ONVARA Powder and solvent for suspension for injection Ref.[115336] Active ingredients: Varicella, live attenuated

FOR SUBCUTANEOUS ADMINISTRATION.

Do not inject intravenously.

Children (12 months to 12 years of age) should receive a 0,5 ml dose administered subcutaneously.

Adolescents (13 years of age and older) and adults should receive a 0,5 ml dose administered subcutaneously.

If a second dose is administered, children (12 months to 12 years of age) should receive the second dose at least 3 months following the initial dose. For those 13 years of age and older, the second dose should be administered 4 to 8 weeks after the initial dose.

The outer aspect of the upper arm (deltoid area) is the preferred site of injection.

Method of administration

The diluent should be stored separately at room temperature (20 to 25°C), or in the refrigerator.

To reconstitute the vaccine, first withdraw 0,7 ml of diluent into the syringe to be used for reconstitution. Inject all of the diluent in the syringe into the vial of lyophilized vaccine and gently agitate to mix thoroughly.

Do not remove the syringe that has been used to inject the diluent into the vial of ONVARA as the reconstituted ONVARA will be withdrawn with the same syringe for administration to the patient.

Withdraw the entire contents into a syringe and inject the total volume (about 0.5 mL) of reconstituted vaccine subcutaneously, preferably into the outer aspect of the upper arm (deltoid region) or the anterolateral thigh.

IT IS RECOMMENDED THAT THE VACCINE BE ADMINISTERED IMMEDIATELY AFTER RECONSTITUTION, TO MINIMIZE LOSS OF POTENCY. DISCARD IF RECONSTITUTED VACCINE IS NOT USED WITHIN 30 MINUTES.

Do not freeze reconstituted vaccine.

There are no data with regard to overdose.

24 months.

After reconstitution, the vaccine should be used immediately. However, the in-use stability has been demonstrated for 30 minutes between 20°C and 25°C.

Discard the vaccine if it is not used within 30 minutes after its preparation.

Store in a refrigerator at 2°C to 8°C. Keep vial in the outer carton to protect from light.

Do not freeze.

Combination pack with vaccine vial and diluent:

For combination packs with vaccine vial and diluent packaged together, store in the refrigerator at 2 to 8°C. DO NOT STORE THE COMBINATION PACK IN THE FREEZER.

Keep out of reach of children.

Vial: 3 ml clear Type 1 borosilicate glass vial with a grey rubber stopper and a silver aluminium cap with a blue plastic cap.

Sterile Diluent Vial: 0,7 ml water for injection in a 3 ml glass vial with grey rubber stopper and dark grey plastic flip-off cap. 3 ml vial of ONVARA and 3 ml vial of DILUENT is packed together in a cardboard carton with the package insert and patient information leaflet.

Pack sizes of 1 or 10 vials.

Not all pack sizes may be marketed.

CAUTION: A sterile syringe free of preservatives, antiseptics, and detergents should be used for each injection and/or reconstitution of ONVARA because these substances may inactivate the vaccine virus.

It is important to use a separate sterile syringe and needle for each patient to prevent transmission of infectious agents from one individual to another.

To reconstitute the vaccine, use only the diluent supplied (Sterile Diluent for Merck, Sharp, & Dohme Live Virus Vaccines), since it is free of preservatives or other anti-viral substances which might inactivate the vaccine virus.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. ONVARA when reconstituted is a clear, colourless to pale yellow liquid.