Vaccines Products

How Supplied:

• AREXVY is supplied as 2 components: A single-dose vial of lyophilized antigen component (powder) and a single-dose vial of adjuvant suspension component (liquid) (packaged without syringes or needles)

Storage & Handling:

Storage before reconstitution:

• Adjuvant suspension component vials: Store refrigerated between 2°C and 8°C (36°F and 46°F). Store in the original package in order to protect vials from light. Do not freeze. Discard if the adjuvant suspension component has been frozen.
• Lyophilized antigen component vials: Store refrigerated between 2°C and 8°C (36°F and 46°F). Store in the original package in order to protect vials from light. Do not freeze. Discard if the antigen component has been frozen.

Storage after reconstitution:

• Administer immediately or store in the refrigerator between 2°C and 8°C (36°F to 46°F) or at room temperature [up to 25˚C (77˚F)] for up to 4 hours prior to use
• Protect vials from light
• Discard reconstituted vaccine if not used within 4 hours
• Do not freeze. Discard if the vaccine has been frozen.

How Supplied:

• BEXSERO is available in 0.5-mL single-dose, disposable, prefilled TIP-LOK syringes (Luer Lock syringes) packaged without needles. TIP-LOK syringes are to be used with Luer Lock compatible needles.
• The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex

Storage & Handling:

• Do not freeze
• Discard if the vaccine has been frozen
• Store refrigerated, at 36°F to 46°F (2°C to 8°C)
• Protect from light
• Do not use after the expiration date

How Supplied:

• BOOSTRIX is available in 0.5-mL single-dose vials and single-dose, disposable, prefilled TIP-LOK syringes (Luer Lock syringes) packaged without needles. TIP-LOK syringes are to be used with Luer Lock compatible needles.
• The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex. The vial stoppers are not made with natural rubber latex.

How Supplied:

• ENGERIX-B (preservative-free formulation) is available in prefilled disposable TIP-LOK syringes (Luer Lock syringes) packaged without needles (pediatric/adolescent and adult doses) and single-dose vials (adult dose only). TIP-LOK syringes are to be used with Luer Lock compatible needles.
• The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex. The vial stoppers are not made with natural rubber latex.

How Supplied:

• FLUARIX is supplied in 0.5-mL single-dose, disposable, prefilled TIP-LOK syringes (Luer Lock syringes) packaged without needles. TIP-LOK syringes are to be used with Luer Lock compatible needles.
• The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex.

How Supplied:

• FLULAVAL is available in 0.5-mL single-dose, disposable, prefilled TIP-LOK syringes (Luer Lock syringes) packaged without needles. TIP-LOK syringes are to be used with Luer Lock compatible needles.
• The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex.

How Supplied:

• HAVRIX is available in single-dose prefilled disposable TIP-LOK syringes (Luer Lock syringes) packaged without needles (Preservative-Free Formulation). TIP-LOK syringes are to be used with Luer Lock compatible needles.
• The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex.

How Supplied:

HIBERIX Vial and Vial Presentation:

• HIBERIX Vial and Vial presentation is supplied in a carton packaged without syringes or needles containing:
  • 10 single-dose vials of Lyophilized Antigen Component in a carton
  • 10 single-dose vials of Sterile Saline Diluent in a carton
• The stopper of the vial containing Lyophilized Antigen Component or Sterile Saline Diluent are not made with natural rubber latex.

HIBERIX Vial and Prefilled Syringe Presentation:

• HIBERIX Vial and Prefilled Syringe Presentation is supplied in a carton containing:
  • 10 single-dose vials of Lyophilized Antigen Component
  • 10 single-dose, prefilled, ungraduated TIP-LOK syringes (Luer Lock syringes) of Sterile Saline Diluent packaged without needles
• TIP-LOK syringes are to be used with Luer Lock compatible needles.
• The stopper of the vial containing Lyophilized Antigen Component and the tip cap and rubber plunger stopper of the prefilled syringe containing Sterile Saline Diluent are not made with natural rubber latex.

Storage & Handling

• Lyophilized Antigen Component vials: Store refrigerated between 2° and 8°C (36° and 46°F). Protect vials from light.
• Sterile Saline Diluent prefilled syringes and vials: Store refrigerated or at controlled room temperature between 2° and 25°C (36° and 77°F). Do not freeze. Discard if the diluent has been frozen.

 

How Supplied:

• INFANRIX is available in 0.5-mL single-dose, disposable, prefilled TIP-LOK syringes (Luer Lock syringes) packaged without needles. TIP-LOK syringes are to be used with Luer Lock compatible needles.
• The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex.

How Supplied:

• KINRIX is available in 0.5-mL single-dose, disposable, prefilled TIP-LOK syringes (Luer Lock syringes) packaged without needles. TIP-LOK syringes are to be used with Luer Lock compatible needles.
• The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex.

How Supplied:

MENVEO Two-Vial Presentation:

• MENVEO two-vial presentation is supplied in cartons containing:
  • 5 vials containing MenCYW-135 liquid conjugate component (Vial 1; gray cap)
  • 5 vials containing MenA lyophilized conjugate component (Vial 2; orange cap)
• One vial of MenCYW-135 liquid conjugate component (Vial 1) and one vial of MenA lyophilized conjugate component (Vial 2) must be combined before use to form a single dose (0.5 mL) of MENVEO (packaged without syringes or needles). Each carton contains 5 doses of MENVEO.
• The container closures (synthetic rubber stoppers) are not made with natural rubber latex.

