4.1. Therapeutic indications

Supemtek TIVr is indicated for active immunization for the prevention of influenza disease in adults and children from 9 years of age and older.

Supemtek TIVr should be used in accordance with official recommendations.

4.2. Posology and method of administration

Posology

Adults and children from 9 years of age

One dose of 0.5 mL.

Paediatric population

Safety and efficacy of Supemtek TIVr have not been established in individuals below 3 years of age.

Current available safety and immunogenicity data of Supemtek TIVr in children from 3 to less than 8 years of age are described in section 5.1 but no recommendation on a posology can be made.

Method of administration

For intramuscular injection only. The preferred site is in the deltoid muscle.

The vaccine must not be injected intravascularly and must not be mixed with other vaccines in the same syringe.

For instructions on the handling of the vaccine before administration, see section 6.6.

4.3. Contraindications

Hypersensitivity to the active substances, to any of the excipients listed in section 6.1 or to any trace residues such as octylphenol ethoxylate.

4.4. Special warnings and precautions for use

Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

Hypersensitivity and anaphylaxis

Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.

Concurrent illness

Vaccination should be postponed in patients with acute febrile illness until the fever is resolved.

Immunodeficiency

Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient to prevent influenza.

Thrombocytopenia and coagulation disorders

As with all injectable vaccines, Supemtek TIVr must be administered with caution to individuals with thrombocytopaenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects.

Syncope

Syncope 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. Procedures should be in place to prevent falling and injury and to manage syncope.

Protection

As with any vaccine, vaccination with Supemtek TIVr may not protect all vaccinees.

Excipients with known effect

Sodium content

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say is essentially “sodium free”.

Polysorbate 20 content

This medicine contains 0.0275 mg of polysorbate 20 (E432) in each 0.5 mL dose. Polysorbates may cause allergic reactions.

4.5. Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed, nor data to assess the concomitant administration of Supemtek TIVr with other vaccines.

If Supemtek TIVr is to be given at the same time as another injectable vaccine, the vaccines should always be administered at different injection sites.

4.6. Fertility, pregnancy and lactation

Pregnancy

A large amount of data on pregnant women (more than 14 500 pregnancy outcomes from a retrospective study), indicates no malformative nor foeto/neonatal toxicity of Quadrivalent Influenza Vaccine (recombinant, prepared in cell culture) (Supemtek) when administered during pregnancy.

One animal study performed with Supemtek TIVr did not indicate direct or indirect harmful effects with respect to pregnancy, embryo-foetal development or early post-natal development.

Supemtek TIVr can be used during pregnancy in accordance with official recommendations.

Breastfeeding

It is not known whether Supemtek TIVr vaccine is excreted in human milk.

An assessment of the risks and benefits should be performed by a health care professional before administering Supemtek TIVr to a breastfeeding woman.

Fertility

No human fertility data are available.

The animal study with Supemtek TIVr did not indicate harmful effects on female fertility.

4.7. Effects on ability to drive and use machines

Supemtek TIVr has no or negligible influence on the ability to drive and use machines. However, caution should be used when driving or using machines if the ability to react is reduced due to some of the effects mentioned under section 4.8.

4.8. Undesirable effects

Summary of the safety profile

Safety data for Supemtek TIVr are derived from the quadrivalent recombinant influenza vaccine (Supemtek) as both vaccines are manufactured using the same process and have overlapping compositions.

The most common adverse reactions occurring after vaccine administration were injection-site reactions (tenderness and pain) reported overall by 48% and 37% of study participants 18-49 years of age receiving Supemtek respectively. In study participants 50 years of age and older, injection site tenderness was reported by 34% and injection site pain reported by 19%.

In children/adolescents 9 to 17 years of age who received Supemtek, the most common injection-site adverse reaction was pain (34.4%). The most common systemic adverse reactions were myalgia (19.3%), headache (18.5%) and malaise (16.1%).

The severity of the adverse reactions was mild to moderate. Onset usually occurred within the first 3 days after vaccination. All resolved without sequelae.

Tabulated list of adverse reactions

The adverse reactions are listed by MedDRA system organ class under headings of frequency using the following convention:

Very common (≥1/10);

Common (≥1/100 to <1/10);

Uncommon (≥1/1 000 to <1/100);

Rare (≥1/10 000 to <1/1 000);

Very rare (<1/10 000);

Frequency not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.

Supemtek has been administered to and safety data collected from 998 adults 18-49 years of age (Study 1) and 4328 adults 50 years of age and older (Study 2), and from 658 adults 18-49 years of age (Study 4) and from 641 children/adolescents 9-17 years of age (Study 4).

Table 1: Adverse reactions reported following vaccination with quadrivalent recombinant influenza vaccine (Supemtek) in adults and children 9 years and older during clinical trials and post-marketing surveillance

MedDRA System Organ class

Very common

Common

Uncommon

Rare

Frequency not known

Immune system disorders

Hypersensitivity including anaphylactic reaction

Nervous system disorders

Headache, Malaise/Fatigue

Dizziness(4,6,8)

Guillain-Barré syndrome7

Respiratory, thoracic and mediastinal disorders

Asthma(5,6,10), Cough, Oropharyngeal pain(9), Rhinorrhoea(5,6)

Metabolism and nutrition disorders

Decreased Appetite(5,6)

Gastrointestinal disorders

Nausea(8)

Abdominal discomfort(5,6), Diarrhoea(4), Vomiting(5,6)

Skin and subcutaneous tissue disorders

Dermatitis(4,5,9), Pruritus(2,4,9), Rash(4,5,9)

Urticaria(4,6,9)

Musculoskeletal and connective tissue disorders

Myalgia(1), Arthralgia(1,9)

General disorders and administration site conditions

Local tenderness, Local pain/Injection site pain

Fever (2,3), Shivering(5,6)/Chills, Firmness(5,6)/ Swelling, Redness/Injection site erythema, Bruising(5,6), Induration(5,6)

Flu-like symptoms(4,6), Injection site pruritus(4), Rash(5,6)

(1) Reported as common in adults 50 years of age and older.

(2) Reported as rare in adults 50 years of age and older.

(3) ≥38.0°C.

(4) Reported as unsolicited adverse reaction.

(5) Not reported in adults 50 years of age and older.

(6) Not reported in adults 18-49 years of age.

(7) Reported from post-marketing surveillance.

(8) Reported as uncommon in children/adolescents 9 to 17 years of age.

(9) Not reported in children/adolescents 9 to 17 years of age.

(10) Reported in one participant of 9 to 17 years of age with pre-existing asthma who experienced an exacerbation. with onset on day 2, assessed by the investigator as related to vaccination.

Reporting of suspected adverse reactions

Reporting 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 Medicines and Healthcare products Regulatory Agency (MHRA), Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

No cases of overdose reported.