Things you should do
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Tell your doctor or Haemophilia Treatment Centre immediately if you notice
- any sudden signs and symptoms of a severe allergic reaction. - your bleeding is not controlled or worsens after using ADVATE. Tell any doctors, dentists, or pharmacists you visit that you are using ADVATE 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 ADVATE in the pack until it is time to use it so that it is protected from light.
Keep ADVATE in the refrigerator at 2°C to 8°C. Do not freeze.
|
Do not use ADVATE if you:
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,
- whether your body have built up antibodies to ADVATE,
- whether you are using ADVATE to prevent or treat bleeding.
How to use ADVATE
Preparing ADVATE
Inspecting ADVATE
How long to use ADVATE
If you forget to use ADVATE
If you use too much ADVATE
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:
factor VIII inhibitors (in patients being treated with factor VIII medicines for the
first time)
Common:
headache
fever
Uncommon:
flu
sore throat
tender red streaks on skin toward the lymph glands
dizziness
unusual taste in the mouth
forgetfulness
migraine
fainting
tremor
eye inflammation
fast or irregular heartbeats
bruise
hot flushes
looking pale
shortness of breath
pain in the upper abdomen
diarrhoea
nausea
vomiting
increased or excessive sweating
itching, rash or hives
discomfort or pain in the chest
chills
feeling abnormal
swelling of hands, ankles or feet
injection site reactions
bleeding or bruising around injection site
increased, decreased or abnormal level of certain blood test results
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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
|
What to do
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sudden or severe allergic reaction which may progress to anaphylaxis including shock
Signs or symptoms 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 ADVATE contains
Active ingredient
(main ingredient) |
octocog alfa pegol
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Other ingredients
(inactive ingredients) |
trehalose dihydrate
histidine mannitol polysorbate 80 sodium chloride calcium chloride dihydrate glutathione trometamol |
Other ingredients
(inactive ingredients) |
water for injections
|
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What ADVATE looks like
Who distributes ADVATE
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 ADVATE using aseptic technique
Using the BAXJECT II device
1. Allow the ADVATE powder and diluent vials to reach room temperature before use.
2. Remove plastic caps from the ADVATE powder and diluent vials.
3. Cleanse rubber stoppers with an alcohol wipe and allow to dry before use.
4. Open the BAXJECT II device package by peeling away the lid, without touching the inside (Figure A). Do not remove the device from the package.
5. Turn the package over. Press straight down to fully insert the clear plastic spike through the diluent vial stopper (Figure B).
6. Grip the BAXJECT II package at its edge and pull the package off the device (Figure C). Do not remove the blue cap from the BAXJECT II device. Do not touch the exposed white plastic spike.
7. Turn the system over so that the diluent vial is on top. Quickly insert the white plastic spike fully into the ADVATE vial stopper by pushing straight down (Figure D). The vacuum will draw the diluent into the ADVATE vial.
8. Swirl gently until the powder is completely dissolved. DO NOT SHAKE.
9. Remove the blue cap from the BAXJECT II device. Connect the syringe to the BAXJECT II (Figure E). DO NOT INJECT AIR into the BAXJECT II device.
10. Turn the system upside down (ADVATE vial now on top). Draw the reconstituted solution into the syringe by pulling the plunger back slowly (Figure F).
11. Disconnect the syringe, attach a suitable needle and inject slowly into the vein over a period of up to 5 minutes (maximum infusion rate of 10 mL per minute).
12. If more than one vial of ADVATE is to be used, the contents of multiple vials may be drawn into the same syringe.