Prevention of influenza, especially in subjects who present a high risk of complications, associated with

Agrippal is indicated in adults and children from 6 months.
The use of Agrippal must be based on official recommendations.

Dosage

Adults: a dose of 0.5 ml

Pediatric population

Children from 36 months and a dose of 0.5 ml.
Children 6 months to 35 months: clinical data are limited. A dose of 0.25 ml or 0.5 ml may be used. The dose administered shall be in accordance with the relevant national recommendations.

For children who have not been vaccinated before, a second dose should be injected after an interval of at least 4 weeks.
Children under 6 months: The safety and efficacy of Agrippal in children under 6 months of age have not been established. No data is available.

Mode of administration

Administer intramuscularly or subcutaneously deep.

Precautions to be taken before handling or administering the vaccine

For instructions on how to prepare the vaccine before administration, see section "Instructions for use, handling and disposal."
The vaccine appears as a liquid, clear.

Pharmaco-therapeutic class, influenza vaccine, ATC code: J07BB02.

Seroprotection is generally obtained within 2 to 3 weeks The duration of post-vaccination immunity against strains homologous to or closely related to the strains of the vaccine is variable but is generally 6 To 12 months.

Agrippal has no or negligible effect on the ability to drive and use machines

Hypersensitivity to active substances, to any of the excipients mentioned in the section, to residues (eg eggs or chicken proteins such as ovalbumin). >
Known hypersensitivity to the following substances which may contain residues: kanamycin or neomycin sulphate, formaldehyde, cetyltrimethylammonium bromide (CTAB), barium sulphate and polysorbate 80.


Anaphylactoid reaction occurred during previous influenza vaccination

Vaccination must be delayed in case of febrile illness or acute infection

As with all vaccines, injectable vaccines, it is recommended to have appropriate medical treatment for the management of a possible anaphylactic reaction following the administration of the vaccine
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Agrippal should not be administered intravascularly.

Anxious reactions, including vasovagal reactions (syncope), hyperventilation, or stress reactions, may occur after, or even before, vaccination as a psychogenic response to injection by a needle. This can be accompanied by several neurological signs such as a transient disorder of vision, paresthesias and movements, tonic-clonic limbs during the recovery phase. It is important that measures be put in place to prevent injuries in case of fainting.


People allergic to latex

Despite the absence of natural rubber latex in the cap of the syringe, the safety of Agrippal in people allergic to latex has not been established.
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Agrippal may be administered concomitantly with other vaccines. However, the injections should be done on two different limbs. It should be noted that the undesirable effects can be intensified.

The immune response may be impaired if the patient is undergoing immunosuppressive treatment.
In the absence of compatibility studies, this vaccine should not be mixed with other medicines.
It is unlikely that an overdose will cause a harmful effect.

Pregnancy

Inactivated influenza vaccines can be used in all stages of pregnancy. The safety data available are more important for the second and third trimesters than for the first quarter. However, data from the use of inactivated influenza vaccines in the world do not indicate abnormal outcomes for the fetus and the mother attributable to the vaccine. >
Breastfeeding

The vaccine may be administered in case of breast-feeding.

Fertility

There are no available data on fertility

Adverse events observed in clinical trials

Tolerance of inactivated trivalent influenza vaccines is evaluated during the course of open, uncontrolled clinical trials conducted annually in accordance with regulatory requirements and including at least 50 adults aged 18 to 60 years and at least 50 Persons aged 61 years and over.

The evaluation of the tolerance is carried out during the first 3 days following the vaccination.

The following adverse reactions have been observed in clinical trials, according to the following frequencies

Very common (≥ 1/10), frequent (≥ 1/100,