RECOMBINATE FOR INJECTION 1000 iuvial

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

ANTIHEMOPHILIC FACTOR (RECOMBINANT)

Available from:

TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.

ATC code:

B02BD02

Dosage:

1000 iu/vial

Pharmaceutical form:

INJECTION, POWDER, FOR SOLUTION

Composition:

ANTIHEMOPHILIC FACTOR (RECOMBINANT) 1000 iu/vial

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

BAXALTA US INC.

Authorization status:

ACTIVE

Authorization date:

2003-12-22

Patient Information leaflet

1 

RECOMBINATE 
[Antihemophilic Factor (Recombinant)] 

DESCRIPTION

RECOMBINATE [Antihemophilic Factor (Recombinant)] is a glycoprotein synthesized by a 
genetically engineered Chinese Hamster Ovary (CHO) cell line.  In culture, the CHO cell line 
secretes recombinant Factor VIII (rFVIII) into the cell culture medium. The rFVIII is purified 
from the culture medium utilizing a series of chromatography columns. A key step in the 
purification process is an immunoaffinity chromatography methodology in which a purification 
matrix, prepared by immobilization of a monoclonal antibody directed to factor VIII, is utilized 
to selectively isolate the rFVIII in the medium. The synthesized rFVIII produced by the CHO 
cells has the same biological effects as human Factor VIII. Structurally the protein has a similar 
combination of heterogenous heavy and light chains as found in human Factor VIII. 

RECOMBINATE is formulated as a sterile, nonpyrogenic, off-white to faint yellow, lyophilized 
powder preparation of concentrated recombinant Factor VIII for intravenous injection. 
RECOMBINATE is available in single-dose vials, which contain nominally 250, 500 and 1000 
International Units per vial.  When reconstituted with the appropriate volume of diluent, the 
product contains the following stabilizers in maximum amounts: For 10 mL reconstitution 
volume; 12.5 mg/mL Albumin (Human), 0.20 mg/mL calcium, 1.5 mg/mL polyethylene glycol 
(3350), 180 mEq/L sodium, 55 mM histidine, 1.5 µg/AHF International Unit (IU) polysorbate-
80. Recombinant Von Willebrand Factor (rVWF) is coexpressed with the rFVIII and helps to 
stabilize it. The final product contains not more than 2 ng rVWF/IU rFVIII which will not have 
any clinically relevant effect in patients with von Willebrand�

Summary of Product characteristics

0729056_13OCT2015_A
TO-07-29056
TO-07-GS001
PMS 293 U
BLACK
SWATCH
SWATCH
SWATCH
SWATCH
SWATCH
SWATCH
SWATCH
SWATCH
TO-15-114-B
PI,RAHF,1.5 CHO,GI&HYL SOURCE, SINGAPORE
0729056
W: 12-1/4 in. H: 7-5/8 in.
0727863
W: 3-1/16 in. H: 1-15/16 in.
1 of 3
NA
918661A01 SGK Red CCole
COMMENTS:
0729056_13OCT2015_A_PAGE 1 OF 3
through the diluent vial stopper. Fig B
6.
Grip the BAXJECT II package at its edge and pull the package off the
device.
Fig C DO NOT REMOVE THE BLUE CAP FROM THE BAXJECT II DEVICE. Do not
touch the exposed white plastic spike.
7.
Turn the system over, so that the diluent vial is on top. Quickly
insert the
white plastic spike fully into the RECOMBINATE vial stopper by pushing
straight down. The vacuum will draw the diluent into the RECOMBINATE
vial. Fig D
8.
Swirl gently until RECOMBINATE is completely dissolved. After
reconstitution, the solution should be colorless to faint yellow, and
substantially free from foreign particles.
NOTE: Do not refrigerate after reconstitution. (see ADMINISTRATION).
ADMINISTRATION: USE ASEPTIC TECHNIQUE
RECOMBINATE is administered by intravenous (IV) injection after
reconstitution.
Administer at room temperature.
RECOMBINATE should be administered not more than 3 hours after
reconstitution.
INTRAVENOUS SYRINGE INJECTION
Parenteral drug products should be inspected for particulate
matter and discoloration prior to administration, whenever
solution and container permit. The solution should be
colorless to faint yellow in appearance. If not, do not use the
solution and notify Baxalta immediately.
Plastic syringes are recommended for use with this product
since proteins such as RECOMBINATE tend to stick to the
surface of all-glass syringes.
1.
Remove the blue cap from the BAXJECT II device. Connect the syringe to
the BAXJECT II device. Fig E DO NOT INJECT AIR.
2.
Turn over the connected vials so that the RECOMBINATE vial is on top.
Draw
the factor concentrate into the syringe by pulling the plunger back
slowly.
Fig F
3.
Disconnect the syringe; attach a suitable needle and inj