Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
–    Glycerol
–    Egg phospholipids
–    Sodium oleate
–    Sodium hydroxide
–       Water for Injections

6.2. IncompatibilitieS

Complete information about incompatibilities is not available.
Never add medication or electrolytes directly to the lipid emulsion. If it is necessary to introduce additives, verify the compatibility and mix thoroughly before administration to the patient.

6.3. Shelf life

The expiry date of the product is indicated on the packaging materials 
When used in neonates and children below 2 years, the solution (in bags and administration sets) should be protected from light exposure until administration is completed (see sections 4.4 and 6.6).

After opening the bag, the contents must be used immediately. The opened bag must never be stored for a subsequent infusion.

6.4. Special precautions for storage

Store at a temperature below 25°C
Do not freeze
Keep the container in the outer carton. Store in protective overwrap
For shelf life after first opening see sec. 6.3.
6.5. Nature and contents of container

The solution is supplied in a bag container.

The bag is a multi-layer plastic bag (EP-SEBS/EVA/EVA2/PCCE) packaged in an oxygen barrier outer packaging. An oxygen absorber can be added inside of the overwrap; discard the sachet after removing the overwrap.

Presentations:

100 ml in bag: Box of 24 or 10 units.
250 ml in bag: Box of 20 or 10 units.
350 ml in bag: Box of 12 or 10 units.
500 ml in bag: Box of 12 or 10 units.
1000 ml in bag: Box of 6 units.
Not all pack sizes may be marketed

6.6. Instructions for use / handling and disposal

Before opening the overwrap, check the colour of the oxygen indicator affixed to the oxygen absorber.
Compare it to the reference colour printed next to the OK symbol and depicted in the printed area of the indicator label. Do not use the product if the colour of the oxygen indicator does not correspond to the reference colour printed next to the OK symbol.
 a. To open

-    Tear the protective overwrap
-    Discard the oxygen absorber/indicator
-    Confirm the integrity of the bag
-    Use only if the bag is not damaged and if the emulsion is a homogeneous liquid with a milky appearance
b. Positioning the infusion

- Suspend the bag
- Remove the plastic protector from the administration outlet
- Firmly insert the infusion spike into the administration outlet
 c. Additions
Do not make any additions directly to the bag.

Lipids present only one component in parenteral nutrition. For a complete parenteral nutrition the concomitant substitution with amino acids, carbohydrates, electrolytes, vitamins, and trace elements is necessary. Before administration to the patient, the compatibility of the components and stability of the admixture must be checked. Admixing should be accompanied by gentle agitation during preparation under strict aseptic conditions.

 d. Administration
For single use only

After opening the bag, the contents must be used immediately. The opened bag must never be stored for a subsequent infusion. Use of a final filter is recommended during administration of all parenteral nutrition solutions, where possible.

Do not re-connect partially used-bags.

Do not connect bags in series in order to avoid the possibility of air embolism due to air contained in the primary bag.

Air embolism can result if residual gas in the bag is not fully evacuated prior to administration if the flexible bag is pressurized to increase flow rates. Use of vented intravenous administration set with the vent in the open position could result in air embolism.

Any unused product or waste material and all necessary devices must be discarded.

One litre containers are bulk source containers for pharmacy use and should not be used for direct intravenous infusion.

When used in neonates and children below 2 years, protect from light exposure, until administration is completed. Exposure of ClinOleic 20% to ambient light, especially if admixtures include trace elements and vitamins, generates peroxides and other degradation products that can be reduced by protection from light exposure (see sections 4.4 and 6.3).

7. LICENSE HOLDER AND MANUFACTURER

LICENSE HOLDER
Remedix Care Ltd.
8 Haorgim St., Ashdod