTABLE 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 PLERIXAFOR ACCORD 20 mg/ml INJECTABLE SOLUTION?
The active ingredient in PLERIXAFOR ACCORD 20 mg/ml INJECTABLE SOLUTION is plerixafor. This information helps identify medicines with the same composition but different brand names.
Who manufactures PLERIXAFOR ACCORD 20 mg/ml INJECTABLE SOLUTION?
PLERIXAFOR ACCORD 20 mg/ml INJECTABLE SOLUTION is manufactured by Accord Healthcare S.L.U.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of PLERIXAFOR ACCORD 20 mg/ml INJECTABLE 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 PLERIXAFOR ACCORD 20 mg/ml INJECTABLE SOLUTION 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 PLERIXAFOR ACCORD 20 mg/ml INJECTABLE SOLUTION?
Other medicines with the same active substance (plerixafor) include MOZOBIL 20 mg/ml INJECTABLE SOLUTION, PLERIXAFOR EUGIA 20 mg/ml INJECTABLE SOLUTION, PLERIXAFOR GLENMARK 20 mg/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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