Coagulation Products Reconstitution Reference Binder

Coagulation Products Reconstitution Reference

Binder

Updated: June 2021

Amanda Bettle, NPIWK Pediatric Bleeding Disorder Clinic. Clinic Phone (902) 470-8752

Sue VanOosten, RN QE2 Adult Hereditary Bleeding Disorder Clinic. Clinic Phone (902) 473-5612 Coordinator’s Pager (902) 473-2220 - pager 2226

Chris Curtis Factor Product Utilization Assistant. NS Provincial Blood Coordinating Team. 902-441-0045

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,

Revised: June 2021

TABLE OF CONTENTS

1 Adynovate - Baxject II Hi-Flow 13 NiaStase RT - Mixpro

2 Alprolix 14 Nuwiq

3 BeneFIX 15 Obizur

4 Beriplex 16 Octaplex -Prothrombin Complex

5 Corifact 17 Rebinyn - Mixpro

6 Eloctate 18 Riastap

7 FEIBA 19 Tretten

8 Fibryga 20 WIlate

9 Hemlibra 21 Xyntha – Solofuse & R2 Kits

10 Humate-P 22

11 JIVI 23

12 Kovaltry 24

BAXJECT II Hi-FlowNeedleless Transfer Device

Instructions for mixing using aseptic technique

AS EASY AS 1-2-3

Baxalta Canada Corporation7125 Mississauga RdMississauga, Ontario L5N 0C2

Baxalta, now part of Shire, remains the market authorization holder

Baxter and Baxalta are trademarks of Shire Pharma Canada.© Copyright 2017, Shire Pharma Canada.

1 CONNECT water vial • Open the BAXJECT II

Hi-Flow device packageby peeling away thelid, without touchingthe inside of thepackage.

• Do not remove theBAXJECT II Hi-Flowdevice from thepackage.

A • Place the vials on aflat surface.

• Turn the package with theBAXJECT II Hi-Flow deviceupside down and place it overthe top of the diluent vial.

• Fully insert the clearplastic spike of the deviceinto the center of the water(diluent) vial’s stopper bypushing straight down.

COLOURSIDEUP

Productvial

Watervial

B

The diluent vial now has the BAXJECT II Hi-Flow device

connected to it and is ready to be connected to the product vial.

2 CONNECT product vial

• Grip the package at its edgeand lift it off the device.

• Be careful not to touch thecoloured plastic spike.

• Do not remove the blue cap fromthe BAXJECT II Hi-Flow device.

• To connect the diluent vial to theproduct vial, turn the diluent vialover and place it on top of the vialcontaining product concentrate.Ensure product vial is on aflat surface.

• Fully insert the coloured plastic spikeinto the product vial’s stopper bypushing straight down.

• Diluent will flow into the product vial.• This should be done right away to

keep the liquid free of germs.

COLOURSIDE

DOWN

B CA

• Swirl the connected vials gentlyand continuously until the productconcentrate is completely dissolved(Do not shake).

• The product concentrate solutionshould look clear and colorless;if not, do not use it and notifyShire/Baxalta immediately.

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

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).

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.

3 WITHDRAW mixed product• Take off the blue cap

from the BAXJECT IIHi-Flow device andconnect the syringe.

• Be careful to notinject air.

COLOURSIDEUP

Product filter

Latex-f

reeml2015105

B • Turn over the connectedvials so that the product vial is on top.

• Draw the productconcentrate solution intothe syringe by pullingback the plunger slowly.

• Disconnect the syringefrom the vials.

C • Attach the infusion needle to the syringe using a winged (butterfly) infusionset, 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 wellwith an alcohol swab.

• Insert the needle into the vein and remove the tourniquet. Slowly infuse themixed 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 onthe infusion site for several minutes.

• Do not recap the needle.

Latex-f

reeml2015105

A

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

using the BeneFIX R2 Kit. Always follow the specific preparation

and administration procedures provided by your hemophilia

treatment centre.

