For GB Healthcare Professionals only .

CELL-BASED QUADRIVALENT INFLUENZA VACCINE

( surface antigen , inactivated ) Seqirus

Order now for the 2022 / 23 season

QIVc is indicated for prophylaxis of influenza in adults and children from 2 years of age .

Contact the Seqirus team on 0345 0093 804 or flu . salesuk @ seqirus . com and secure your QIVc order for 2022 / 23 .

* Option to cancel all or part of your Seqirus flu vaccine ( s ) order if QIVc is not an NHS recommended and reimbursed option for 2022 / 23 .

Date of preparation September 2021 . Job code : GBR-CQIV-21-0006

PRESCRIBING INFORMATION

Cell-based quadrivalent influenza vaccine ( surface antigen , inactivated ) Seqirus ,

suspension for injection in pre-filled syringe . Presentation : Each 0.5ml of cellbased 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 0.5ml 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 ( betapropiolactone , 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 : No clinical data on coadministration with other vaccines are available . Based on clinical experience with cell-based trivalent influenza vaccine ( TIVc ), QIVc can be given at the same time as other vaccines . Pregnancy and Lactation : There are limited data from the use of QIVc in pregnant women . However , inactivated influenza vaccines can be used at all stages of pregnancy . It is unknown whether QIVc is excreted in human milk . No effects on breast-fed newborn / infant are anticipated . QIVc may be used during lactation . 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 at www . medicines . org . uk / emc

GBR-CQIV-21-0003 Date of preparation : September 2021 .

Adverse events should be reported . Reporting forms and information can be found at www . mhra . gov . uk / yellowcard . Adverse events relating to Seqirus products should also be reported to Seqirus UK Limited on 01748 828816 .