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CARBETOCINA GP-PHARM 100 micrograms Injectable Solution in Pre-filled Syringe

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About the medicine

How to use CARBETOCINA GP-PHARM 100 micrograms Injectable Solution in Pre-filled Syringe

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

Carbetocina GP-Pharm 100 microgramos solución inyectable en jeringa precargada

Carbetocina

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, matrona o enfermero.
  • Si experimenta efectos adversos, consulte a su médico, matrona o enfermero, incluso si se trata de efectos adversos que no aparecen en este prospecto. Ver sección 4.

Contenido del prospecto

  1. Qué es Carbetocina GP-Pharm y para qué se utiliza
  2. Qué necesita saber antes de que le administren Carbetocina GP-Pharm
  3. Cómo se administra Carbetocina GP-Pharm
  4. Posibles efectos adversos
  5. Conservación de Carbetocina GP-Pharm
  6. Contenido del envase e información adicional

1. Qué es Carbetocina GP-Pharm y para qué se utiliza

El principio activo de Carbetocina GP-Pharm es la carbetocina. Es similar a una sustancia llamada oxitocina, que es producida naturalmente por el cuerpo para contraer el útero durante el parto.

Carbetocina GP-Pharm se utiliza en el tratamiento de mujeres que acaban de tener un niño.

En algunas mujeres, después del parto el útero (la matriz) no se contrae suficientemente rápido. Esto hace más probable que sangren más de lo normal. Carbetocina GP-Pharm hace contraer el útero y así reduce el riesgo de sangrado.

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 que le administren Carbetocina GP-Pharm

No se debe ulitizarCarbetocina GP-Pharm hasta que el niño haya sido extraído.

Antes de usar Carbetocina GP-Pharm, su médico debe conocer las enfermedades que usted pueda tener. Debe decir a su médico cualquier síntoma nuevo que desarrolle mientras está siendo tratada con Carbetocina GP-Pharm.

No use Carbetocina GP-Pharm

  • Si está embarazada
  • Si está de parto y el niño aún no ha sido extraído
  • Para inducir el parto
  • Si es alérgicaa la carbetocina o a cualquiera de los demás componentes de este medicamento (incluidos en la sección 6).
  • Si es alérgicaa la oxitocina (bien si se lo han administrado por goteo o bien por inyección durante o después del parto)
  • Si tiene cualquier enfermedad de riñóno hígado.
  • Si tiene cualquier enfermedad coronaria grave.
  • Si tiene epilepsia(episodios repetitivos de convulsiones, pérdida de conciencia).

Si sufre alguno de estos síntomas, consúltelo con su médico, matrona o enfermera.

Advertencias y precauciones

Informe a su médico, matrona o enfermera antes de recibir Carbetocina GP-Pharm:

  • Si tiene migrañas (dolor de cabeza repetitivo).
  • Si tiene asma(trastorno respiratorio con episodios repetitivos de dificultad respiratoria, pitos y tos).
  • Si usted tiene preeclampsia (presión arterial elevada en el embarazo) o eclampsia (toxemia gravídica-agitación intensa, movimientos involuntarios).
  • Si tiene problemas con su corazóno su circulación(tal como tensión arterial elevada).
  • Si tiene cualquier otra enfermedad.

Si sufre alguno de estos síntomas, consúltelo con su médico, matrona o enfermera.

Carbetocina GP-Pharm puede causar una acumulación de agua en el cuerpo que puede provocar somnolencia, apatía y dolor de cabeza.

Niños y adolescentes

No relevante en niños menores de 12 años.

La experiencia con adolescentes es limitada.

Uso de Carbetocina GP-Pharm con otros medicamentos

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

Embarazo y lactancia

Carbetocina GP-Pharm no debe utilizarse durante el embarazo y el parto hasta que el niño haya sido extraído.

