Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Mannitol
Cysteine hydrochloride monohydrate
Disodium phosphate dihydrate
Hydrochloric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment)
Water for injections


6.2   Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal product.


6.3   Shelf life
The expiry date of the product is indicated on the packaging materials.

6.4   Special precautions for storage

Store below 25°C. Do not refrigerate or freeze. Protect from light.

6.5   Nature and contents of container
Combodex IV is supplied in 100 mL clear, Type II glass vials, closed with a grey bromobutyl rubber stopper and an aluminium flip-off cap, in a pack size of 10 vials.


6.6   Special precautions for disposal and other handling
Visually inspect Combodex IV for particulate matter and discolouration prior to administration, whenever solution and container permit. If visibly opaque particles, discolouration or other foreign particulates are observed, the solution should not be used.

In the absence of compatibility studies, this medicine should not be mixed with diluents. If less than a full vial is required for a single dose, the correct amount should be infused and the remaining solution discarded (see also section 4.2).

Combodex IV should be used in one patient on one occasion only. It contains no antimicrobial preservative. Any unused solution should be discarded.