Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Sucrose
Polysorbate 80
Disodium phosphate dodecahydrate
Sodium dihydrogen phosphate dihydrate
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

The expiry date of the product is indicated on the packaging materials.
Diluted product: After dilution, the prepared solution for infusion is physically and chemically stable in sodium chloride 9 mg/mL (0.9%) solution for injection. It can be stored for 24 hours at 30ºC and for up to 2 weeks (14 days) in a refrigerator at 2°C -8°C for polypropylene (PP) soft bag & hard bottle, polyethylene (PE) soft bags & hard bottle, polyvinyl chloride (PVC) soft bag and glass vial.


From a microbiological point of view, the prepared solution for infusion 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–8°C, unless dilution has taken place in controlled and validated aseptic conditions.

6.4   Special precautions for storage

Store vials in a refrigerator (2°C–8°C). Do not freeze.
Keep the vial(s) in the outer carton in order to protect from light.

For storage conditions of the diluted medicinal product see section 6.3.

6.5   Nature and contents of container
Actemra is supplied in a vial (type I glass) with a stopper (butyl rubber) containing 4 mL or 10 mL concentrate. Pack sizes of 1 and 4 vials.

Not all pack sizes may be marketed.

6.6   Special precautions for disposal and other handling
Instructions for dilution prior to administration
Parenteral medicinal products should be inspected visually for particulate matter or discolouration prior to administration. Only solutions which are clear to opalescent, colourless to pale yellow and free of visible particles should be diluted. Use a sterile needle and syringe to prepare Actemra.


RA, CRS Patients (≥ 30 kg) and COVID-19
Withdraw a volume of sterile, non-pyrogenic sodium chloride 9 mg/mL (0.9%) solution for injection from a 100 mL infusion bag, equal to the volume of Actemra concentrate required for the patients dose, under aseptic conditions. The required amount of Actemra concentrate (0.4 mL/kg) should be withdrawn from the vial and placed in the 100 mL infusion bag. This should be a final volume of 100 mL. To mix the solution, gently invert the infusion bag to avoid foaming.

Use in the paediatric population
 sJIA, pJIA and CRS Patients ≥ 30 kg
Withdraw a volume of sterile, non-pyrogenic sodium chloride 9 mg/mL (0.9%) solution for injection from a 100 mL infusion bag, equal to the volume of Actemra concentrate required for the patients dose, under aseptic conditions. The required amount of Actemra concentrate (0.4 mL/kg) should be withdrawn from the vial and placed in the 100 mL infusion bag. This should be a final volume of 100 mL. To mix the solution, gently invert the infusion bag to avoid foaming.
 sJIA and CRS Patients < 30 kg
Withdraw a volume of sterile, non-pyrogenic sodium chloride 9 mg/mL (0.9%) solution for injection from a 50 mL infusion bag, equal to the volume of Actemra concentrate required for the patients dose, under aseptic conditions. The required amount of Actemra concentrate (0.6 mL/kg) should be withdrawn from the vial and placed in the 50 mL infusion bag. This should be a final volume of 50 mL. To mix the solution, gently invert the infusion bag to avoid foaming.
 pJIA Patients < 30 kg
Withdraw a volume of sterile, non-pyrogenic sodium chloride 9 mg/mL (0.9%) solution for injection from a 50 mL infusion bag, equal to the volume of Actemra concentrate required for the patients dose, under aseptic conditions. The required amount of Actemra concentrate (0.5 mL/kg) should be withdrawn from the vial and placed in the 50 mL infusion bag. This should be a final volume of 50 mL. To mix the solution, gently invert the infusion bag to avoid foaming.


Actemra is for single-use only.
Any unused product or waste material should be disposed of in accordance with local requirements.

7.    MARKETING AUTHORISATION HOLDER

Roche Pharmaceuticals (Israel) Ltd., P.O. Box 6391, Hod Hasharon, 4524079.

8.    MARKETING AUTHORISATION NUMBER(S)

142.21.31931.00