Coagulation Products Reconstitution Reference Binder - Updated: June 2021
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Coagulation Products
Reconstitution Reference
Binder
Updated: June 2021
June 2021 Dear Healthcare Professional, The Adult Hereditary Bleeding Disorder Clinic, Pediatric Bleeding Disorder Clinic and Nova Scotia Provincial Blood Coordinating Team, are pleased to provide an updated online version of the Coagulation Products – Reconstitution Reference Binder. Some patients in Nova Scotia self-administer their coagulation factor products at home. However, there are occasions when patients may present to the emergency department at your hospital requiring product administration. The purpose of this binder is to provide a resource for nurses and physicians in case they may be required to reconstitute and administer one of the coagulation factor products. We suggest the binder be readily available within your emergency department, as well as facilities where factor products may be administered in the ambulatory clinic / medical day unit. Please use the material included with this letter to create a new binder, update a current binder, or use in a different format that suits your clinical needs. If you have any questions or comments regarding the binder or materials included, please feel free to contact either coordinator or the factor product utilization assistant below. Sincerely, Sue VanOosten, RN Amanda Bettle, NP QE2 Adult Hereditary Bleeding Disorder Clinic. IWK Pediatric Bleeding Disorder Clinic. Clinic Phone (902) 473-5612 Clinic Phone (902) 470-8752 Coordinator’s Pager (902) 473-2220 - pager 2226 Chris Curtis Factor Product Utilization Assistant. NS Provincial Blood Coordinating Team. 902-441-0045
TABLE OF CONTENTS
Adynovate - Baxject II
1 13 NiaStase RT - Mixpro
Hi-Flow
2 Alprolix 14 Nuwiq
3 BeneFIX 15 Obizur
Octaplex -Prothrombin
4 Beriplex 16
Complex
5 Corifact 17 Rebinyn - Mixpro
6 Eloctate 18 Riastap
7 FEIBA 19 Tretten
8 Fibryga 20 WIlate
Xyntha – Solofuse & R2
9 Hemlibra 21
Kits
10 Humate-P 22
11 JIVI 23
12 Kovaltry 24
Revised: June 2021
BAXJECT II Hi-Flow Instructions for mixing
using aseptic technique
Needleless Transfer Device AS EASY AS 1-2-3
1 CONNECT water vial
A • Open the BAXJECT II B • Place the vials on a
Hi-Flow device package flat surface.
by peeling away the • Turn the package with the
COLOUR
lid, without touching SIDE
BAXJECT II Hi-Flow device
UP
the inside of the upside down and place it over
package. the top of the diluent vial.
• Do not remove the • Fully insert the clear
BAXJECT II Hi-Flow Product Water plastic spike of the device
device from the vial vial
into the center of the water
package. (diluent) vial’s stopper by
pushing straight down.
2 CONNECT product vial
A B C
COLOUR
SIDE
DOWN
• Grip the package at its edge • To connect the diluent vial to the • Swirl the connected vials gently
and lift it off the device. product vial, turn the diluent vial and continuously until the product
• Be careful not to touch the over and place it on top of the vial concentrate is completely dissolved
coloured plastic spike. containing product concentrate. (Do not shake).
Ensure product vial is on a • The product concentrate solution
• Do not remove the blue cap from
flat surface. should look clear and colorless;
the BAXJECT II Hi-Flow device.
Baxalta Canada Corporation • Fully insert the coloured plastic spike if not, do not use it and notify
7125 Mississauga Rd into the product vial’s stopper by Shire/Baxalta immediately.
The diluent
Mississauga, vial now has the
Ontario
pushing straight down.
L5N 0C2
BAXJECT II Hi-Flow device
• Diluent will flow into the product vial.
connected
Baxalta, now to
partitofand
Shire,isremains
readythetomarket
be authorization holder
connected to the product vial. • This should be done right away to
Baxter and Baxalta are trademarks of Shire Pharma Canada. keep the liquid free of germs.
© Copyright 2017, Shire Pharma Canada.
NOTE: Visual Aid only. Always refer to monograph included with product.
Adynovate:
https://www.takeda.com/48f6b5/siteassets/en-ca/home/what-we-do/our-medicines/product-monographs/adynovate/adynovate-pm-en.pdf
3 WITHDRAW mixed product
A • Take off the blue cap B • Turn over the connected
from the BAXJECT II COLOUR
vials so that the product
Hi-Flow device and SIDE
UP vial is on top.
connect the syringe. • Draw the product
• Be careful to not concentrate solution into
15
10
20
ml
Latex-free
5
inject air. the syringe by pulling
15
10
20
ml
Latex-free
5
Product
filter
back the plunger slowly.
• Disconnect the syringe
from the vials.
NOTE: If you are using more than one vial of product concentrate, the contents of more than one
vial may be drawn into the same syringe. Make sure you mix each vial of product concentrate with the
Sterile Water for Injection, USP that is provided in the box (following the previous outlined steps).
You will need a separate BAXJECT II Hi-Flow device to mix each additional vial of product concentrate.
C • Attach the infusion needle to the syringe using a winged (butterfly) infusion
set, if available. Point the needle up and remove any air bubbles by gently
tapping the syringe with your finger and slowly and carefully pushing air
out of the syringe and needle.
• Apply a tourniquet and get the infusion site ready by wiping the skin well
with an alcohol swab.
• Insert the needle into the vein and remove the tourniquet. Slowly infuse the
mixed product. Do not infuse any faster than 10 mL per minute.
• Take the needle out of the vein and use sterile gauze to put pressure on
the infusion site for several minutes.
• Do not recap the needle.
Place used infusion needle, syringe, vials and BAXJECT II Hi-Flow system in a hard-walled Sharps
container for proper disposal (do not dispose in household trash).
Do not attempt to do an infusion unless you have been taught how by your healthcare provider or hemophilia center.
Always follow the specific instructions given by your healthcare provider. If you are unsure of the procedures,
please call your healthcare provider before using.
Shire Pharma Canada ULC
22 Adelaide St. West, Suite 3800
Toronto, Ontario
M5H 4E3
Baxalta Canada Corporation, now part of Shire, remains the market authorization holder.
