- Approval Id
- bcb5e3beab8ceea7
- Drug Name
- Albumex 20
- Product Name
- Albumex 20
- Approval Number
- SIN12139P
- Approval Date
- 2002-12-02
- Registrant
- BLOOD SERVICES GROUP, HEALTH SCIENCES AUTHORITY
- Licence Holder
- BLOOD SERVICES GROUP, HEALTH SCIENCES AUTHORITY
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION, SOLUTION, CONCENTRATE
- Dosage
- **DOSAGE AND ADMINISTRATION**
**Dosage**
**_Hypoproteinaemia in the acutely ill patient_**
The usual daily dose is 50–75 g human albumin (250–375 mL of Albumex® 20). The rate of administration should not exceed 2 mL per minute, as more rapid infusion may precipitate circulatory overload and pulmonary oedema.
The infusion of Albumex® 20 is not justified in hypoproteinaemic states associated with chronic cirrhosis, malabsorption, protein losing enteropathies, pancreatic insufficiency or undernutrition.
**_Shock_**
The dose should be determined by the patient’s condition and response to treatment. The usual initial dose of 20 g human albumin (100 mL of Albumex® 20) may be administered as a blood volume expander at a rate of 2 to 4 mL per minute.
The rate of infusion may be increased in emergencies and repeated in 15 to 30 minutes if necessary. The total dose should not exceed the level of albumin found in the normal individual i.e. about 2 g per kg body weight in the absence of active bleeding.
If concentrated albumin (>5%) is given, it should be accompanied by the intravenous infusion of a crystalloid solution. Failure to supply this additional fluid may lead to dehydration of the tissues.
The precise nature and strength of the crystalloid solution will depend on the requirements of the patient for electrolytes and fluid.
**_Burns_**
The usual dose is 20–80 g human albumin (100–400 mL of Albumex® 20) given daily at the rate of about 1 mL per minute.
Beyond 24 hours, Albumex® 20 can be used to maintain plasma colloid osmotic pressure.
A reasonable goal is the maintenance of a plasma albumin concentration of 25 g/L or a colloid osmotic pressure of 20 mmHg.
The continuing need for albumin is occasioned by losses from denuded areas and decreased albumin synthesis.
**_Acute respiratory distress syndrome_**
Commence with a dose of 50 g human albumin (250 mL of Albumex® 20) over the first 24 hours together with diuretic therapy. Thereafter the dose is adjusted to maintain vital signs, particularly central venous pressure, urine output and plasma albumin concentration.
**_Haemodialysis_**
Patients with significant fluid overload prior to dialysis may benefit from the administration of 20–40 g human albumin (100–200 mL of Albumex® 20) at the end of the dialysis procedure.
**_Plasma exchange_**
Replace albumin removed on a gram-for-gram basis, e.g. removal of 2.5 L plasma should be accompanied by replacement with 125 g human albumin (625 mL of Albumex® 20), either prediluted or followed by 4–5 volumes of an appropriate crystalloid solution (see **Administration–Dilution of concentrated albumin 20%**).
**Monitoring advice**
It is recommended that blood pressure is monitored during administration of Albumex® 20.
To avoid circulatory overload the rate and volume of infusion should be monitored frequently.
Myocardial function should also be monitored e.g. central venous pressure, arterial pressure and pulse rate.
It is also recommended that plasma electrolytes, prothrombin time, biochemistry and haematological status should be monitored.
**Administration**
NOTE: Albumex® 20 contains no antimicrobial preservative. It must, therefore, be used immediately after opening the bottle. Any unused solution should be discarded appropriately. Use in one patient on one occasion only.
Albumex® 20 is normally clear or slightly opalescent. If it appears to be turbid by transmitted light, it must not be used and the bottle should be returned unopened to the Blood Services Group.
Albumex® 20 should always be administered by intravenous infusion using appropriate IV administration equipment. Albumex® 20 is packaged in a glass bottle that must be vented during use.
In some cases a dose of albumin is added to a suitable crystalloid solution.
**Dilution of concentrated albumin 20%:** Albumex® 20 can be diluted to an iso-oncotic protein concentration (4–5% albumin) prior to administration, in the proportion of 1 mL of Albumex® 20 to 4 mL of suitable crystalloid solution and administered by the usual intravenous technique.
Under no circumstances should water be used since the lower tonicity will lead to intravascular haemolysis.
