Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS

6.1    List of excipients
Water for injections
Sucrose
Sodium citrate
Polysorbate 80
Sodium Hydroxide (for pH adjustment)

6.2    Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3    Shelf life

The expiry date of the product is indicated on the packaging materials 
6.4    Special precautions for storage

Pre-filled syringe
Store in a refrigerator (2°C - 8°C).
Do not freeze.
Keep the pre-filled syringe in its sealed blister and in the outer carton in order to protect from light.
Prior to use, the unopened blister may be kept at room temperature (below 25°C) for up to 24 hours.

Vial

Store in a refrigerator (2°C - 8°C).
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
Prior to use, the unopened vial may be kept at room temperature (below 25°C) for up to 24 hours.


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6.5    Nature and contents of container

Pre-filled syringe

0.165 ml sterile solution in a pre-filled syringe (type I glass) with a bromobutyl rubber plunger stopper and a syringe cap consisting of a white, tamper-evident rigid seal with a grey bromobutyl rubber tip cap including a Luer lock adapter. The pre-filled syringe has a plunger rod and a purple finger grip, and is packed in a sealed blister.

Pack size of 1 pre-filled syringe.

Vial
0.23 ml sterile solution in a 2ml glass vial with a coated rubber stopper sealed with an aluminium cap with a purple plastic flip-off disk.

Pack size of 1 vial and 1 blunt filter needle (18G x 1½″, 1.2 mm x 40 mm, 5 μm).

Not all pack sizes may be marketed.
6.6    Special precautions for disposal and other handling

Pre-filled syringe

The pre-filled syringe contains more than the recommended dose of 6 mg. The extractable volume of the pre-filled syringe (0.165 ml) is not to be used in total. The excess volume should be expelled prior to injection. Injecting the entire volume of the pre-filled syringe could result in overdose. To expel the air bubble along with the excess medicinal product, slowly push the plunger until the edge below the dome of the rubber stopper is aligned with the black dosing line on the syringe (equivalent to 0.05 ml, i.e., 6 mg brolucizumab).

The solution should be inspected visually upon removal from the refrigerator and prior to administration. If particulates or cloudiness are visible, the pre-filled syringe must not be used and appropriate replacement procedures followed.

The pre-filled syringe is sterile and for single use only. Do not use if the packaging, or pre-filled syringe are damaged or expired. Detailed instructions for use are provided in the package leaflet.

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

Vial
The vial contains more than the recommended dose of 6 mg. The extractable volume of the vial (0.23 ml) is not to be used in total. The excess volume should be expelled prior to injection. Injecting the entire volume of the vial could result in overdose. The injection dose must be set to the 0.05 ml dose mark, i.e. 6 mg brolucizumab.
The solution should be inspected visually upon removal from the refrigerator and prior to administration. If particulates or cloudiness are visible, the vial must not be used, and appropriate replacement procedures must be followed.
The content of the vial and the filter needle are sterile and for single use only. Do not use if the packaging, vial and/or filter needle are damaged or expired. Detailed instructions for use are provided in the package leaflet.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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7.    REGISTRATION HOLDER AND IMPORTER

Novartis Israel Ltd., POB 7126, Tel-Aviv