•

I

■ If refrigerated, allow

BeneFIX and the

pre-filled diluent

syringe to come to

room temperature.

■ Wash your hands with good

soapy lather for a minimum

of 30 seconds.

■ Remove plastic flip top cap.

■ Wipe top of vial with

alcohol swab.

■ Remove cover from plastic

vial adapter package.

■ Place adapter over BeneFIX

vial, press down firmly until

it snaps into place.

■ Leave plastic cover on adapter

until you are ready to connect

the syringe.

■ Attach plunger rod to diluent

syringe by inserting the rod

into the syringe and turning.

■ Remove plastic cap from

diluent syringe by bending

up and down to break the seal.

■ Remove plastic cover

on vial adapter.

■ Connect the syringe to adapter

on BeneFIX vial.

■ Insert tip of syringe into

adapter opening.

■ Push firmly and turn in

a clockwise direction.

■ Slowly push down plunger of

syringe to inject all diluent into

BeneFIX vial.

■ Don't remove syringe.

■ Gently swirl vial until all the

BeneFIX powder is dissolved.

■ Solution should be clear

and colourless.

■ Invert vial, slowly draw reconstituted

BeneFIX into syringe.

■ Remove syringe from vial by pulling

and turning counter clockwise.

If using more than one vial:

,1 :•·

� ' .:.

.L

.. J;j

■ Prepare all the vials of BeneFIX you

need, leaving the diluent syringes

attached until you are ready to draw

back the solution.

■ Remove all of the diluent syringes

from the vial adapters, leaving the

vial adapters in place.

■ 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.

■ Transfer the large luer lock syringe

to the next vial adapter to draw back

this BeneFIX solution.

■ Repeat these steps with as many vials

as required.

1 After preparing BeneFIX it should be injected intravenously

over several minutes, as directed by your hemophilia

treatment centre.

Talk to your doctor or hemophilia treatment centre

if you have any questions about BeneF/X.

NOTE: Visual Aid only. Always refer to monograph included with product.

Benefix:

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: _________________ _ Biatherapi

es far Life'" CSL Behring

Beriplex·p Y::I Human Prothrombin Complex

• Ensure product and water vialsare at room temperature.

• Remove caps from vials and wipestoppers with alcohol swab. RemoveMix2Vial '" package lid.

··'2 I•

..iiii'

Dilumt vial Product via I

- =

'--' --

Before you begin, wash hands thoroughly. Use aseptic technique.

• Place water vial on a flat clean surface andhold firmly.

Pierce the vial with the blue tip ofthe transfer device. Use a quickfirm motion.

• Pull off the remainingpackage and discard.

• 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 by grasping the blue portion of thedevice and turning it counterclockwise.

• Draw air into empty syringe.

• Screw syringe clockwise into thewhite portion of the device.

• Push air into vial.

• Turn the system upside down.

• Draw the solution into syringe.

-

-

ffi

Mix2Vial ...

1¼iter (diluent}-

Tight grip Diluent Adapter

(blue}

Integrated

filter--

Product adapter

(clear}

* Mix2Vial is a trademark of West or one of its Subsidiaries.

For information on Beriplex� P/N, please refer to the product information at www.cslbehring.ca.

CSL Behring Canada Ottawa, Ontario, K 1 P 6L5 836008,2011.

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.pdf

Corifact™ 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 slightlyyellowish, 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.pdf

Approval Date: Dec 8, 2015

NOTE: Visual Aid only. Always refer to monograph included with product. Corifact:

https://labeling.cslbehring.ca/PM/CA/Corifact/EN/Corifact-Product-Monograph.pdf

NOTE: 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

NOTE: 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

1 Warm the unopened vial containing the solvent (Sterile Water for Injection, EP) to room temperature if necessary (e.g. using a sterile 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.

3 Open the package of BAXJECT II Hi-Flow device by peeling away the paper lid without touching the inside. Do not remove the transfer device from the package.

