Patient Medication Information: uses, side effects, how to take - Menquadfi
What MenQuadfi is used for:
MenQuadfi is a vaccine used to help protect you or your children against infections caused by bacteria called "Neisseria meningitidis" types A, C, W and Y.
MenQuadfi is used in individuals 6 weeks of age and older to prevent meningococcal disease caused by Neisseria meningitidis types A, C, W and Y.
Neisseria meningitidis is passed from person to person and can cause:
- Meningitis (inflammation of the tissues that surround the brain and spinal cord)
- Septicemia (infection of the blood)
Both can result in serious disease with lasting effects and possibly death.
MenQuadfi does not protect against Neisseria meningitidis type B disease.
How MenQuadfi works:
MenQuadfi causes your body to produce its own natural protection against bacteria that can cause meningococcal diseases (“Neisseria meningitidis” types A, C, W and Y). After you receive the vaccine, your body begins to make substances called antibodies. Antibodies help your body to fight disease. If a vaccinated person comes into contact with one of the germs that cause this disease, the body is usually ready to destroy it. The amount of time it takes for your body to develop enough antibodies to protect you from meningococcal diseases can vary. It can take a few weeks after your vaccination.
The great majority of people who get vaccinated with MenQuadfi will produce enough antibodies to protect them against meningococcal diseases (groups A, C, W and Y). However, as with all vaccines, 100% protection cannot be guaranteed.
The ingredients in MenQuadfi are:
Medicinal ingredient(s): Meningococcal (groups A, C, W and Y) polysaccharides conjugated to tetanus toxoid protein carrier.
Non-medicinal ingredients: Sodium Chloride, 50 mM Sodium Acetate (pH 6.0), Sterile Water for Injection.
MenQuadfi comes in the following dosage form(s):
MenQuadfi is a clear, colourless liquid vaccine that is injected into a muscle. A single dose is 0.5 mL.
Do not receive MenQuadfi if:
- are allergic to the active substances or any of the other ingredients present in MenQuadfi. Symptoms may include rash, itching, difficulty breathing, shortness of breath or swelling of the face, lips, throat, or tongue. If you are not sure if you are allergic, talk to your doctor, pharmacist or nurse before you receive MenQuadfi.
- are a person with a known history of Guillain-Barré Syndrome unless the potential benefits outweigh the risks of administration.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take MenQuadfi. Talk about any health conditions or problems you may have, including if you:
- ever fainted from an injection. Fainting, sometimes with falling, can occur (mostly in adolescents and young adults) following, or even before, any injection with a needle.
- a disease weakening your body’s natural defenses (immune system). Your response to vaccines may not be optimal.
- thrombocytopenia or bleeding disorders or receiving anticoagulant therapy.
- Experienced illness with high fever (over 38°C). There is no need to delay vaccination for a minor infection such as a cold. However, talk to your doctor, pharmacist or nurse first.
pregnancy and/or breast-feeding
Other warnings you should know about:
MenQuadfi is not likely to affect your ability to drive or use machines. However, do not drive or use any machines if you are not feeling well.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
MenQuadfi may not have an optimal effect if used with medicines that weaken the immune system such as high-dose corticosteroids or chemotherapy.
How to take MenQuadfi:
- MenQuadfi is given as a 0.5 mL injection in the muscle in the upper arm or in the thigh depending on your age and muscle mass.
MenQuadfi will be given to you by a healthcare professional in a healthcare setting.
Usual dose:
Primary Vaccination:
Infants from 6 weeks to less than 6 of age: Four doses (each of 0.5 mL), given with an interval of at least 2 months, with the fourth dose administered in the second year of life (at 12 to 18 months of age).
- Men-ACWY naïve infants from 6 months through 11 months of age: Two doses (each of 0.5 mL) with the second dose administered in the second year of life (at 12 to 18 months of age)
- Men-ACWY naïve individuals from 12 months of age and older: One single dose (0.5 mL).
