Medicinal Products

ENGERIX B 20 micrograms / 1 mL

Generic drug of the therapeutic class: Infectiology - Parasitology
Active ingredients: Hepatitis B surface antigen
laboratory: Glaxosmithkline

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

Indication

ENGERIX B is indicated for active immunization against infection with hepatitis B virus (HBV) caused by all known subtypes in non-immunized subjects. The populations to be immunized are determined on the basis of official recommendations.

The occurrence of hepatitis D should be prevented by immunization with ENGERIX B, since hepatitis D (caused by the delta virus) does not occur in the absence of infection with hepatitis B virus. .

Dosage ENGERIX B 20 micrograms / 1 mL Suspension for injection Box of 1 pre-filled syringe of 1 mL

Dosage

dosage

ENGERIX B 20 micrograms / 1 ml is for subjects aged 16 and over.

ENGERIX B 10 micrograms / 0.5 ml is for subjects up to and including 15 years old.

However, in subjects aged between 11 and 15 years, ENGERIX B 20 micrograms / 1 ml can also be used, with a 2-dose regimen, in cases where there is only a small risk of infection with the virus. hepatitis B during the vaccination period and if adherence to the complete vaccination schedule can be ensured (see below and section on Pharmacodynamic properties ).

Primary vaccination schedule

· Subjects aged 16 and over:

Two primary vaccination schedules may be proposed:

A schematic, with injection at 0, 1, and 6 months which confers an optimal protection to the 7 th month and produces a high concentration of antibody.

An accelerated schema, with injection at 0, 1 and 2 months, which confers a faster protection, and must allow a better compliance of the subject. With this scheme, a fourth dose should be given at the 12th month to provide long-term protection since the antibody concentration after the 3rd dose is lower than that obtained with the 0, 1 and 6 month pattern.

· Subjects aged 18 and over:

In exceptional circumstances, when even more rapid immunity is needed, such as for a traveler traveling to areas of high endemicity, and starting a vaccination schedule for hepatitis B in the month prior to departure, a 3 intramuscular injections at 0, 7 and 21 days may be proposed. When this regimen is applied, a booster dose is recommended 12 months after the first injection.

· Subjects aged 11 to 15 years old included:

In subjects aged between 11 and 15 years, ENGERIX B 20 micrograms / 1 ml can be administered in a 0, 6 months schedule. However, in this case, protection against hepatitis B may only be obtained after the second dose (see section 5.1 ). Thus, this scheme should be used only when the risk of hepatitis B virus infection during the vaccination period is low and when compliance with the 2-injection regimen can be assured. If these two conditions can not be met (eg hemodialysis patients, travelers in endemic areas and persons in close contact with infected subjects), the 3-dose or accelerated schedule with ENGERIX B 10 micrograms / 0.5 ml should be used. to be used.

· Patients with renal impairment including hemodialysis patients 16 years of age and older:

The primary vaccination schedule for patients with renal impairment including hemodialysis patients is four double doses (2 x 20 micrograms) at 0, 1, 2 and 6 months after the first dose. The immunization schedule must be adapted to ensure an anti-HBs antibody concentration greater than or equal to the allowed protective level of 10 IU / l.

· Existing or suspected exposure to hepatitis B virus:

In circumstances where exposure to the hepatitis B virus is recent (for example, puncture with a contaminated needle), the first dose of ENGERIX B may be administered concomitantly with hepatitis B immunoglobulins, which, however, must be administered at a separate injection site (see section Interactions with other medicinal products and other forms of interaction ). The primary vaccination schedule of 0, 1, 2 and 12 months should be preferred.

These immunization patterns can be adapted to take into account national policy recommendations.

Recall

Current data do not warrant the need for a booster dose in healthy subjects who have received a complete primary vaccination regimen (Lancet 2000, 355: 561). However, in immunocompromised subjects such as patients with renal insufficiency, hemodialysis patients or HIV positive patients, reminders should be administered to maintain an anti-HBs antibody concentration greater than or equal to the allowed protective level of 10 IU / l. For these immunocompromised individuals, it is recommended to monitor the post-vaccination status every 6-12 months.

National recommendations for booster vaccination should be considered.

Interchangeability of hepatitis B vaccines:

See section Interactions with other drugs and other forms of interaction . "Interactions with other drugs and other forms of interaction".

Administration mode

ENGERIX B is to be injected intramuscularly in the deltoid region.

Exceptionally, the vaccine may be administered subcutaneously in patients with thrombocytopenia or in patients prone to hemorrhage.

Against indications

ENGERIX B should not be administered to subjects with hypersensitivity to the active substance or to any of the excipients listed in the Composition section or to subjects who have had evidence of hypersensitivity with previous administration of ENGERIX B.

As with other vaccines, administration of ENGERIX B should be delayed in subjects with acute severe febrile illness. The presence of a minor infection is not a contraindication to vaccination.

Adverse effects Engerix B

The current formulation of ENGERIX B does not contain thiomersal (an organomercuric compound).

The following adverse reactions have been reported following the use of the vaccine formulation with or without thiomersal.

· Clinical trials

In a clinical study conducted with the current formulation (formulation without thiomersal), the incidence of pain, redness, swelling, fatigue, gastroenteritis, headache and fever was comparable to that seen in clinical trials with previous formulations of vaccine containing thiomersal.

The safety profile presented below is based on data from 5329 subjects followed in 23 studies.

The frequencies per dose are defined as follows:

Very common: (> 1/10)

Frequent: (> 1/100 and <1/10)

Uncommon: (> 1/1000 and <1/100)

Rare: (> 1/10 000 and <1/1000)

Very rare: (<1 / 10, 000)

In each frequency group the adverse effects are presented in decreasing order of severity.

Blood and lymphatic system disorders

Rare: lymphadenopathy.

Nervous system disorders

Frequent: drowsiness, headache

Uncommon: dizzying sensations.

Rare: paresthesia.

Gastrointestinal disorders

Common: gastrointestinal symptoms (such as nausea, vomiting, diarrhea, abdominal pain)

Skin and subcutaneous tissue disorders

Rare: hives, pruritus, rash.

Musculoskeletal and systemic disorders

Uncommon: myalgia.

Rare: arthralgia.

Metabolism and nutrition disorders

Common: loss of appetite

General disorders and administration site conditions

Very common: pain and redness at the injection site, fatigue.

Common: fever (37.5 ° C), malaise, swelling at the injection site, injection site reactions (such as induration).

Uncommon: flu-like syndrome.

Psychiatric disorders

Very common: irritability.

A comparative trial in subjects aged 11 to 15 years included showed that the incidence of local and general solicited symptoms reported with a two-dose schedule of ENGERIX B 20 micrograms / 1 ml was similar to that reported with a three-fold regimen. doses of ENGERIX B 10 micrograms / 0.5 ml.

· Post marketing surveillance

Blood and lymphatic system disorders

Thrombocytopenia.

Nervous system disorders

Encephalitis, encephalopathy, convulsions, paralysis, neuritis (including Guillain-Barré syndrome, optic neuritis, multiple sclerosis), neuropathy, hypoaesthesia.

Skin and subcutaneous tissue disorders

Erythema multiforme, angioedema, lichen planus.

Musculoskeletal and systemic disorders

Arthritis, muscle weakness.

Infections and infestations

Meningitis.

Vascular disorders

Vasculitis, hypotension.

Immune system disorders

Anaphylaxis, allergic reactions including anaphylactoid reactions and pseudo serum sickness.

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