Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Lipid emulsion compartment :

•   purified egg phosphatide
•   glycerol;
•   sodium oleate;
•   sodium hydroxide; for pH adjustment
•   water for injections.
Amino acid solution compartment :

• glacial acetic acid; for pH adjustment
• water for injections.


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Glucose solution compartment :

• hydrochloric acid; for pH adjustment
• water for injections.

6.2. Incompatibilities
Do not add other medicinal products or substances to any components of the bag or to the reconstituted emulsion without first confirming their compatibility and the stability of the resulting preparation (in particular the stability of the lipid emulsion or formation of precipitates).

As with any parenteral nutrition admixture, calcium and phosphate ratios must be considered. Excess addition of calcium and phosphate, especially in the form of mineral salts, may result in formation of calcium phosphate precipitates

Incompatibilities may be produced for example by excessive acidity (low pH) or inappropriate content of divalent cations (Ca2+ and Mg2+), which may destabilise the lipid emulsion.
Check compatibility with solutions administered simultaneously through the same administration set, catheter or cannula.
Do not administer before, simultaneously with or after blood through the same equipment because of the risk of pseudoagglutination.

6.3. Shelf life

2 years if the overwrap is not damaged.
It is recommended that the product be used immediately after the non-permanent seals between the three compartments have been broken.
However, the reconstituted emulsion has been shown to be stable for a maximum of 7 days between 2°C and 8°C, followed by a maximum of 48 hours at temperatures not exceeding 25°C.
After adding supplements (electrolytes, organic phosphate, trace elements, vitamins; see section 6.6.) : For specific admixtures, chemical and physical in-use stability has been demonstrated for 7 days at 2°C to 8°C, followed by 48 hours below 25°C. From a microbiological point of view, any admixture 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°C to 8°C, unless addition of supplements has taken place in controlled and validated aseptic conditions.

6.4.   Special precautions for storage

Do not store above 25°C.
Do not freeze.
Keep the container in the outer carton in order to protect from light.
For storage of the reconstituted emulsion, see section 6.3
6.5. Nature and contents of container

The 3 -compartment bag is a multi-layer plastic bag. The inner (contact) layer of the bag material is made of a blend of polyolefinic copolymers and is compatible with amino acid solutions, glucose solutions and lipid emulsions. Other layers are made of EVA (poly(ethylene-vinyl acetate)), and of a copolyester.
The bag is packaged in an oxygen barrier overwrap, which contains an oxygen absorber in a sachet.
The glucose compartment is fitted with an injection site to be used for addition of supplements.
The amino acid compartment is fitted with an administration site for insertion of the spike of the infusion set.
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After the seals have been broken, the capacity of the bag is sufficient to enable vitamins, electrolytes and trace elements to be added.

Presentations

1000 ml in a 3 compartment bag (400 ml 10% amino acid solution (corresponding to 10g/100ml) + 400 ml 40% glucose solution (corresponding to 40g/100ml) + 200 ml 20% lipid emulsion (corresponding to
20g/100ml))
Carton with 6 bags

1500 ml in a 3 -compartment bag (600 ml 10% amino acid solution (corresponding to 10g/100ml) + 600 ml 40% glucose solution (corresponding to 40g/100ml) + 300 ml 20% lipid emulsion (corresponding to
20g/100ml))
Carton with 4 bags

2000 ml in a 3 -compartment bag (800 ml 10% amino acid solution (corresponding to 10g/100ml) + 800 ml
40% glucose solution (corresponding to 40g/100ml) + 400 ml 20% lipid emulsion (corresponding to
20g/100ml))
Carton with 4 bags
2500 ml in a 3 -compartment bag (1000 ml 10% amino acid solution (corresponding to 10g/100ml) + 1000 ml 40% glucose solution (corresponding to 40g/100ml) + 500 ml 20% lipid emulsion (corresponding to 20g/100ml))
Carton with 2 bags
6.6.   Special precautions for disposal and other handling a. To open
-      Tear the protective overwrap.
-      When present, discard the oxygen absorber sachet after removing the overwrap.
-      Confirm the integrity of the bag and of the non-permanent seals.
-      Use only if the bag is not damaged, if the non-permanent seals are intact (i.e. no mixture of the contents of the three compartments) and if the amino acids solution and the glucose solution are clear, colorless, or slightly yellow, practically free of visible particles, and if the lipid emulsion is a homogeneous liquid with a milky appearance.
 b. Mixing the solutions and the emulsion

Ensure that the product is at ambient temperature when breaking the non-permanent seals.
Manually roll the bag onto itself, starting at the top of the bag (hanger end). The non-permanent seals will disappear from the side near the inlets. Continue to roll until the seals are open along half of their length.
Mix by inverting the bag at least 3 times.
 c. Preparation of the infusion

Aseptic conditions must be observed.
Suspend the bag.
Remove the plastic protector from the administration outlet.
Firmly insert the spike of the infusion set into the administration outlet.
d. Additions

The capacity of the bag is sufficient to enable additions such as, vitamins, electrolytes, and trace elements.
Any additions (including vitamins) may be made into the reconstituted mixture (after the non-permanent seals have been opened and the contents of the three compartments have been mixed).


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Vitamins may also be added into the glucose compartment before the mixture has been reconstituted (before opening the non-permanent seals and before mixing the solutions and the emulsion).

When making additions to the formulation, the final osmolarity of the mixture should be measured before administration via a peripheral vein

Oliclinomel may be supplemented with:
-      Electrolytes : stability has been demonstrated up to a total quantity of 150 mmol of sodium, 150 mmol of potassium, 5.6 mmol of magnesium and 5 mmol of calcium per litre of the ternary mixture.
-      Organic phosphate: stability has been demonstrated for additions of up to 22 mmol per bag.
-      Trace elements and vitamins: Stability has been demonstrated with commercially available preparations of vitamins and trace elements (containing up to 1 mg of iron). Compatibility for other additives is available upon request.

Additions must be performed by qualified personnel under aseptic conditions.

These additions are made into the injection site using a needle:
-      Prepare the injection site,
-      Puncture the injection site and inject,
-      Mix the contents of the bag and the additives.
 e. Administration

For single use only.

Only administer the product after the non-permanent seals between the 3 compartments have been broken and the contents of the 3 compartments have been mixed.
Ensure that the final emulsion for infusion does not show any evidence of phase separation.

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

Do not reconnect any partially used bag
Do not connect bags in series in order to avoid the air embolism due to air contained in the primary bag.

Any unused product or waste material and all necessary devices must be discarded.
Do not store any partially used bags and discard all devices after use