HUMAN ALBUMIN GRIFOLS 20%/50ML

Država: Malezija

Jezik: angleščina

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktivna sestavina:

ALBUMIN HUMAN

Dostopno od:

GRIFOLS MALAYSIA SDN. BHD.

INN (mednarodno ime):

ALBUMIN HUMAN

Izdeluje:

INSTITUTO GRIFOLS S.A.

Lastnosti izdelka

Solution for infusion
Composition
Active ingredient: Human albumin.
Solution containing 20% of protein of which at least 95% is human albumin.
Human Albumin Grifols 20% has a hyperoncotic effect.
Excipients: Sodium caprylate, sodium N-acetyltryptophanate and water for injections.
Aluminium content ≤200 µg/l.
The solution contains between 130 - 160 mmol/l of sodium and not more than 2 mmol/l of
potassium.
Pharmaceutical form and content
Solution for infusion.
Each 100 ml contains 20 g of human albumin.
Activity
Human Albumin Grifols 20% is a sterile serum albumin solution derived from pooled venous
blood plasma and obtained by fractionation according to Cohn's method with cold ethanol.
The product is pasteurised at 60 ºC for 10 hours.
Manufacturer
Instituto Grifols, S.A.
Can Guasch, 2 - Parets del Vallès
08150 Barcelona - SPAIN
Therapeutic indications
Restoration and maintenance of circulating blood volume where volume deficiency has been
demonstrated, and use of a colloid is appropriate.
The choice of albumin rather than artificial colloid will depend on the clinical situation of the
individual patient, based on official recommendations.
Contraindications
Hypersensitivity to albumin preparations or to any of the excipients.
Precautions
If allergic or anaphylactic-type reactions occur, the infusion should be stopped immediately and
appropriate treatment instituted. In case of shock, the current medical standards for shock-
treatment should be observed.
Albumin should be used with caution in conditions where hypervolaemia and its consequences or
haemodilution could represent a special risk for the patient. Examples of such conditions are:
- Decompensated cardiac insufficiency
- Hypertension
- Oesophageal varices
- Pulmonary oedema
- Haemorrhagic diathesis
- Severe anaemia
- Renal and post-renal anuria
The colloid-osmotic effect of human albumin 20% is approximately four times that of blood
plasma. Therefore, when concentrated albumin is administered, care must be taken to assure
adequate hydration of the patie