Agrippal S10.5 ml/prefilled syringe

Prophylaxis of influenza (flu), especially in those who run an increased risk of associated complications. The use of Agrippal S1 0.5 ml/prefilled syringe should be based on official recommendations.

One dose (0.5 ml) contains Influenza virus surface antigens (haemagglutinin and neuraminidase), propagated in fertilized hen’s eggs from healthy chicken flocks, and inactivated with formaldehyde, of the following strains: A/California/07/2009 (H1N1)-like strain (A/California/07/2009, NYMC X-181): 15 micrograms. haemagglutinin A/Perth/16/2009 (H3N2)-like strain (A/Victoria/210/2009, NYMC X-187): 15 micrograms haemagglutinin. B/Brisbane/60/2008-like strain (B/Brisbane/60/2008): 15 micrograms haemagglutinin.

Vaccines, Anti-sera & Immunoglobulin

Influenza virus vaccine inactivated promotes immunity to influenza virus by inducing specific antibody formation.

Adult and children over 3 years of age: one dose of 0.5 ml.Children from 6 to 36 months of age: one dose of 0.25 ml. For children who have not previously been vaccinated, a second dose should be given after an interval of at least 4 weeks.Administration: Intramuscular injection (IM) on deltoid. Agrippal S1 0.5 ml/prefilled syringe should be administered before the beginning of the influenza season or as required by the epidemiological situation. Vaccination should be repeated every year with an age-appropriate dose of vaccine of updated antigen composition.

Dosage: Adults and children over 36 months of age: 0.5ml Children from 6 to 35 months of age: clinical data are limited. Doses of 0.25 ml or 0.5 ml have been used. Administrations: For children who have not previously been vaccinated, a second dose should be given after an interval of at least 4 weeks. If half a dose (0.25 ml) is to be administered, discard half the contained volume (up to the mark indicated on the syringe barrel), before injection. Immunisation should be carried out by intramuscular or deep subcutaneous injection. The vaccine should be allowed to reach room temperature before use. Shake before use. Seroprotection is generally obtained within 2 to 3 weeks. The duration of postvaccinal immunity to homologous strains or to strains closely related to the vaccine strains varies but is usually 6-12 months.

Agrippal S1 0.5 ml/prefilled syringe may be given at the same time as other vaccines. Immunisation should be carried out on separate limbs. It should be noted that the adverse reactions may be intensified. The immunological response may be diminished if the patient is undergoing immunosuppressant treatment. Following influenza vaccination, false positive results in serology tests using the ELISA method (blood test) to detect antibodies against HIV1, Hepatitis C and especially HTLV1 have been observed. The Western Blot technique disproves the false-positive ELISA results. The transient false positive reactions could be due to the IgM response by the vaccine.

Hypersensitivity to the active substances, to any of the excipients and to residues, e.g. eggs, chicken proteins, such as ovalbumin. The vaccine may contain residues of the following substances, e.g. kanamycin and neomycin sulphate, formaldehyde, cetyltrimethylammonium bromide (CTAB) and polysorbate 80. Immunisation shall be postponed in patients with febrile illness or acute infection.

As with all medicinal products this product may cause undesirable effects. Local reactions: redness, swelling, pain, induration. Sytemical reactions: fever, dizziness, shivering, fatigue, sweating, myalgia, arthralgia, pruritus, rash, headache. These reactions usually disappear within one or two days without treatment. Reactions such as shock and eclampsia, vasculitis (inflammation of the blood vessels) with transient renal involvement, neurological disorders are rarely seen. If any unmentioned discomfort appeared, please seek medical help.

Influenza vaccine should be used during pregnancy only when clearly needed and possible advantages outweigh the potential risk of fetus. There is no known contra-indication to the use of Influenza vaccine during lactation.

Antibody response in patients with endogenous (due to illness) or iatrogenic (due to medicine) immunosuppression (poor immune response) may be insufficient. As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine. Agrippal S1 0.5 ml/prefilled syringe should under no circumstances be administered intravascularly.

Agrippal S1 0.5 ml/prefilled syringe must be stored in a refrigerator (2°C-8°C). Do not freeze. Keep the syringe in the outer carton in order to protect from light. Any unused product or waste material should be disposed of in accordance with local requirements.

Vaccines, Anti-sera & Immunoglobulin

The limited data from vaccinations in pregnant women do not indicate that adverse foetal and maternal outcomes were attributable to the vaccine. The use of this vaccine may be considered from the second trimester of pregnancy. For pregnant women with medical conditions that increase their risk of complications from influenza, administration of the vaccine is recommended, irrespective of their stage of pregnancy. Agrippal S1 0.5 ml/prefilled syringe may be used during lactation.