Pharmaceutical particulars : מידע רוקחי

6     PHARMACEUTICAL PARTICULARS
6.1 List of excipients

Sucrose
L-arginine hydrochloride
L-histidine
L-histidine monohydrochloride
Polysorbate 80

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.
In-use stability of the reconstituted solution in the vial has been demonstrated for 8 hours at 2°C-8°C.
In-use stability of the diluted solution in sodium chloride 9 mg/mL (0.9%) solution for injection in infusion bag has been demonstrated for 12 hours at 20°C-25°C or 24 hours at 2°C-8°C.

The combined in-use stability of vedolizumab in the vial and infusion bag with sodium chloride 9 mg/mL (0.9%) solution for injection is a total of 12 hours at 20°C-25°C or 24 hours at 2°C-8°C. A 24 hour period may include up to 8 hours at 2°C-8°C for reconstituted solution in the vial and up to
12 hours at 20°C-25°C for diluted solution in the infusion bag but the infusion bag must be stored in the refrigerator (2°C-8°C) for the rest of the 24 hour period.

Do not freeze the reconstituted solution in the vial or the diluted solution in the infusion bag.

Storage condition
Refrigerator (2°C-8°C)          20°C-25°C
Reconstituted solution in the vial                           8 hours                 Do not hold1 Diluted solution in sodium chloride 9 mg/mL
24 hours2,3                    12 hours2
(0.9%) solution for injection
1
Up to 30 minutes are allowed for reconstitution
2
This time assumes the reconstituted solution is immediately diluted in the sodium chloride 9 mg/mL (0.9%) solution for injection and held in the infusion bag only. Any time that the reconstituted solution was held in the vial should be subtracted from the time the solution may be held in the infusion bag.
3 This period may include up to 12 hours at 20 °C-25 °C.

6.4 Special precautions for storage

Store in a refrigerator (2 °C-8 °C). Keep the vial in the outer carton in order to protect from light.
For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.

6.5 Nature and contents of container

Powder for concentrate for solution for infusion in Type 1 glass vial (20 mL) fitted with rubber stopper and aluminium seal with a plastic flip off cap.

Each pack contains 1 vial.

6.6 Special precautions for disposal and other handling
Instructions for reconstitution and infusion

1.       Use aseptic technique when preparing Entyvio I.V. solution for intravenous infusion.
2.       Remove flip-off cap from the vial and wipe with alcohol swab. Reconstitute vedolizumab with
4.8 mL of sterile water for injections at room temperature (20 °C-25 °C), using a syringe with a
21-25 gauge needle.
3.       Insert the needle into the vial through the centre of the stopper and direct the stream of liquid to the wall of the vial to avoid excessive foaming.
4.       Gently swirl the vial for at least 15 seconds. Do not vigorously shake or invert.
5.       Let the vial sit for up to 20 minutes at room temperature (20 °C-25 °C), to allow for reconstitution and for any foam to settle; the vial can be swirled and inspected for dissolution during this time. If not fully dissolved after 20 minutes, allow another 10 minutes for dissolution.
6.       Inspect the reconstituted solution visually for particulate matter and discolouration prior to dilution. Solution should be clear or opalescent, colourless to light yellow and free of visible particulates. Reconstituted solution with uncharacteristic colour or containing particulates must not be administered.
7.       Once dissolved, gently invert vial 3 times.
8.       Immediately withdraw 5 mL (300 mg) of reconstituted Entyvio using a syringe with a 21-25 gauge needle.
9.       Add the 5 mL (300 mg) of reconstituted Entyvio to 250 mL of sterile sodium chloride 9 mg/mL (0.9%) solution for injection, and gently mix the infusion bag (5 mL of sodium chloride 9 mg/mL (0.9%) solution for injection does not have to be withdrawn from the infusion bag prior to adding Entyvio). Do not add other medicinal products to the prepared infusion solution or intravenous infusion set. Administer the infusion solution over 30 minutes (see section 4.2).

Once reconstituted, the infusion solution should be used as soon as possible.

Do not store any unused portion of the reconstituted solution or infusion solution for reuse.
Each vial is for single use only.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.