Influvac

Influvac

vaccine, influenza

Manufacturer:

Abbott

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Influenza virus surface antigens, sub-unit vaccine (haemagglutinin and neuraminidase).
Description
Influvac also contains the following excipients: Potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, sodium chloride, calcium chloride, magnesium chloride hexahydrate and water for injections.
Influvac complies with the World Health Organization and competent authority decision.
Action
Pharmacology: Pharmacotherapeutic Group: Influenza vaccine, ATC Code: J07BB02.
Seroprotection is generally obtained within 2-3 weeks. The duration of post-vaccinal immunity to homologous strains or to strains closely related to the vaccine strains varies but is usually 6-12 months.
Indications/Uses
Prevention of influenza, especially in those who run an increased risk of associated complications. The use of Influvac should be based on official recommendations. Vaccination is particularly recommended for the following categories of patients, depending on national immunization policies: Persons ≥65 years, regardless of their health condition; adults and children with chronic disorders of the pulmonary or cardiovascular systems, including asthma; chronic metabolic diseases eg, diabetes mellitus; chronic renal dysfunction; immunodeficiencies due to disease or immunosuppressant medication (eg, cytostatics or corticosteroids) or radiotherapy; children and teenagers (6 months to 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.
Dosage/Direction for Use
Adults and Children from 36 months: 0.5 mL.
Children 6-35 months: Clinical data are limited. Dosages of 0.25 or 0.5 mL have been used.
For children who have not previously been vaccinated, a 2nd dose should be given after an interval of at least 4 weeks.
Immunisation should be carried out by IM or deep SC injection.
Overdosage
Overdosage is unlikely to have any untoward effect.
Contraindications
Hypersensitivity to trivalent inactivated influenza virus, any of the excipients of Influvac and to residues of eggs, chicken protein (Influvac does not contain >1 mcg ovalbumin/dose), formaldehyde, cetyltrimethylammonium bromide, polysorbate 80 or gentamicin.
Immunisation shall be postponed in patients with febrile illness or acute infection.
Special Precautions
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.
Influvac should under no circumstances be administered intravascularly.
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Effects on the Ability to Drive or Operate Machinery: Influvac is unlikely to produce an effect on the ability to drive and use machines.
Use in pregnancy & lactation: The limited data from vaccinations in pregnant women do not indicate that adverse fetal and maternal outcomes were attributable to the vaccine. The use of Influvac may be considered from the 2nd 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.
Influvac may be used during lactation.
Use In Pregnancy & Lactation
The limited data from vaccinations in pregnant women do not indicate that adverse fetal and maternal outcomes were attributable to the vaccine. The use of Influvac may be considered from the 2nd 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.
Influvac may be used during lactation.
Adverse Reactions
Adverse Reactions Observed from the Clinical Trials: The safety of trivalent inactivated influenza vaccines is assessed in open-label, uncontrolled clinical trials performed as annual update requirement, including at least 50 adults 18-60 years and at least 50 elderly ≥61 years.
Safety evaluation is performed during the first 3 days following vaccination.
The following undesirable effects have been observed during clinical trials [frequency: Common (≥1/100, <1/10)].
Nervous System Disorder: Headache*.
Skin and Subcutaneous Tissue Disorder: Sweating*.
Musculoskeletal and Connective Tissue Disorders: Myalgia, arthralgia*.
General Disorders and Administration Site Conditions: Fever, malaise, shivering, fatigue.
Local Reactions: Redness, swelling, pain, ecchymosis, induration*.
*These reactions usually disappear within 1-2 days without treatment. Adverse Reactions Reported from Post-Marketing Surveillance: Blood and Lymphatic System Disorders: Transient thrombocytopenia, transient lymphadenopathy.
Immune System Disorders: Allergic reactions, in rare cases leading to shock, angioedema.
Nervous System Disorders: Neuralgia, paraesthesia, febrile convulsions, neurological disorders eg, encephalomyelitis, neuritis and Guillain-Barre syndrome.
Vascular Disorders: Vasculitis associated in very rare cases with transient renal involvement.
Skin and Subcutaneous Tissue Disorders: Generalised skin reactions including pruritus, urticaria or nonspecific rash.
Drug Interactions
Influvac 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 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, Influvac must not be mixed with other medicinal products.
Caution For Usage
Instruction for Use and Handling: Unused vaccine and other waste material should be disposed of in compliance with local rules for the disposal of products of this nature.
Influvac should be allowed to reach room temperature before use. Shake before use.
For administration of a 0.25-mL dose from a syringe, push the front side of the plunger exactly to the edge of the hub (the knurled polypropylene ring); a reproducible volume of vaccine remains in the syringe, suitable for administration.
Storage
Store at +2°C to +8°C (in a refrigerator). Do not freeze. Protect from light.
Shelf-Life: 1 year.
ATC Classification
J07BB02 - influenza, inactivated, split virus or surface antigen ; Belongs to the class of influenza viral vaccines.
Presentation/Packing
Vaccine 0.5 mL (susp for inj, colourless clear liquid, single-dose pre-filled syringe) x 1's.
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