© 2017 Shire. All rights reserved.
SHIRE and the Shire Logo are registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affiliates.
BAXJECT is a registered trademark of Baxalta Incorporated, a wholly owned, indirect subsidiary of Shire plc. CABS11417-0003HF
NOTE: Visual Aid only. Always refer to monograph included with product.
Adynovate:
https://www.takeda.com/48f6b5/siteassets/en-ca/home/what-we-do/our-medicines/product-monographs/adynovate/adynovate-pm-en.pdf
NOTE: Visual Aid only. Always refer to monograph included with product.
Alprolix:
https://products.sanofi.ca/en/alprolix.pdf
NOTE: Visual Aid only. Always refer to
monograph included with product.
Alprolix:
https://products.sanofi.ca/en/alprolix.pdf
Preparing Bene FIX using the R2 �:���stitution Kit
The following steps are provided as general guidelines for ■ Connect the syringe to adapter
using the BeneFIX R2 Kit. Always follow the specific preparation on BeneFIX vial.
and administration procedures provided by your hemophilia
treatment centre.
■ Insert tip of syringe into
adapter opening.
■ If refrigerated, allow ■ Push firmly and turn in
BeneFIX and the a clockwise direction.
pre-filled diluent
syringe to come to ■ Slowly push down plunger of
room temperature. syringe to inject all diluent into
BeneFIX vial.
■ Wash your hands with good
soapy lather for a minimum ■ Don't remove syringe.
of 30 seconds.
■ Gently swirl vial until all the
BeneFIX powder is dissolved.
■ Solution should be clear
and colourless.
■ Remove plastic flip top cap.
■ Wipe top of vial with
alcohol swab. ■ Invert vial, slowly draw reconstituted
BeneFIX into syringe.
■ Remove syringe from vial by pulling
and turning counter clockwise.
■ Remove cover from plastic
vial adapter package.
■ Place adapter over BeneFIX If using more than one vial:
vial, press down firmly until
■ Prepare all the vials of BeneFIX you
' ..
it snaps into place. ,1 :•· .L need, leaving the diluent syringes
■ Leave plastic cover on adapter attached until you are ready to draw
until you are ready to connect back the solution.
the syringe.
� .:. J;j ■ Remove all of the diluent syringes
from the vial adapters, leaving the
■ Attach plunger rod to diluent vial adapters in place.
syringe by inserting the rod
into the syringe and turning.
■ Remove the large luer lock syringe
from the packaging and attach it
to the vial adapter and draw back
the BeneFIX solution as in step 11.
I
■ Transfer the large luer lock syringe
• ■ Remove plastic cap from
diluent syringe by bending to the next vial adapter to draw back
up and down to break the seal. this BeneFIX solution.
■ Repeat these steps with as many vials
as required.
1 After preparing BeneFIX it should be injected intravenously
■ Remove plastic cover over several minutes, as directed by your hemophilia
on vial adapter. treatment centre.
NOTE: Visual Aid only. Always refer to monograph included with product.
Talk to your doctor or hemophilia treatment centre
Benefix:
if you have any questions about BeneF/X.
https://www.pfizer.ca/benefix-coagulation-factor-ix-recombinant
NOTE: Visual Aid only. Always refer to monograph included with product.
Benefix:
https://www.pfizer.ca/benefix-coagulation-factor-ix-recombinant
Hospital: __________________ i
Biatherap es far Life'" CSL Behring
Beriplex·p Y::I
.. - =
Human Prothrombin Complex
··' I• Dilumt vial Product via I
2
• Ensure product and water vials
--
are at room temperature.
• Remove caps from vials and wipe
iiii'
stoppers with alcohol swab. Remove
Mix2Vial ...
Mix2Vial '" package lid. '--'
Before you begin, wash hands thoroughly. Use aseptic technique.
• Place water vial on a flat clean surface and
hold firmly.
Pierce the vial with the blue tip of
the transfer device. Use a quick
firm motion. 1¼iter
(diluent}-
Tight grip
• Pull off the remaining Diluent Adapter
package and discard. (blue}
Integrated
--
filter
Product
adapter
(clear}
• Place PRODUCT vial on a flat surface and hold firmly.
Turn the WATER vial along with the device upside down. «1
1•
Pierce the product vial with the clear tip of the device. ;
Use a quick firm motion. The water flows automatically
into the PRODUCT vial. ,:----·�
'-4
-
• Swirl gently, do not shake.
• When water vial is empty, remove it * Mix2Vial is a trademark of West or one of its Subsidiaries.
by grasping the blue portion of the
device and turning it counterclockwise.
• Draw air into empty syringe.
• Screw syringe clockwise into the
white portion of the device.
-
ffi
• Push air into vial. For information on Beriplex� P/N, CSL Behring Canada
please refer to the product Ottawa, Ontario, K1 P 6L5
• Turn the system upside down. information at www.cslbehring.ca. 836008,2011.
• Draw the solution into syringe.
NOTE: Visual Aid only. Always refer to monograph included with product.
Beriplex:
https://labeling.cslbehring.ca/PM/CA/Beriplex-PN/EN/Beriplex-PN-Product-Monograph.pdfCorifact™ 250/ Corifact™ 1250
Factor XIII Concentrate, Human
CSL Behring Canada, Inc.
How to prepare for administration:
Administration
Corifact (Factor XIII Concentrate, Human) should be reconstituted according to the instructions below.
The reconstituted solution shou8ld be administered aseptically by slow intravenous injection at a rate
not exceeding 4 mL per minute/ Corifact must not be mixed with other medicinal products. It must be
administered aseptically though a separate infusion line.
Preparation and Reconstitution
Prepare and reconstitute using aseptic techniques
Do not use Corifact beyond the expiration date on the vial label and carton
Perform a visual inspection of the reconstituted solution. Make sure it is colorless to slightly
yellowish, slightly opalescent, and free from visible particles.
The procedures below are provided as general guidelines for the preparation and reconstitution of
Corifact.
NOTE: Visual Aid only. Always refer to monograph included with product.