Se ha visto que pequeñas cantidades de carbetocina pasan de la sangre de madres en periodo de lactancia a la leche materna, pero se asume que se degrada en el intestino del lactante.

La lactancia materna no necesita ser restringida después del uso de Carbetocina GP-Pharm.

CarbetocinaGP-Pharm contiene sodio

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

3. Cómo se administra Carbetocina GP-Pharm

Carbetocina GP-Pharm se administra mediante una inyecciónen una de sus venas o en uno de sus músculos, inmediatamente después de la extracción de su bebé. La dosis es una jeringa precargada (100 microgramos).

Si se le administra más Carbetocina GP-Pharm de la que debiera

Si se le ha administrado accidentalmente más Carbetocina GP-Pharm de la que debiera, puede sufrir hiperactividad uterina con contracciones fuertes que puede llevar a la rotura uterina o hemorragia postparto. Puede también sufrir somnolencia, apatía y dolor de cabeza, causada por la acumulación de líquidos. Se deberá tratar con otra medicación y posible cirugía.

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.

Cuando se administra Carbetocina GP-Pharmen una de sus venas después de una cesárea

Muy frecuentes: pueden afectar a más de 1 de cada 10 mujeres:

  • Náuseas
  • Dolor de estómago
  • Prurito (picor)
  • Rubor (piel roja)
  • Sensación de calor
  • Tensión arterial baja
  • Dolor de cabeza
  • Temblores

Frecuentes: hasta 1 de cada 10 mujeres:

  • Vómitos
  • Vértigo
  • Dolor de espalda o pecho
  • Sabor metálico en la boca
  • Anemia (disminución de los glóbulos rojos)
  • Disnea (dificultad respiratoria)
  • Escalofríos
  • Dolor general

No conocida: la frecuencia no puede estimarse en base a los datos disponibles

  • Aceleración de los latidos del corazón
  • Latidos del corazón lentos que pueden provocar una parada cardíaca (cuando el corazón deja de latir)

Efectos secundarios observados con productos similares que podrían esperarse con la carbetocina:

Latidos cardíacos irregulares, dolor de pecho, desmayos o palpitaciones que puede significar que el corazón no está latiendo correctamente.

Reacciones alérgicas (incluyendo reacción alérgica grave y repentina con dificultad para respirar, hinchazón, aturdimiento, latido cardiaco rápido, sudoración, presión sanguínea baja y pérdida de conocimiento).

Ocasionalmente algunas mujeres podrían experimentar sudoración.

Cuando se administraCarbetocina GP-Pharmen uno de sus músculos después del parto vaginal

Poco frecuentes: pueden afectar hasta 1 de cada 100 mujeres

  • Náuseas
  • Dolor de estómago
  • Vómitos
  • Presión arterial baja
  • Anemia
  • Dolores de cabeza
  • Mareos
  • Latidos rápidos
  • Dolor de espalda o pecho
  • Debilidad muscular
  • Escalofríos
  • Fiebre
  • Dolor general

Raras: pueden afectar a menos de 1 de cada 1,000 mujeres

  • Rubor (piel roja)
  • Prurito (picor)
  • Disnea
  • Temblores
  • Dificultad para orinar

Efectos secundarios observados en productos similares a carbetocina:

Latidos cardíacos lentos, latidos cardíacos irregulares, dolor de pecho, desmayos o palpitaciones, que puede significar que el corazón no está latiendo correctamente.

Reacciones alérgicas (incluyendo reacción alérgica grave y repentina con dificultad para respirar, hinchazón, aturdimiento, latido cardiaco rápido, sudoración, presión sanguínea baja y pérdida de conocimiento).

Comunicación de efectos adversos:

Si experimenta cualquier tipo de efecto adverso, consulte a su médico, matrona 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: 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 Carbetocina GP-Pharm

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

Las jeringas precargadas de Carbetocina GP-Pharm se conservan en el embalaje original para protegerlas de la luz. Conservar en nevera (2ºC – 8ºC).

