Posology : מינונים

4.2    Posology and method of administration                                           administered, the possibility of transmitting infective
The concentration of the albumin preparation, dosage                            agents cannot be totally excluded. This also applies to and the infusion-rate should be adjusted to the                                 unknown or emerging viruses and other pathogens.
patient’s individual requirements.
There are no reports of virus transmissions with
Posology                                                                        albumin manufactured to European Pharmacopoeia The dose required depends on the size of the patient,                           specifications by established processes.
the severity of trauma or illness and on continuing fluid and protein losses. Measures of adequacy of                               Appropriate vaccination (hepatitis A and B) should be circulating volume, and not plasma albumin levels,                              considered for patients in regular/repeated receipt of should be used to determine the dose required.                                  plasma-derived human albumin solutions.

If human albumin is to be administered, haemodynamic                            It is strongly recommended that every time that performance should be monitored regularly; this may                             Zenalb® 4.5 is administered to a patient, the name include:                                                                        and batch number of the product are recorded in order - arterial blood pressure and pulse rate                                        to maintain a link between the patient and the batch - central venous pressure                                                       of product.
- pulmonary artery wedge pressure
- urine output                                                            4.5   Interactions with other medicinal products and - electrolyte                                                                   other forms of interactions - haematocrit/haemoglobin                                                       No specific interactions of human albumin with other medicinal products are known.
Method of administration
Human albumin can be directly administered by the                         4.6   Pregnancy and lactation intravenous route.                                                              The safety of Zenalb® 4.5 for use in human pregnancy The infusion rate should be adjusted according to the                           has not been established in controlled clinical trials.
individual circumstances and the indication.                                    However, clinical experience with albumin suggests that no harmful effects on the course of pregnancy, or
In plasma exchange the infusion should be adjusted to                           on the foetus or the neonate are to be expected.
the rate of removal.
No animal reproduction studies have been conducted