Corifact:
https://labeling.cslbehring.ca/PM/CA/Corifact/EN/Corifact-Product-Monograph.pdfNOTE: Visual Aid only. Always refer to monograph included with product.
Corifact:
https://labeling.cslbehring.ca/PM/CA/Corifact/EN/Corifact-Product-Monograph.pdf
Approval Date: Dec 8, 2015NOTE: Visual Aid only. Always refer to monograph included with product.
Eloctate:
https://www.biogen.ca/content/dam/corporate/en_CA/pdfs/products/ELOCTATE/ELOCTATE_PM_E.pdfNOTE: Visual Aid only. Always refer to monograph included with product. Eloctate: https://www.biogen.ca/content/dam/corporate/en_CA/pdfs/products/ELOCTATE/ELOCTATE_PM_E.pdf
BAXJECT II HI FLOW WITH FEIBA NF®
FEIBA NF is indicated for use in Hemophilia A and B patients with inhibitors for:
• Control of spontaneous bleeding episodes • Routine prophylaxis to prevent or reduce the frequency of
• Surgical interventions bleeding episodes in adults and children >6 years of age
RECONSTITUTION OF POWDER TO PREPARE A SOLUTION FOR INJECTIONS
Note: Use aseptic technique throughout entire procedure.
1 Warm the unopened vial containing the 4 B) Grip the package at its edge and pull the
solvent (Sterile Water for Injection, EP) to room package off BAXJECT II Hi-Flow. Do not
temperature if necessary (e.g. using a sterile remove the blue cap from BAXJECT II Hi-Flow.
water bath for warming within several minutes,
max. +37°C).
2 Remove the protective caps from the FEIBA vial
and solvent vial and cleanse the rubber stoppers
with germicidal solution of both and allow to dry.
Place the vials on a flat surface.
5 With the transfer device attached to the solvent
3 Open the package of vial, invert the system so that the solvent vial is on
BAXJECT II Hi-Flow top of the device. Insert the purple plastic spike of
device by peeling away BAXJECT II Hi-Flow through the FEIBA vial stopper.
the paper lid without The vacuum will draw the solvent into the FEIBA vial.
touching the inside.
Do not remove the
transfer device from
the package.
4 A) Turn the package
over and insert the
6 Swirl gently until all the material is dissolved.
clear plastic spike
Ensure that FEIBA is completely dissolved,
through the solvent
otherwise active material will not pass through
stopper.
the device filter.
NOTE: Visual Aid only. Always refer to monograph included with product.
FEIBA: https://www.takeda.com/491aab/siteassets/en-ca/home/what-we-do/our-medicines/product-monographs/feiba-nf/feiba-
nf-pm-en.pdfINJECTION/INFUSION
1 Remove the blue cap from BAXJECT II Hi-Flow. Take the syringe and connect
it to BAXJECT II Hi-Flow (DO NOT DRAW AIR INTO THE SYRINGE).
2 Invert the system (with FEIBA vial on top). Draw the FEIBA solution into the
syringe by pulling the plunger back slowly.
3 Disconnect the syringe.
4 Slowly inject the solution intravenously with a winged set for injection.
NOTE:
• Do not exceed an infusion rate of 2 U FEIBA/kg/Body Weight per minute.
• Do not refrigerate after reconstitution!
• After reconstitution, the solution should be inspected for particulate matter and discoloration prior to administration. Do not use
solutions that are cloudy or have deposits.
• Mixing of FEIBA with other products or substances must be avoided. It is advisable to flush venous access lines with isotonic saline
prior to and after infusion of FEIBA.
• After complete reconstitution of FEIBA NF its injection or infusion should be commenced as promptly as practicable, but must be
completed within three hours following reconstitution.
• The solution must be given by intravenous injection or intravenous drip infusion and the maximum injection or infusion rate must not
exceed 2 units per kg of body weight per minute. In a patient with a body weight of 75 kg, this corresponds to an infusion rate of 2.5 -
7.5 mL per minute depending on the number of units per vial (see label on vial).
Consult the product monograph at https://www.shirecanada.com/-/media/shire/shireglobal/shirecanada/pdffiles/
product%20information/feiba-nf-pm-en.pdf for contraindications, warnings, precautions, adverse reactions,
interactions, dosing, administration, storage and conditions of clinical use. The product monograph is also available
by calling us at 1-800-268-2772.
Reference: Feiba NF Product Monograph. Shire Pharma Canada ULC. April 26, 2018.
SHIRE and the Shire Logo are trademarks or registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affiliates.
FEIBA NF is a trademark or registered trademark of Baxalta Incorporated, a wholly-owned, indirect subsidiary of Shire plc.
Shire Pharma Canada ULC, 22 Adelaide St. West, Suite 3800, Toronto, ON Canada M5H 4E3 © 2018 Shire. All rights reserved. PRMCDA/CA//0500
86174
NOTE: Visual Aid only. Always refer to monograph included with product.
FEIBA: https://www.takeda.com/491aab/siteassets/en-ca/home/what-we-do/our-medicines/product-monographs/feiba-nf/feiba-nf-pm-en.pdfReconstitution Instructions
Fibrinogen Concentrate (Human) Powder Ensure the Fibryga® vial and the water for injection are at room temperature
for Solution for Injection / Infusion, 1 g/vial
1 2 3 4
Lay out the Fibryga® kit contents on Remove the plastic caps and Peel away the paper cover of the Maintain the transfer device in its
a clean flat surface. You will need a discard. Clean the rubber stoppers outer package of the Octajet® outer package. Place the Octajet®
50 mL syringe. with an alcohol swab and allow transfer device. device onto the Fibryga® vial and
them to dry. spike. Ensure the plastic clips of the
Octajet® device securely lock to the
Fibryga® vial.
5 6 7 8
While holding onto the powder vial, Hold the Fibryga® vial on a flat Remove the blue ring and press the Gently swirl the powder vial until
remove the outer package from the surface. Invert the water vial and water vial down using downward the powder is fully dissolved. Do
Octajet® device. Do not touch the place it over the blue water spike. force in one motion (to start the not shake the vial – this will cause
blue water spike. Push spike of the Octajet® through vacuum) then let the water flow foam formation.
the rubber stopper of the water vial into the Fibryga® vial automatically.
in one smooth motion.