5 With the transfer device attached to the solvent vial, invert the system so that the solvent vial is on top of the device. Insert the purple plastic spike of BAXJECT II Hi-Flow through the FEIBA vial stopper. The vacuum will draw the solvent into the FEIBA vial.

6 Swirl gently until all the material is dissolved. Ensure that FEIBA is completely dissolved, otherwise active material will not pass through the device filter.

4 A) Turn the package over and insert the clear plastic spike through the solvent stopper.

4 B) Grip the package at its edge and pull the package off BAXJECT II Hi-Flow. Do not remove the blue cap from BAXJECT II Hi-Flow.

BAXJECT II HI FLOW WITH FEIBA NF®

RECONSTITUTION OF POWDER TO PREPARE A SOLUTION FOR INJECTIONS

Note: Use aseptic technique throughout entire procedure.

• Control of spontaneous bleeding episodes• Surgical interventions

FEIBA NF is indicated for use in Hemophilia A and B patients with inhibitors for:

• Routine prophylaxis to prevent or reduce the frequency ofbleeding episodes in adults and children >6 years of age

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.pdf

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).

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.

86174

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.

INJECTION/INFUSION

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

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.pdf

Gently swirl the powder vial until the powder is fully dissolved. Do not shake the vial – this will cause foam formation.

© Octapharma Canada Inc. Fibryga® and Octajet® are registered trademarks of Octapharma. FIB.02.20.EN

Remove the blue ring and press the water vial down using downward force in one motion (to start the vacuum) then let the water fl ow into the Fibryga® vial automatically.

Maintain the transfer device in its outer package. Place the Octajet®

device onto the Fibryga® vial and spike. Ensure the plastic clips of the Octajet® device securely lock to the Fibryga® vial.

In one hand, hold the Fibryga® vial and secure the clear portion of the transfer device. In the other hand, hold the water vial and grip the blue 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.

Open fi lter package and attach 50 mL syringe.Attach the fi lter and syringe to the Luer lock on the Fibryga® vial.

Withdraw the solution through the fi lter into the syringe.

Hold the Fibryga® vial on a fl at surface. Invert the water vial and place it over the blue water spike. Push spike of the Octajet® through the rubber stopper of the water vial in one smooth motion.Ensure the water vial fully covers both holes of the blue water spike to avoid vacuum loss.

Reconstitution InstructionsEnsure the Fibryga® vial and the water for injection are at room temperatureFibrinogen Concentrate (Human) Powder

for Solution for Injection / Infusion, 1 g/vial

Remove the plastic caps and discard. Clean the rubber stoppers with an alcohol swab and allow them to dry.

Peel away the paper cover of the outer package of the Octajet®

transfer device.

Lay out the Fibryga® kit contents on a clean fl at surface. You will need a 50 mL syringe.

1

5

9

2

6

10

3

7

11

4

8

While holding onto the powder vial, remove the outer package from the Octajet® device. Do not touch the blue water spike.

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

FIB.02.20.ENReference: 1. Fibryga® Product Monograph. Octapharma. August 10, 2018.

Vial SizeVolume of WFI to be

Added to VialApproximate Available

VolumeNominal Concentration

per mL

1g 50 mL 50 mL 20mg

Administration Instructions

DescriptionFIBRYGA® (Fibrinogen Concentrate (Human), 1 g/vial) is a sterile, freeze dried preparation of highly purified fibrinogen.

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 Clinical Use

FIBRYGA® is indicated for the treatment of acute bleeding episodes and perioperative prophylaxis in adult and pediatric patients with congenital afibrinogenemia and hypofibrinogenemia.

Contraindications FIBRYGA® is contraindicated in individuals who have manifested severe immediate hypersensitivity reactions, including anaphylaxis to FIBRYGA® or its components.

Storage

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.

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.

Dosage

For detailed dosing instructions see the FIBRYGA®

Product Monograph.

