Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients

Powder:
Sodium chloride
Sucrose
L-histidine
Calcium chloride dihydrate
Polysorbate 80
L-methionine
Sodium hydroxide
Hydrochloric acid
Solvent:
Sodium chloride
Water for injections

6.2   Incompatibilities

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

6.3   Shelf life

Unopened vial
The expiry date of the product is indicated on the packaging materials.
During the shelf life, the product may be kept at:
• room temperature (≤ 30°C) for a single period no longer than 9 months or
• above room temperature (30ºC up to 40ºC) for a single period no longer than 3 months.

Once the product has been taken out of the refrigerator, the product must not be returned to the refrigerator.

Please record the beginning of storage and the storage temperature on the product carton.

After reconstitution:
Chemical and physical in-use stability have been demonstrated for:
• 24 hours stored at 2°C – 8°C
• 4 hours stored at ≤30ºC, for product which has been kept for a single period no longer than 9 months at room temperature (≤30°C)
• 4 hours stored up to 40ºC, for product which has been kept for a single period no longer than 3 months at above room temperature (30ºC up to 40ºC)

From a microbiological point of view, the medicinal 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 and would normally not be longer than as stated above, unless reconstitution has taken place in controlled and validated aseptic conditions.

Any unused reconsitituted product stored at room temperature (<30ºC) or up to 40ºC for more than 4 hours should be discarded.


6.4   Special precautions for storage

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

For storage at room temperature (<30ºC) or up to 40ºC and storage conditions after reconstitution of the medicinal product, see section 6.3.

6.5   Nature and contents of container

Each pack of NovoEight 500 IU, 1000 IU and 2000 IU powder and solvent for solution for injection contains:

–     1 glass vial (type I) with powder and chlorobutyl rubber stopper –     1 sterile vial adapter for reconstitution
–     1 pre-filled syringe of 4 ml solvent with backstop (polypropylene), a rubber plunger (bromobutyl) and a syringe cap with a stopper (bromobutyl)
–     1 plunger rod (polypropylene).

6.6   Special precautions for disposal and other handling

NovoEight is to be administered intravenously after reconstitution of the powder with the solvent supplied in the syringe. After reconstitution the solution appears as a clear or slightly opalescent solution. Do not use solutions that are cloudy or have deposits.

You will also need an infusion set (tubing and butterfly needle), sterile alcohol swabs, gauze pads and plasters. These devices are not included in the NovoEight package.

Always use an aseptic technique.

Reconstitution
A)
Take the vial, the vial adapter and the pre-filled                   A syringe out of the carton. Leave the plunger rod untouched in the carton. Bring the vial and the pre-filled syringe to room temperature. You can do this by holding them in your hands until they feel as warm as your hands. Do not use any other way to heat the vial and pre-filled syringe.


B)
Remove the plastic cap from the vial. If the                         B plastic cap is loose or missing, do not use the vial. Wipe the rubber stopper on the vial with a sterile alcohol swab and allow it to air dry for a few seconds before use.


C)
Remove the protective paper from the vial                 C adapter. If the protective paper is not fully sealed or if it is broken, do not use the vial adapter.
Do not take the vial adapter out of the protective cap with your fingers.



D)
Turn over the protective cap and snap the vial            D adapter onto the vial. Once attached do not remove the vial adapter from the vial.



E)
Lightly squeeze the protective cap with your              E thumb and index finger as shown. Remove the protective cap from the vial adapter.


F)
Grasp the plunger rod by the wide top and                 F immediately connect the plunger rod to the syringe by turning it clockwise into the plunger inside the prefilled syringe until resistance is felt.



G)
Remove the syringe cap from the prefilled                 G syringe by bending it down until the perforation breaks. Do not touch the syringe tip under the syringe cap.


H)
Screw the prefilled syringe securely onto the                          H vial adapter until resistance is felt.



I)
Hold the pre-filled syringe slightly tilted with                       I the vial pointing downwards. Push the plunger rod to inject all the solvent into the vial.



J)
Keep the plunger rod pressed down and swirl                            J the vial gently until all the powder is dissolved.
Do not shake the vial as this will cause foaming.



It is recommended to use NovoEight immediately after reconstitution. For storage conditions of the reconstituted medicinal product see section 6.3.

If a larger dose is needed, repeat steps A to J with additional vials, vial adapters and pre-filled syringes.


Administration of the reconstituted solution

K)
Keep the plunger rod pushed completely in.                           K Turn the syringe with the vial upside down. Stop pushing the plunger rod and let it move back on its own while the reconstituted solution fills the syringe. Pull the plunger rod slightly downwards to draw the reconstituted solution into the syringe.

In case you only need part of the entire vial, use the scale on the syringe to see how much reconstituted solution you withdraw, as instructed by your doctor or nurse.

While holding the vial upside down, tap the syringe gently to let any air bubbles rise to the top. Push the plunger rod slowly until all air bubbles are gone.
L)
Unscrew the vial adapter with the vial.                              L 


NovoEight is now ready for injection. Locate a suitable site and slowly inject NovoEight into the vein over a period of 2-5 minutes.

Disposal
After injection, safely dispose of all unused NovoEight solution, the syringe with the infusion set, the vial with the vial adapter and other waste materials as instructed by your pharmacist.

Do not throw it out with the ordinary household waste.