Ensure the water vial fully covers
both holes of the blue water spike
to avoid vacuum loss.
9 10 11
In one hand, hold the Fibryga® vial Open filter package and attach Withdraw the solution through the
and secure the clear portion of the 50 mL syringe. filter into the syringe.
transfer device. In the other hand, Attach the filter and syringe to the
hold the water vial and grip the blue Luer lock on the Fibryga® vial.
disc of the transfer device.
In one motion, remove the water vial
together with the blue spike/disc.
Do not remove the water vial alone
as it will expose the spike.
NOTE: Visual Aid only. Always refer to monograph included with product.
© Octapharma Canada Inc.
Fibryga® and Octajet® are registered trademarks of Octapharma. Fibryga: FIB.02.20.EN
https://services-prod-canada.octapharma.com/download/x/1a97f494f8/fibryga-pm-en-20201119.pdfVolume of WFI to be Approximate Available Nominal Concentration
Vial Size
Added to Vial Volume per mL
1g 50 mL 50 mL 20mg
Administration Instructions
FIBRYGA (Fibrinogen Concentrate (Human), 1 g/vial) is a sterile, freeze dried preparation of highly purified fibrinogen.
®
Description FIBRYGA® is prepared from large pools of human plasma employing precipitations, filtrations and chromatographic steps. Pathogen
inactivation/removal is accomplished by a solvent detergent (S/D) method and nanofiltration (20 nm).
Indications and FIBRYGA® is indicated for the treatment of acute bleeding episodes and perioperative prophylaxis in adult and pediatric patients
Clinical Use with congenital afibrinogenemia and hypofibrinogenemia.
FIBRYGA® is contraindicated in individuals who have manifested severe immediate hypersensitivity reactions, including anaphylaxis
Contraindications
to FIBRYGA® or its components.
FIBRYGA® can be stored at +2°C to +25°C for up to 36 months from the date of manufacture. Do not use product after expiry date.
Storage Stability of the reconstituted solution has been demonstrated for up to 24 hours at + 25°C. Discard partially used vials.
Do not freeze. Protect from exposure to light. Keep in a safe place out of the reach and sight of children.
The recommended target fibrinogen plasma level is 100 mg/dL for minor bleeding or minor surgery and 150 mg/dL for major
bleeding or major surgery.
FIBRYGA® dose when baseline fibrinogen level is known
Dose should be individually calculated for each patient based on the target plasma fibrinogen level based on the type of bleeding,
Dosage actual measured plasma fibrinogen level and body weight, using the following formula:
For detailed
dosing instructions [Target level (mg/dL) - measured level (mg/dL)]
Dose (mg/kg body weight) =
see the FIBRYGA® 1.8 (mg/dL per mg/kg body weight)
Product Monograph.
FIBRYGA® dose when baseline fibrinogen level is not known
If the patient’s fibrinogen level is not known, the recommended dose is 60 mg per kg of body weight administered intravenously.
Monitoring of patient’s fibrinogen level is recommended during treatment with FIBRYGA®.
NOTE: Visual Aid only. Always refer to monograph included with product.
Fibryga: https://services-prod-canada.octapharma.com/download/x/1a97f494f8/fibryga-pm-en-20201119.pdf
Reference: 1. Fibryga® Product Monograph. Octapharma. August 10, 2018. FIB.02.20.ENInstructions for Use
HEMLIBRA® (emicizumab injection)
Pr
FOR SUBCUTANEOUS USE
NOTE: Visual Aid only. Always refer to monograph included with product.
Hemlibra: https://www.rochecanada.com/PMs/Hemlibra/Hemlibra_PM_E.pdfBe sure that you read, understand, and follow the Instructions for Use before injecting HEMLIBRA. Your healthcare
provider should show you how to prepare, measure, and inject HEMLIBRA properly before you use it for the first
time. Ask your healthcare provider if you have any questions.
Important Information:
• Do
not inject yourself or someone else unless you have been shown how to by your healthcare provider.
• Make sure the name HEMLIBRA (emicizumab injection) appears on the box and vial label.
•
Before opening the vial, read the vial label to make sure you have the medicine strength(s) needed to give
the dose prescribed by your healthcare provider.
•
HEMLIBRA comes in four strengths. Depending on your dose, you may need to use more than one vial
to give your total prescribed dose. Your healthcare provider will determine your dose in millilitres (mL)
that you will need to give based on your body weight. Do not use different HEMLIBRA vials of different
concentrations when combining vials to achieve the prescribed dose.
• Check the expiration date on the box and vial label. Do not use if the expiration date has passed.
• nly use the vial one time. After you inject your dose, dispose of (throw away) any unused HEMLIBRA left
O
in the vial. Do not save unused HEMLIBRA in the vial for later use.
•
When using a transfer needle with filter:
– Only use the syringes, transfer needles with filter, and injection needles that your healthcare provider
prescribes.
– Only use the syringes, transfer needles with filter, and injection needles one time. Dispose of (throw away)
any used syringes and needles.
• your prescribed dose is more than 2 mL, you will need to give more than one subcutaneous injection
If
of HEMLIBRA. Contact your healthcare provider for the appropriate injection instructions.
• Do not inject the medicine intravenously.
Storing HEMLIBRA vials, needles, and syringes:
• Store HEMLIBRA in the original carton to protect the vials from light.
• Store HEMLIBRA in the refrigerator at 2°C to 8°C (36°F to 46°F).
• Do not freeze.
• Do not shake HEMLIBRA.
•
Take the vial out of the refrigerator 15 minutes before use and allow it to reach room temperature
(below 30°C) before preparing an injection.
•
Once removed from the refrigerator, the unopened vial can be kept at room temperature for up to 7 days.
After storage at room temperature, unopened vials may be returned to the refrigerator. Cumulative storage
time (total amount of time outside cold storage) at room temperature should not exceed 7 days.
•
Discard vials that have been kept at room temperature for more than 7 days or exposed to temperatures
above 30°C.
• When using a transfer needle with filter: keep the transfer needle with filter, injection needle, and syringe dry.