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 Carbetocina GP-Pharm

  • El principio activo es la carbetocina. Cada jeringa precargada contiene un mililitro con 100 microgramos de carbetocina.
  • Los demás componentes son: cloruro de sodio, ácido acético glacial para ajuste de pH, agua para preparaciones inyectables.

Aspecto del producto y contenido del envase

Carbetocina GP-Pharm es una solución clara e incolora, preparada para inyección intravenosa o intramuscular y proporcionada en envases que contienen cinco jeringas precargadas de 1 ml.

Carbetocina GP-Pharm debe ser usada sólo en unidades de obstetricia especializadas bien equipadas.

Titular de la Autorización de Comercialización y responsables de la fabricación

GP Pharm, S.A.

Pol. Ind. Els Vinyets – Els Fogars Sector 2.Carretera Comarcal C-244, Km. 22

08777 Sant Quintí de Mediona (Barcelona)

España

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

España: Carbetocina GP-Pharm 100 microgramos solución inyectable en jeringa precargada

Alemania:Carbetocin Aguettant 100 Mikrogramm/ml Injektionslösung in einer Fertigspritze

Austria:Carbetocin Aguettant 100 Mikrogramm/ml Injektionslösung in einer Fertigspritze

Italia:Carbetocina Aguettant

Francia:Carbetocine Aguettant 100 microgrammes/ml, solution injectable en seringue pré-remplie

Bélgica:Carbetocine Aguettant 100 microgrammes/ml solution injectable en seringue préremplie / 100 Mikrogramm/ml Injektionslösung in einer Fertigspritze / 100 microgram/ml oplossing voor injectie in voorgevulde spuit

Dinamarca:Carbetocin Aguettant 100 mikrogram/ml injektionsvæske, opløsning i fyldt injektionssprøjte

Finlandia:Carbetocin Aguettant 100 mikrogram/ml, injektioneste, liuos, esitäytetty ruisku

Noruega:Carbetocin Aguettant 100 mikrogram/ml injeksjonsvæske, oppløsning i ferdigfylt sprøyte

Suecia:Carbetocin Aguettant 100 mikrogram/ml injektionsvätska, lösning i förfylld spruta

Fecha de la última revisión de este prospecto: mayo 2023.

Otras fuentes de información

La información detallada de este medicamento está disponible en la página web de la Agencia Española de Medicamentos y Productos Sanitaroshttp://www.aemps.gob.es/.

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Frequently Asked Questions

Is a prescription required for CARBETOCINA GP-PHARM 100 micrograms Injectable Solution in Pre-filled Syringe?
CARBETOCINA GP-PHARM 100 micrograms Injectable Solution in Pre-filled Syringe 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 CARBETOCINA GP-PHARM 100 micrograms Injectable Solution in Pre-filled Syringe?
The active ingredient in CARBETOCINA GP-PHARM 100 micrograms Injectable Solution in Pre-filled Syringe is carbetocin. This information helps identify medicines with the same composition but different brand names.
Who manufactures CARBETOCINA GP-PHARM 100 micrograms Injectable Solution in Pre-filled Syringe?
CARBETOCINA GP-PHARM 100 micrograms Injectable Solution in Pre-filled Syringe is manufactured by Gp Pharm S.A.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of CARBETOCINA GP-PHARM 100 micrograms Injectable Solution in Pre-filled Syringe 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 CARBETOCINA GP-PHARM 100 micrograms Injectable Solution in Pre-filled Syringe 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 CARBETOCINA GP-PHARM 100 micrograms Injectable Solution in Pre-filled Syringe?
Other medicines with the same active substance (carbetocin) include DURATOBAL 100 micrograms/ml INJECTABLE SOLUTION, OXITOCIN KABI 10 IU/ML INJECTABLE SOLUTION AND PERFUSION SOLUTION, SYNTOCINON 10 IU/mL Injectable Solution and Perfusion 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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