- influenza vaccine (surface antigen, inactivated)
POM: Prescription only medicine
This information is intended for use by health professionals
- A/Michigan/45/2015 (H1N1)pdm09-like strain
15 micrograms HA **
- A/Singapore/INFIMH-16-0019/2016 (H3N2)-like strain
15 micrograms HA **
- B/Colorado/06/2017-like strain (B/Victoria/2/87 lineage)
(B/Maryland/15/2016, NYMC BX-69A)
15 micrograms HA **
per 0.5 ml dose
PosologyAdults: 0.5 ml.
Paediatric populationChildren 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 section 6.6. 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 Imuvac in children less than 6 months have not been established. No data are available.
Method of AdministrationImmunisation 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 section 6.6.
PregnancyInactivated 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 foetal and maternal outcomes attributable to the vaccine.
Breast-feedingImuvac may be used during breast-feeding
FertilityNo fertility data are available
ADVERSE REACTIONS OBSERVED FROM CLINICAL TRIALSThe safety of trivalent inactivated influenza vaccines is assessed in open label, uncontrolled clinical trials performed as annual update requirement, including at least 50 adults aged 18 - 60 years of age and at least 50 elderly aged 61 years or older. Safety evaluation is performed during the first 3 days following vaccination. The following undesirable effects have been observed during clinical trials with the following frequencies: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100).Tabulated list of adverse reactions:
≥ 1/100, < 1/10
≥ 1/1,000, < 1/100
Nervous system disorders
Skin and subcutaneous tissue disorders
Musculoskeletal and connective tissue disorders
General disorders and administration site conditions
fever, malaise, shivering, fatigue
Local reactions: redness, swelling, pain, ecchymosis, induration*
ADVERSE REACTIONS REPORTED FROM POST-MARKETING SURVEILLANCEAdverse reactions reported from post marketing surveillance are, in addition to the reactions which have also been observed during the clinical trials, the following:
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, such as encephalomyelitis, neuritis and Guillain Barré 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 non-specific rash
Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
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