Patient Medication Information: uses, side effects, how to take - Panenza
What is PANENZA used for?
PANENZA is a non-adjuvanted vaccine used to prevent influenza (flu) caused by a pandemic virus in individuals 6 months of age and older.
Pandemic influenza is caused by a new influenza virus in which people have no prior immunity and can spread rapidly around the world. The signs of a pandemic flu are similar to those of a regular flu but may be more serious.
How does PANENZA work?
When a person is given the vaccine, the immune system (the body’s natural defense system) will produce its own protection (antibodies) against the disease. None of the ingredients in the vaccine can cause the flu.
The vaccine is given by injection with a needle in the upper arm and may require two doses given three weeks apart. Children and the elderly may not be optimally protected until after receiving the second dose of the vaccine.
As with all vaccines, PANENZA may not fully protect all persons who are vaccinated.
What are the ingredients in PANENZA?
Medicinal ingredients: Each 0.5 mL dose of PANENZA contains 15 micrograms of hemagglutinin of the Influenza virus (inactivated, split virion) of the following strain:
A/California/7/2009 (H1N1)
Non-medicinal ingredients: disodium phosphate dihydrate, potassium chloride, potassium dihydrogen phosphate, sodium chloride, thiomersal (45 micrograms per 0.5 mL dose), and water for injections.
Other ingredients: trace amounts of egg and chicken proteins, neomycin, octoxynol-9, and formaldehyde.
PANENZA comes in the following dosage forms:
Suspension for injection in a multidose vial
Do not use PANENZA if:
- if you previously had a sudden life-threatening allergic reaction to any ingredient of PANENZA or to any of the substances that may be present in trace amounts, or following a previous influenza vaccine
- if you have a severe infection with a high temperature. Your vaccination will usually be postponed until you are feeling better. A minor infection such as a cold should not be a problem, but your doctor should advise whether you could still be vaccinated with PANENZA.
If you are not sure, talk to your doctor or pharmacist before having this vaccine.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take PANENZA. Talk about any health conditions or problems you may have, including if you:
- had an allergic reaction to any ingredient contained in the vaccine, to thiomersal, to egg or chicken proteins, or other influenza vaccination.
- have a bleeding problem such as a coagulation disorder.
- have a low immunity due to a disease or treatment that suppress the immune system.
- have had Guillain-Barré syndrome within 6 weeks of receiving a previous vaccine.
are pregnant or breastfeeding.
Other warnings you should know about:
In the first few weeks after vaccination with PANENZA, the results of blood tests to look for certain virus infection may not be correct. Tell the doctor requesting these tests that you have recently been given PANENZA.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
PANENZA should not be given at the same time as other vaccines.
How to take PANENZA:
For adults and children >1 year of age, inject the vaccine into the deltoid muscle.
For infants and children <1 year of age, inject the vaccine in the anterolateral aspect of the thigh.
Usual dose:
Individuals 3 years of age and older: Two doses of 0.5 mL administered with an interval of at least 21 days between doses.
Children from 6 months to 35 months of age: Two half-doses of 0.25 mL administered with an interval of at least 21 days between doses.
PANENZA is not recommended in children less than 6 months of age.
Overdose:
| If you think you, or a person you are caring for, have received too much PANENZA, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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Missed Dose:
Not applicable for this vaccine.
What are possible side effects from using PANENZA?
These are not all the possible side effects you may have when taking PANENZA. If you experience any side effects not listed here, tell your healthcare professional.
Allergic reactions may occur following vaccination, in rare cases leading to shock. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. Healthcare professionals are aware of this possibility and have emergency treatment available for use in such cases.
The following side effects of PANENZA are very common (more than 1 in 10 people) or common (between 1 to 10 in 100 people):
- Injection site: pain, redness, swelling, hardening, and bruising
- Headache
- Muscular pain
- Feeling unwell
- Shivering
- Fever
In children 6 to 23 months of age, the following additional side effects of PANENZA are very common or common:
- Drowsiness
- Abnormal crying
- Lost of appetite
- Irritability
- Vomiting
Most of these side effects usually disappeared without treatment within 1 to 3 days after onset. In children aged less than 3 years, some side effects may disappear within 8 days after onset, or require medication such as for the treatment of fever or pain.
Very rarely, vasculitis (inflammation of blood vessels) temporarily affecting the kidneys, and neurological disorders (affecting the nerves and brain) such as paresthesia, neuritis and Guillain Barré syndrome have been reported.
The serious side effects listed below have occurred after vaccination with PANENZA or with similar vaccines to prevent the flu.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | |
|---|---|---|
| Only if severe | In all cases | |
| VERY RARE (1 in 10 000 people) | ✓ | |
| Allergic Reactions: rash, itching or hives on the skin, swelling of the face, lips, tongue, or other parts of the body | ✓ | |
| Anaphylaxis: difficulty breathing, dizziness, a weak and rapid pulse, skin rash, vomiting, fainting | ✓ | |
| Febrile seizure: fever, brief convulsion or fit of uncontrolled body movements | ✓ | |
| Guillain-Barré Syndrome: muscle weakness and pain, feeling of pins and needles, paralysis | ✓ | |
| Lymphadenopathy: temporary swelling of the glands in the neck, armpit or groin | ✓ | |
| Neuritis: pain, weakness, numb and tingly arms | ✓ | |
| Thrombocytopenia: temporary reduction in blood platelets can result in bruising or bleeding, red skin spots | ✓ | |
| Vasculitis: purple colored skin spots, swollen blood vessel, pain, and in very rare cases kidney problems | ✓ | |
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 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, Health Canada and Sanofi Pasteur Limited 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 (http://www.phac-aspc.gc.ca/im/aefi-essi-form-eng.php) and send it to your local Health Unit. |
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Storage:
Store in a refrigerator at 2° to 8°C. Do NOT freeze. Keep the vial in the outer carton in order to protect from light.
After first opening, use PANENZA within 7 days if stored in a refrigerator (2° to 8°C).
Do not use after the expiration date.
Keep out of reach and sight of children.
If you want more information about PANENZA:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the Sanofi Canada website (www.sanofi.ca), or by calling 1- 888-621-1146.