If the product has been stored in the refrigerator it should be allowed to reach room temperature before administration. Do not use if the solution has been frozen.
It is strongly recommended that every time Albumex® 20 is administered to a patient, the name and batch number of the product be recorded in order to maintain a link between the patient and the batch of the product.
_The following procedure is recommended_
1. Remove the plastic cover from the seal.
2. Apply a suitable antiseptic to the exposed part of the rubber stopper and allow to dry.
3. Stand the bottle upright and insert the air vent needle vertically in one of the indentations of the stopper. It is preferable to use a long airway needle fitted with a filter. If not available, a short needle attached to a non-wettable filter may be used.
4. Clamp the tubing of the giving set and insert the perforator vertically through one of the other indentations of the stopper. **Should the stopper become dislodged, do not use this bottle and discard the solution appropriately.**
5. Invert the bottle and attach the hanger to a support approximately one metre above the patient.
6. Allow the tubing to fill by adjusting the clamp. Insert the giving set needle into a vein and adjust the rate of flow.
7. When the bottle is empty, clamp the tubing and transfer the air vent needle and the needle at the upper end of the giving set to a further bottle of Albumex® 20 or to a bottle containing a crystalloid solution, according to requirements.
8. **Should leakage become evident during administration, cease the infusion and discard the solution appropriately. Recommence the infusion with a new bottle and giving set.**
**Compatibility with other fluids**
The addition of other drugs to Albumex® 20 has not been evaluated.
Albumex® 20 should not be mixed with protein hydrolysates, amino acid solutions, solutions containing alcohol, or solutions containing drugs that bind to albumin e.g. calcium channel blockers, antibiotics and benzodiazepines.
- Route Of Administration
- INTRAVENOUS
- Indication Info
- **INDICATIONS**
**Hypoproteinaemia in the acutely ill patient**
Albumex® 20 is administered when there are existing or anticipated clinical problems or complications from reduced oncotic pressure, and/or as an adjunct to diuretic therapy.
**Shock**
Albumex® 20 may be used for the resuscitation of patients in shock due to acute loss of blood or plasma, but 4–5% human albumin is preferred when available.
**Burns**
Extensive burns are followed by sequential shifts in the distribution of body water, salt and proteins, resulting in hypovolaemic shock and circulatory failure.
Initially (during the first 24 hours) there is an increased vascular permeability leading to loss of water and proteins into the extravascular compartment, and haemoconcentration. Large volumes of crystalloid solutions should be infused to restore the constricted intravascular fluid space, and smaller amounts of Albumex® 20 are required to maintain adequate plasma volume and colloid osmotic pressure.
**Adult respiratory distress syndrome**
The clinical syndrome is characterised by inadequate oxygenation secondary to pulmonary interstitial oedema, complicating shock and postoperative states resulting in a decreased central venous pressure, decreased plasma albumin concentration, rising blood pressure, reduced cardiac output, lowered pulse rate and a falling renal output.
The acute condition can be controlled by diuretics and Albumex® 20 in amounts sufficient to maintain vital signs.
In patients who have undergone abdominal surgery, the intravenous (IV) administration of albumin solution (20%) immediately after the operation has been shown to improve lung compliance and gaseous exchange.
**Haemodialysis**
Albumex® 20 may be used to assist with the rapid removal of excess extravascular fluid and to maintain perfusion pressure.
**Plasma exchange**
Therapeutic plasma exchange is a procedure in which approximately one plasma volume is exchanged with a colloid replacement solution. The choice of replacement fluid and its concentration are determined by the particular clinical situation and the frequency of the procedure.
Iso-oncotic albumin solution is the preferred replacement material. If the patient’s serum albumin level is not maintained, concentrated albumin (20%) may be indicated. If exchange occurs less frequently than once a week, less concentrated colloids may be appropriate.
- Contraindications
- **CONTRAINDICATIONS**
Albumex® 20 must not be used if there is a history of allergy to this product. Albumin is contraindicated in patients with cardiac failure, pulmonary oedema or severe anaemia.
The infusion of Albumex® 20 is not justified in hypoproteinaemic states associated with chronic cirrhosis, malabsorption, protein losing enteropathies, pancreatic insufficiency or undernutrition.
In chronic nephrosis, infused albumin solution (20%) is promptly excreted by the kidneys with no relief of the chronic oedema.
- Atc Code
- B05AA01
- Atc Item Name
- albumin
- Pharma Manufacturer Name
- blood services group, health sciences authority
