Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients


Amount in vial with 100 ml Amount in vial with 50 ml
N1-acetyl D/L - tryptophan    392 mg                           196 mg Chloride                      max 355 mg                       max 177.5 mg Sodium                        288 mg                           144 mg Caprylate                     228 mg                           114 mg Potassium                     max 8 mg                         max 4 mg Water for injection           Ad 100 ml                        Ad 50 ml 


6.2   Incompatibilities

Human Albumin 20 % Behring, low salt, must not be mixed with other medicinal products (except the recommended diluents in section 6.6 "Special precautions for disposal and other handling"), whole blood and packed red cells.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.
Human Albumin 20 % Behring, low salt, must not be used after the expiry date given on the pack and container.
Once the container has been opened, the contents should be used immediately.

6.4   Special precautions for storage

Do not store above 25 °C. Do not freeze.
Keep the infusion bottle in the outer carton in order to protect from light.
Keep out of the reach and sight of children!

6.5   Nature and contents of container

Immediate containers
Vial of 50 ml, colourless glass (Type II Ph. Eur.), sealed with a rubber stopper, aluminium seal and plastic flip-off cap.

Vial of 100 ml, colourless glass (Type II Ph. Eur.), sealed with a rubber stopper, aluminium seal and plastic flip-off cap.
Presentations
Infusion vial with 50 ml
Infusion vial with 100 ml

Not all pack sizes may be marketed.

6.6   Special precautions for disposal and other handling
Any unused product or waste material should be disposed of in accordance with local requirements.

Method of administration
Human albumin can be administered by the intravenous route, either undiluted or after dilution in an isotonic solution (e.g. 5 % glucose or 0.9 % sodium chloride).
Albumin solutions must not be diluted with water for injections as this may cause haemolysis in recipients.

If large volumes are administered, the product should be warmed to room or body temperature before use.

Do not use solutions which are cloudy or contain residues (deposits/particles). This may indicate that the protein is unstable or that the solution has become contaminated.

Once the container has been opened, the contents have to be used immediately.