Influvac

Influenza virus surface antigens (inactivated) (hemagglutinin and neuraminidase.
This vaccine complies with the World Health Organization (WHO) recommendation (southern hemisphere) and competent authority decision.
Trivalent Influenza Vaccine (Surface Antigen, Inactivated) (Influvac) may contain traces of eggs (such as ovalbumin, chicken proteins), formaldehyde, cetyltrimethylammonium bromide, polysorbate 80 or gentamicin, which are used during the manufacturing process (see Contraindications).
Suspension for injection (IM/SC) in prefilled syringe: a colorless clear liquid, filled in single-dose syringes.
Excipients/Inactive Ingredients: Potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, sodium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate and water for injections.

Pharmacotherapeutic group: Influenza vaccine. ATC Code: J07BB02.
Pharmacology: Pharmacodynamics: 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.
Pharmacokinetics: Not applicable.
Toxicology: Preclinical safety data: Not applicable.

Prophylaxis of influenza; especially those who run an increased risk of associated complications.
Trivalent Influenza Vaccine (Surface Antigen, Inactivated) (Influvac) is indicated in adults and children from 6 months of age.
The use of Trivalent Influenza Vaccine (Surface Antigen, Inactivated) (Influvac) should be based on official recommendations.
Vaccination is particularly recommended for the following categories of patients, depending on national immunization policies: Persons aged ≥ 65 years, regardless their health condition.
Adults and children with chronic disorders of the pulmonary or cardiovascular systems, including asthma.
Adults and children with chronic metabolic diseases such as diabetes mellitus.
Adults and children with chronic renal dysfunction.
Adults and children with immunodeficiencies due to disease or immunosuppressant medication (e.g., cytostatics or corticosteroids) or radiotherapy.
Children and teenagers (6 months - 18 years) who receive long-term acetylsalicylic acid containing medication, and might therefore be at risk for developing Reye's syndrome following an influenza infection.

Posology: Adults: 0.5 mL.
Pediatric population: Children from 36 months onwards: 0.5 mL.
Children from 6 months to 35 months: Clinical data are limited. Dosages of 0.25 mL or 0.5 mL may be given, for detailed instructions on administering a 0.25 mL or 0.5 mL dose, see Special precautions for disposal and other handling under Cautions for Usage. The dose given should be in accordance with existing national recommendations.
For children, who have not previously been vaccinated, a second dose should be given after an interval of at least 4 weeks.
Children less than 6 months: the safety and efficacy of Trivalent Influenza Vaccine (Surface Antigen, Inactivated) (Influvac) in children less than 6 months have not been established. No data are available.
Method of Administration: Immunization should be carried out by intramuscular or deep subcutaneous injection.
Precautions to be taken before handling or administrating the medicinal product: For instructions for preparation of the medicinal product before administration, see Special precautions for disposal and other handling under Cautions for Usage.

Overdosage is unlikely to have any untoward effect.

Hypersensitivity to the active substances, to any of the excipients listed in Excipients/Inactive Ingredients under Description or to any component that may be present as traces such as eggs (ovalbumin, chicken proteins), formaldehyde, cetyltrimethylammonium bromide, polysorbate 80 or gentamicin.
Immunization shall be postponed in patients/children with febrile illness or acute infection.

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.
Trivalent Influenza Vaccine (Surface Antigen, Inactivated) (Influvac) should under no circumstances be administered intravascularly.
As with other vaccines administered intramuscularly, Trivalent Influenza Vaccine (Surface Antigen, Inactivated) (Influvac) should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following an intramuscular administration to these subjects.
Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress-related reactions can occur following, or even before, any vaccination as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paresthesia and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury from faints.
Trivalent Influenza Vaccine (Surface Antigen, Inactivated) (Influvac) is not effective against all possible strains of influenza virus. Trivalent Influenza Vaccine (Surface Antigen, Inactivated) (Influvac) is intended to provide protection against those strains of virus from which the vaccine is prepared and to closely related strains.
As with any vaccine, a protective immune response may not be elicited in all vaccinees.
Antibody response in patients/children with endogenous or iatrogenic immunosuppression may be insufficient.
Interference with serological testing: see Interactions.
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially 'sodium-free'. This medicine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially "potassium-free".
Effects on ability to drive and use machines: Trivalent Influenza Vaccine (Surface Antigen, Inactivated) (Influvac) has no or negligible influence on the ability to drive and use machines.

Pregnancy: Inactivated influenza vaccines can be used in all stages of pregnancy. Larger datasets on safety are available for the second and third trimester, compared with the first trimester; however, data from worldwide use of influenza vaccine do not indicate any adverse fetal and maternal outcomes attributable to the vaccine.
Breastfeeding: Trivalent Influenza Vaccine (Surface Antigen, Inactivated) (Influvac) may be used during breastfeeding.
Fertility: No fertility data are available.

Summary of safety profile: The most frequently reported adverse drug reactions following use of Trivalent Influenza Vaccine (Surface Antigen, Inactivated) (Influvac) are local and/or systemic reactions such as injection site pain or fatigue and headache. Most of these adverse reactions are of mild to moderate intensity.
These reactions usually disappear within 1-2 days without treatment.
In rare cases, allergic reactions may evolve to shock, angioedema (see Precautions).
Tabulated summary of adverse reactions: The following undesirable effects have been observed during clinical trials or are resulting from post-marketing experience with the following frequencies: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); and not known (adverse reactions from post-marketing experience; cannot be estimated from the available data). (See table.)

Click on icon to see table/diagram/image

Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Trivalent Influenza Vaccine (Surface Antigen, Inactivated) (Influvac) may be given at the same time as other vaccines. Immunization 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/child is undergoing immunosuppressant treatment.
Following influenza vaccination; false positive results in serology tests using the ELISA method to detect antibodies against HIV1, Hepatitis C and especially HTLV1 have been observed. The Western Blot technique disproves the false-positive ELISA test results. The transient false-positive reactions could be due to the IgM response by the vaccine.

Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Special precautions for disposal and other handling: The vaccine should be allowed to reach room temperature before use. Shake before use. Inspect visually prior to administration.
For the administration of a 0.25 mL dose from a single dose 0.5 mL syringe, push the front side of the plunger exactly to the edge of the mark so that half of the volume is eliminated; a volume of 0.25 mL of the vaccine remains in the syringe, suitable for administration. See Dosage & Administration.
Any unused product or waste material should be disposed of in accordance with local requirements.

Shelf life: 12 months.
Store at temperatures between 2-8°C. Do not freeze.
Store in the original package in order to protect from light.

Vaccines, Antisera & Immunologicals

J07BB02 - influenza, inactivated, split virus or surface antigen ; Belongs to the class of influenza viral vaccines.

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