Instructions for use

 

ELOCTA is administered by intravenous (IV) injection after dissolving the powder for injection with the solvent supplied in the pre-filled syringe. Each ELOCTA pack contains:

Package

A) 1 Powder vial, B) 3 mL Solvent in pre-filled syringe, C) 1 Plunger rod, D) 1 Vial adapter, E) 1 Infusion set, F) 2 Alcohol swabs, G) 2 Plasters, H) 1 Gauze pad

ELOCTA should not be mixed with other solutions for injection or infusion 

Preparation1

 

Wash your hands before opening the pack

1. Check the name and strength of the package, to make sure it contains the correct medicine. Check the expiry date on the ELOCTA carton. Do not use if the medicine has expired

2. If ELOCTA has been stored in a refrigerator, allow the vial of ELOCTA (A) and the syringe with solvent (B) to reach room temperature before use. Do not use external heat

Steps

3. Place the vial on a clean flat surface. Remove the plastic flip-top cap from the ELOCTA vial

Steps

4. Wipe the top of the vial with one of the alcohol swabs (F) provided in the pack and allow to air dry. Do not touch the top of the vial or allow it to touch anything else once wiped

5. Peel back the protective paper lid from the clear plastic vial adapter (D). Do not remove the adapter from its protective cap. Do not touch the inside of the vial adapter package

Steps

6. Hold the vial adapter in its protective cap and place it squarely over the top of the vial. Press down firmly until the adapter snaps into place on top of the vial, with the adapter spike penetrating the vial stopper

Steps

7. Attach the plunger rod (C) to the solvent syringe by inserting the tip of the plunger rod into the opening in the syringe plunger. Turn the plunger rod firmly clockwise until it is securely seated in the syringe plunger

Steps

8. Break off the white, tamper-resistant, plastic cap from the solvent syringe by bending at the perforation cap until it snaps off. Set the cap aside by placing it with the top down on a flat surface. Do not touch the inside of the cap or the syringe tip

Steps

9. Lift the protective cap away from the adapter and discard

Steps

10. Connect the solvent syringe to the vial adapter by inserting the tip of the syringe into the adapter opening. Firmly push and turn the syringe clockwise until it is securely connected

Steps

11. Slowly depress the plunger rod to inject all the solvent into the ELOCTA vial

Steps

12. With the syringe still connected to the adapter and the plunger rod pressed down, gently swirl the vial until the powder is dissolved. Do not shake

13. The final solution must be inspected visually before administration. The solution should appear clear to slightly opalescent and colourless. Do not use the solution if cloudy or contains visible particles

Steps

14. Ensuring that the syringe plunger rod is still fully pressed down, invert the vial. Slowly pull on the plunger rod to draw back all the solution through the vial adapter into the syringe

Steps

15. Detach the syringe from the vial adapter by gently pulling and turning the vial counter clockwise

Note: If you use more than one vial of ELOCTA per injection, each vial should be prepared separately as per the previous instructions (steps 1 to 13) and the solvent syringe should be removed, leaving the vial adapter in place. A single large luer lock syringe may be used to draw back the prepared contents of each of the individual vials

16. Discard the vial and the adapter

Note: If the solution is not to be used immediately, the syringe cap should be carefully put back on the syringe tip. Do not touch the syringe tip or the inside of the cap

After preparation, ELOCTA can be stored at room temperature for up to 6 hours before administration. After this time, the prepared ELOCTA should be discarded. Protect from direct sunlight

Need additional guidance? The two videos below, ‘How to prepare ELOCTA’ and ‘How to administer ELOCTA’ may be useful for you and your patients

These videos are also available on https://www.ELOCTA-instructions.com/

Reference

1. ELOCTA, Summary of Product Characteristics, 2019.

Instructions for use

 

ELOCTA is administered by intravenous (IV) injection after dissolving the powder for injection with the solvent supplied in the pre-filled syringe. Each ELOCTA pack contains:

Package

A) 1 Powder vial, B) 3 mL Solvent in pre-filled syringe, C) 1 Plunger rod, D) 1 Vial adapter, E) 1 Infusion set, F) 2 Alcohol swabs, G) 2 Plasters, H) 1 Gauze pad

ELOCTA should not be mixed with other solutions for injection or infusion 

Preparation1

 

Wash your hands before opening the pack

1. Check the name and strength of the package, to make sure it contains the correct medicine. Check the expiry date on the ELOCTA carton. Do not use if the medicine has expired

2. If ELOCTA has been stored in a refrigerator, allow the vial of ELOCTA (A) and the syringe with solvent (B) to reach room temperature before use. Do not use external heat

Steps

3. Place the vial on a clean flat surface. Remove the plastic flip-top cap from the ELOCTA vial

Steps

4. Wipe the top of the vial with one of the alcohol swabs (F) provided in the pack and allow to air dry. Do not touch the top of the vial or allow it to touch anything else once wiped

5. Peel back the protective paper lid from the clear plastic vial adapter (D). Do not remove the adapter from its protective cap. Do not touch the inside of the vial adapter package

Steps

6. Hold the vial adapter in its protective cap and place it squarely over the top of the vial. Press down firmly until the adapter snaps into place on top of the vial, with the adapter spike penetrating the vial stopper

Steps

7. Attach the plunger rod (C) to the solvent syringe by inserting the tip of the plunger rod into the opening in the syringe plunger. Turn the plunger rod firmly clockwise until it is securely seated in the syringe plunger

Steps

8. Break off the white, tamper-resistant, plastic cap from the solvent syringe by bending at the perforation cap until it snaps off. Set the cap aside by placing it with the top down on a flat surface. Do not touch the inside of the cap or the syringe tip

Steps

9. Lift the protective cap away from the adapter and discard

Steps

10. Connect the solvent syringe to the vial adapter by inserting the tip of the syringe into the adapter opening. Firmly push and turn the syringe clockwise until it is securely connected

Steps

11. Slowly depress the plunger rod to inject all the solvent into the ELOCTA vial

Steps

12. With the syringe still connected to the adapter and the plunger rod pressed down, gently swirl the vial until the powder is dissolved. Do not shake

13. The final solution must be inspected visually before administration. The solution should appear clear to slightly opalescent and colourless. Do not use the solution if cloudy or contains visible particles

Steps

14. Ensuring that the syringe plunger rod is still fully pressed down, invert the vial. Slowly pull on the plunger rod to draw back all the solution through the vial adapter into the syringe

Steps

15. Detach the syringe from the vial adapter by gently pulling and turning the vial counter clockwise

Note: If you use more than one vial of ELOCTA per injection, each vial should be prepared separately as per the previous instructions (steps 1 to 13) and the solvent syringe should be removed, leaving the vial adapter in place. A single large luer lock syringe may be used to draw back the prepared contents of each of the individual vials

16. Discard the vial and the adapter

Note: If the solution is not to be used immediately, the syringe cap should be carefully put back on the syringe tip. Do not touch the syringe tip or the inside of the cap

After preparation, ELOCTA can be stored at room temperature for up to 6 hours before administration. After this time, the prepared ELOCTA should be discarded. Protect from direct sunlight

Need additional guidance? The two videos below, ‘How to prepare ELOCTA’ and ‘How to administer ELOCTA’ may be useful for you and your patients

These videos are also available on https://www.ELOCTA-instructions.com/

Reference

1. ELOCTA, Summary of Product Characteristics, 2019.