Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS

6.1.   List of Excipients
Glycine, glycocholic acid, soybean lecithin, sodium hydroxide, hydrochloric acid.

6.2.   Incompatibilities

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

•       Additives may be incompatible with parenteral nutrition containing Cernevit.
•      If co-administration of drugs that are incompatible at the Y-site is necessary, administer via separate IV lines.

•      Vitamin A and thiamine in Cernevit may react with bisulfites in parenteral nutrition solutions (e.g., as a result of admixtures) leading to degradation of vitamin A and thiamine.

•      An increase in pH of a solution may increase the degradation of some vitamins. This should be considered when adding alkaline solutions to the admixture containing Cernevit.

•      Folic acid stability can be impaired with increased calcium concentrations in an admixture.

6.3.   Shelf Life

The expiry date of the product is indicated on the packaging materials.
After reconstitution with 5 ml water for injection should not be kept for more than 24 hours at 2-8°C.

Chemical and Physical in-use stability has been demonstrated for Cernevit for 24 hours when reconstituted with 5ml of Water for Injections and stored under refrigeration. 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 to 8°C, unless reconstitution/dilution etc has taken place in controlled and validated aseptic conditions.

6.4.   Special Precautions for Storage

Do not store above 25ºC.
Keep the vial in the outer carton. Protect from heat and light.
For reconstituted product see sec. 6.3.

6.5.   Nature and Contents of Container

Type I Ph.Eur. brown glass vial with an elastomer stopper, containing an orange- yellow sterile cake of powder;

Box of 1, 10 or 20 vials of lyophilised powder. Not all pack sizes may be marketed 
6.6.   Instructions for Use/Handling.

Aseptic conditions must be followed during reconstitution and when used as part of an admixture in parenteral nutrition.
Using a syringe, inject 5 ml of water for injections. The obtained solution is yellow- orange in colour.

Mix gently to dissolve the lyophilized powder.
Before transfer from the vial, Cernevit must be completely dissolved.
Do not use unless the reconstituted solution is clear, the original seal is intact and the container is undamaged.

After addition of Cernevit to a parenteral nutrition solution, check for any abnormal colour change and/or the appearance of precipitates, insoluble complexes, or crystals.
Mix the final solution thoroughly when Cernevit is used as an admixture in parenteral nutrition.
Single use only. Any unused portion of reconstituted Cernevit should be discarded and should not be stored for subsequent admixing.
Use of a final filter is recommended during administration of all parenteral nutrition solutions.


7.   LICENSE HOLDER AND MANUFACTURER
License Holder

Remedix Care Ltd.
8 Haorgim St., Ashdod