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, actual measured plasma fibrinogen level and body weight, using the following formula:

Dose (mg/kg body weight) = [Target level (mg/dL) - measured level (mg/dL)]

1.8 (mg/dL per mg/kg body weight)

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

Instructions for UsePrHEMLIBRA® (emicizumab injection)

FOR SUBCUTANEOUS USE

NOTE: Visual Aid only. Always refer to monograph included with product.Hemlibra: https://www.rochecanada.com/PMs/Hemlibra/Hemlibra_PM_E.pdf

https://www.rochecanada.com/PMs/Hemlibra/Hemlibra_PM_E.pdf

2

Be 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 givethe dose prescribed by your healthcare provider.

• HEMLIBRA comes in four strengths. Depending on your dose, you may need to use more than one vialto 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 differentconcentrations 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.

• Only use the vial one time. After you inject your dose, dispose of (throw away) any unused HEMLIBRA leftin 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.

• If your prescribed dose is more than 2 mL, you will need to give more than one subcutaneous injectionof 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 storagetime (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 temperaturesabove 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

3

Inspecting 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.


4

INCLUDED IN THE BOX:

• Vial containing HEMLIBRA

• HEMLIBRA Patient Medication Information

NOT INCLUDED IN THE BOX:

• Alcohol wipes– Note: If you need to use more than one

vial to inject your prescribed dose, you mustuse a new alcohol wipe for each vial.

• Gauze• Cotton ball

• Syringe with low dead space (LDS) plungerImportant:– 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.

• 18G transfer needle with 5 micrometer filter– Note: If you need to use more than one vial

to inject your prescribed dose, you must usea new transfer needle with filter for each vial.Do not use the transfer needle with filter toinject HEMLIBRA.

• 26G injection needle with safety shield(used to inject HEMLIBRA)– Note: Do not use the injection needle

to withdraw HEMLIBRA from the vial.

• Sharps disposal container


5

Getting ready:

• Before use, allow the vial(s) to warm up to room temperature for about15 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.

• Let the skin dry for about 10 seconds. Do not touch, fan, or blowon 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 aninjection, at least 2.5 cm (1 inch) away from the area you usedfor 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.

GE

TTING

RE

AD

Y


6

Preparing 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 syringesin 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 theinjection site for at least 10 seconds, until bleeding has stopped.

• If you have bruising (small area of bleeding under the skin), an ice pack can also be applied with gentlepressure 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.

• Put your used needles and syringes in a sharps disposal container right away after use. Do not disposeof (throw away) any loose needles and syringes in your household trash.

• If you do not have a sharps disposal container, you may use a household container that is:– 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 guidelinesfor the right way to dispose of your sharps disposal container.

• Do not dispose of (throw away) any used sharps disposal container in your household trash unless yourcommunity guidelines permit this. Do not recycle your used sharps disposal container.

IMPORTANT: ALWAYS KEEP THE SHARPS DISPOSAL CONTAINER OUT OF REACH OF CHILDREN.


7

HEMLIBRA: 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).

• Clean the top of the vial(s) stopper with an alcohol wipe.

• Throw away the vial cap(s) into the sharpsdisposal container.

STEP 2. ATTACH TRANSFER NEEDLE WITH FILTER TO SYRINGE

• Push and twist the transfer needle with filter clockwiseonto the syringe until it is fully attached.

• Slowly pull back the plunger and draw air into the syringethat is the same amount for your prescribed dose.

PR

EPA

RA

TION


8

STEP 3. UNCAP TRANSFER NEEDLE WITH FILTER

• Hold the syringe by the barrel with the transfer needle with filterpointing up.

• Carefully pull the transfer needle with filter cap straight off andaway from your body. Do not throw the cap away. Place thetransfer needle with filter cap down on a clean, flat surface.You will need to recap the transfer needle with filter aftertransferring the medicine.

• Do not touch the needle tip or place it on a surface after theneedle cap has been removed.

STEP 4. INJECT AIR INTO VIAL

• Keep the vial on the flat working surface and insert the transferneedle with filter and syringe straight down into the centre ofthe vial stopper.

– Note: When inserting the needle, you may need to hold thevial steady by hand.

• Keep the needle in the vial and turn the vial upside down.

