Medicinal Products

ENCEPUR 1.5 micrograms / 0.5 mL

Generic drug of the therapeutic class: Infectiology - Parasitology
Active ingredients: Tick-borne encephalitis virus
laboratory: Novartis Vac. Diagn. Gmbh

Injectable suspension
Box of 1 pre-filled syringe with 0.5 mL needle
All forms

Indication

ENCEPUR is indicated for active immunization (prophylactic) against tick-borne encephalitis in adults and children from 12 years

ENCEPUR should be administered according to official recommendations defining the needs and timing of vaccination against tick-borne encephalitis.

Dosage ENCEPUR 1.5 micrograms / 0.5 mL Suspension for injection Box of 1 pre-filled syringe with 0.5 mL needle

Dosage

a) Diagram of primary vaccination

Classic scheme of vaccination:

Dose 1: (J0) 0.50 ml

Dose 2: (1 to 3 months after D0) 0.50 ml

Dose 3: (9 to 12 months after the second injection) 0.50 ml

The second injection can be advanced and administered 2 weeks after the first. The conventional scheme is to be used preferably for patients remaining at risk of infection. Seroconversion is usually given no earlier than 14 days after the second injection.

Reminder: When immunization is complete, the antibody titres are maintained for at least 3 years, the recommended recall date.

If rapid immunization is necessary, the 3 injections can be performed according to a shortened diagram:

Dose 1: (J0) 0.50 ml

Dose 2: (J7) 0.50 ml

Dose 3: (J21) 0.50 ml

Seroconversion is generally provided at the earliest 14 days after the second injection, that is to say at D21.

Reminder: When immunization is complete, antibody titers are maintained for at least 12 to 18 months, the recommended recall date.

In immunocompromised individuals or over 59 years old, antibody titres should be checked after the second dose (conventional vaccination) or after the third dose (rapid vaccination). If necessary a third dose may be considered.

b) Recall vaccination

Following a complete primary vaccination according to one of the two regimens, an injection of 0.5 ml of Encepur is sufficient to stimulate immunity.

Based on the results of long-term clinical trials of the persistence of immune protection, the following intervals should be observed for the booster dose according to the rapid vaccination schedule.

Rapid vaccination

1st booster dose

Next reminders

From 12 to 49 years old

Recommended 12 to 18 months after

Every 5 years

> 49 years

Recommended 12 to 18 months after

Every 5 years

Based on the results of long-term clinical trials of the persistence of immune protection, the following intervals should be observed for the booster dose according to the conventional vaccination schedule.

Conventional vaccination

1st booster dose

Next reminders

From 12 to 49 years old

After 3 years

Every 5 years

> 49 years

After 3 years

Every 3 years

Administration mode

This vaccine should be injected intramuscularly, preferably in the deltoid region.

If necessary, the vaccine can be administered subcutaneously in patients prone to hemorrhage.

Against indications

Hypersensitivity to the active substance, to any of the excipients, or to production residues (formaldehyde, chlortetracycline hydrochloride, gentamycin, neomycin).

Severe hypersensitivity to egg and chicken proteins (anaphylactic reaction after oral ingestion of egg protein).

Vaccination against tick-borne encephalitis should be postponed if the person has an acute febrile illness.

Adverse effects Encepur

Adverse reactions reported during clinical trials and post-marketing follow-up. are listed below in MedDRA terminology (organ system and frequency) for all age groups. Frequency is defined as: very common (≥ 10%); frequent (≥ 1% and <10%); uncommon (≥ 0.1% and <1%); rare (≥ 0.01% and <0.1%); very rare (<0.01%).

General disorders and administration site conditions

· Very common: transient pain at the injection site, malaise.

· Frequent:

o reaction at the injection site: erythema, edema;

o Influenza syndrome (sweating, tremors) more particularly reported after administration of the first vaccine dose and usually disappearing within 72 hours;

o fever> 38 ° C.

· Very rare: reaction at the injection site: granuloma.

Musculoskeletal and systemic disorders

· Very common: myalgia.

· Common: arthralgia.

· Rare: Arthalgia and cervical myalgia that can evoke meningitis during the few days following administration and disappear spontaneously without sequelae.

Blood and lymphatic system disorders

· Very rare:

o lymphadenopathies;

o transient thrombocytopenia

Gastrointestinal disorders

· Common: nausea

· Uncommon: vomiting.

· Very rare: diarrhea.

Nervous system disorders

· Very common: headache.

· Very rare:

o paresthesia;

o Isolated cases of central or peripheral nervous system disorders such as Guillain-Barré syndrome have been reported.

Immune system disorders

· Very rare: allergic reactions (generalized urticaria, mucosal edema, stridor, dyspnea, bronchospasm, hypotension and other circulatory disorders that may be accompanied by transient nonspecific disturbances of vision).

Clinical experience with this vaccine has not shown an increase in the frequency of primary symptoms of autoimmune diseases, although this possibility can not be completely ruled out. However, in the current state of knowledge, a certain link of causality between the vaccination and the risk of autoimmune diseases could not be demonstrated.

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