PRESCRIBING INFORMATION
Adjuvanted quadrivalent influenza vaccine ( surface antigen , inactivated ) Seqirus ,
suspension for injection in pre-filled syringe . Presentation : Each 0.5 ml dose of adjuvanted quadrivalent influenza vaccine ( aQIV ) contains 15 micrograms of each of the four strains that comply with the World Health Organization quadrivalent vaccine recommendations ( Northern Hemisphere ), with adjuvant MF59C . 1 ( 9.75 mg squalene , 1.175 mg polysorbate 80 , 1.175 mg sorbitan trioleate , 0.66 mg sodium citrate , 0.04 mg citric acid ). Indications : Prophylaxis of influenza in the elderly ( 65 years of age and older ). Dosage and Administration : A single 0.5 ml dose by intramuscular injection only ( preferred site is the deltoid muscle of the upper arm ). Contraindications : Hypersensitivity to the active substances , components of the adjuvant , excipients ( sodium chloride , potassium chloride , potassium dihydrogen phosphate , disodium phosphate dihydrate , magnesium chloride hexahydrate , calcium chloride dihydrate ), or to possible trace residues ( ovalbumin , kanamycin , neomycin sulphate , formaldehyde , cetyltrimethylammonium bromide , hydrocortisone ). A severe allergic reaction ( e . g . anaphylaxis ) to previous influenza vaccination . Warnings and Precautions : In order to improve the traceability of biological medicinal products , the name and the batch number of the administered product should be clearly recorded . Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine . Do not inject intravenously , subcutaneously or intradermally . aQIV must not be mixed with other vaccines in the same syringe . Postpone vaccination in patients with febrile illness until fever is resolved . Caution when administering to individuals with thrombocytopenia or bleeding disorder since bleeding may occur following intramuscular administration . Syncope ( fainting ) 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 , paraesthesia and tonic-clonic limb movements during recovery . Ensure procedures are in place to avoid injury from faints . Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient to prevent influenza . A protective immune response may not be elicited in all vaccine recipients . Interactions : If aQIV is to be used at the same time as another vaccine , it should be administered at separate injection sites and preferably on different limbs .
Cell-based quadrivalent influenza vaccine ( surface antigen , inactivated ) Seqirus ,
suspension for injection in pre-filled syringe . Presentation : Each 0.5 ml of cell-based quadrivalent influenza vaccine ( QIVc ) contains 15 micrograms of each of four purified virus strains propagated in Madin Darby Canine Kidney ( MDCK ) cells that comply with the World Health Organization quadrivalent vaccine recommendations ( Northern Hemisphere ) for the current season . Indications : Prophylaxis of influenza in adults and children from 2 years of age . Dosage and Administration : Adults and children aged 2 years and over should receive a single 0.5 ml dose , children less than 9 years of age who have not been previously vaccinated against influenza , should receive a second dose at least 4 weeks apart . For intramuscular injection only . The preferred site for injection is the deltoid muscle of the upper arm . Young children with insufficient deltoid mass should be vaccinated in the anterolateral aspect of the thigh . Contraindications : Hypersensitivity to the active substance , to any of the excipients ( sodium chloride , potassium chloride , magnesium chloride hexahydrate , disodium phosphate dihydrate , potassium dihydrogen phosphate ), or to possible trace residues ( beta-propiolactone , cetyltrimethylammonium bromide , and polysorbate 80 ). Warnings and Precautions : In order to improve the traceability of biological medicinal products , the name and the batch number of the administered product should be clearly recorded . Appropriate medical treatment and supervision should be readily available in case of an anaphylactic event following administration . Do not inject intravenously , subcutaneously or intradermally . QIVc must not be mixed with other vaccines in the same syringe . Vaccination should be postponed in patients with acute febrile illness until fever is resolved . As with all injectable vaccines , QIVc must be administered with caution to individuals with thrombocytopenia or a bleeding disorder since bleeding may occur following intramuscular administration . Syncope ( fainting ) can occur following or before any vaccination as a psychogenic response to the needle injection . This can be accompanied by several neurological signs such as transient visual disturbance , paraesthesia , and tonic-clonic limb movements during recovery . It is important that procedures are in place to avoid injury from faints . Endogenous or iatrogenic immunosuppression may result in insufficient antibody response . A protective immune response may not be elicited in all vaccine recipients . Interactions :
Adverse reactions may be intensified by any co-administration . Data assessed by the MHRA supports concomitant administration of Fluad ( trivalent formulation ) with COVID-19 mRNA Vaccine BNT162b2 ( Pfizer / BioNTech ) and COVID-19 Vaccine AstraZeneca . The data show that the antibody responses are unaffected and that the reactogenicity profile is acceptable . Pregnancy and Lactation : This vaccine is for use in elderly adults 65 years and older . It is not to be used in women who are , or may be , pregnant or breast-feeding . Effects on Ability to Drive and Use Machines : No or negligible influence on the ability to drive and use machines . Side Effects : The most common reactions ( ≥1 / 10 ) are headache , injection-site pain , and fatigue . Commonly reported reactions ( ≥1 / 100 to < 1 / 10 ) are loss of appetite , nausea , diarrhoea , myalgia , arthralgia , ecchymosis , chills , erythema , induration , and influenza-like illness . Uncommon reactions ( ≥1 / 1000 to < 1 / 100 ) include vomiting and fever ( ≥38 ° C ). In addition to the adverse reactions observed during clinical trials , the following adverse events were reported from postmarketing surveillance in individuals 65 years of age and older for Fluad Tetra , and / or for Fluad ( trivalent formulation ), which is relevant because both vaccines are manufactured using the same process and have overlapping compositions thrombocytopenia , lymphadenopathy , extensive swelling of injected limb , injection-site cellulitis-like reaction , Injection side swelling , peripheral swelling , asthenia , malaise , pyrexia , allergic reactions including anaphylactic shock ( in rare cases ), anaphylaxis , muscular weakness , pain in extremity , encephalomyelitis , Guillain-Barré syndrome , convulsions , neuritis , neuralgia , paraesthesia , syncope , presyncope , dizziness , generalised skin reactions ( erythema multiforme , erythema , urticaria , pruritus , non-specific rash , angioedema ), vasculitis that may be associated with transient renal involvement . Overdose : Overdose is unlikely to have any untoward effect . Legal Category : POM . Package Quantities : Packs of 1 or 10 pre-filled syringes . Marketing Authorisation Number : PLGB 47991 / 0007 . Basic NHS Cost : £ 13.50 per 0.5 ml pre-filled syringe , £ 135.00 per 10 pack . Marketing Authorisation Holder : Seqirus UK Ltd ., Point , 29 Market Street , Maidenhead SL6 8AA , United Kingdom . For full prescribing information and details of other side effects , please see the Summary of Product Characteristics : www . medicines . org . uk / emc / product / 12881 /
GBR-AQIV-23-0010 Date of preparation : May 2023