• With the needle pointing upwards, push on the plungerto inject the air from the syringe above the medicine.

• Keep your finger pressed down on the syringe plunger.

• Do not inject air into the medicine as this could createair bubbles in the medicine.


https://www.rochecanada.com/PMs/Hemlibra/Hemlibra_PM_E.pdf

9

STEP 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 theamount 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 airbubbles. Too large an air bubble can reduce the dose you receive.

• Remove the larger air bubbles by gently tapping the syringebarrel with your fingers until the air bubbles rise to the top of thesyringe. Move the tip of the needle above the medicine and slowlypush the plunger up to push the air bubbles out of the syringe.

• If the amount of HEMLIBRA in the syringe is now at or below your prescribed dose, move the tip of the needle to within themedicine and slowly pull back the plunger until you have morethan the amount of HEMLIBRA needed for your prescribed dose.


• Repeat the steps above until you have removed the largerair 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.


10

STEP 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 capand scoop upwards to cover the needle.

• Once the needle is covered, push the transfer needle withfilter cap towards the syringe to fully attach it with one handto prevent accidentally sticking yourself with the needle.

STEP 8. CLEAN INJECTION SITE

• Select and clean your injection site area using an alcohol wipe.

• Let the skin dry for about 10 seconds. Do not touch, fan,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 twistingcounter-clockwise and gently pulling.

• Throw away the used transfer needle with filter into a sharpsdisposal container.


11

HEMLIBRA: STEPS FOR INJECTION

STEP 1. ATTACH INJECTION NEEDLE TO SYRINGE

• Push and twist the injection needle clockwise onto the syringeuntil it is fully attached.

• Do not use the injection needle to withdraw HEMLIBRA from vial.

STEP 2. MOVE SAFETY SHIELD

• Move the safety shield away from the needle and towardsthe syringe barrel.

STEP 3. UNCAP INJECTION NEEDLE

• Carefully pull the injection needle cap straightaway fromthe 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, HEMLIBRAin the syringe must be injected right away.

INJE

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12

STEP 4. ADJUST PLUNGER TO PRESCRIBED DOSE

• Hold the syringe with the needle pointing up and slowly push theplunger to your prescribed dose.

• Check your dose, ensure the top rim of the plunger is in line withthe 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 ata 45° to 90° angle with a quick, firm action. Do not hold orpush on the plunger while inserting the needle.

• Hold the position of the syringe and let go of the pinchedinjection site.

STEP 6. INJECT HEMLIBRA

• Slowly inject all of the HEMLIBRA by gently pushing the plungerall the way down.

• Remove the needle and syringe from the injection site at the sameangle as inserted.


13

HEMLIBRA: 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 downagainst a flat surface with a firm, quick motion until you heara “click”.

• If you do not hear a click, look to see that the needle is fullycovered by the safety shield.

• Keep your fingers behind the safety shield and away from theneedle at all times.

• Do not detach the injection needle.

STEP 2. THROW AWAY USED HEMLIBRA VIAL(S), NEEDLE, AND SYRINGE

• Put your used vial(s), needles, vial and injection needle caps, andused syringes in a sharps disposal container right away after use.

• Do not try to remove the used injection needle from the usedsyringe.

• Do not recap the injection needle with the cap.

Important: Always keep the sharps disposal container out of the reach of children.

DISP

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14

HEMLIBRA: 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 capand scoop upwards to cover the needle.

• Once the needle is covered, push the transfer needle with filter captowards the syringe to fully attach it with one hand to preventaccidentally sticking yourself with the needle.

STEP B. REMOVE TRANSFER NEEDLE WITH FILTER

• Remove the transfer needle with filter from the syringe by twistingcounter-clockwise and gently pulling.

• Dispose of (throw away) the used transfer needle with filter intoa 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 thesyringe until it is fully attached.

• Slowly pull back the plunger and draw some air into the syringe.


15

STEP D. UNCAP TRANSFER NEEDLE WITH FILTER

• Hold the syringe by the barrel with the transfer needle with filtercap pointing up.

