HUMAN ALBUMIN GRIFOLS 20%

Land: Singapore

Språk: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv ingrediens:

ALBUMIN (HUMAN SERUM) (VENOUS)

Tilgjengelig fra:

GRIFOLS ASIA PACIFIC PTE. LTD.

ATC-kode:

B05AA01

Dosering :

0.2 g/ml

Legemiddelform:

INFUSION, SOLUTION

Sammensetning:

ALBUMIN (HUMAN SERUM) (VENOUS) 0.2 g/ml

Administreringsrute:

INTRAVENOUS

Resept typen:

Prescription Only

Produsert av:

INSTITUTO GRIFOLS SA

Autorisasjon status:

ACTIVE

Autorisasjon dato:

1988-05-13

Informasjon til brukeren

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

Preparatomtale

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