Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
ALBUMIN (HUMAN SERUM) (VENOUS)
GRIFOLS ASIA PACIFIC PTE. LTD.
B05AA01
0.2 g/ml
INFUSION, SOLUTION
ALBUMIN (HUMAN SERUM) (VENOUS) 0.2 g/ml
INTRAVENOUS
Prescription Only
INSTITUTO GRIFOLS SA
ACTIVE
1988-05-13
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. SPECIAL 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 ad Read the complete document
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. SPECIAL 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 hydrati Read the complete document