(meningococcal groups A, B, C, W, and Y vaccine)

Prescribing Information
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Dosage and Administration

2 DOSAGE AND ADMINISTRATION

For intramuscular use only.

2.1 Dose and Schedule

Administer 2 doses (approximately 0.5 mL each) of PENBRAYA 6 months apart.

2.2 Preparation

PENBRAYA is supplied in a kit that includes a vial of Lyophilized MenACWY Component (a sterile white powder), a prefilled syringe containing the MenB Component and a vial adapter.

To form PENBRAYA, reconstitute the Lyophilized MenACWY Component with the MenB Component as described in the instructions below.

Step 1

Step 1. Attachment of the vial adapter to the vial.

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Remove the flip top cap from the vial of Lyophilized MenACWY Component.
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Peel off the top cover from the vial adapter packaging.
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While keeping the vial adapter in its packaging, center the adapter over the vial’s stopper and attach to the vial with a straight downward push.
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Remove the packaging.
Step 2

Step 2. Resuspension of the MenB Component.

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Shake the syringe containing the MenB Component vigorously to obtain a white homogenous suspension. Do not use if the contents cannot be resuspended.
Step 3

Step 3. Connection of the syringe containing the MenB Component to the vial adapter.

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Hold the syringe by the Luer lock adapter.
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Twist to remove the syringe cap.
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Connect the syringe to the vial adapter by turning the Luer lock.
Step 4

Step 4. Reconstitution of the Lyophilized MenACWY Component with the MenB Component to form PENBRAYA.

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Inject the entire contents of the syringe into the vial.
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Hold the plunger rod down and gently swirl the vial until the powder is completely dissolved (less than 1 minute).
Step 5

Step 5. Withdrawal of PENBRAYA.

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Invert the vial completely and slowly withdraw the entire contents into the syringe for an approximately 0.5 mL dose of PENBRAYA.
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Twist to disconnect the syringe from the vial adapter.
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Attach a sterile needle suitable for intramuscular injection.

2.3 Administration

For intramuscular use only.

After reconstitution, PENBRAYA is a homogeneous white suspension. If the vaccine is not a homogenous suspension, shake to resuspend prior to administration. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard if either condition is present.

Administer PENBRAYA immediately or store between 2°C and 30°C (36°F and 86°F) and use within 4 hours. Discard reconstituted vaccine if not used within 4 hours.

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