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"DRUG's INFO"
| Sunday, January 28, 2007 |
| Human Albumin 20 % Biotest FH |
1. Composition
1000 ml solution contain :
- active ingredients :
Human Plasma Protein 200 g
of which albumin at least 96 %
- Exipients :
Caprylate : 2.31 g (16mmol)
N-Acetyl-DL-tryptophanate : 3.94 g (16 mmol)
Sodium 2.80 (122 mmol)
Chloride 3.90 g (110 mmol)
water for injection 1000 ml
2. Presentation
Solution for intravenous infusion
Vial with 50 ml
Vial with 100 ml
3. Indication
Restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated and use of colloid is appropiate. The choice of albumin rather than artificial colloid will depend on the clinical situation of the individual patient, based on official recommendations.
4. Contraindications
Hypersensitivity to albumin preparation or to any the excipients.
5. Special warning and special precaution for use
If allergic or anaphylactic type reactions occur, the infusion should be stopped immediately and appropriate treatment instituted, in case of shock the current medical standarts for shock-treatment should be observed.
Albumin should be used with coution in conditions where hypervolaemia and its concequences or haemodelution could represent a special risk for the patient.
Examples of such condition are :
- Decompensated cardiac insufficeincy
- Hypertension
- Oesophageal varices
- Pulmonary oedema
- Haemorragic diathesis
- Severe anemia
- Renal and post renal anuria
6. Effects on Ability to drive and use machines
There are no indications that human albumin may impai the abilities to drive or to operate machines.
7. Interaction with other medicine
No specific interactions of human albumin with other products are known.
8. Dosage
The dose required depends on the size of the patient, the severity of trauma or illness and on continuing fluid or protein losses.
If the human albumin is to be administered, haemodynamic performance should be monitored regularly; this may include :
- arterial blood pressure and pulse rate
- central venous pressure
- pulmonary artery wedge pressure
- Urine output
- Electrolyte
- haemaotcrit/HB.
9. Mode of Administration
Human albumin can be directly administered by the intravenous route or it can also be diluted in an isotonic solution. The infusion rate should be adjusted according to the individual circumstance and the indication.
10. Overdose
Hypervolaemia may occur if the dosage and rate of infusions are too hight. At the first clinical sign of cardiovascular overload (headache, dyspnoea).The infusions sholud be stopped immediately.
Reference :
Patient Information Leaflet, Biotest Pahrma, Germany. |
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