Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Powder
L-lysine monohydrochloride

sodium chloride trisodium citrate glycine disodium phosphate dihydrate citric acid polysorbate 80 tri-n-butyl phosphate.

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 injection/infusion sets should be used because treatment failure can occur as a consequence of human factor IX adsorption to the internal surface of some injection/infusion equipment.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.
After reconstitution, chemical and physical in-use stability has been demonstrated for 1 hour up to 25°C.
From a microbiological point of view, unless the method of opening/reconstitution precludes the risk of microbial contamination, the reconstituted medicinal product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 1 hour up to 25°C.

6.4   Special precautions for storage

Store in a refrigerator (2°C to 8°C).
Do not freeze.
Can be stored up to 3 months at 25°C. Record date of removal from refrigerator on carton.
Keep the vials in the outer carton in order to protect from light.
For storage conditions after reconstitution of the medicinal product, see section 6.3.
Do not use beyond the expiry date on the label.
6.5   Nature and contents of container

500 IU

-500 IU powder in a 30 ml vial (type 1 glass) with a stopper (halobutyl rubber), with an overseal (aluminium) and tamper evident flip-off cap (polypropylene)
-10 ml solvent in a 30 ml vial (type 1 glass) for reconstitution
-One Mix2Vial™ transfer device

1000 IU

-1000 IU powder in a 50 ml vial (type 1 glass) with a stopper (halobutyl rubber), with an overseal (aluminium) and tamper evident flip-off cap (polypropylene)
-20 ml solvent in a 50 ml vial (type 1 glass) for reconstitution

-One Mix2Vial™ transfer device

Not all pack sizes may be marketed.
6.6   Special precautions for disposal and other handling

Replenine-VF should only be reconstituted with water for injections provided with the product. The 500 IU presentation should be reconstituted using 10 ml solvent. The 1000 IU presentation should be reconstituted using 20 ml solvent.

The containers of Replenine-VF and water for Injections should be brought to between 20°C and 25°C prior to the removal of the flip-off cap from the product vial.

Reconstituted medicinal product should be inspected visually for particulate matter and discolouration prior to administration. The solution should be clear or slightly opalescent. Do not use solutions that are cloudy or have deposits. Use the product immediately after reconstitution or within 1 hour.

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

Instructions for reconstitution:

You can reconstitute your product in two ways using the Transfer Device called Mix2VialTM: (A) Reconstituting in Full Volume or
(B) Reconstituting with Half Volume

(A) Reconstituting in Full Volume
Step 1
• Remove the cap from the product vial and clean the top of the stopper with an alcohol swab.
• Repeat this step with the water vial.
• Peel back the top of the Mix2Vial™ transfer device package but leave the device in the package.


Step 2
• Place the blue end of the Mix2Vial™ transfer device on the water vial and push straight down until the spike penetrates the rubber stopper and snaps into place.
• Remove the plastic outer packaging from the Mix2Vial™ transfer device and discard it, taking care not to touch the exposed end of the device.



Step 3
• Turn the water vial upside down with the device still attached.
• Place the clear end of the Mix2Vial™ transfer device on the product vial and push straight down until the spike penetrates the rubber stopper and snaps into place.


Step 4
• The water will be pulled into the product vial by the vacuum contained within it.
• Gently swirl the vial to make sure the product is thoroughly mixed. Do not shake the vial.
• A clear or slightly pearl-like solution should be obtained, usually in about 2 to 2 ½ minutes (5 minutes maximum).


Step 5
• Separate the empty water vial and blue part from the clear part by unscrewing anti-clockwise.
• Draw air into the syringe by pulling the plunger to the required volume of water added.
• Connect the syringe to the white filter.
• Push the air in the syringe into the vial.


Step 6
• Immediately invert the vial of solution which will be drawn into the syringe.
• Disconnect the filled syringe from the Mix2Vial™ transfer device.
• The product is now ready for administration. Follow the normal safety practices for administration. Use the product immediately after reconstitution, the product must not be stored.



Note: If you have more than one vial to make up your dose, repeat Steps 1 to 6 withdrawing the solution in the vial into the same syringe.

The Mix2Vial™ transfer device supplied with the product is sterile and cannot be used more than once.

B)     Reconstituting with Half Volume

To use the Mix2Vial™ transfer device for reconstituting Replenine-VF in half volumes, it is first necessary to remove and discard half the water volume from the water for injections vial.
• Pierce the stopper of the water vial with a needle and syringe and draw up half the volume of water.
• Check that the correct amount is withdrawn. This needle and syringe, with its contents, should be safely disposed of.
• The remaining water in the vial will be used for reconstitution (half the original volume).
• To complete the dissolving process, follow steps 1 to 6 in Section A above.
• The product is then ready for administration.

Note: If you have more than one vial to make up your dose, repeat the above steps withdrawing the solution in the vial into the same syringe.

The Mix2Vial™ transfer device supplied with the product is sterile and cannot be used more than once.