KEEP HEMLIBRA AND ALL MEDICINES OUT OF THE REACH OF CHILDREN.
NOTE: Visual Aid only. Always refer to monograph included with product.
Hemlibra: https://www.rochecanada.com/PMs/Hemlibra/Hemlibra_PM_E.pdf
2Inspecting the HEMLIBRA vial and your supplies:
• Collect all supplies listed over the next few pages to prepare and give your injection.
• Check
the expiration date on the box, on the vial label, and on the supplies listed over the next few pages.
• Do
not use if the expiration date has passed.
• Inspect the supplies for damage. Do not use if they appear damaged or if they have been dropped.
• Place the supplies on a clean, well-lit flat work surface.
HEMLIBRA is clear to slightly yellow in colour. Do not use the vial if:
• the medicine is cloudy, hazy, or discoloured.
• the medicine contains particles.
• the cap covering the stopper is missing.
NOTE: Visual Aid only. Always refer to monograph included with product.
Hemlibra: https://www.rochecanada.com/PMs/Hemlibra/Hemlibra_PM_E.pdf
3INCLUDED IN
THE BOX:
• Vial containing HEMLIBRA
• HEMLIBRA Patient Medication Information
NOT INCLUDED • lcohol wipes
A
IN THE BOX: – N ote: If you need to use more than one
vial to inject your prescribed dose, you must
use a new alcohol wipe for each vial.
• Gauze
• Cotton ball
• yringe with low dead space (LDS) plunger
S
Important:
– For injection amount up to 1 mL, use a
1 mL LDS syringe.
– For injection amount over 1 mL, use a
2 mL or 3 mL LDS syringe.
• 1
8G transfer needle with 5 micrometer filter
– N ote: If you need to use more than one vial
to inject your prescribed dose, you must use
a new transfer needle with filter for each vial.
Do not use the transfer needle with filter to
inject HEMLIBRA.
• 2
6G injection needle with safety shield
(used to inject HEMLIBRA)
– N ote: Do not use the injection needle
to withdraw HEMLIBRA from the vial.
• S
harps disposal container
NOTE: Visual Aid only. Always refer to monograph included with product.
Hemlibra: https://www.rochecanada.com/PMs/Hemlibra/Hemlibra_PM_E.pdf
4GETTING READY
Getting ready:
•
Before use, allow the vial(s) to warm up to room temperature for about
15 minutes on a clean, flat surface away from direct sunlight.
• Do not try to warm the vial by any other way.
• Wash your hands well with soap and water.
Selecting and preparing an injection site:
• Clean the chosen injection site area using an alcohol wipe.
• the skin dry for about 10 seconds. Do not touch, fan, or blow
Let
on the cleaned area before your injection.
• You can use your:
– Thigh (front and middle)
– Stomach area (abdomen), except for 5 cm (2 inches) around the navel
(belly button)
– Outer area of the upper arm (only if a caregiver is giving the injection)
•
You should use a different injection site each time you give an
injection, at least 2.5 cm (1 inch) away from the area you used
for your previous injection.
• Do
not inject into areas that could be irritated by a belt or waistband.
Do not inject into moles, scars, bruises, or areas where the skin is tender,
red, hard, or the skin is broken.
NOTE: Visual Aid only. Always refer to monograph included with product.
Hemlibra: https://www.rochecanada.com/PMs/Hemlibra/Hemlibra_PM_E.pdf
5Preparing the syringe for injection:
• Do not touch exposed needles or place them on a surface once the cap has been removed.
• HEMLIBRA must not be stored in the syringe.
• Once the syringe has been filled with HEMLIBRA, it must be used immediately.
• Once
the injection needle cap has been removed, the medicine in the syringe must be subcutaneously injected
(i.e., injected under the skin) within 5 minutes. Do not use the syringe if the needle touches any surface.
•
Dispose of (throw away) any used vial(s), needles, vial and injection needle caps, and used syringes
in a sharps or puncture-proof container.
Important information after the injection:
• Do not rub the injection site after an injection.
• If
you see drops of blood at the injection site, you can press a sterile cotton ball or gauze over the
injection site for at least 10 seconds, until bleeding has stopped.
• you have bruising (small area of bleeding under the skin), an ice pack can also be applied with gentle
If
pressure to the site. If bleeding does not stop, please contact your healthcare provider.
Disposing of used HEMLIBRA vial(s), needles, and syringes:
• Dispose of (throw away) any used caps, vial(s), needles, and syringes in a sharps or disposal container.
• your used needles and syringes in a sharps disposal container right away after use. Do not dispose
Put
of (throw away) any loose needles and syringes in your household trash.
• you do not have a sharps disposal container, you may use a household container that is:
If
– made of heavy-duty plastic.
– can be closed with a tight-fitting, puncture resistant lid, without sharps being able to come out.
– upright and stable during use.
– leak-resistant.
– properly labelled to warn of hazardous waste inside the container.
•
When your sharps disposal container is almost full, you will need to follow your community guidelines
for the right way to dispose of your sharps disposal container.
• not dispose of (throw away) any used sharps disposal container in your household trash unless your
Do
community guidelines permit this. Do not recycle your used sharps disposal container.
IMPORTANT: ALWAYS KEEP THE SHARPS DISPOSAL CONTAINER OUT OF REACH OF CHILDREN.
NOTE: Visual Aid only. Always refer to monograph included with product.
Hemlibra: https://www.rochecanada.com/PMs/Hemlibra/Hemlibra_PM_E.pdf
6HEMLIBRA: STEPS FOR INJECTION PREPARATION USING THE
TRANSFER NEEDLE WITH FILTER
STEP 1. REMOVE VIAL CAP AND CLEAN TOP
• Take the cap off the vial(s).
PREPARATION
• Clean the top of the vial(s) stopper with an alcohol wipe.
•
Throw away the vial cap(s) into the sharps
disposal container.
STEP 2. ATTACH TRANSFER NEEDLE WITH FILTER TO SYRINGE
• ush and twist the transfer needle with filter clockwise
P
onto the syringe until it is fully attached.
•
Slowly pull back the plunger and draw air into the syringe
that is the same amount for your prescribed dose.