Booster Vaccination:
- A single dose of MenQuadfi may be administered to adolescents and adults who are at continued risk for meningococcal disease if at least 4 years have elapsed since a prior dose of meningococcal (Groups A, C, W, Y) conjugate vaccine (see 14 Clinical Trials).
Overdose:
If you think you, or a person you are caring for, have taken too much MenQuadfi, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed dose:
Not applicable to this vaccine
Possible side effects from using MenQuadfi:
These are not all the possible side effects you may have when taking MenQuadfi. If you experience any side effects not listed here, tell your healthcare professional.
The following side effects may happen in children (2 years of age and older), adolescents, adults and the elderly.
Very common (may affect more than 1 in 10 people)
- Pain where the injection was given
- Muscle pain
- Headache
- Generally feeling unwell
Common (may affect up to 1 in 10 people)
- Redness or swelling where the injection was given
- Fever
Uncommon (may affect up to 1 in 100 people)
- Itching, warmth, bruising or rash where the injection was given
- Vomiting
- Feeling dizzy
- Nausea
- Fatigue
The following side-effects can happen in any age-group.
Not Known (cannot be estimated from available data)
- Hypersensitivity including anaphylaxis
- Fits (convulsions) with or without fever
The following side effects can be seen in infants and toddlers from 6 weeks through 23 months of age
Very common (may affect more than 1 in 10 vaccinated)
- feeling irritable
- crying
- tenderness where the injection was given
- feeling drowsy
- loss of appetite
- redness where the injection was given
- fever swelling where the injection was given
- vomiting
Common (may affect up to 1 in 10 vaccinated)
- bruising, diarrhea
Uncommon (may affect up to 1 in 100 vaccinated)
- bleeding, collection of blood under the skin, lump where the injection was given firmness or rash where the injection was given
- warmth where the injection was given rash
- itching where the injection was given hives irritation of the nose and throat
- difficulty sleeping
Rare (may affect up to 1 in 1 000 vaccinated):
- Nose or throat infection or runny or stuffy nose
- Cough
- tiny blood spots under the skin, rash with flat and reddened area, itchy, red and dry skin or skin redness
- constipation
- discolouration, reaction or scab where injection was given
Very rare (may affect less than 1 in 10 000 vaccinated)
- Allergic reaction: sudden, severe allergic reactions with difficulty breathing, hives, swelling of the face and throat, a fast heartbeat, dizziness, weakness, sweating and loss of consciousness
Not Known (cannot be estimated from available data)
- Hypersensitivity
- Fits (convulsions) with or without fever
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional in all cases | Get immediate medical help |
|---|---|---|
| Very Rare | ||
| Anaphylactic reaction: sudden, severe allergic reactions with difficulty breathing, hives, swelling of the face and throat, a fast heartbeat, dizziness, weakness, sweating and loss of consciousness | ✓ | |
| Not Known (cannot be estimated from available data) | ||
| Hypersensitivity: allergic reaction which appear as skin rashes, itching, swelling (especially of the face, lips, tongue, or throat), or breathing difficulties | ✓ | |
| Fits (convulsions with or without fever): sudden stiffness of the whole body or parts, falling down, body shakes or jerks rhythmically, may or may not loss of consciousness | ✓ |
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Reporting suspected side effects for vaccines
For the general public: Should you experience a side effect following immunization, please report it to your healthcare professional.
Should you require information related to the management of the side effect, please contact your healthcare professional. The Public Health Agency of Canada (PHAC), Health Canada (HC), and Sanofi Pasteur cannot provide medical advice.
For healthcare professionals: If a patient experiences a side effect following immunization, please complete the Adverse Events Following Immunization (AEFI) Form appropriate for your province/territory (Reporting Adverse Events Following Immunization (AEFI) in Canada) and send it to your local Health Unit.
Storage:
Store in a refrigerator (+2˚C to +8˚C).
Do not freeze.
Keep out of reach and sight of children.
If you want more information about MenQuadfi:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (Drug Product Database: Access the database); the manufacturer’s website www.sanofi.com/en/canada; or by calling 1-888-621-1146 (no charge).