Posology : מינונים

4.2.   Posology and Method of Administration


Posology
1 vial per day

Intravenous route exclusively.

Method of Reconstitution:
The single-dose vial of CERNEVIT is reconstituted by adding 5 ml of Sterile Water for Injection into the vial and gently mixing to dissolve the lyophilized powder. The obtained solution is yellow-orange in colour. The resultant solution should be administered by intravenous infusion. After reconstitution, CERNEVIT should be used immediately or stored under refrigeration (2-8°C) for no more than 24 hours. To minimize vitamin losses in parenteral nutrition admixtures, add the vitamins immediately prior to administration and complete administration within 24 hours.
Discard any unused portion. Many parenteral vitamins are light sensitive and exposure to light should be minimized.

Notes
The total amount of powder in the vial (by weight)

The mean weight of the amount of powder in a Cernevit vial is 0.747g per vial with the approved limits of 0.710 g - 0.784 g according to the registered specifications for finished product release.

Volume after reconstitution
After reconstitution with 5 ml of solution, the final volume of the reconstituted Cernevit is 5.5 ml.

This medicinal product must not be mixed with other medicinal products except if compatibility and stability have been demonstrated.
Compatibility with solutions administered simultaneously through the same tubing must be checked.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solutions and container permit. Use of a final filter is recommended during administration of all parenteral solutions where possible.

From a microbiological point of view, the product should be used immediately after reconstitution. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user unless reconstitution has taken place under controlled and validated aseptic conditions.

Adults and Children aged 11 years and above
Adults and children aged 11 years and above should receive the contents of one vial (5 ml) per day.