MENVEO One-Vial Presentation:

• MENVEO one-vial presentation is supplied in cartons containing:
  • 10 Vials containing MENVEO (pink cap)
• Each carton contains 10 single dose vials of MENVEO. Each dose is 0.5 mL.
• The container closures (synthetic rubber stoppers) are not made with natural rubber latex.

Storage & Handling:

For two-vial presentation before reconstitution and one-vial presentation:

• Do not freeze. Frozen/previously frozen product should be discarded.
• Store refrigerated, away from the freezer compartment, at 36°F to 46°F (2°C to 8°C)
• Protect from light.
• Vaccine must be maintained at 36°F to 46°F (2˚C to 8˚C) during transport
• Do not use after the expiration date

How Supplied:

• PEDIARIX is available in 0.5-mL single-dose, disposable, prefilled TIP-LOK syringes (Luer Lock syringes) packaged without needles. TIP-LOK syringes are to be used with Luer Lock compatible needles.
• The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex.

How Supplied:

• PENMENVY is supplied in cartons containing:
  • 10 vials of Lyophilized MenACWY Component (powder) and
  • 10 prefilled TIP-LOK syringes (Luer Lock syringes) of MenB Component (liquid) packaged without needles.
• TIP-LOK syringes are to be used with Luer Lock compatible needles.
• The tip cap and rubber plunger of the prefilled syringe and the stopper of the vial are not made with natural rubber latex.

Storage & Handling:

Storage before reconstitution:

• Store refrigerated, away from the freezer compartment, at 36°F to 46°F (2°C to 8°C).
• Store in the original carton to protect from light.
• Do not freeze. Discard if the carton has been frozen.

Storage after reconstitution:

• Use immediately after reconstitution.

How Supplied:

• Supplied as 2 components: Single-dose vials of lyophilized antigen component accompanied by single-dose prefilled ungraduated syringes of sterile water diluent (packaged without needles)

Storage & Handling:

• Vials of lyophilized antigen component: Store refrigerated between 36° and 46°F (2° and 8°C). Protect vials from light.
• Prefilled ungraduated syringes of sterile water diluent: Store refrigerated between 36° and 46°F (2° and 8°C) or at controlled room temperature up to 77°F (25°C).
• Do not freeze lyophilized antigen component or sterile water diluent.
• Administer immediately after reconstitution. If not used immediately, store refrigerated between 36˚ and 46˚F (2˚ and 8˚C) and administer within 8 hours. Discard reconstituted vaccine if not used within 8 hours. Do not freeze. Discard if the reconstituted vaccine has been frozen.

How Supplied:

ROTARIX Vial and Oral Dosing Applicator Presentation:

• Available in single-dose vials of lyophilized vaccine component, accompanied by a prefilled oral dosing applicator of liquid diluent (1 mL) with a plunger stopper, and a transfer adapter for reconstitution

ROTARIX Oral Dosing Applicator Only Presentation:

• Supplied as a single, 1.5 mL dose in a prefilled oral dosing applicator with a plunger stopper

Storage & Handling:

ROTARIX Vial and Oral Dosing Applicator Presentation:

• Lyophilized vaccine component in vials: Store refrigerated at 2° to 8°C (36° to 46°F)
• Protect vials from light
• Diluent in oral dosing applicators: Store refrigerated at 2° to 8°C (36° to 46°F) or at a controlled room temperature up to 25°C (77°F). Do not freeze. Discard if the diluent has been frozen.
• ROTARIX should be administered within 24 hours of reconstitution
• After reconstitution, store refrigerated at 2° to 8°C (36° to 46°F) or at a controlled room temperature up to 25°C (77°F). Do not freeze. Discard if the reconstituted vaccine has been frozen.
• Discard the reconstituted vaccine in biological waste container if not used within 24 hours

ROTARIX Oral Dosing Applicator Only Presentation:

• Store refrigerated at 2° to 8°C (36° to 46°F)
• Do not freeze. Discard if the vaccine has been frozen
• Keep in original package to protect from light

How Supplied:

SHINGRIX Vial and Vial Presentation:

• SHINGRIX vial and vial presentation is supplied as 2 components: A single‑dose vial of Lyophilized gE Antigen Component (powder) which must be reconstituted with a single‑dose vial of Adjuvant Suspension Component (liquid) (packaged without syringes or needles).

SHINGRIX Prefilled Syringe Presentation:

• SHINGRIX is available as 0.5-mL single dose, disposable, prefilled TIP-LOK syringes (Luer Lock syringes) packaged without needles. TIP-LOK syringes are to be used with Luer Lock compatible needles.

Storage & Handling:

SHINGRIX Vial and Vial Presentation:

Storage before Reconstitution:

• Store refrigerated between 2°C and 8°C (36°F and 46°F).
• Protect vials from light. Do not freeze. Discard if frozen.

Storage after Reconstitution:

• Administer immediately or store refrigerated between 2°C and 8°C (36°F and 46°F) for up to 6 hours prior to use.
• Discard reconstituted vaccine if not used within 6 hours.
• Do not freeze. Discard if frozen.

SHINGRIX Prefilled Syringe Presentation:

• Store refrigerated between 2°C and 8°C (36°F and 46°F).
• Protect from light.
• Do not freeze. Discard if frozen.
• Administer SHINGRIX as soon as possible after the prefilled syringe is removed from the refrigerator. SHINGRIX prefilled syringe maybe be kept for up to 72 hours at temperatures between 8°C and 25°C (46°F and 77°F).

How Supplied:

• TWINRIX is available in 1-mL single-dose prefilled disposable TIP-LOK syringes (Luer Lock syringes) packaged without needles (Preservative-Free Formulation). TIP-LOK syringes are to be used with Luer Lock compatible needles.
• The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex.