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HSA Approval

HUMAN ALBUMIN GRIFOLS INJECTION 5%

SIN11285P

HUMAN ALBUMIN GRIFOLS INJECTION 5%

HUMAN ALBUMIN GRIFOLS INJECTION 5%

February 15, 2000

GRIFOLS ASIA PACIFIC PTE. LTD.

GRIFOLS ASIA PACIFIC PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantGRIFOLS ASIA PACIFIC PTE. LTD.
Licence HolderGRIFOLS ASIA PACIFIC PTE. LTD.

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

INJECTION

**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.

INTRAVENOUS

Medical Information

**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

B05AA01

albumin

Manufacturer Information

GRIFOLS ASIA PACIFIC PTE. LTD.

INSTITUTO GRIFOLS SA

Grifols Biologicals LLC (Optional manufacturer of Fraction V)

Active Ingredients

ALBUMIN (HUMAN SERUM) (VENOUS)

5%

Albumin human

Documents

Package Inserts

Human Albumin Grifols Injection 5% PI.pdf

Approved: April 5, 2012

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