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HUMAN ALBUMIN GRIFOLS INJECTION 5% [SIN11285P]
Active ingredients: HUMAN ALBUMIN GRIFOLS INJECTION 5%
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Product Info
HUMAN ALBUMIN GRIFOLS INJECTION 5%
[SIN11285P]
Product information
Active Ingredient and Strength | ALBUMIN (HUMAN SERUM) (VENOUS) - 5% |
Dosage Form | INJECTION |
Manufacturer and Country | INSTITUTO GRIFOLS SA - SPAIN |
Registration Number | SIN11285P |
Licence Holder | GRIFOLS ASIA PACIFIC PTE. LTD. |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | B05AA01 |
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.
Posology
In general, the dosage and the infusion-rate should be adjusted to the patient's individual requirements.
When human albumin is used in replacement therapy, the dosage required is guided by the usual circulatory parameters. The lowest limit for the colloidal osmotic pressure is 20 mm Hg (2.7 kPa).
If human albumin is to be administered, the dose in grams required can be estimated using the following calculation:
[required total protein (g/l) - actual total protein (g/l)] x plasma volume (l) x 2
The physiological plasma volume may be calculated as approximately 0.04 l/kg body weight.
As the formula in any case is only approximate, laboratory monitoring of achieved protein concentration is recommended.
In cases of extensive substitution and in cases with haematocrit below 30% see "Precautions" – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Paediatric use:
In children the physiological plasma volume is age-dependent, this fact must be taken into account.
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
