Երկիր: Սինգապուր
Լեզու: անգլերեն
Աղբյուրը: HSA (Health Sciences Authority)
ALBUMIN (HUMAN SERUM) (VENOUS)
GRIFOLS ASIA PACIFIC PTE. LTD.
B05AA01
5.00%
INJECTION
ALBUMIN (HUMAN SERUM) (VENOUS) 5%
INTRAVENOUS
Prescription Only
INSTITUTO GRIFOLS SA
ACTIVE
2000-02-15
SOLUTION FOR INJECTION COMPOSITION Each ml contains: - Active ingredient: Human albumin 0.050 g - Excipients: Sodium caprylate, sodium N-acetyltryptophanate and water for injection. Solution with 50 g plasmaprotein/l with a human albumin content of at least 95%. The solution contains between 130 - 160 mmol/l of sodium and not more than 2 mmol/l of potassium. PHARMACEUTICAL FORM AND CONTENT Injectable solution with 5 g/100 ml of human albumin. ACTIVITY Human Albumin Grifols ® 5% is a sterile serum albumin solution derived from pooled venous blood plasma and obtained by fractionation according to Cohn's method with cold ethanol. Each unit of plasma used in the preparation of Human Albumin Grifols ® 5% has been found non- reactive for the hepatitis B surface antigen (HBsAg), for the antibodies to human immunodeficiency viruses (HIV-1 and HIV-2) and to the hepatitis C virus (HCV). The product is pasteurised at 60 ºC for 10 hours. HOLDER OF THE MARKETING AUTHORISATION Instituto Grifols, S.A. Can Guasch, 2 - Parets del Vallès 08150 Barcelona - SPAIN THERAPEUTIC INDICATIONS Human Albumin Grifols ® 5% is indicated for: - Albumin replacement in patients with albumin and blood volume deficiency. Suitable for premature born babies and dialysis patients. CONTRAINDICATIONS - A history of allergic reaction to albumin preparations. - Allergic reaction to this preparation. - All conditions in which hypervolaemia and its consequences (e.g. increased stroke volume, elevated blood pressure) or haemodilution could represent a special risk for the patient. Examples of such conditions are: · Decompensated cardiac insufficiency · Hypertension · Oesophageal varices · Pulmonary edema · Haemorrhagic diathesis · Renal and post-renal anuria · Severe anaemia PRECAUTIONS Human Albumin Grifols ® 5% is for intravenous administration use. If allergic reactions occur, the infusion should be stopped immediately. If allergic reactions persist then appropriate treatment is recommended. In anaphylactic reactions, treatment should Կարդացեք ամբողջական փաստաթուղթը
SOLUTION FOR INJECTION COMPOSITION Each ml contains: - Active ingredient: Human albumin 0.050 g - Excipients: Sodium caprylate, sodium N-acetyltryptophanate and water for injection. Solution with 50 g plasmaprotein/l with a human albumin content of at least 95%. The solution contains between 130 - 160 mmol/l of sodium and not more than 2 mmol/l of potassium. PHARMACEUTICAL FORM AND CONTENT Injectable solution with 5 g/100 ml of human albumin. ACTIVITY Human Albumin Grifols ® 5% is a sterile serum albumin solution derived from pooled venous blood plasma and obtained by fractionation according to Cohn's method with cold ethanol. Each unit of plasma used in the preparation of Human Albumin Grifols ® 5% has been found non- reactive for the hepatitis B surface antigen (HBsAg), for the antibodies to human immunodeficiency viruses (HIV-1 and HIV-2) and to the hepatitis C virus (HCV). The product is pasteurised at 60 ºC for 10 hours. HOLDER OF THE MARKETING AUTHORISATION Instituto Grifols, S.A. Can Guasch, 2 - Parets del Vallès 08150 Barcelona - SPAIN THERAPEUTIC INDICATIONS Human Albumin Grifols ® 5% is indicated for: - Albumin replacement in patients with albumin and blood volume deficiency. Suitable for premature born babies and dialysis patients. CONTRAINDICATIONS - A history of allergic reaction to albumin preparations. - Allergic reaction to this preparation. - All conditions in which hypervolaemia and its consequences (e.g. increased stroke volume, elevated blood pressure) or haemodilution could represent a special risk for the patient. Examples of such conditions are: · Decompensated cardiac insufficiency · Hypertension · Oesophageal varices · Pulmonary edema · Haemorrhagic diathesis · Renal and post-renal anuria · Severe anaemia PRECAUTIONS Human Albumin Grifols ® 5% is for intravenous administration use. If allergic reactions occur, the infusion should be stopped immediately. If allergic reactions persist then appropriate treatment is recommended. In anaphylactic reactions, treatment should follow Կարդացեք ամբողջական փաստաթուղթը