Vocabria Caution For Usage

Special precautions for disposal and other handling: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Suspension for injection: Full instructions for use and handling of Vocabria injection are provided as follows.
Instructions for Use: The following information is intended for healthcare professionals only.
Overview: A complete dose requires two injections: VOCABRIA and rilpivirine.
3 mL of cabotegravir and 3 mL of rilpivirine.
Cabotegravir and rilpivirine are suspensions that do not need further dilution or reconstitution. The preparation steps for both medicines are the same.
Cabotegravir and rilpivirine are for intramuscular use only. Both injections must be administered to the gluteal sites. The administration order is not important.
Note: The ventrogluteal site is recommended.
The pack contains: 1 vial of cabotegravir.
Also needed: 1 vial adaptor; 1 syringe; 1 injection needle (0.65 mm, 38 mm [23 gauge, 1.5 inches]) (consider the patient's build and use medical judgment to select an appropriate injection needle length); Non-sterile gloves; 2 alcohol swabs; 2 gauze pads; A suitable sharps container; 1 rilpivirine 3 mL pack (make sure to have the rilpivirine pack close by before starting).
Preparation: 1. Inspect vial.
Check that the expiry date has not passed. Inspect the vial immediately. If foreign matter can be seen, do not use the product.
Note: The cabotegravir vial has a brown tint to the glass. Do not use if the expiry date has passed.
2. Wait 15 minutes.
If the pack has been stored in a fridge, remove and wait at least 15 minutes before the injection is ready to be given to allow the medicine to come to room temperature.
3. Shake vigorously.
Hold the vial firmly and vigorously shake for a full 10 seconds. Invert the vial and check the resuspension. It should look uniform. If the suspension is not uniform, shake the vial again. It is also normal to see small air bubbles.
4. Remove vial cap.
Remove the cap from the vial. Wipe the rubber stopper with an alcohol swab. Do not allow anything to touch the rubber stopper after wiping it.
5. Peel open vial adaptor.
Peel off the paper backing from the vial adaptor packaging.
Note: Keep the adaptor in place in its packaging for the next step.
6. Attach vial adaptor.
Press the vial adaptor straight down onto the vial using the packaging. The vial adaptor should snap securely into place. When ready, lift off the vial adaptor packaging.
7. Prepare syringe.
Remove the syringe from its packaging. Draw 1 mL of air into the syringe. This will make it easier to draw up the liquid later.
8. Attach syringe.
Hold the vial adaptor and vial firmly. Screw the syringe firmly onto the vial adaptor. Press the plunger all the way down to push the air into the vial.
9. Slowly draw up dose.
Invert the syringe and vial, and slowly withdraw as much of the liquid as possible into the syringe. There might be more liquid than the dose amount.
10. Unscrew syringe.
Screw the syringe off the vial adaptor.
Note: Keep the syringe upright to avoid leakage. Check that the cabotegravir suspension looks uniform and white to light pink.
11. Attach needle.
Peel open the needle packaging part way to expose the needle base. Keeping the syringe upright, firmly twist the syringe onto the needle. Remove the needle packaging from the needle.
Injection: 12. Prepare injection site.
Injections must be administered to the gluteal sites. Select from the following areas for the injection: Ventrogluteal (recommended); Dorsogluteal (upper outer quadrant).
Note: For gluteal intramuscular use only. Do not inject intravenously.
13. Remove cap.
Fold the needle guard away from the needle. Pull off the injection needle cap.
14. Remove extra liquid.
Hold the syringe with the needle pointing up. Press the plunger to the 3 mL dose to remove extra liquid and any air bubbles.
Note: Clean the injection site with an alcohol swab. Allow the skin to air dry before continuing.
15. Stretch skin.
Use the z-track injection technique to minimise medicine leakage from the injection site. Firmly drag the skin covering the injection site, displacing it by about an inch (2.5 cm). Keep it held in this position for the injection.
16. Insert needle.
Insert the needle to its full depth, or deep enough to reach the muscle.
17. Inject dose.
Still holding the skin stretched - slowly press the plunger all the way down. Ensure the syringe is empty. Withdraw the needle and release the stretched skin immediately.
18. Assess the injection site.
Apply pressure to the injection site using a gauze. A small bandage may be used if a bleed occurs. Do not massage the area.
19. Make needle safe.
Fold the needle guard over the needle. Gently apply pressure using a hard surface to lock the needle guard in place. The needle guard will make a click when it locks.
After injection: 20. Dispose safely.
Dispose of used needles, syringes, vials and vial adaptors according to local health and safety laws.
Repeat for 2nd medicine: If both medicines have not yet been injected, use the steps for preparation and injection for Rilpivirine which has its own specific Instructions for Use.
Incompatibilities: Tablet: Not applicable.
Suspension for injection: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.