IMOJEV®

Abbreviated Prescribing Information

See local prescribing information for full details prior to prescribing

TRADE NAME OF MEDICINAL PRODUCT AND PRESENTATION

IMOJEV® contains Live, attenuated, recombinant Japanese encephalitis virus, Mannitol, Lactose monohydrate, Glutamic acid, Potassium Hydroxide, Histidine, Human Serum Albumin. Diluent : sodium chloride for diluent and water for injection. No adjuvant or antimicrobial preservative is added. Imojev is Powder and diluent for suspension for injection. The powder is a white to creamy white homogeneous cake which might be retracted from the sides of the vial.

The diluent is a clear solution. After reconstitution, IMOJEV® is a colourless to amber suspension.

THERAPEUTIC INDICATIONS

Imojev is indicated for prophylaxis of Japanese encephalitis caused by the Japanese

encephalitis virus, in subjects from 9 months of age and over.

POSOLOGY AND METHOD OF ADMINISTRATION

Posology

Primary Vaccination::

Subjects 9 months of age and over one 0.5 mL single injection of the reconstituted vaccine.

Booster

- Paediatric population

If a long term protection is required, one 0.5 mL dose of IMOJEV® should be given as a long booster dose after primary vaccination. The booster dose should be given preferably 12 months after primary vaccination and can be given up to 24 months after primary vaccination. One 0.5 mL dose of Imojev can also be given as a booster vaccination in children who were previously given an inactivated Japanese encephalitis vaccine for primary vaccination, in accordance with the recommended timing for the booster of the inactivated Japanese encephalitis vaccine.

*Immunity is maintained at a high level at least 4 years after the booster dose when the vaccine used for primary vaccination is JE-CV (Imojev)

- Adult population:

The need for and timing of a possible booster dose have not yet been determined.

Method of administration

Once the freeze-dried vaccine has been completely reconstituted using the diluent provided, it is administered via the subcutaneous route.

In subjects 2 years of age and over, the recommended injection site is the deltoid region of

the upper arm.

In subjects between 9 and 24 months of age, the recommended injection site is the anterolateral aspect of the thigh or the deltoid region.

Do not administer by intravascular injection

IMOJEV® must not be mixed with any other injectable vaccine(s) or medicinal product(s)

Instructions for reconstitution and administration

Using aseptic technique, IMOJEV® vaccine is reconstituted by injecting all the 0.4% sodium chloride solution into the vial of freeze-dried vaccine, using the syringe and one of the needles provided in the carton. The vial is gently swirled. After complete dissolution, a 0.5 ml dose of the reconstituted suspension is withdrawn into this same syringe. For injection, the syringe is fitted with the second needle provided in the package.

The product should be used once reconstituted.

CONTRAINDICATIONS

IMOJEV® should not be administered to anyone with a history of severe allergic reaction to any component of the vaccine or after previous administration of the vaccine or a vaccine

containing the same components or constituents.

Vaccination must be postponed in case of febrile or acute disease.

Congenital or acquired immune deficiency impairing cellular immunity, including immunosuppressive therapies such as chemotherapy, high doses of systemic corticosteroids given generally for 14 days or more.

IMOJEV® must not be administrated to persons with symptomatic HIV infection or with

asymptomatic HIV infection when accompanied by evidence of impaired immune function.

SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following administration of the vaccine. For patients following a treatment with high doses of systemic corticosteroids given for 14 days or more, it is advisable to wait for at least one month or more following the interruption of therapy before carrying out the vaccination until immune function has recovered. Do not administer by intravascular injection.

INTERACTIONS

Separate injection sites and separate syringes should be used when other vaccines are concomitantly administered with IMOJEV®.

From 12 months of age, IMOJEV may be administered at the same time with MMR vaccine. No studies on concomitant administration with vaccine against measles either stand alone or combined.

For children living in areas where risk for measles is high, IMOJEV® may be administered at the same time as measles vaccine, either stand alone or combined with mumps and/or rubella vaccines, from 9 months of age.

