Pharmaceutical particulars : מידע רוקחי

6.      PHARMACEUTICAL PARTICULARS
6.1     List of excipients

Powder
Sucrose
Sodium chloride
Histidine
Calcium chloride dihydrate
Polysorbate 20
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)

Solvent
Water for injections

6.2   Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Only the provided infusion set should be used because treatment failure can occur as a consequence of coagulation factor VIII adsorption to the internal surfaces of some injection equipment.

6.3   Shelf life

Unopened vial
The expiry date of the product is indicated on the packaging materialsDuring the shelf-life, the product may be stored at room temperature (up to 30°C) for a single period not exceeding 6 months. The date that the product is removed from refrigeration should be recorded on the carton. After storage at room temperature, the product may not be returned to the refrigerator. Do not use beyond the expiry date printed on the vial or six months after removing the carton from refrigeration, whichever is earlier.

After reconstitution
After reconstitution, chemical and physical stability has been demonstrated for 6 hours when stored at room temperature (up to 30°C). Protect product from direct sunlight. After reconstitution, if the product is not used within 6 hours, it must be discarded. From a microbiological point of view, the product should be used immediately after reconstitution. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

6.4   Special precautions for storage

Store in a refrigerator (2°C - 8°C). Do not freeze. Keep the vial in the outer carton in order to protect from light.

For storage conditions after reconstitution of the medicinal product, see section 6.3.

6.5   Nature and contents of container
Each pack contains:
-     powder in a type 1 glass vial with a chlorobutyl rubber stopper -     3 mL solvent in a type 1 glass pre-filled syringe with a bromobutyl rubber plunger stopper -     a plunger rod
-     a sterile vial adapter for reconstitution
-     a sterile infusion set
-     two alcohol swabs
-     two plasters
-     one gauze pad.

Pack size of 1.

6.6   Special precautions for disposal and other handling
The vial of lyophilised product powder for injection must be reconstituted with the supplied solvent (water for injections) from the pre-filled syringe using the sterile vial adapter for reconstitution.
The vial should be gently swirled until all of the powder is dissolved.

Reconstituted medicinal product should be inspected visually for particulate matter and discoloration prior to administration. The solution should be clear to slightly opalescent and colourless. Do not use solutions that are cloudy or have deposits.


Additional information on reconstitution and administration:

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



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.

Wash your hands before opening the pack.

Preparation:
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.

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



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.

6.    Place the vial on a flat surface. 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.


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.


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.


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



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.



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



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.

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.


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



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.


Administration (Intravenous injection):

ELOCTA should be administered using the infusion set (E) provided in this pack.

1.    Open the infusion set package and remove the cap at the end of the tubing. Attach the syringe with the prepared ELOCTA solution to the end of the infusion set tubing by turning clockwise.



2.    If needed apply a tourniquet and prepare the injection site by wiping the skin well with the other alcohol swab provided in the pack.


3.    Remove any air in the infusion set tubing by slowly depressing on the plunger rod until liquid has reached the infusion set needle. Do not push the solution through the needle. Remove the clear plastic protective cover from the needle.

4.    Insert the infusion set needle into a vein as instructed by your doctor or nurse and remove the tourniquet. If preferred, you may use one of the plasters (G) provided in the pack to hold the plastic wings of the needle in place at the injection site. The prepared product should be injected intravenously over several minutes. Your doctor may change your recommended injection rate to make it more comfortable for you.


5.    After completing the injection and removing the needle, you should fold over the needle protector and snap it over the needle.



6.    Please safely dispose of the used needle, any unused solution, the syringe and the empty vial in an appropriate medical waste container as these materials may hurt others if not disposed of properly. Do not reuse equipment.


Any unused medicinal product or waste material should be disposed of in accordance with local requirements.


7.    MANUFACTURER:
Swedish Orphan Biovitrum AB (publ)
Strandbergsgatan 49, 11 276 Stockholm
Sweden