Things you should do
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Tell your doctor of Haemophilia Treatment Centre immediately if you notice
- any sudden signs and symptoms of a severe, sudden allergic reaction. - your bleeding is not controlled or worsens after using ADYNOVATE. Tell any doctors, dentists, or pharmacists you visit that you are using ADYNOVATE
or if you are about to have any blood tests.
Keep all your appointments with your doctor and any blood tests.
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Things you should not do
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Do not give your medicine to anyone else, even if they appear to have the same condition
as you.
Do not stop using your medicine or change the dosage without checking with your doctor.
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Looking after your medicine
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Keep ADYNOVATE in the pack until it is time to use it so that it is protected from
light.
Keep ADYNOVATE in the refrigerator at 2°C to 8°C. Do not freeze.
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Do not use ADYNOVATE if:
Check with your doctor if you:
Pregnancy and breastfeeding
How much to use
- your body weight,
- the amount of factor VIII your body is able to make,
- how much, how often and where you are bleeding,
- if your body have built up antibodies to ADYNOVATE.
How to use ADYNOVATE
Preparing ADYNOVATE
Inspecting ADYNOVATE
How often to use ADYNOVATE
If you forget to use ADYNOVATE
If you use too much ADYNOVATE
Things you should do
Tell your doctor and/or Haemophilia Treatment Centre straight away if you notice:
Things you should not do:
Driving or using machines
Looking after your medicine
Getting rid of any unwanted medicine
Less serious side effects
Less serious side effects
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What to do
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Very common:
headache
Common:
dizziness
nausea
diarrhoea
rash
hives
Uncommon:
flushing
redness of the eye
allergic reactions
easily bruising or bleeding due to development of factor VIII inhibitors
increase in some type of white blood cells
skin reactions at site of injection
itchy rash
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Speak to your doctor or Haemophilia Treatment Centre if you have any of these less
serious side effects and they worry you.
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Serious side effects
Serious side effects
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What to do
|
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Uncommon:
severe, sudden allergic reaction which may progress to anaphylaxis including shock
Signs or symptoms of an allergic response include:
rash, hives, wheals, or generalised itching,
swelling of your face, lips and tongue or any parts of the body,
shortness of breath, wheezing, difficulty in breathing,
tightness or discomfort in the chest, chest pain,
dizziness and fainting.
|
Stop the injection immediately.
Call your doctor or Haemophilia Treatment Centre straight away, or go straight to
the Emergency Department at your nearest hospital if you notice any of these serious
side effects.
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Reporting side effects
What ADYNOVATE contains
Active ingredient
(main ingredient)
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rurioctocog alfa pegol
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Other ingredients
(inactive ingredients)
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calcium chloride dihydrate
glutathione
histidine
mannitol
polysorbate 80
sodium chloride
trehalose dihydrate
trometamol
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Other ingredients
(inactive ingredients)
|
water for injections
|
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What ADYNOVATE looks like
Who distributes ADYNOVATE
Level 39, 225 George Street
Sydney NSW 2000
Australia
Telephone: 1800 012 612
www.takeda.com/en-au
Level 10, 21 Queen Street
Auckland 1010
New Zealand
Telephone: 0508 169 077
www.takeda.com/en-au
Preparing ADYNOVATE using aseptic technique
Using the BAXJECT II Hi-Flow device
1. Use aseptic technique (clean and germ free) and a flat work surface during the reconstitution procedure.
2. Allow the ADYNOVATE powder and diluent vials to reach room temperature before use.
3. Remove plastic caps from the ADYNOVATE powder and diluent vials.
4. Cleanse rubber stoppers with an alcohol wipe and allow to dry before use.
5. Open the BAXJECT II Hi-Flow device package by peeling away the lid, without touching the inside (Figure A). Do not remove the device from the package.
6. Turn the package over. Press straight down to fully insert the clear plastic spike through the diluent vial stopper (Figure B).
7. Grip the BAXJECT II Hi-Flow package at its edge and pull the package off the device (Figure C). Do not remove the blue cap from the BAXJECT II Hi-Flow device. Do not touch the exposed purple plastic spike.
8. Turn the system over so that the diluent vial is on top. Quickly insert the purple plastic spike fully into the ADYNOVATE powder vial stopper by pushing straight down (Figure D). The vacuum will draw the diluent into the ADYNOVATE powder vial.
9. Swirl gently until the ADYNOVATE powder is completely dissolved. The powder should dissolve rapidly (usually in less than 1 minute).
1. Remove the blue cap from the BAXJECT II Hi-Flow device (Figure E). Connect the syringe to the BAXJECT II Hi-Flow. Use of a Luer-lock syringe is recommended.
2. Turn the system upside down (ADYNOVATE powder vial now on top). Draw the reconstituted solution into the syringe by pulling the plunger back slowly (Figure F). Do not draw air into the syringe.
3. Disconnect the syringe; attached a needle suitable for intravenous injection. If more than one vial of ADYNOVATE is to be used, the contents of multiple vials may be drawn into the same syringe.
4. Administer the dose by injecting the solution directly into the vein over a period of up to 5 minutes (maximum infusion rate of 10 mL per min).
Using the BAXJECT III system
1. Take the sealed blister out from the pack and allow the ADYNOVATE powder and diluent vials to reach room temperature before use.
2. Open the blister package by peeling away the lid. Remove the preassembled BAXJECT III system from the blister.
3. Place the pre-assembled BAXJECT III system on a flat surface with the diluent vial on top (Figure 1). The diluent vial has a blue stripe. Do not remove the blue cap until instructed in a later step.
4. Hold the lower end of the pre-assembled BAXJECT III system with one hand, and use the other hand to press down firmly on the diluent vial until the system is fully collapsed and the diluent flows down into the ADYNOVATE powder vial (Figure 2). Do not tilt the system until all the diluent is completely transferred to the ADYNOVATE powder vial.
5. Check to make sure the diluent transfer is complete. Swirl gently until all the ADYNOVATE powder is dissolved (Figure 3). The powder should dissolve rapidly (usually in less than 1 minute).
1. Remove the blue cap from the BAXJECT III device. Connect the syringe to the BAXJECT III device. Use of a Luer-lock syringe is recommended.
2. Turn the system upside down (ADYNOVATE powder vial now on top). Draw the reconstituted solution into the syringe by pulling the plunger back slowly. Do not draw air into the syringe.
3. Disconnect the syringe; attach a needle suitable for intravenous injection. If more than one vial of ADYNOVATE is to be used, the contents of multiple vials may be drawn into the same syringe.
4. Administer the dose by injecting the solution directly into the vein over a period of up to 5 minutes (maximum infusion rate 10 mL per min).