Description:

Indications:

Active Immunization against disease caused by Influenza viruses (2021-2022 formula recommended by WHO).

How was FluGuard^® produced and how does it work?

FluGuard^® contains pure proteins of recombinant hemagglutinin (HA) from four serotypes of influenza virus which is announced yearly for seasonal vaccination against influenza by WHO.

The proteins are produced in insect cell culture using the baculovirus expression system that is not able to replicate in human cells. Each one of four HA in cell line is being expressed by a baculovirus vector and then being extracted and purified by linear chromatography.

These proteins act as an antigen to induce humoral immune response hemagglutinin inhibitors antibodies.

Important information about FluGuard^® administration:

• FluGuard^® is indicated for persons 18 years of age and older.
• FluGuard^® is injected as a single dose of 0.5 mL dose and intramuscularly (deltoid muscle).
• This vaccine should not be mixed in the same syringe with any other vaccine and intravenous injection should be avoided.
• Before inserting the needle into the pre-filled FluGuard^® syringe, invert it gently and then insert the needle.
• For all parenteral drug products, inspecting drug from visual aspects such as existing foreign particles and discoloration is essential. In the presence of any of the above (presence of external particles or discoloration) the vaccine injection is prohibited.

Do not use FluGuard^® vaccine in the following cases:

• If you have a severe allergy (e.g., anaphylaxis) to any components of the vaccine.

Warnings and Precautions:

Before using the vaccine, consult with your health care provider or pharmacist.

Management of hypersensitivity reactions:

Appropriate medical treatment and supervision must be available to manage possible hypersensitivity reactions following administration of FluGuard^® Quadrivalent.

Guillain Barré Syndrome (GBS):

Evidence for a causal relation of GBS with other influenza vaccines is inconclusive; if an excess risk exists, it is probably slightly more than one additional case per 1 million persons vaccinated.

If GBS has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give FluGuard^® should be based on careful considerations of the potential benefits and risks.

Altered Immunocompetence:

If you have a weak or altered immune system (due to disease, taking medicines such as corticosteroids, or chemotherapy), inform your health care provider.

Limitations of vaccine effectiveness:

Like any other vaccine, this vaccine may not cause immunization in all individuals.

• If you have a short period of illness with fever, its preferred not to get vaccine until elimination of the fever.
• If you have problems with blood clotting and are easily bruised, inform your doctor.
• If you have a history of malaise and lethargy before or after injecting any medicine, inform your doctor or a pharmacist.
• Proteins exist in this vaccine, are not be able to cause immunogenicity.
• This vaccine does not stimulate immune system against other respiratory infections.
• Best time for injection: As the highest possibility of getting influenza is from months October-March, if people have not get vaccinated in Autumn, they can inject it until spring.

Drug interactions?

There is no available information about interaction of this vaccine with other vaccines.

If you have to inject another vaccine at the same time, the vaccine should be given in a different site of injection.

This parenteral product should not be mixed with any other medicines.

Use in specific populations:

Pregnancy and lactation:

FluGuard^® administration during pregnancy is under investigation.

There is no available information about FluGuard^® excretion into human breast milk.

The decision to give the FluGuard^® during pregnancy should be based on careful consideration of the potential benefits and risks

Fertility:

There is insufficient information about vaccine effect on human fertility.

Animal clinical trials did not prove adverse effects on female fertility.

Pediatrics Use:

Efficacy and safety of FluGuard^® have not been established in children 6 months to 18 years.

Potential adverse effects:

Very common (≥10%)

• Headache
• Fatigue
• Local pain
• Local Tenderness
• Myalgia
• Arthralgia

Very common (≥10%)

• Nausea
• Erythema at injection site
• Fever higher than 38º C
• Chills
• Feeling Cold

Very common (≥10%)

• Cough
• Sore-throat
• Diarrhea
• Rash and Dermatitis
• Pruritus
• Flu like syndrome

Rare ( < 1%):

• Dizziness
• Urticaria

Frequency of complication according to the percentage of prevalence is Very minor, not predictable.

• Hypersensitivity reactions such as anaphylactic reactions
• Neuropathic problems that can cause neck tenderness, dizziness, malaise, anesthesia, fatigue, loss of balance, paralysis, and disability of full or half of the body (Guillain-Barre syndrome)

Adverse effects report:

If you feel any adverse event, even cases that is not mentioned in this brochure, be sure to tell a doctor or a pharmacist.

You can directly report the adverse effects to Iran Food and Drug Administration’s website (www.fda.gov.ir) or with number +98-21-8609-2503.

How to store FluGuard^®:

• Keep the medicine out of the reach and sight of children.
• FluGuard^® should be refrigerated (at 2 to 8º C) and protected from light.
• Do not freeze. Discard if product has been frozen.
• In order to protect the vaccine from light, Keep the vaccine in the original box.
• Do not use FluGuard^® after expiry date on the label. Expiry date is always the last day of the month.
• Before injecting solution, examine the inside of syringe carefully.
• In case of observing particles, discoloration or turbidity, avoid injecting drug. If you have any doubts about the appearance of the solution, consult you pharmacist.