NOTE: Visual Aid only. Always refer to monograph included with product.
Hemlibra: https://www.rochecanada.com/PMs/Hemlibra/Hemlibra_PM_E.pdf
7STEP 3. UNCAP TRANSFER NEEDLE WITH FILTER
• the syringe by the barrel with the transfer needle with filter
Hold
pointing up.
•
Carefully pull the transfer needle with filter cap straight off and
away from your body. Do not throw the cap away. Place the
transfer needle with filter cap down on a clean, flat surface.
You will need to recap the transfer needle with filter after
transferring the medicine.
• o not touch the needle tip or place it on a surface after the
D
needle cap has been removed.
STEP 4. INJECT AIR INTO VIAL
•
Keep the vial on the flat working surface and insert the transfer
needle with filter and syringe straight down into the centre of
the vial stopper.
– N
ote: When inserting the needle, you may need to hold the
vial steady by hand.
• Keep the needle in the vial and turn the vial upside down.
•
With the needle pointing upwards, push on the plunger
to inject the air from the syringe above the medicine.
• Keep your finger pressed down on the syringe plunger.
• not inject air into the medicine as this could create
Do
air bubbles in the medicine.
NOTE: Visual Aid only. Always refer to monograph included with product.
Hemlibra: https://www.rochecanada.com/PMs/Hemlibra/Hemlibra_PM_E.pdf
8STEP 5. TRANSFER HEMLIBRA TO SYRINGE
• Slide the tip of the needle down so that it is within the medicine.
• Slowly pull back the plunger to fill the syringe with more than the
amount of HEMLIBRA needed for your prescribed dose.
• Be careful not to pull the plunger out of the syringe.
Important: If your prescribed dose is more than the amount of HEMLIBRA in the vial, withdraw all HEMLIBRA
and go to the “Combining Vials” section now.
STEP 6. REMOVE AIR BUBBLES
•
Keep the needle in the vial and check the syringe for larger air
bubbles. Too large an air bubble can reduce the dose you receive.
• Remove
the larger air bubbles by gently tapping the syringe
barrel with your fingers until the air bubbles rise to the top of the
syringe. Move the tip of the needle above the medicine and slowly
push the plunger up to push the air bubbles out of the syringe.
• the amount of HEMLIBRA in the syringe is now at or below
If
your prescribed dose, move the tip of the needle to within the
medicine and slowly pull back the plunger until you have more
than the amount of HEMLIBRA needed for your prescribed dose.
• Be careful not to pull the plunger out of the syringe.
•
Repeat the steps above until you have removed the larger
air bubbles.
Note: Ensure you have enough HEMLIBRA in the syringe to complete your dose before moving on to the
next step. If you cannot remove all of HEMLIBRA, turn the vial upright to reach the remaining amount.
Do not use the transfer needle with filter to inject HEMLIBRA as this may cause harm,
such as pain and bleeding.
NOTE: Visual Aid only. Always refer to monograph included with product.
Hemlibra: https://www.rochecanada.com/PMs/Hemlibra/Hemlibra_PM_E.pdf
9STEP 7. RECAP TRANSFER NEEDLE WITH FILTER
• Remove the syringe and transfer needle with filter from the vial.
• Using
one hand, slide the transfer needle with filter into the cap
and scoop upwards to cover the needle.
•
Once the needle is covered, push the transfer needle with
filter cap towards the syringe to fully attach it with one hand
to prevent accidentally sticking yourself with the needle.
STEP 8. CLEAN INJECTION SITE
• Select and clean your injection site area using an alcohol wipe.
• the skin dry for about 10 seconds. Do not touch, fan,
Let
or blow on the cleaned area before your injection.
STEP 9. REMOVE TRANSFER NEEDLE WITH FILTER
•
Remove the transfer needle with filter from the syringe by twisting
counter-clockwise and gently pulling.
•
Throw away the used transfer needle with filter into a sharps
disposal container.
NOTE: Visual Aid only. Always refer to monograph included with product.
Hemlibra: https://www.rochecanada.com/PMs/Hemlibra/Hemlibra_PM_E.pdf
10HEMLIBRA: STEPS FOR INJECTION
STEP 1. ATTACH INJECTION NEEDLE TO SYRINGE
•
Push and twist the injection needle clockwise onto the syringe
until it is fully attached.
• D
o not use the injection needle to withdraw HEMLIBRA from vial.
STEP 2. MOVE SAFETY SHIELD
•
Move the safety shield away from the needle and towards
the syringe barrel.
INJECTION
STEP 3. UNCAP INJECTION NEEDLE
• C
arefully pull the injection needle cap straightaway from
the syringe.
• Dispose of (throw away) the cap into a sharps disposal container.
• Do not touch the needle tip or allow it to touch any surface.
•
After the injection needle cap has been removed, HEMLIBRA
in the syringe must be injected right away.
NOTE: Visual Aid only. Always refer to monograph included with product.
Hemlibra: https://www.rochecanada.com/PMs/Hemlibra/Hemlibra_PM_E.pdf
11STEP 4. ADJUST PLUNGER TO PRESCRIBED DOSE
•
Hold the syringe with the needle pointing up and slowly push the
plunger to your prescribed dose.
• Check
your dose, ensure the top rim of the plunger is in line with
the mark on the syringe for your prescribed dose.
STEP 5. SUBCUTANEOUS (UNDER THE SKIN) INJECTION
•
Pinch the selected injection site and fully insert the needle at
a 45° to 90° angle with a quick, firm action. Do not hold or
push on the plunger while inserting the needle.
•
Hold the position of the syringe and let go of the pinched
injection site.
STEP 6. INJECT HEMLIBRA
•
Slowly inject all of the HEMLIBRA by gently pushing the plunger
all the way down.
•
Remove the needle and syringe from the injection site at the same
angle as inserted.
NOTE: Visual Aid only. Always refer to monograph included with product.
Hemlibra: https://www.rochecanada.com/PMs/Hemlibra/Hemlibra_PM_E.pdf
12HEMLIBRA: STEPS FOR DISPOSAL
STEP 1. COVER NEEDLE WITH SAFETY SHIELD
• Move the safety shield forward 90°, away from the syringe barrel.
