TOGETHER
STRONGER
IN THE FIGHT AGAINST FLU
PRESCRIBING INFORMATION ( GREAT BRITAIN )
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 : 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 , and generalised skin reactions ( including pruritus , urticaria , or non-specific rash ). 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-CQIV-22-0004 Date of preparation : August 2022
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 .
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 acute 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 tonicclonic 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 . 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 ). No post-marketing data are currently available for aQIV , however the post-marketing experience with Fluad ( trivalent formulation ) is relevant to aQIV as both vaccines are manufactured using the same process and have overlapping compositions . Adverse reactions reported from post-marketing surveillance with Fluad include thrombocytopenia , lymphadenopathy , extensive swelling of injected limb lasting more than one week , injection-site cellulitis-like reaction , allergic reactions including anaphylactic shock ( in rare cases ), anaphylaxis , angioedema , muscular weakness , nervous system disorders ( encephalomyelitis , Guillain-Barré syndrome , convulsions , neuritis , neuralgia , paraesthesia ), generalised skin reactions ( erythema multiforme , urticaria , pruritus or non-specific rash ), 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-22-0003 Date of preparation : August 2022
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 .
Copyright © Seqirus UK Limited 2022 . GBR-AQIV-22-0035 . October 2022 .