Pharmaceutical particulars : מידע רוקחי

6       PHARMACEUTICAL PARTICULARS

6.1     List of excipients
Glycerol
Purified egg phospholipids
Sodium oleate all-rac-α-Tocopherol
Sodium hydroxide (pH adjuster)
Acetic acid, glacial (pH adjuster)
Hydrochloric acid (pH adjuster)
Water for injections
6.2     Incompatibilities
SmofKabiven Electrolyte Free may only be mixed with other medicinal products for which compatibility has been documented.

6.3     Shelf life
Shelf life of the medicinal product as packaged for sale: The expiry date of the product is indicated on the packaging materials.

Shelf life after mixing
Chemical and physical in-use stability of the mixed three chamber bag has been demonstrated for 36 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.

Shelf life after mixing with additives
From a microbiological point of view, the product should be used immediately when additions have been made. If not used immediately, the in-use storage time and conditions prior to use are the responsibility of the user and should normally not be longer than 24 hours at 2-8°C.

6.4     Special precautions for storage
Do not store above 25°C. Do not freeze. Store in overpouch.

Shelf life after mixing: See section 6.3.
Shelf life after mixing with additives: See section 6.3.
6.5     Nature and contents of container
The container consists of a multichamber inner bag and an overpouch. The inner bag is separated into three chambers by peelable seals. An oxygen absorber is placed between the inner bag and the overpouch. The inner bag is made of a multilayer polymer film, alternatively Excel or Biofine. The Excel innerbag film consists of three layers. The inner layer consists of poly (propylene/ethylene) copolymer and styrene/ethylene/butylene/styrene thermoplastic elastomer (SEBS).
The middle layer consists of SEBS and the outer layer consists of copolyester- ether. The infusion port is equipped with a polyolefine cap. The additive port is equipped with a synthetic polyisoprene (latex-free) stopper.

The Biofine inner bag film consists of poly(propylene-co-ethylene), synthetic rubber poly[styrene-block-(butylene-co-ethylene)] (SEBS) and synthetic rubber poly(styrene-block-isoprene) (SIS). The infusion and additive ports are made of polypropylene and synthetic rubber poly[styrene-block-(butylene-co-ethylene)] (SEBS) equipped with synthetic polyisoprene (latex-free) stoppers. The blind port, which is only used during manufacturing, is made of polypropylene equipped with a synthetic polyisoprene (latex-free) stopper.

Pack sizes:
1 x 986 ml, 4 x 986 ml
1 x1477 ml, 4 x 1477 ml
1 x 1970 ml, 2 x 1970 ml (Excel), 4 x 1970 ml (Biofine)
1 x 2463 ml, 2 x 2463 ml (Excel), 3 x 2463 ml (Biofine)

Not all pack sizes may be marketed.
6.6     Special precautions for disposal and other handling
Instructions for use
Do not use if package is damaged. Use only if the amino acid and glucose solutions are clear and colourless or slightly yellow and the lipid emulsion is white and homogenous. The contents of the three separate chambers have to be mixed before use, and before any additions are made via the additive port.
Additions should be only to the activated bag. The phosphate and calcium additions should be as far apart as possible, i.e. phosphate at the beginning and calcium at the end of the addition sequence. The bag should be mixed well between each addition.

After separation of the peelable seals the bag should be inverted on a number of occasions to ensure a homogenous mixture, which does not show any evidence of phase separation.

Compatibility
Only medicinal or nutrition solutions for which compatibility has been documented may be added to SmofKabiven Electrolyte Free.
The compatibility of SmofKabiven and SmofKabiven EF (for central administration) in parenteral nutrition admixtures has been investigated. The tested compositions listed in the table below are compatible and stable after admixing.

Compatibility data are available with the named branded products Dipeptiven, Vamin 18 EF, Addaven, Vitalipid N Adult/Infant, Soluvit N, Addiphos and Glycophos in defined amounts and generics of electrolytes in defined concentrations. When making electrolyte additions, the amounts already present in the bag should be taken into account to meet the clinical needs of the patient. Generated data supports additions to the activated bag according to the summary table below:

Maximal total contents
SmofKabiven/SmofKabiven              493 ml      986 ml      1477 ml      1970 ml   2463 ml EF bag sizes

Additive                                                     Volume
Dipeptiven                           0 - 100     0 - 300     0 - 300      0 - 300    0 - 300 ml          ml          ml           ml         ml

Vamin 18 EF                          0 - 160     0 - 330     0 - 660      0 - 660    0 - 660 ml          ml          ml           ml         ml
Addaven                               0 - 10     0 - 10       0 - 10      0 - 10     0 - 10 ml         ml           ml          ml         ml
Soluvit N                           0 - 1 vial 0 - 1 vial 0 - 1 vial 0 - 1 vial 0 - 1 vial Vitalipid N Adult/Infant              0 - 10     0 - 10       0 - 10      0 - 10     0 - 10 ml         ml           ml          ml         ml
Electrolyte limits1                                       Concentration Sodium                                                     ≤ 150 mmol/l Potassium                                                  ≤ 150 mmol/l Calcium                                                     ≤ 5 mmol/l Magnesium                                                   ≤ 5 mmol/l Phosphate inorganic                                           ≤ 15 mmol/l (Addiphos)                                                        OR
OR                                                            ≤ 30 mmol/l Phosphate organic
(Glycophos)
Zinc                                                         ≤ 0.2 mmol/l Selenium                                                       ≤ 1 µmol/l 1.   includes amounts from all products
Note: This table is intended to indicate compatibility. It is not a dosing guideline.

Addition should be made aseptically.

For single use only. Any mixture remaining after infusion must be discarded.
Any unused medicinal product or waste material should be disposed in accordance with local requirement.

7    Manufacturer:

Fresenius Kabi AB, Uppsala, Sweden.
8    Registration holder:
Cure Medical & Technical supply Ltd, 6 Hashiloach St., P.O.B. 3340, Petach Tikva.