VAXIGRIPTETRA SH

Abbreviated prescribing information

See local prescribing information for full details prior to prescribing

1. TRADE NAME OF THE MEDICINAL PRODUCT AND PRESENTATION

VaxigripTetra SH is suspension for injection in pre-filled syringe of 0.5 ml that contains

A/Sydney/5/2021 (H1N1)pdm09-like virus (A/Sydney/5/2021, SAN-013); A/Darwin/9/2021 (H3N2)-like virus (A/Darwin/9/2021, IVR-228); B/Austria/1359417/2021-like virus (B/Michigan/01/2021, wild type); B/Phuket/3073/2013 - like virus (B/Phuket/3073/2013, wild type). The other components include the following: buffer solution containing sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate, water for injections.

The vaccine complies with W.H.O recommendations (Southern Hemisphere) for the 2023 season.

2. THERAPEUTIC INDICATION

VaxigripTetra NH is indicated for the prevention of influenza disease caused by the two influenza A virus subtypes and the two influenza B virus types contained in the vaccine for:

- active immunisation of adults, including pregnant women, and children from 6 months of age.

- passive protection of infant(s) from birth to less than 6 months of age following vaccination of pregnant women (see Sections posology and method of administration; Special warnings and precautions for use; Fertility, pregnancy and lactation and Pharmacodynamic properties – clinical trials).

The use of VaxigripTetra NH should be based on official recommendations.

3. POSOLOGY AND METHOD OF ADMINISTRATION

Posology:

Adults: one dose of 0.5 ml.

Paediatric population

• Children from 6 months to 17 years of age: one dose of 0.5 ml.

For children less than 9 years of age who have not previously been vaccinated, a second dose of 0.5 ml should be given after an interval of at least 4 weeks.

• Infants younger than 6 months of age: No data are available regarding the safety and efficacy of VaxigripTetra NH administration (active immunisation) in infants younger than 6 months of age.

Regarding passive protection, one 0.5-ml dose given to pregnant women may protect infants from birth to less than 6 months of age; however not all these infants will be protected (see Section Pharmacodynamic properties – clinical trials).

Method of administration:

Intramuscular or subcutaneous injection. The preferred site for intramuscular injection is the anterolateral aspect of the thigh (or the deltoid muscle if muscle mass is adequate) in children 6 months through 35 months of age, or the deltoid muscle in children from 36 months of age and adults.

4. CONTRA-INDICATIONS

Hypersensitivity to the active substances, to any of the excipients listed in section List of Excipients or to any component that may be present as traces such as eggs (ovalbumin, chicken proteins), neomycin, formaldehyde and octoxinol-9.

Vaccination should be postponed in case of moderate or severe febrile disease or acute disease.

5. SPECIAL WARNING AND PRECAUTIONS FOR USE

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine.

VaxigripTetra SH should under no circumstances be administered intravascularly.

As with other vaccines administered intramuscularly, the vaccine should be administered with caution to subjects with thrombocytopaenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects.

Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. Procedures should be in place to prevent injury from fainting and manage syncopal reactions.

VaxigripTetra SH is intended to provide protection against those strains of influenza virus from which the vaccine is prepared.

As with any vaccine, vaccination with VaxigripTetra SH may not protect all vaccinees. Regarding passive protection, not all infants younger than 6 months of age born to women vaccinated during pregnancy will be protected (see Section Pharmacodynamic properties – clinical trials).

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

6. INTERACTIONS

No interaction studies have been performed with VaxigripTetra SH.

VaxigripTetra SH can be given at the same time as other vaccines, based on clinical experience with Vaxigrip. Separate injection sites and separate needles should be used in case of concomitant administration.

The immunological response may be reduced if the patient is undergoing immunosuppressant treatment.

Following influenza vaccination, false positive results in serology tests using the ELISA method to detect antibodies against HIV1, Hepatitis C and especially HTLV1 have been observed. The Western Blot technique disproves the false-positive ELISA test results. The transient false positive results could be due to the IgM response by the vaccine

7. PREGNANCY AND LACTATION

Pregnancy

VaxigripTetra NH can be administered in all stages of pregnancy based on the safety data from clinical studies and post-marketing experience. Because of the known adverse consequences of influenza infection in pregnant women, health authorities recommend vaccination of pregnant women.

Breastfeeding

There are no data on the use of VaxigripTetra SH in breastfeeding women.

Based on experience with inactivated influenza vaccines, VaxigripTetra NH may be used during breastfeeding

Fertility There are no fertility data available in Humans. One animal study with VaxigripTetra SH did not indicate harmful effects on female fertility

8. UNDESIRABLE EFFECTS

Adults and elderly

Nervous system disorders

Very common: headache

Musculoskeletal and connective tissue disorders

Very common: myalgia

General disorders and administration site conditions

Very common: malaise, injection site pain

Common: shivering, fever, injection site erythema, injection site swelling, injection site induration

Pediatric population

Nervous system disorders

Very common: headache

Musculoskeletal and connective tissue disorders

Very common: myalgia

General disorders and administration site conditions

Very common: malaise, shivering, injection site pain, injection site swelling, injection site erythema, injection site induration

Common: fever, injection site ecchymosis

Children from 6 to 35 months

Nervous system disorders

Very common: headache

Gastrointestinal disorders

Very common : vomiting

Musculoskeletal and connective tissue disorders

Very common : Myalgia

General disorders and administration site conditions

Very common : Irritability, appetite lost, abnormal crying, malaise, fever,

drowsiness, injection site pain/tenderness, injection site erythema Common : Shivering, injection site induration, injection site swelling, injection site

ecchymosis

For uncommon, rare and very rare side effects see full prescribing information

Pregnant women

In clinical studies conducted in pregnant women in South Africa and Mali with Vaxigrip (TIV), frequencies of local and systemic solicited reactions reported within 7 days following administration of Vaxigrip, were generally consistent with those reported for the adult population during clinical studies conducted with Vaxigrip; In the study conducted in South Africa, local reactions were more frequent in the Vaxigrip group than in the placebo group in both HIV-negative and HIV-positive cohorts.

There were no other significant differences in solicited reactions between Vaxigrip and placebo groups in both cohorts.

In one clinical study conducted in pregnant women in Finland with VaxigripTetra NH, frequencies of local and systemic solicited reactions reported within 7 days following administration of VaxigripTetra NH were consistent with those reported for the non-pregnant adult population during clinical studies conducted with VaxigripTetra NH even though higher for some adverse reactions (injection site pain, malaise, shivering, headache, myalgia). When higher frequencies were observed, this increase was also seen with Vaxigrip (TIV), used as comparator, suggesting a clinical study effect in this pregnant women population.

9. OVERDOSE

Cases of administration of more than the recommended dose (overdose) have been reported with VaxigripTetra NH. When adverse reactions were reported, the information was consistent with the known safety profile of VaxigripTetra NH described in Section Undesirable effects

10. PHARMACODYNAMICS PROPERTIES

ATC code: J07BB02

Presentation: Box, 1 prefilled syringe 0,5 ml Reg No. DKI2059703543A1

Date of revision: 14 June 2023 (based on BPOM approval on 02 June 2023)

This information is intended for Health Care Professional only. See local product information for full details information