What is Emerade™?
Emerade™ is used for the emergency treatment of a sudden, severe and life-threatening allergic reaction. This is type of severe reaction is called anaphylaxis. Emerade™ is used in people who are at a higher risk for severe allergic reactions and in people with a history of allergic reactions.
How do I use Emerade™?
Emerade™ is easy-to-use and intuitive, watch the video to learn how to use your Emerade™.
When should I use Emerade™?
Use Emerade™ immediately at the first sign or symptom of a severe allergic reaction in response to a known or suspected allergen. In some cases, the signs are not as obvious, please talk to your doctor for more information.
What dosage strengths are currently available for Emerade™?
Emerade™ is currently available in:
Emerade™ 0.5 mg
Emerade™ 0.3 mg
Children who weigh more than 30 kg: 0.3 mg
Adults who weigh less than 60 kg: 0.3 mg
Adults weighing more than 60 kg: 0.3 mg to 0.5 mg (based on clinical judgement)
How is Emerade™ packaged?
Emerade™ has a durable, plastic outer case to protect the auto-injector and labelling. It is also labelled with different colors to distinguish the different dosages.
Emerade™ is available in a pack size of one pre-filled pen.
Emerade™ 0.5 mg
Emerade™ 0.3 mg
Why is it important to consider body weight and age when determining dose?
As you grow older, the amount of epinephrine you require can change. Both age and weight should be a consideration when calculating the dose. Your dose or your child’s dose will be determined by your doctor.
I am a caregiver, how can I practice using my Emerade™ or get a trainer device?
Can I purchase Emerade™?
Emerade™ can be purchased with or without a prescription. Contact your healthcare provider for more information on how to obtain Emerade™.
Does Emerade™ contain latex or meta-sulfite?
Emerade™ does not contain latex, however it contains meta-bisulfite. This can cause allergic reactions and bronchospasm in those with a history of asthma. Consult your doctor for more information, regardless, Emerade™ is the first line emergency treatment for severe, life-threatening allergic reactions.
Can I travel with my Emerade™?
Yes, you can travel with your Emerade™. Make sure to always carry your Emerade™ in case of severe allergic reactions.
Remember to store at room temperature (15ºC to 25ºC) and do not freeze.
Questions and Answers about the EMERADE® recall
What is EMERADE® used for?
EMERADE® is used for the emergency treatment of a sudden, severe, and life-threatening allergic reaction. This type of severe reaction is called anaphylaxis. EMERADE® is used in people:
- who are at a higher risk for severe allergic reactions
- with a history of allergic reactions
It is used to treat people with severe allergies to:
- foods like peanuts, tree nuts, shellfish, fish, milk, eggs and wheat
- insect stings like those from bees, wasps, hornets, yellow jackets and fire ants
- insect bites like those from mosquitos and black flies
- certain medicines
- other allergens (a substance that causes allergies)
These severe allergic reactions can also be caused by exercise, asthma or by unknown causes1.
Why is EMERADE® being recalled?
The company has chosen to initiate this voluntary action due to the potential risk that the auto-injector may fail to activate or activate prematurely if dropped. This decision is part of the company’s ongoing commitment to ensuring all of its products meet the highest standards of quality. Bausch Health, Canada takes matters such as this very seriously, which is why this action has been taken promptly after coming to light.
How serious is this issue?
A risk to the patient's health cannot be excluded. Failure to activate is evaluated as life-threatening, which is why Bausch Health has voluntarily decided to make this recall, to the patient level, meaning patients with EMERADE® should return it to their pharmacy.
How serious is the probability of this problem causing EMERADE® not to work when it is needed in a potentially life-threatening situation?
We don’t believe the probability is high but are taking this action to protect Canadians who have EMERADE® and might need to use it.
Is someone who has recently successfully used an EMERADE® device because of an anaphylactic reaction in any danger or risk of health effects?
No, the potential risk is that when EMERADE® is dropped and will be needed by someone having an anaphylactic reaction that the device might not activate and not deliver the epinephrine dose.
What part of the EMERADE® inventory is affected?
This affects all non-expired inventory of EMERADE® in Canada. Bausch Health, Canada has asked wholesalers and pharmacists to immediately stop all sales of EMERADE®. Individuals in possession of non-expired EMERADE® auto-injectors should return them to their pharmacy.
Are you working with Health Canada on this recall?
Health Canada has been fully informed in accordance with the required procedures for drug recalls in Canada.
What alternatives are available for those who need an epinephrine auto-injector?
There are other epinephrine auto-injectors available through pharmacies across Canada.
What should patients do?
There are other epinephrine auto-injectors available through pharmacies across Canada. The patient should speak with their doctor to determine which epinephrine auto-injector is right for them. If the patient is not seeking public or private insurance coverage for their epinephrine auto-injector, they can acquire a different type of auto-injector directly from the pharmacy. However, if they have public or private insurance coverage, they will require a new prescription from their doctor for a different replacement.
Do you know when the issue will be resolved and EMERADE® will be available again?
Our priority at present is to focus on the recall. Therefore, we cannot comment on availability at this time.
Using your Emerade™
Should I always be carrying 2 Emerade™ pens?
Yes, make sure to always have access to 2 Emerade™ pens.
Do I need to swing my Emerade™ to activate it?
No. Just press the needle end gently against the outer side of the upper thigh – into the muscle. A “click” can be heard when the injection goes into the muscle.
How long should I hold Emerade™ during the injection?
Hold Emerade™ against the thigh for about 5 seconds.
How many doses of Emerade™ should I take?
After using your Emerade™, call 911 or go to the emergency room immediately. Even after medical attention, make sure to stay within close proximity to a hospital or where you can call 911 for the next 48 hours.
If you or your child do not feel better or get worse, you can inject another dose of Emerade™ 5 to 15 minutes after the first injection.
Do not inject more than 2 injections right after each other. It is, therefore, recommended that you always carry 2 Emerade™ pens with you at all times.
Look for these signs if you feel that you have taken too much epinephrine as it may lead to dangerously high blood pressure, stroke or death.
Signs of an overdose include:
- Irregular heartbeat
- Abnormal heartbeat
- Difficulty breathing caused by a build-up of fluid in your lungs.
In case of overdose, make sure to contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
How do I know I have taken my Emerade™?
You can confirm that you have taken your dose because the plunger is now visible. You can also check by lifting the label at the picture of the arrow, some solution may remain in the pen.
Are there any precautions to prevent accidental injections?
Yes, the needle shield prevents accidental injections as it must be removed prior to injection. You should not remove the needle shield unless you need to use the pen.
Do not inject Emerade™ into the vein (intravenously (IV)), buttocks, hands, fingers, feet or toes.
If you accidentally inject it into any of these areas, go right away to the nearest hospital (emergency room) for further treatment.
Maintaining your Emerade™
How do I store my Emerade™?
Store at room temperature (15º C to 25º C), do not freeze and keep it out of reach and sight of children.
Make sure to always carry your Emerade™ in case of severe allergic reactions.
How do I discard my Emerade™?
Talk to your doctor or pharmacist about how to properly discard of any used or unused Emerade™ pens.
When should I discard my Emerade™?
Throw away and replace the pen:
- after the expiry date which is indicated on the label.
- if the solution in the pen has changed colour or contains particles. You can check the colour of the solution by lifting the label on the pen at the picture of the arrow.
- if there are any signs that pen is leaking.
- if you drop the pen on the ground or in water. The pen is not waterproof.
Emerade™ has an expected shelf-life of approximately 18 months from the date of production.