HUMAN ALBUMIN GRIFOLS 5%250ML

Land: Maleisië

Taal: Engels

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

Werkstoffen:

ALBUMIN HUMAN

Beschikbaar vanaf:

GRIFOLS MALAYSIA SDN. BHD.

INN (Algemene Internationale Benaming):

ALBUMIN HUMAN

Eenheden in pakket:

250ml mL

Geproduceerd door:

INSTITUTO GRIFOLS S.A.

Productkenmerken

Solution for infusion
COMPOSITION
Active ingredient: Human albumin.
Solution containing 5% of protein of which at least 95% is human
albumin.
Human Albumin Grifols
®
5% is mildly hypooncotic to normal plasma.
Excipients: Sodium chloride, 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 5 g 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.
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
When albumin is given, the electrolyte status of the patient should be
monitored (see section
Posology) and appropriate steps taken to restore or maintain the
electrolyte balance.