• Holding the syringe with one hand, press the safety shield down
against a flat surface with a firm, quick motion until you hear
a “click”.
• you do not hear a click, look to see that the needle is fully
If
covered by the safety shield.
•
Keep your fingers behind the safety shield and away from the
needle at all times.
• Do not detach the injection needle.
STEP 2. THROW AWAY USED HEMLIBRA VIAL(S), NEEDLE, AND SYRINGE
• ut your used vial(s), needles, vial and injection needle caps, and
P
used syringes in a sharps disposal container right away after use.
• D
o not try to remove the used injection needle from the used
syringe.
• Do not recap the injection needle with the cap.
DISPOSAL
Important: Always keep the sharps disposal container out of the reach of children.
NOTE: Visual Aid only. Always refer to monograph included with product.
Hemlibra: https://www.rochecanada.com/PMs/Hemlibra/Hemlibra_PM_E.pdf
13HEMLIBRA: STEPS FOR COMBINING VIALS USING THE
TRANSFER NEEDLE WITH FILTER
If you need to use more than one vial to get to your total prescribed dose, follow these steps after you have
drawn up HEMLIBRA from the first vial:
STEP A. RECAP TRANSFER NEEDLE WITH FILTER
• Remove the syringe and transfer needle with filter from the first vial.
• Using
one hand, slide the transfer needle with filter into the cap
and scoop upwards to cover the needle.
• nce the needle is covered, push the transfer needle with filter cap
O
towards the syringe to fully attach it with one hand to prevent
accidentally sticking yourself with the needle.
STEP B. REMOVE TRANSFER NEEDLE WITH FILTER
•
Remove the transfer needle with filter from the syringe by twisting
counter-clockwise and gently pulling.
•
Dispose of (throw away) the used transfer needle with filter into
a sharps disposal container.
STEP C. ATTACH NEW TRANSFER NEEDLE WITH FILTER TO SYRINGE
Note: You must use a new transfer needle with filter each time you
withdraw HEMLIBRA from a new vial.
• Push and twist a new transfer needle with filter clockwise onto the
syringe until it is fully attached.
• Slowly pull back the plunger and draw some air into the syringe.
NOTE: Visual Aid only. Always refer to monograph included with product.
Hemlibra: https://www.rochecanada.com/PMs/Hemlibra/Hemlibra_PM_E.pdf
14STEP D. UNCAP TRANSFER NEEDLE WITH FILTER
•
Hold the syringe by the barrel with the transfer needle with filter
cap pointing up.
•
Carefully pull the transfer needle with filter cap straight off and away
from your body. Do not throw the cap away. You will need to
recap the transfer needle with filter after drawing up the medicine.
• Do not touch the needle tip.
STEP E. INJECT AIR INTO VIAL
•
With the new vial on the flat working surface, insert the new
transfer needle with filter and syringe straight down into the
centre of the vial stopper.
– N
ote: When inserting the needle with filter, you may need to
hold the vial steady by hand.
•
Keep the transfer needle with filter in the vial and turn the vial
upside down.
•
With the needle pointing upwards, inject the air from the
syringe above the medicine.
• Keep your finger pressed down on the syringe plunger.
• not inject air into the medicine as this could create
Do
air bubbles in the medicine.
COMBINING VIALS
NOTE: Visual Aid only. Always refer to monograph included with product.
Hemlibra: https://www.rochecanada.com/PMs/Hemlibra/Hemlibra_PM_E.pdf
15STEP F. TRANSFER HEMLIBRA TO SYRINGE
•
Slide the tip of the needle down so that it is within
the medicine.
•
Slowly pull back the plunger to fill the syringe barrel more than
the amount of HEMLIBRA needed for your prescribed dose.
• Be careful not to pull the plunger out of the syringe.
Note: Ensure you have enough HEMLIBRA in the syringe to complete your dose before moving on to the
next step. If you cannot remove all of HEMLIBRA, turn the vial upright to reach the remaining amount.
Do not use the transfer needle with filter to inject HEMLIBRA as this may cause harm,
such as pain and bleeding.
Repeat steps A to F with each additional vial until you have more than the amount of HEMLIBRA
needed for your prescribed dose. Once completed, keep the transfer needle with filter inserted
in the vial and return to Step 6 “Remove air bubbles” in the “Preparation – Transfer needle with
filter” section. Continue with the remaining steps.
If you want more information about HEMLIBRA:
• Talk to your healthcare professional.
• Educational materials for healthcare professionals and patients are available from Hoffmann-La Roche Limited
by calling 1-888-762-4388.
•
Find the full product monograph that is prepared for healthcare professionals and includes this
Patient Medication Information, by visiting the Health Canada website; the manufacturer’s website
www.rochecanada.com, or by calling 1-888-762-4388.
NOTE: Visual Aid only. Always refer to monograph included with product.
Hemlibra: https://www.rochecanada.com/PMs/Hemlibra/Hemlibra_PM_E.pdf
16If you require this information in an accessible format, please contact Roche at 1-800-561-1759.
© Copyright 2021, Hoffmann-La Roche Limited
HEMLIBRA® Registered trade-mark of Chugai Seiyaku Kabushiki Kaisha, used under license.
Hoffmann-La Roche Limited
Mississauga, ON L5N 5M8
29126E21 NOTE: Visual Aid only. Always refer to monograph included with product.
Hemlibra: https://www.rochecanada.com/PMs/Hemlibra/Hemlibra_PM_E.pdfHospital: ®
QUICK REFERENCE
Mix2Vial®*
(needleless transfer device) INSTRUCTIONS FOR USE**
1 Preparation
• Before infusion, ensure the product and Mix2Vial
®
Diluent vial Product vial
Humate-P®– Key Information
diluent vials are at room temperature. (sterile water)
Produced Primarily from Canadian Plasma
• Remove flip caps of the diluent and Humate-P®
and wipe the rubber stoppers with an antiseptic • Available in a range of formats
solution. Allow to dry.
