Albúmina humana

Presentación

Albúmina 20% (CSL Behring, AEMPS) y 25% (Albuminex, BPL, FDA)

¿Para qué sirve albúmina humana? Indicaciones autorizadas

Restablecimiento y mantenimiento del volumen circulatorio sanguíneo cuando se haya demostrado un déficit de volumen y el uso de un coloide se considere apropiado.

AEMPS (CIMA) · ALBUMINA HUMANA CSL BEHRING 200 G/L SOLUCION PARA PERFUSION · 4.1 Indicaciones terapéuticas

Contraindicaciones de albúmina humana

Hipersensibilidad a la albúmina o a alguno de los excipientes incluidos en la sección 6.1.

AEMPS (CIMA) · ALBUMINA HUMANA CSL BEHRING 200 G/L SOLUCION PARA PERFUSION · 4.3 Contraindicaciones

Ajuste en insuficiencia renal

Parámetro que cita la fuente: Diálisis / TRRC

Initial dose of 25 g (including renal dialysis).

FDA (DailyMed) · ALBUMINEX · Dosage and administration · texto original en inglés

For renal dialysis; the initial dose should not exceed 25 g and patients should be carefully observed for signs of fluid overload.

FDA (DailyMed) · ALBUMINEX · Dosage and administration · texto original en inglés

Indication | Dose Hypovolemia | Adults: Initial dose of 25 g (including renal dialysis). For acute liver failure: initial dose of 12 to 25 g. (• 2.1 ) Prevention of central volume depletion after paracentesis due to cirrhotic ascites | Adults: 8 g for every 1000 mL of ascitic fluid removed. (• 2.1 ) Hypoalbuminemia including from burns | Adults: 50 to 75 g For pre- and post-operative hypoproteinemia: 50 to 75 g. For…

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Indication | Dose

Hypovolemia | Adults: Initial dose of 25 g (including renal dialysis). For acute liver failure: initial dose of 12 to 25 g. (• 2.1 )

Prevention of central volume depletion after paracentesis due to cirrhotic ascites | Adults: 8 g for every 1000 mL of ascitic fluid removed. (• 2.1 )

Hypoalbuminemia including from burns | Adults: 50 to 75 g For pre- and post-operative hypoproteinemia: 50 to 75 g. For burn therapy after the first 24 h: initial dose of 25 g and dose adjustment to maintain plasma protein concentration of 2.5 g per 100 mL. Third space protein loss due to infection: initial dose of 50 to 100 g. (• 2.1 )

Acute nephrosis | Adults: 25 g together with diuretic once a day for 7-10 days. (• 2.1 )

Adult respiratory distress syndrome (ARDS) | Adults: 25 g over 30 minutes and repeated at 8 hours for 3 days, if necessary. (• 2.1 )

Cardiopulmonary bypass procedures | Adults: Initial dose of 25 g. (• 2.1 )

Indication | Dose

Hypovolemia | Hypovolemia Adults: Initial dose of 25 g. If hemodynamic stability is not achieved within 15 to 30 minutes, an additional dose may be given. For acute liver failure: initial dose of 12 to 25 g. An infusion rate of 1-2 mL per minute is usually indicated. For renal dialysis; the initial dose should not exceed 25 g and patients should be carefully observed for signs of fluid overload.

Prevention of central volume depletion after paracentesis due to cirrhotic ascites | Adults: 8 g for every 1000 mL of ascitic fluid removed.

Hypoalbuminemia including from burns | Adults: 50 to 75 g For pre- and post-operative hypoproteinemia: 50 to 75 g. In burns, therapy usually starts with administration of large volumes of crystalloid solution to maintain plasma volume. After 24 hours: initial dose of 25 g and dose adjustment to maintain plasma protein concentration of 2.5 g per 100 mL or a serum protein concentration of 5.2 g per 100 mL. Third space protein loss due to infection or burns: initial dose of 50 to 100 g. An infusion rate of 1-2 mL per minute is usually indicated in the absence of shock. Treatment should always be guided by hemodynamic response.

Acute nephrosis | Adults: 25 g together with diuretic once a day for 7-10 days

Adult respiratory distress syndrome (ARDS) | Adults: 25 g over 30 minutes and repeated at 8 hours for 3 days, if necessary.

Cardiopulmonary bypass procedures | Adults: Initial dose of 25 g. Additional amounts may be administered as clinically indicated.

FDA (DailyMed) · ALBUMINEX · Dosage and administration table · texto original en inglés

Ajuste en insuficiencia hepática

For acute liver failure: initial dose of 12 to 25 g.

FDA (DailyMed) · ALBUMINEX · Dosage and administration · texto original en inglés

For acute liver failure: initial dose of 12 to 25 g.