If QIVc is to be used at the same time as another vaccine , it should be administered at separate injection sites and preferably on different limbs . Adverse reactions may be intensified by any co-administration . Data assessed by the MHRA supports concomitant administration of QIVc with COVID-19 mRNA Vaccine BNT162b2 ( Pfizer / BioNTech ) and COVID-19 Vaccine AstraZeneca . The data show that the antibody responses are unaffected and that the reactogenicity profile is acceptable . Pregnancy and Lactation : Inactivated influenza vaccines , such as QIVc , can be given in any stage of pregnancy . Larger safety datasets are available on vaccine use during the second or third trimester , compared with the first trimester . Data from worldwide use of influenza vaccines do not indicate any adverse foetal or maternal outcomes attributable to the vaccine . Effects on Ability to Drive and Use Machines : QIVc has no or negligible influence on the ability to drive and use machines . Side Effects : The most common reactions ( ≥1 / 10 ) are injection site pain , ecchymosis , erythema , induration , headache , fatigue , myalgia , loss of appetite . Additionally , injection site tenderness , irritability , sleepiness and change in eating habits were reported in children 2 to < 6 years . Commonly reported adverse reactions ( ≥1 / 100 to < 1 / 10 ) include nausea , vomiting , diarrhoea , arthralgia , chills / shivering and fever ( ≥38 ° C ). Vomiting in the elderly , and fever in adults and elderly were uncommon . The following have been reported post-marketing : extensive swelling of injected limb , allergic reactions ( including anaphylactic shock ), paraesthesia , generalised skin reactions ( including pruritus , urticaria , or non-specific rash ), and Guillain-Barre Syndrome . Paediatric subjects generally reported higher rates of local and systemic reactions compared to adults aged 18 years and over . Overdose : There are no data for overdose with QIVc . Legal Category : POM . Package Quantities : Packs of 1 or 10 pre-filled syringes . Marketing Authorisation Number : PLGB 47991 / 0006 . Basic NHS Cost : £ 12.50 per 0.5ml pre-filled syringe , £ 125.00 per 10-pack . Marketing Authorisation Holder : Seqirus UK Ltd ., Point , 29 Market Street , Maidenhead SL6 8AA , United Kingdom . For full prescribing information and details of other side effects see the Summary of Product Characteristics : www . medicines . org . uk / emc / product / 12882
GBR-QIVc-23-0004 Date of preparation : May 2023
Adverse events should be reported . Reporting forms and information can be found at www . mhra . gov . uk / yellowcard . Adverse events relating to CSL Seqirus products should also be reported to Seqirus UK Limited on 01748 828816 .
References : 1 . aQIV Summary of Product Characteristics 2023 . 2 . QIVc Summary of Product Characteristics 2023 . 3 . NHS England . Vaccines for 2023 / 24 seasonal flu vaccination programme . 2023 . Available from : https :// www . gov . uk / government / publications / national-flu-immunisation-programme-plan / national-flu-immunisation-programme-2023-to-2024-letter [ Accessed September 2023 ]. 4 . NHS England . Vaccines for 2022 / 23 seasonal flu vaccination programme . 2022 . Available from : https :// webarchive . nationalarchives . gov . uk / ukgwa / 20230504185117 / https :// www . england . nhs . uk / publication / annual-seasonal-flu-vaccination-programme-and-reimbursement-guidance / [ Accessed September 2023 ]. 5 . NHS England . Vaccines for 2021 / 22 seasonal flu vaccination programme . 2021 . Available from : https :// webarchive . nationalarchives . gov . uk / ukgwa / 20220412191534 / https :// www . gov . uk / government / publications / national-flu-immunisation-programme-plan / appendix-crecommended-influenza-vaccines [ Accessed September 2023 ]. 6 . NHS England . Vaccines for 2020 / 21 seasonal flu vaccination programme . 2020 . Available from : https :// webarchive . nationalarchives . gov . uk / ukgwa / 20210701160234 / https :// www . gov . uk / government / publications / national-flu-immunisation-programme-plan [ Accessed September 2023 ]. 7 . NHS England . Vaccines for 2019 / 20 seasonal flu vaccination programme . 2019 . Available from : https :// www . england . nhs . uk / wp-content / uploads / 2019 / 03 / annual-national-flu-programme-2019-to-2020-1 . pdf [ Accessed September 2023 ]. 8 . NHS England . Vaccines for 2018 / 19 seasonal flu vaccination programme . 2018 . Available from : https :// webarchive . nationalarchives . gov . uk / ukgwa / 20210701160234 / https :/ www . gov . uk / government / publications / national-flu-immunisation-programme-plan [ Accessed September 2023 ].
GBR-AQIV-23-0050 | September 2023 © Seqirus UK Limited 2023