Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Xylitol
Hydrochloric acid, concentrated (for pH adjustment) Water for injections
6.2 Incompatibilities
This medicinal product must only be mixed with other medicinal products for which compatibility has been documented, see section 6.6.
6.3 Shelf life
The expiry date of the product is indicated on the packaging materials Shelf life after mixing
Chemical and physical in-use stability after dilution has been demonstrated for 24 hours at 25°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless mixing has taken place in controlled and validated aseptic conditions.
6.4 Special precautions for storage
Do not store above 30oC.
For storage conditions after mixing of the medicinal product, see section 6.3.
6.5 Nature and contents of container
Ampoule (polypropylene) 20 x 10 ml
6.6 Special precautions for disposal and other handling Compatibility
Should not be given undiluted. Only medicinal products and nutrition solutions where compatibility has been documented may be added to Addaven. Addaven is used as an additive to parenteral nutrition admixtures in compounded bags where data are available. Compatibility data are available for the addition of 10 ml Addaven to the named branded products SMOFlipid, Intralipid 20%, Aminoven 10%, Vamin 18 EF, Dipeptiven, Omegaven, Soluvit N and Vitalipid N Adult, Addiphos, Glycophos in defined amounts and generics of glucose and electrolytes in defined concentrations. 10 ml of Addaven can also be added to the SmofKabiven and Kabiven range of products. Addaven should never be added directly to a lipid emulsion because of the destabilising effects of trace elements. It is recommended that the macronutrients (amino acid solution and glucose with or without lipid emulsion) are mixed first, before adding the Addaven and any further additions, e.g. vitamins or electrolytes. Additions should be made aseptically.
Disposal
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
MANUFACTURED BY:
Fresenius Kabi Norge AS, Halden, Norway FOR Fresenius Kabi AB, Uppsala, Sweden
REGISTRATION HOLDER:
Cure Medical & Technical Supply
6 Hashiloach st., P.O.B. 3340, Petach-Tikva