FDA (DailyMed) · ALBUMINEX · Dosage and administration · texto original en inglés

Indication | Dose Hypovolemia | Adults: Initial dose of 25 g (including renal dialysis). For acute liver failure: initial dose of 12 to 25 g. (• 2.1 ) Prevention of central volume depletion after paracentesis due to cirrhotic ascites | Adults: 8 g for every 1000 mL of ascitic fluid removed. (• 2.1 ) Hypoalbuminemia including from burns | Adults: 50 to 75 g For pre- and post-operative hypoproteinemia: 50 to 75 g. For…

Leer la sección completa

Indication | Dose

Hypovolemia | Adults: Initial dose of 25 g (including renal dialysis). For acute liver failure: initial dose of 12 to 25 g. (• 2.1 )

Prevention of central volume depletion after paracentesis due to cirrhotic ascites | Adults: 8 g for every 1000 mL of ascitic fluid removed. (• 2.1 )

Hypoalbuminemia including from burns | Adults: 50 to 75 g For pre- and post-operative hypoproteinemia: 50 to 75 g. For burn therapy after the first 24 h: initial dose of 25 g and dose adjustment to maintain plasma protein concentration of 2.5 g per 100 mL. Third space protein loss due to infection: initial dose of 50 to 100 g. (• 2.1 )

Acute nephrosis | Adults: 25 g together with diuretic once a day for 7-10 days. (• 2.1 )

Adult respiratory distress syndrome (ARDS) | Adults: 25 g over 30 minutes and repeated at 8 hours for 3 days, if necessary. (• 2.1 )

Cardiopulmonary bypass procedures | Adults: Initial dose of 25 g. (• 2.1 )

Indication | Dose

Hypovolemia | Hypovolemia Adults: Initial dose of 25 g. If hemodynamic stability is not achieved within 15 to 30 minutes, an additional dose may be given. For acute liver failure: initial dose of 12 to 25 g. An infusion rate of 1-2 mL per minute is usually indicated. For renal dialysis; the initial dose should not exceed 25 g and patients should be carefully observed for signs of fluid overload.

Prevention of central volume depletion after paracentesis due to cirrhotic ascites | Adults: 8 g for every 1000 mL of ascitic fluid removed.

Hypoalbuminemia including from burns | Adults: 50 to 75 g For pre- and post-operative hypoproteinemia: 50 to 75 g. In burns, therapy usually starts with administration of large volumes of crystalloid solution to maintain plasma volume. After 24 hours: initial dose of 25 g and dose adjustment to maintain plasma protein concentration of 2.5 g per 100 mL or a serum protein concentration of 5.2 g per 100 mL. Third space protein loss due to infection or burns: initial dose of 50 to 100 g. An infusion rate of 1-2 mL per minute is usually indicated in the absence of shock. Treatment should always be guided by hemodynamic response.

Acute nephrosis | Adults: 25 g together with diuretic once a day for 7-10 days

Adult respiratory distress syndrome (ARDS) | Adults: 25 g over 30 minutes and repeated at 8 hours for 3 days, if necessary.

Cardiopulmonary bypass procedures | Adults: Initial dose of 25 g. Additional amounts may be administered as clinically indicated.

FDA (DailyMed) · ALBUMINEX · Dosage and administration table · texto original en inglés

Reconstitución de albúmina humana

No requiere.

Dilución de albúmina humana

Directa o diluida en solución isotónica (glucosa 5% o SF 0.9%). NUNCA diluir con agua para inyección (hemólisis). Atemperar si se infunden grandes volúmenes.

Administración de albúmina humana

Infusión IV.

Estabilidad y periodo de validez

Compatibilidad de albúmina humana

Compatible con

• Glucosa 5%
• SF 0.9%

Incompatible con

• Agua para inyección como diluyente (hemólisis)
• Sangre total y concentrados de hematíes; otros medicamentos

Conservación y protección de la luz

CSL Behring 20%: no conservar por encima de 25 °C. Albuminex 25%: no por encima de 30 °C. No congelar.

Mantener el vial en su embalaje exterior para protegerlo de la luz (ambas fuentes).

Advertencias

• No usar si la solución está turbia o tiene sedimento.
• Hemoderivado: registrar el número de lote.

Diferencias entre fuentes oficiales

• Tras abrir: uso inmediato (CSL Behring) vs iniciar en 4 h (Albuminex). Temperatura máxima 25 °C vs 30 °C.

Fuentes

1. AEMPS (CIMA) · ALBUMINA HUMANA CSL BEHRING 200 G/L SOLUCION PARA PERFUSIONCsl Behring Gmbh · Albúmina humana 200 g/L (20%) solución para perfusión · versión 2021-02-06
2. FDA (DailyMed) · ALBUMINEXBPL · Albuminex 25% (12.5 g/50 mL y 25 g/100 mL) · versión 2024-12-31

Identificación

ATC

B05AA01

SNOMED CT (VTM)

789264004

RxNorm

828529