Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS
6.1    List of excipients

Powder:
α,α-Trehalose dihydrate
Poloxamer 407
Sodium chloride
Disodium hydrogen phosphate dihydrate
Human serum albumin
Potassium dihydrogen phosphate
Potassium chloride

Solvent:
Sodium chloride
Water for injections
6.2    Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other vaccine or medicinal products except for the solvent provided.

6.3    Shelf life

The expiry date of the product is indicated on the packaging materials.
After reconstitution with the solvent provided, Qdenga should be used immediately.

If not used immediately, Qdenga must be used within 2 hours.

Chemical and physical in-use stability have been demonstrated for 2 hours at room temperature (up to 32.5°C) from the time of reconstitution of the vaccine vial. After this time period, the vaccine must be discarded. Do not return it to the refrigerator.

From a microbiological point of view Qdenga should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

6.4       Special precautions for storage

Store in a refrigerator (2°C to 8°C). Do not freeze.
Store in the original package.
For storage conditions after reconstitution of Qdenga, see section 6.3.

6.5       Nature and contents of container

Qdenga powder and solvent for solution for injection:
•    Powder (1 dose) in glass vial (Type-I glass), with a stopper (butyl rubber) and aluminium seal with green flip-off plastic cap + 0.5 mL solvent (1 dose) in glass vial (Type-I glass), with a stopper (bromobutyl rubber) and aluminium seal with purple flip-off plastic cap 
Pack size of 1 or 10.

Qdenga powder and solvent for solution for injection in pre-filled syringe: 
•    Powder (1 dose) in vial (Type-I glass), with a stopper (butyl rubber) and aluminium seal with green flip-off plastic cap + 0.5 mL solvent (1 dose) in pre-filled syringe (Type-I glass), with a plunger stopper (bromobutyl) and a tip cap (polypropylene), with 2 separate needles 
Pack size of 1 or 5.

•    Powder (1 dose) in vial (Type-I glass), with a stopper (butyl rubber) and aluminium seal with green flip-off plastic cap + 0.5 mL solvent (1 dose) in pre-filled syringe (Type-I glass), with a plunger stopper (bromobutyl) and a tip cap (polypropylene), without needles 
Pack size of 1 or 5.

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

Instructions for reconstitution of the vaccine with the solvent presented in vial 
Qdenga is a 2-component vaccine that consists of a vial containing lyophilised vaccine and a vial containing solvent. The lyophilised vaccine must be reconstituted with solvent prior to administration.

Use only sterile syringes for reconstitution and injection of Qdenga. Qdenga should not be mixed with other vaccines in the same syringe.

To reconstitute Qdenga, use only the solvent (0.22% sodium chloride solution) supplied with the vaccine since it is free of preservatives or other anti-viral substances. Contact with preservatives, 
antiseptics, detergents, and other anti-viral substances is to be avoided since they may inactivate the vaccine.

Remove the vaccine and solvent vials from the refrigerator and place at room temperature for approximately 15 minutes.

•   Remove the caps from both vials and clean the surface of stoppers on top of the vials using an alcohol wipe.
•   Attach a sterile needle to a sterile 1 mL syringe and insert the needle into the solvent vial. The recommended needle is 23G.
•   Slowly press the plunger completely down.
•   Turn the vial upside down, withdraw the entire contents of the vial and continue to pull plunger out to 0.75 mL.
Solvent vial                     A bubble should be seen inside of the syringe.
•   Invert the syringe to bring the bubble back to the plunger.

• Insert the needle of the syringe assembly into the lyophilised vaccine vial.
• Direct the flow of the solvent toward the side of the vial while slowly depressing the plunger to reduce the chance of forming bubbles.


Lyophilised vaccine vial

•   Release your finger from the plunger and, holding the assembly on a flat surface, gently swirl the vial in both directions with the needle syringe assembly attached.
•   DO NOT SHAKE. Foam and bubbles may form in the reconstituted product.
•   Let the vial and syringe assembly sit for a while until the solution becomes clear. This takes about 30-60 seconds.

Reconstituted vaccine
Following reconstitution, the resulting solution should be clear, colourless to pale yellow, and essentially free of foreign particulates. Discard the vaccine if particulates are present and/or if it appears discoloured.

•   Withdraw the entire volume of the reconstituted Qdenga solution with the same syringe until an air bubble appears in the syringe.
•   Remove the needle syringe assembly from the vial.
•   Hold the syringe with the needle pointing upwards, tap the side of the syringe to bring the air bubble to the top,
discard the attached needle and replace with a new sterile needle, expel the air bubble until a small drop of
Reconstituted vaccine                  the liquid forms at the top of the needle. The recommended needle is 25G 16 mm.

•   Qdenga is ready to be administered by subcutaneous injection.

Qdenga should be administered immediately after reconstitution. Chemical and physical in-use stability have been demonstrated for 2 hours at room temperature (up to 32.5°C) from the time of reconstitution of the vaccine vial. After this time period, the vaccine must be discarded. Do not return it to the refrigerator. From a microbiological point of view Qdenga should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.


Instructions for reconstitution of the vaccine with solvent presented in pre-filled syringe 
Qdenga is a 2-component vaccine that consists of a vial containing lyophilised vaccine and solvent provided in the pre-filled syringe. The lyophilised vaccine must be reconstituted with solvent prior to administration.

Qdenga should not be mixed with other vaccines in the same syringe.

To reconstitute Qdenga, use only the solvent (0.22% sodium chloride solution) in the pre-filled syringe supplied with the vaccine since it is free of preservatives or other anti-viral substances. Contact with preservatives, antiseptics, detergents, and other anti-viral substances is to be avoided since they may inactivate the vaccine.

Remove the vaccine vial and pre-filled syringe solvent from the refrigerator and place at room temperature for approximately 15 minutes.


•   Remove the cap from the vaccine vial and clean the surface of stopper on top of the vial using an alcohol wipe.
•   Attach a sterile needle to the pre-filled syringe and insert the needle into the vaccine vial. The recommended needle is 23G.
•   Direct the flow of the solvent toward the side of the vial while slowly depressing the plunger to reduce the chance of forming bubbles.
Lyophilised vaccine vial

•   Release your finger from the plunger and, holding the assembly on a flat surface, gently swirl the vial in both directions with the needle syringe assembly attached.
•   DO NOT SHAKE. Foam and bubbles may form in the reconstituted product.
•   Let the vial and syringe assembly sit for a while until the solution becomes clear. This takes about 30-60 seconds.

Reconstituted vaccine
Following reconstitution, the resulting solution should be clear, colourless to pale yellow, and essentially free of foreign particulates. Discard the vaccine if particulates are present and/or if it appears discoloured.



•   Withdraw the entire volume of the reconstituted Qdenga solution with the same syringe until an air bubble appears in the syringe.
•   Remove the needle syringe assembly from the vial. Hold the syringe with the needle pointing upwards, tap the side of the syringe to bring the air bubble to the top,
discard the attached needle and replace with a new sterile needle, expel the air bubble until a small drop of the liquid forms at the top of the needle. The
Reconstituted vaccine                 recommended needle is 25G 16 mm.
•   Qdenga is ready to be administered by subcutaneous injection.

Qdenga should be administered immediately after reconstitution. Chemical and physical in-use stability have been demonstrated for 2 hours at room temperature (up to 32.5°C) from the time of reconstitution of the vaccine vial. After this time period, the vaccine must be discarded. Do not return it to the refrigerator. From a microbiological point of view Qdenga should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

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