Imojev

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 sterile solution.
After reconstitution, IMOJEV is a colourless to amber suspension.
IMOJEV is a monovalent, live attenuated viral vaccine.
Active ingredients: Live, attenuated, recombinant Japanese encephalitis virus: 4.0-5.8 log PFU* per dose (0.5 mL).
*Plaque Forming Unit.
Excipients/Inactive Ingredients: Mannitol, lactose, glutamic acid, potassium hydroxide, histidine, Human Serum Albumin, sodium chloride and water for injections.
No adjuvant or microbial preservative is added.

Pharmacology: Pharmacodynamics: Mechanism of Action: The vaccine is a live attenuated virus. Following administration, the virus replicates locally and elicits neutralising antibodies and cell-mediated immune responses that are specific to the Japanese encephalitis virus. Available results indicate that protection is mainly mediated by neutralising antibodies.
In nonclinical studies, all animals that received a single dose of the vaccine developed specific neutralising antibodies against Japanese encephalitis virus and were protected against infection by a virulent Japanese encephalitis virus experimental challenge.
A single dose administration of IMOJEV is as immunogenic as a three-dose regimen of an inactivated Japanese encephalitis comparator vaccine administered in adults 18 years of age and over. A seroprotective level of antibodies is generally reached 14 days after vaccination.
In persons 9 months of age and over, a seroprotective level of antibodies is generally reached 28 days after vaccination.
Pharmacokinetics: Not applicable.

IMOJEV is indicated for prophylaxis of Japanese encephalitis caused by the Japanese encephalitis virus, in persons from 9 months of age and over.

Persons 9 months of age and over: one single dose of reconstituted IMOJEV 0.5 mL injection should be administered for primary immunization.
In children and adolescents up to 18 years of age, if along term protection* is required, one 0.5 mL dose of IMOJEV should be given as a booster dose after the first vaccination. The booster dose should be given preferably 1 year after the first vaccination and can be given up to 2 years after the first vaccination.
One 0.5 mL dose of IMOJEV can also be given as a booster vaccination in children who were previously given 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 regardless the vaccine used for first vaccination.
In adults, there is no need for a booster dose after 5 years after the administration of a single dose of IMOJEV.
Once the freeze-dried vaccine has been completely reconstituted using the diluent provided (see Instructions for use under Cautions for Usage), it is administered via the subcutaneous route.
In persons 2 years of age and over, the recommended injection site is the deltoid region of the upper arm.
In persons 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).
Contact with disinfectants is to be avoided since they may inactivate the vaccine virus.

Not documented.

IMOJEV should not be administered to anyone with a history of severe allergic reaction to any component of the vaccine or history of severe allergic reaction 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 for 14 days or more (see Precautions).
IMOJEV must not be administered to persons with symptomatic HIV infection or with asymptomatic HIV infection when accompanied by evidence of impaired immune function.
Pregnancy (see Use in Pregnancy under Use in Pregnancy & Lactation).
Lactation (see Use in Lactation under Use in Pregnancy & Lactation).

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.
IMOJEV should under no circumstances be administered intravascularly.
Effects on the Ability to Drive: No studies on the effects on the ability to drive or use machines have been performed.

Use in Pregnancy: 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 contraindication (see Contraindications).
Use in Lactation: 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 (see Contraindications).

Possible side effects: Like all medicines, IMOJEV can cause side effects, although not everybody gets them.
During clinical trials, the following side effects were reported with the use of IMOJEV.
Adults: Very common (more than 1 in 10 persons): Tiredness (fatigue), feeling unwell (malaise), injection site pain; Headache; Muscular pain (myalgia).
Common (more than 1 in 100 persons and less than 1 in 10 persons): Feeling hot, chills, injection site redness (erythema), injection site itching (pruritus), injection site swelling, injection site bruising; Dizziness; Joint pain (arthralgia); Diarrhoea, nausea, abdominal pain, vomiting; Throat pain (pharyngolaryngeal pain), shortness of breath (dyspnea), runny nose (rhinorrhoea), cough, wheezing, nasal congestion; Rash.
Uncommon (more than 1 in 1,000 persons and less than 1 in 100 persons): Fever (pyrexia).
Rare (more than 1 in 10,000 persons and less than 1 in 1,000 persons): Viral infections such as influenza-like illness.
Children: Very common (more than 1 in 10 persons): Fever (pyrexia), feeling unwell (malaise), irritability, injection site pain/tenderness, injection site redness (erythema); Headache, sleepiness (somnolence); Muscular pain (myalgia); Vomiting; Loss of appetite; Crying.
Common (more than 1 in 100 persons and less than 1 in 10 persons): Injection site swelling.
Uncommon (more than 1 in 1,000 persons and less than 1 in 100 persons): Injection site reactions (hardening of skin [induration], bruising, localised swelling filled with blood [haematoma], bleeding [haemorrhage]); Itchy rash (urticaria); Upper respiratory tract infection.
Rare (more than 1 in 10,000 persons and less than 1 in 1,000 persons): Injection site itching (pruritus); Rash, rash characterized by spot and bump (maculo-papular rash), changes in the colour of the skin after inflammatory reaction (post inflammatory pigmentation change); Viral infection.
No additional side effect has been identified since the vaccine came on the market.
If any of the side effects gets serious, or if patient notices any side effects not listed, tell the doctor or pharmacist.

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 as vaccines against measles, mumps, or rubella, 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 case of immunosuppressive therapy or corticosteroid therapy, refer to sections Contraindications and Precautions.
Administering the vaccine in persons who have previously received immunoglobulins: In order to avoid any neutralisation of the attenuated viruses contained in the vaccine, vaccination must 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.

Instructions for use: 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.
After use, any remaining vaccine and container must be disposed of safely, preferably by heat inactivation or incineration, according to locally agreed procedures.

Store in a refrigerator (2-8°C).
Do not freeze.
Keep the vials in the outer carton in order to protect from light.

Vaccines, Antisera & Immunologicals

J07BA03 - encephalitis, Japanese, live attenuated ; Belongs to the class of encephalitis viral vaccines.

Rx