Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

D-Mannitol
Glacial acetic acid
Polysorbate 20
Sodium hydroxide
Water for injections

6.2   Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3   Shelf life

Unopened vial
The expiry date of the product is indicated on the packaging materials.
After opening
From a microbiological point of view, once opened, the medicinal product should be diluted and infused immediately.

After preparation of infusion
Chemical and physical in-use stability of the diluted solution has been demonstrated as follows: 
Infusion solution preparation           Storage at 2°C to 8°C            Storage at 20°C to 25°C protected from light                and room light
Sodium chloride 9 mg/mL                        96 hours                         72 hours (0.9%)
Sodium chloride 4.5 mg/mL                       24 hours                        24 hours (0.45%)

From a microbiological point of view, unless the method of dilution precludes the risk of microbial contamination, the diluted solution should be infused immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

6.4   Special precautions for storage

Store in a refrigerator (2°C - 8°C).
Do not freeze.
Store in the original package in order to protect from light.
For storage conditions after dilution of the medicinal product, see section 6.3.

6.5   Nature and contents of container

10 mL of concentrate in a vial (Type I glass) with a halobutyl rubber stopper and an aluminium seal fitted with a removable plastic cap.

Pack size of 1 vial.

6.6   Special precautions for disposal and other handling
Bavencio is compatible with polyethylene, polypropylene, and ethylene vinyl acetate infusion bags, glass bottles, polyvinyl chloride infusion sets and in-line filters with polyethersulfone membranes with pore sizes of 0.2 micrometre.

Handling instructions
An aseptic technique for the preparation of the solution for infusion should be used.

•     The vial should be visually inspected for particulate matter and discoloration. Bavencio is a clear, colourless to slightly yellow solution. If the solution is cloudy, discoloured, or contains particulate matters, the vial should be discarded.
•     An infusion bag of appropriate size (preferably 250 mL) containing either sodium chloride 9 mg/mL (0.9%) or with sodium chloride 4.5 mg/mL (0.45%) should be used. The required volume of Bavencio should be withdrawn from the vial(s) and transferred to the infusion bag.
Any partially used or empty vials have to be discarded.
•     The diluted solution should be mixed by gently inverting the bag in order to avoid foaming or excessive shearing of the solution.
•     The solution should be inspected to ensure it is clear, colourless, and free of visible particles.
The diluted solution should be used immediately once prepared.
•     Do not co-administer other medicinal products through the same intravenous line. Administer the solution for infusion using a sterile, non-pyrogenic, low-protein binding 0.2 micrometre in-line or add-on filter as described in section 4.2.

After administration of Bavencio, the line should be flushed with either sodium chloride 9 mg/mL (0.9%) or with sodium chloride 4.5 mg/mL (0.45%).

Do not freeze or shake the diluted solution. If refrigerated, allow the diluted solution in the intravenous bags to come to room temperature prior to use.


Disposal
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.