• Open the Mix2Vial® package by peeling away • 3-hour window for administration after
the lid. Leave the Mix2Vial in its clear outer reconstitution
packaging to maintain sterility.
• Stored at room temperature or in the
2 Connect diluent vial
refrigerator, at +2ºC to +25ºC, until
• Place diluent vial on an even flat surface and hold firmly. expiration date on label1
• Grip the Mix2Vial® together with the clear packaging and
firmly snap the blue end onto the diluent stopper (Fig.2).
Fig. 2
3 Remove packaging
• While holding onto the diluent, carefully remove
the clear outer packaging from Mix2Vial®.
• Ensure that only the clear outer packaging is
removed. (Fig. 3).
Humate-P® package: Humate-P® vial, diluent vial,
Mix2Vial®
Fig. 3
Administration: Patient receiving more than one vial, the
4 Connect product vial contents of two vials may be drawn into the same syringe
through a separate unused Mix2Vial® set before attaching the
• Place product vial on a flat surface and hold firmly. vein needle.
Invert the diluent vial with the attached Mix2Vial®.
Humate-P® should be inspected visually for particulate matter
• Firmly snap the transparent adapter onto the product vial (Fig. 4). and discoloration prior to administration. The solution should
The diluent flows automatically into the be clear or slightly opalescent. Even if the directions for use
product vial. for the reconstitution procedure are precisely followed, it is
not uncommon for a few flakes or particles to remain. The
• With the diluent and product vial still attached, gently swirl to ensure filter included in the Mix2Vial® device removes those particles
that the product is fully dissolved (Fig. 5). Do not shake. Fig. 4 Fig. 5 completely. Filtration does not influence dosage calculations. Do
not use visibly cloudy solutions or solutions still containing flakes
5 Unscrew diluent vial or particles after filtration.
Do not refrigerate after reconstitution.
• Hold the product-side of the Mix2Vial® set with one hand.
Grasp the blue diluent side of the Mix2Vial set with the other *Mix2Vial® is a registered trademark of West Pharma. Services IL, Ltd., a
hand. subsidiary of West Pharmaceutical Services Inc.
Humate-P® is a registered trademark of CSL Behring GmbH.
• Unscrew the set into two pieces (Fig. 6). Biotherapies for Life® is a registered trademark of CSL Behring LLC.
** For detailed instructions, please refer to Part III of the Product
Fig. 6 Monograph. For more information and a complete risk/benefit profile,
please contact Customer Service at 1-866-773-7721 ext. 2386 or refer to
6 Withdraw mixed solution the Product Monograph available on our website at www.cslbehring.ca.
• Draw air into an empty sterile syringe.
Reference: 1. Humate-P® Product Monograph, May 7, 2019.
• While product vial is upright, screw the syringe into the Mix2Vial® set.
• Inject air into the product vial. NOTE: Visual Aid only. Always refer to monograph included
• Keeping the syringe plunger pressed, turn the system upside down. with product.
Humate-P:
• Draw the concentrate into the syringe by pulling the plunger back ®
slowly (Fig 7). https://labeling.cslbehring.ca/PM/CA/Humate-P/EN/Humate-
CSL Behring Canada, Inc
• Keeping the syringe plunger facing down, unscrew the syringe from P-Product-Monograph.pdf 55 Metcalfe St., Suite 1460
the Mix2Vial® (Fig 8). Ottawa, ON K1P 6L5
• Attach the syringe to a venipuncture set. Fig. 7 Fig. 8
HUM201905138EN www.cslbehring.ca
20190138_HumateP_Reconstitution_tear_off_sheet_V16.indd 1 8/13/19 3:50 PMHOW DO I PREPARE JIVI?
Always follow the instructions provided by your doctor on how to prepare Jivi. These steps can be used as a guide.*
1 WARM 2 FLIP 3 PRESS 4 SNAP
vial and cap off vial together vial cap off
syringe and disinfect and vial syringe
in hands rubber adapter Do not touch
stopper in housing syringe tip
with hand
or any surface
5 REMOVE 6 ATTACH 7 ATTACH 8 INJECT
and discard prefilled plunger rod diluent slowly
adapter syringe Avoid into vial
housing touching
sides and
threads of
plunger rod
9 SWIRL 10 PUSH 11 REFILL 12 DETACH
vial gently plunger down syringe from vial adapter
to mix and turn Remove as and attach to
upside-down much air administration set
Do not shake
Do not use as possible
solution if before
cloudy or detaching
contains syringe
particles by slowly
and carefully
pushing air
back into vial
* Please refer to your Patient Medication Information leaflet for full administration information.
NOTE: Visual Aid only. Always refer to monograph included with product. Antihemophilic Factor (Recombinant, B-domain deleted, PEGylated)
JIVI: https://omr.bayer.ca/omr/online/Jivi-pm-en.pdf
Facteur antihémophilique (recombinant pégylé à domaine B tronqué)WHAT VIAL SIZES ARE AVAILABLE FOR JIVI?
Jivi is available in the following
single-use vial sizes and is prepared
with 2.5 mL of sterile water for injection:
500 IU 1,000 IU 2,000 IU 3,000 IU
HOW IS JIVI STORED?
2 –8°C 25°C
under refrigeration for 6 months
when kept in outer carton or up to 30ºC for 3 months
to protect from light Do not re-refrigerate once
Do not freeze removed from refrigeration
Do not use beyond the expiration
date on the labels and cartons
Use immediately (within
3 hours) after reconstitution
Talk to your doctor for more information on Jivi
Bayer Inc., 2920 Matheson Blvd. E., Mississauga, Ontario L4W 5R6
® TM see www.bayer.ca/tm-mc
© 2020, Bayer Inc.
PP-JIV-CA-0075-1 NOTE: Visual Aid only. Always refer to monograph included with product. Antihemophilic Factor (Recombinant, B-domain deleted, PEGylated)
JIVI: https://omr.bayer.ca/omr/online/Jivi-pm-en.pdf Facteur antihémophilique (recombinant pégylé à domaine B tronqué)NOTE: Visual Aid only. Always refer to monograph included with product. Kovaltry: https://omr.bayer.ca/omr/online/kovaltry-pm-en.pdf
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