Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Trehalose dihydrate
L-histidine hydrochloride monohydrate
L-histidine
Poloxamer 188
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 dilution
In use stability (shelf life of the diluted product): dilution in the following infusion solution in polyolefine, polypropylene, polyvinylchloride, and polyethylene soft bag: sodium chloride 0.9%., chemical and physical in-use stability has been demonstrated for 24 hours at 28°C followed by 24 hours not above 30°C followed by the administration duration of max. 24 hours.

From a microbiological point of view, the prepared infusion solution 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 in a refrigerator (2°C-8°C).
Do not freeze.

Keep the vial in the outer carton 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

40 mL concentrate in a 50 mL vial (clear Type I glass) with stopper (butyl rubber). Pack size of 1 vial.

6.6   Special precautions for disposal and other handling
Instructions for dilution
Gazyva should be prepared by a healthcare professional using aseptic technique. Do not shake the vial.
Use a sterile needle and syringe to prepare Gazyva.

For CLL cycles 2 – 6 and all FL cycles
Withdraw 40 mL of concentrate from the vial and dilute in polyvinyl chloride (PVC) or non-PVC polyolefin infusion bags containing sodium chloride 9 mg/mL (0.9%) solution for injection.

CLL only – Cycle 1
To ensure differentiation of the two infusion bags for the initial 1,000 mg dose, it is recommended to utilise bags of different sizes to distinguish between the 100 mg dose for Cycle 1 Day 1 and the 900 mg dose for Cycle 1 Day 1 (continued) or Day 2. To prepare the 2 infusion bags, withdraw 40 mL of concentrate from the vial and dilute 4 mL into a 100 mL PVC or non-PVC polyolefin infusion bag and the remaining 36 mL in a 250 mL PVC or non-PVC polyolefin infusion bag containing sodium chloride 9 mg/ml (0.9%) solution for injection. Clearly label each infusion bag. For storage conditions of the infusion bags see section 6.3.



Dose of Gazyva to be           Required amount of Gazyva                Size of PVC or non-PVC administered                       concentrate                        polyolefin infusion bag 100 mg                             4 mL                                   100 mL 900 mg                            36 mL                                   250 mL 1000 mg                            40 mL                                   250 mL 
Do not use other diluents such as glucose (5%) solution (see section 6.2).

The bag should be gently inverted to mix the solution in order to avoid excessive foaming. The diluted solution should not be shaken or frozen.

Parenteral medicinal products should be inspected visually for particulates and discolouration prior to administration.

No incompatibilities have been observed between Gazyva, in concentration ranges from 0.4 mg/mL to 20.0 mg/mL after dilution of Gazyva with sodium chloride 9 mg/mL (0.9%) solution for injection,
and:
•     PVC, polyethylene (PE), polypropylene or polyolefin bags
•     PVC, polyurethane (PUR) or PE infusion sets
•     optional inline filters with product contact surfaces of polyethersulfone (PES), a 3-way stopcock infusion aid made from polycarbonate (PC), and catheters made from polyetherurethane (PEU).

Disposal

Any unused medicinal 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)

153-41-34195-00