Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1. List of excipients
Sucrose
SM-102 (lipid nanoparticles):
- SM-102
- Cholesterol
- DSPC (1,2-distearoyl-sn-glycero-3-phosphocholine)
- PEG2000 DMG (1,2-Dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000) Trometamol hydrochloride (Tris-HCl)
Trometamol (Tris)
Sodium acetate trihydrate
Acetic acid (Glacial)
Water for injections

6.2. Incompatibilities

This medicinal product must not be mixed with other medicinal products or diluted.
6.3. Shelf life

Unopened vial
The expiry date of the product is indicated on the packaging materials.

The unopened vaccine vial may be stored refrigerated at 2°C to 8°C, protected from light, for a maximum of 30 days. Within this period, up to 12 hours may be used for transportation at 2°C to 8°C (see section 6.4).

Once thawed the vaccine should not be refrozen.

The unopened vaccine may be stored at 8°C to 25°C up to 24 hours after removal from refrigerated conditions.

Punctured vial
Chemical and physical in-use stability has been demonstrated for 19 hours at 2°C to 25ºC after 
initial puncture (within the allowed use period of 30 days at 2°C to 8ºC and 24 hours at 8°C to 25ºC). From a microbiological point of view, the product should be used immediately. If the vaccine is not used immediately, in-use storage times and conditions are the responsibility of the user.

6.4. Special precautions for storage

Store in a freezer at -25ºC to -15ºC.
Keep the vial in the outer carton in order to protect from light.
Do not store on dry ice or below -50ºC.
For storage conditions after thawing and first opening see section 6.3.
Transportation of thawed vials in liquid state at 2°C to 8°C
If transport at -50°C to -15°C is not feasible, available data support transportation of one or more thawed vials in liquid state for up to 12 hours at 2°C to 8°C (within the 30 days shelf life at 2°C to 8°C). Once thawed and transported in liquid state at 2°C to 8°C, vials should not be refrozen and should be stored at 2°C to 8°C until use.

6.5. Nature and contents of container

5 mL dispersion in a type 1 glass or type 1 equivalent glass multidose vial with a stopper (chlorobutyl rubber) and a red flip-off plastic cap with seal (aluminium seal).

Pack size: 10 multidose vials. Each vial contains 5 mL.

6.6. Special precautions for disposal and other handling
The vaccine should be prepared and administered by a trained healthcare professional using aseptic techniques to ensure sterility of the dispersion.

Store vials and pre-filled syringes in a freezer at -25˚C to -15˚C.

Keep the vial and pre-filled syringe in the outer carton in order to protect from light.
Multidose vial

The vaccine comes ready to use once thawed.

Do not shake or dilute. Swirl the vial gently after thawing and before each withdrawal.
A maximum of ten (10) doses (of 0.5 mL each) or a maximum of twenty (20) doses (of 0.25 mL each) can be withdrawn from each vial (red flip-off cap).

Pierce the stopper preferably at a different site each time. Do not puncture the vial more than 20 times.

An additional overfill is included in each vial to ensure that a maximum of 10 doses of 0.5 mL or a maximum of 20 doses of 0.25 mL can be delivered.

Thaw each multidose vial before use following the instructions below (Table 5).
When the vial is thawed in the refrigerator, let it sit at room temperature for 15 minutes before administering.


Table 5. Thawing instructions for multidose vials before use
Thaw instructions and duration
Thaw                             Thaw
Configuration          temperature (in a Thaw duration temperature     Thaw duration refrigerator)                    (at room temperature)
2 hours and
Multidose vial         2° – 8°C                         15°C – 25°C    1 hour 30 minutes



Disposal

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