• Carefully pull the transfer needle with filter cap straight off and awayfrom your body. Do not throw the cap away. You will need torecap 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 newtransfer needle with filter and syringe straight down into thecentre of the vial stopper.

– Note: When inserting the needle with filter, you may need tohold the vial steady by hand.

• Keep the transfer needle with filter in the vial and turn the vialupside down.

• With the needle pointing upwards, inject the air from thesyringe above the medicine.

• Keep your finger pressed down on the syringe plunger.

• Do not inject air into the medicine as this could createair bubbles in the medicine.

CO

MB

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G V

IALS


16

STEP F. TRANSFER HEMLIBRA TO SYRINGE

• Slide the tip of the needle down so that it is withinthe medicine.

• Slowly pull back the plunger to fill the syringe barrel more thanthe amount of HEMLIBRA needed for your prescribed dose.


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 Limitedby calling 1-888-762-4388.

• Find the full product monograph that is prepared for healthcare professionals and includes thisPatient Medication Information, by visiting the Health Canada website; the manufacturer’s websitewww.rochecanada.com, or by calling 1-888-762-4388.


If you require this information in an accessible format, please contact Roche at 1-800-561-1759.

© Copyright 2021, Hoffmann-La Roche LimitedHEMLIBRA® Registered trade-mark of Chugai Seiyaku Kabushiki Kaisha, used under license.

29126E21

Hoffmann-La Roche Limited Mississauga, ON L5N 5M8


Mix2Vial®*(needleless transfer device)

QUICK REFERENCE INSTRUCTIONS FOR USE**

• Before infusion, ensure the product anddiluent vials are at room temperature.

• Remove flip caps of the diluent and Humate-P®

and wipe the rubber stoppers with an antisepticsolution. Allow to dry.

• Open the Mix2Vial® package by peeling awaythe lid. Leave the Mix2Vial in its clear outerpackaging to maintain sterility.

• Place diluent vial on an even flat surface and hold firmly.

• Grip the Mix2Vial® together with the clear packaging andfirmly snap the blue end onto the diluent stopper (Fig.2).

• While holding onto the diluent, carefully removethe clear outer packaging from Mix2Vial®.

• Ensure that only the clear outer packaging isremoved. (Fig. 3).

• Place product vial on a flat surface and hold firmly.Invert the diluent vial with the attached Mix2Vial®.

• Firmly snap the transparent adapter onto the product vial (Fig. 4). The diluent flows automatically into theproduct vial.

• With the diluent and product vial still attached, gently swirl to ensurethat the product is fully dissolved (Fig. 5). Do not shake.

• Hold the product-side of the Mix2Vial® set with one hand.Grasp the blue diluent side of the Mix2Vial set with the otherhand.

• Unscrew the set into two pieces (Fig. 6).

• Draw air into an empty sterile syringe.• While product vial is upright, screw the syringe into the Mix2Vial® set.• Inject air into the product vial.• Keeping the syringe plunger pressed, turn the system upside down.• Draw the concentrate into the syringe by pulling the plunger back

slowly (Fig 7).• Keeping the syringe plunger facing down, unscrew the syringe from

the Mix2Vial® (Fig 8).• Attach the syringe to a venipuncture set.

22 Connect diluent vial

33 Remove packaging

44 Connect product vial

55 Unscrew diluent vial

66 Withdraw mixed solution

1 1 Preparation Humate-P®– Key Information

• Available in a range of formats

• 3-hour window for administration afterreconstitution

• Stored at room temperature or in therefrigerator, at +2ºC to +25ºC, untilexpiration date on label1

*Mix2Vial® is a registered trademark of West Pharma. Services IL, Ltd., asubsidiary of West Pharmaceutical Services Inc.Humate-P® is a registered trademark of CSL Behring GmbH.Biotherapies for Life® is a registered trademark of CSL Behring LLC.

