HUMAN ALBUMIN GRIFOLS INJECTION 5%

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

ALBUMIN (HUMAN SERUM) (VENOUS)

Available from:

GRIFOLS ASIA PACIFIC PTE. LTD.

ATC code:

B05AA01

Dosage:

5.00%

Pharmaceutical form:

INJECTION

Composition:

ALBUMIN (HUMAN SERUM) (VENOUS) 5%

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

INSTITUTO GRIFOLS SA

Authorization status:

ACTIVE

Authorization date:

2000-02-15

Patient Information leaflet

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

Summary of Product characteristics

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