Pharmaceutical particulars : מידע רוקחי

6.      PHARMACEUTICAL PARTICULARS

6.1.    List of excipients
Powder : human albumin solution;
sodium chloride;
histidine;
macrogol 3350;
calcium chloride dihydrate.

Solvent : water for injections.

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


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


6.3.    Shelf life after reconstitution
The reconstituted product is stable for 3 hours at room temperature (15°C - 25°C) 
6.4.    Special precautions for storage

Store in a refrigerator (2°C – 8°C).
Do not freeze.
Store in the outer carton in order to protect from light.
Within its shelf-life, the product may be stored at 15°C - 25°C prior to use for up to six months.
Do not return to refrigeration following storage at 15°C - 25°C.
For storage conditions after reconstitution of the medicinal product, see section 6.3.
Do not refrigerate after reconstitution.


Recombinate Powder for Solution for Injection- BAXIJET ll,   26 2. 2015, RH 6.5.    Nature and contents of container

A single pack contains a powder vial, a 10 ml solvent vial (both type I glass with rubber stoppers) and a device for reconstitution (BAXJECT II) + one sterile single-use plastic syringe + one sterile mini-infusion set + 2 alcohol swabs + 2 plasters.
Alternatively to BAXJECT II a needle device for reconstitution comprising one sterile double-ended needle (to transfer the solvent into the Recombinate vial), one sterile filter needle (to transfer the reconstituted solution into the syringe) can be provided.
Pack size of 1

6.6.    Special precautions for disposal and other handling

The preparation is to be administered intravenously after reconstitution with the provided sterile water for injections. The disposable plastic syringe provided with the product should be used.

-         Use within three hours after reconstitution.
-         Do not refrigerate preparation after reconstitution.
-         Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
-         The solution should be clear or slightly opalescent. Do not use solutions that are cloudy or have deposits. Reconstituted products should be inspected visually for particulate matter and discoloration prior to administration.
-       Do not use if the product, its sterile barrier system or its packaging is damaged or shows any sign of deterioration.


Recombinate Powder for Solution for Injection- BAXIJET ll,    26 2. 2015, RH Reconstitution: Use Aseptic Technique
Reconstitution with BAXJECT II                                           Reconstitution with needles 1.   Bring Recombinate (powder) and Sterilised Water for              1.   Bring Recombinate (powder) and Sterilised Water Injections (solvent) to 15-25°C.                                      for Injections (solvent) to 15-25°C.
2.   Remove caps from powder and solvent vials.                       2.   Remove caps from powder and solvent vials.
3.   Cleanse stoppers with alcohol swabs. Place the vials on          3.   Cleanse stoppers with alcohol swabs. Place the vials a flat surface.                                                       on a flat surface.
4.   Open the package of BAXJECT II device by peeling                 4.   Remove protecting covering from one end of double- away the paper lid without touching the inside (Fig. a).              ended needle and insert exposed needle through Do not remove the device from the package.                            stopper of solvent vial.
5.   Turn the package over and insert the clear plastic spike         5.   Remove protective covering from other end of through the solvent stopper. Grip the package at its                  double-ended needle. Invert solvent vial over the edge and pull the package off BAXJECT II (Fig. b). Do                 upright Recombinate vial, then rapidly insert free end not remove the blue cap from BAXJECT II device.                       of the needle through the Recombinate vial stopper at its centre. The vacuum in the vial will draw in the solvent.
6.   With BAXJECT II attached to the solvent vial, invert             6.   Disconnect the two vials by removing needle from the system so that the solvent vial is on top of the                  solvent vial stopper, then remove needle from device. Insert the white plastic spike through the                    Recombinate vial. Swirl gently until all material is Recombinate stopper. The vacuum will draw the solvent                 dissolved. Be sure that Recombinate is completely into the Recombinate vial (Fig. c).                                   dissolved, otherwise active material will be removed by the filter needle.
7.   Swirl gently until all material is dissolved. Be sure that
Recombinate is completely dissolved; otherwise active material will not pass through the device filter. The product dissolves rapidly (usually in less than 1 minute).
Fig. a                     Fig. b                  Fig. c



Administration: Use Aseptic Technique
It is recommended that administration commence within                 It is recommended that administration commence three hours after reconstitution. The reconstituted                   within three hours after reconstitution. The material should not be refrigerated. Parenteral drug                  reconstituted material should not be refrigerated.
products should be inspected for particulate matter and               Parenteral drug products should be inspected for discoloration prior to administration, whenever solution              particulate matter and discoloration prior to and container permit. A colourless to faintly yellow                  administration, whenever solution and container appearance is acceptable for Recombinate.                             permit. A colourless to faintly yellow appearance is acceptable for Recombinate.
1.   Remove the blue cap from BAXJECT II. DO NOT                      1.   Attach filter needle to the disposable syringe and DRAW AIR INTO THE SYRINGE. Connect the                                draw back plunger to admit air into syringe.
syringe to BAXJECT II (Fig. d).
2.   Invert the system (with concentrate vial on top). Draw           2.   Insert filter needle into reconstituted Recombinate.
the concentrate into the syringe by pulling the plunger back slowly (Fig. e).
3.   Disconnect the syringe.                                          3.   Inject air into vial and then withdraw the reconstituted material into the syringe.


Recombinate Powder for Solution for Injection- BAXIJET ll,        26 2. 2015, RH 

4.   Attach the administration set to the syringe. Inject          4.   Remove and discard filter needle. Attach intravenously. The preparation can be administered at a            administration set to the syringe. Inject rate of up to 10 ml per minute. The pulse rate should be           intravenously. The preparation can be administered at determined before and during administration of                     a rate of up to 10 ml per minute. The pulse rate Recombinate. Should a significant increase occur,                  should be determined before and during reducing the rate of administration or temporarily                 administration of Recombinate. Should a significant interrupting the injection usually allows the symptoms             increase occur, reducing the rate of administration or to disappear promptly. (See sections 4.4 and 4.8).                 temporarily interrupting the injection usually allows the symptoms to disappear promptly. (See sections
4.4 and 4.8).
Fig. d Fig. e                                                 5.   A separate unused filter needle must be used to withdraw each vial of reconstituted Recombinate.



7.   REGISTRATION NUMBERS
Recombinate, 250 IU/10 ml, powder and solvent for solution for injection : 143 82 31871 00.
Recombinate, 500 IU/10 ml, powder and solvent for solution for injection : 143 83 31872 00.
Recombinate, 1000 IU/10 ml, powder and solvent for solution for injection : 143 84 31873 00.