** For detailed instructions, please refer to Part III of the Product Monograph. For more information and a complete risk/benefit profile, please contact Customer Service at 1-866-773-7721 ext. 2386 or refer to the Product Monograph available on our website at www.cslbehring.ca.

Reference: 1. Humate-P® Product Monograph, May 7, 2019.

Humate-P® package: Humate-P® vial, diluent vial, Mix2Vial®

Administration: Patient receiving more than one vial, the contents of two vials may be drawn into the same syringe through a separate unused Mix2Vial® set before attaching the vein needle.

Humate-P® should be inspected visually for particulate matter and discoloration prior to administration. The solution should be clear or slightly opalescent. Even if the directions for use for the reconstitution procedure are precisely followed, it is not uncommon for a few flakes or particles to remain. The filter included in the Mix2Vial® device removes those particles completely. Filtration does not influence dosage calculations. Do not use visibly cloudy solutions or solutions still containing flakes or particles after filtration.

Do not refrigerate after reconstitution.

CSL Behring Canada, Inc55 Metcalfe St., Suite 1460

Ottawa, ON K1P 6L5www.cslbehring.ca HUM201905138EN

®Hospital:

Produced Primarily from Canadian Plasma Mix2Vial® Diluent vial Product vial

(sterile water)

Fig. 3

Fig. 4 Fig. 5

Fig. 6

Fig. 7 Fig. 8

Fig. 2

20190138_HumateP_Reconstitution_tear_off_sheet_V16.indd 1 8/13/19 3:50 PM

NOTE: Visual Aid only. Always refer to monograph included with product. Humate-P:

®

https://labeling.cslbehring.ca/PM/CA/Humate-P/EN/Humate-P-Product-Monograph.pdf

HOW 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.*

Antihemophilic Factor (Recombinant, B-domain deleted, PEGylated)Facteur antihémophilique (recombinant pégylé à domaine B tronqué)

* Please refer to your Patient Medication Information leaflet for full administration information.

4 SNAPcap off syringe

Do not touch syringe tip with hand or any surface

3 PRESStogether vial and vial adapter in housing

1 WARMvial and syringe in hands

2 FLIPcap off vial and disinfect rubber stopper

6 ATTACHprefilled syringe

8 INJECTdiluent slowly into vial

5 REMOVEand discard adapter housing

7 ATTACHplunger rod

Avoid touching sides and threads of plunger rod

12 DETACHfrom vial adapter and attach to administration set

9 SWIRLvial gently to mix

Do not shake

Do not use solution if cloudy or contains particles

10 PUSHplunger down and turn upside-down

11 REFILLsyringe

Remove as much air as possible before detaching syringe by slowly and carefully pushing air back into vial

NOTE: Visual Aid only. Always refer to monograph included with product. JIVI: https://omr.bayer.ca/omr/online/Jivi-pm-en.pdf

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:

HOW IS JIVI STORED?

Antihemophilic Factor (Recombinant, B-domain deleted, PEGylated)Facteur antihémophilique (recombinant pégylé à domaine B tronqué)

500 IU 1,000 IU 2,000 IU 3,000 IU

Talk to your doctor for more information on Jivi

2–8°Cunder refrigeration

25°Cfor 6 months

or up to 30ºC for 3 monthsDo not re-refrigerate once removed from refrigeration

when kept in outer carton to protect from lightDo not freeze

Do not use beyond the expiration date on the labels and cartons

Use immediately (within 3 hours) after reconstitution

PP-JIV-CA-0075-1

Bayer Inc., 2920 Matheson Blvd. E., Mississauga, Ontario L4W 5R6® TM see www.bayer.ca/tm-mc© 2020, Bayer Inc.

NOTE: Visual Aid only. Always refer to monograph included with product. JIVI: https://omr.bayer.ca/omr/online/Jivi-pm-en.pdf

NOTE: Visual Aid only. Always refer to monograph included with product. Kovaltry: https://omr.bayer.ca/omr/online/kovaltry-pm-en.pdf

Documents

Coagulation Products Reconstitution Reference Binder