IMOJEV® may be administered to adults at the same time as yellow fever vaccine

In the case of immunosuppressive therapy or corticosteroid therapy see contraindication and special warning and precautions for use

Administering the vaccine in subjects who have previously received immunoglobulins:

In order to avoid any neutralisation of the attenuated viruses contained in the vaccine, vaccination must generally not be performed within 6 weeks, and preferably not within 3 months of injection of immunoglobulins or blood products containing immunoglobulins,

such as blood or plasma.

PREGNANCY AND LACTATION

Animal studies did not indicate direct or indirect harmful effects with respect to pregnancy,

embryo-foetal development, parturition or post-natal development

As with all live attenuated vaccines, pregnancy constitutes a contra-indication

Animal studies did not indicate direct or indirect harmful effects with respect to lactation. It is not known whether this vaccine is excreted in human milk.

IMOJEV® vaccination is contraindicated in breastfeeding women.

Animal studies did not indicate direct or indirect harmful effects with respect to female fertility. No fertility data are available in humans.

UNDESIRABLE EFFECTS

Data from clinical trials

In adult population: The most frequently reported systemic reactions after the administration of IMOJEV® vaccine were headache, fatigue, malaise and myalgia. All these reactions were as frequently reported as after the administration of the inactivated Japanese encephalitis comparator vaccine or a placebo.

The most frequently reported reaction at the injection site after the administration of IMOJEV® vaccine was injection site pain. All the injection site reactions were less frequently reported than after the administration of the inactivated Japanese encephalitis comparator vaccine and as frequently reported as after the administration of a placebo.

The following possibly related Adverse Events were reported during clinical trials within 30 days after vaccination:

General disorders and administration site conditions:

Very common: fatigue, malaise, injection site pain

Common: feeling hot, chills, injection site erythema, injection site pruritus, injection site swelling, injection site bruising

Nervous system disorders:

Very common: headache

Common: dizziness

Musculoskeletal and connective tissue disorders

Very common: myalgia

Common: arthralgia

Gastrointestinal disorder

Common: diarrhoea, nausea, abdominal pain, vomiting respiratory, thoracic and mediastinal disorders

Respiratory, thoracic and mediastinal disorders:

Common: pharyngolaryngeal pain, dyspnea, rhinorrhea, cough, wheezing, nasal congestion

Skin and subcutaneous tissue disorders

Common: rash

Data from clinical trials

In pediatric population

The most frequently reported systemic reactions were malaise, myalgia, fever and headache, and myalgia in children (2 to 5 years) previously immunized with a two-dose primary vaccination with an inactivated Japanese encephalitis vaccine; and irritability, appetite lost, crying and fever in infants and toddlers (9 to 24 months) nor previously immunized with a Japanese encephalitis vaccine.

The most frequently reported reactions at the injection site after the administration of IMOJEV® was injection site pain/tenderness and injection site erythema.

These adverse events observed during paediatric clinical trials were generally of mild intensity and of short duration. The onset of systemic reactions was generally seen within 3 days after immunisation.

The following related Adverse Events were reported during clinical trials within 28 days after vaccination:

General disorders and administration site conditions

Very common : Pyrexia, malaise, irritability, injection site pain/tenderness, injection site erythema

Common : Injection site swelling

Nervous system disorders

Very common : Headache, somnolence

Musculoskeletal and connective tissue disorders

Very common : Myalgia

Gastrointestinal disorders

Very common : Vomiting

Metabolism and nutrition disorders

Very common : Appetite loss

Psychiatric disorders

Very common : Crying

PHARMACODYNAMIC PROPERTIES

ATC code: J07BA03.

Presentation: Box, 1 vial + 1 vial of NaCl @ 0.5 mL + 1 syringe + 2 needles

Box, 10 vial @ 4 doses @ 0.5 mL + 10 vial of NaCl @ 2 mL

(DKI1541000144A1)

Date of revision: 10 July 2023 (based on BPOM approval 07 July 2023)

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