Meningococcal B Vaccine Bexsero

Meningococcal B Vaccine Bexsero View larger

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Bexsero is a vaccine against meningococcal B infections

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For warnings, precautions for use and cons-indications, see the manual of Bexsero.

Description Bexsero

Bexsero Meningococcal against invasive meningococcal serogroup B
Class
Inert vaccine
- Protein multicomponent
Adjuvant: Aluminium hydroxide
Form and presentation

Suspension for injection.

Opalescent white liquid suspension.

Composition of Bexsero

One dose (0.5 ml) contains:

1. Antigens

NHBA recombinant fusion protein (heparin-binding antigen) Neisseria meningitidis Group B, (1, 2): 50 micrograms
NadA recombinant protein (adhesin A) Neisseria meningitidis group B (1, 2): 50 micrograms
FHbp recombinant fusion protein (factor binding protein H) Neisseria meningitidis group B (1, 2): 50 micrograms
Outer membrane vesicle (OMV) of Neisseria meningitidis group B strain NZ98 / 254 measured as a proportion of the total protein containing the antigen PorA P1.4 (2): 25 micrograms

(1) produced in E. coli cells, the recombinant DNA
(2) adsorbed onto aluminum hydroxide (0.5mg Al3 +)
2. Other Products

Sodium chloride
Sucrose
Histidine
Water for injections

Indications

Bexsero is indicated for the active immunization of subjects from the age of 2 months against invasive disease caused by meningococcal group B Neisseria meningitidis

The impact of invasive disease in different age groups and epidemiologic variability of antigens of group B strains in different geographical areas must be taken into account during vaccination. See section Pharmacodynamics for information on protection against specific strains to group B. This vaccine should be used in accordance with official recommendations.

New: Opinion of the High Council of Public Health (10.25.13) on the place of Bexsero vaccine in the prevention of invasive meningococcal B.

Dosage Bexsero

The dosage includes primary and booster vaccination.

Please consult the manual to find the table Bexsero doses depending on age.

Administration mode

The vaccine is given by deep intramuscular injection, preferably in the anterolateral aspect of the thigh in infants or the deltoid muscle of the upper arm region in older subjects.
Separate injection sites must be used if more vaccines are administered simultaneously.
The vaccine must not be injected intravenously, subcutaneously or intradermally and should not be mixed with other vaccines in the same syringe.
For instructions on handling of the vaccine prior to administration, see the instructions for Bexsero.

Warnings on drugs

Warning, the drug is not a product like any other. Read the package leaflet before ordering. Do not leave medicines within reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.

Please tell your online pharmacist of current treatments to identify any incompatibilities. The order confirmation form contains a custom message field provided for this purpose.

Click here to find the instructions for this drug Bexsero on the website of the National Agency of Drug Safety and health products.

Pharmacovigilance Reporting an or effect (s) Adverse (s) bound (s) use of a medicament

VIDAL OF THE FAMILY

Bexsero

Vaccine against meningococcal infections

. Presentations . Composition . Indications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS (summary)

BEXSERO: suspension for injection IM ; 0.5 ml pre-filled syringe with needle.
Refunded at 65%. - price: 88,15 euro (s).
List I

Laboratory GlaxoSmithKline

COMPOSITION (summary)
p dose
Group B Neisseria meningitidis proteins (adsorbed on aluminum hydroxide) 175 μg

INDICATIONS (summary)
This vaccine is composed of fragments of meningococcus of group B. It contains no living organisms .
It is used in the prevention of invasive meningococcal B infections (mainly meningitis and septicemia).
WARNING (Contents)
This vaccine does not protect against meningitis due to other organisms other than the meningococcus of group B.
In case of high fever, acute illness, it is preferable to defer vaccination.
Kanamycin is used to make this vaccine. This antibiotic persists in minute amount in the injectable solution. In addition, the cap of the syringe may contain latex, theoretically capable of causing an allergic reaction in predisposed persons. If you have a history of allergy to one of these two substances, tell your doctor.
As with all vaccines , exceptional cases of severe allergic reactions have been reported; this risk justifies the need to carry out vaccination in a medical setting where emergency treatment can be undertaken without delay.
A malaise (fainting) can occur after any vaccination, and even before, especially in adolescents, in reaction to the stress of the sting. Tell your doctor if you experience any ailments during a vaccination.
As for all products injected intramuscularly, precautions are necessary in case of anticoagulant treatment or significant drop in blood platelets (risk of hematoma at the injection site).
DRUG INTERACTIONS (summary)
This vaccine can be injected on the same day as other vaccines, but changing the injection site. It should not be mixed with another injectable product in the same syringe.
PREGNANCY AND BREAST-FEEDING (summary)
This vaccine may be used in pregnant or nursing women if there is an immediate need for exposure to the disease.
DIRECTIONS FOR USE AND DOSAGE (summary)
Shake the suspension well before use, warm to room temperature if necessary. The injection should be done intramuscularly (in the upper arm in the child or adult, in the thigh in the infant).

Usual dosage:

  • Adult and child over 11 years: 2 injections at least 1 month apart.
  • Child 6 months to 10 years: 2 injections at least 2 months apart.
  • Infant from 2 to 5 months: 3 injections at least 1 month apart.
A booster dose is required for children under 2 years of age to provide prolonged protection.
TIPS (summary)
Febrile reactions due to vaccines can be controlled by taking paracetamol.
To maintain its effectiveness, this medication should be stored between + 2 ° C and + 8 ° C (the coldest part of the refrigerator). However, failure of the cold chain for a limited time (a few hours at room temperature below 25 ° C) should not be of any consequence. In practice, if necessary, a few hours can separate the purchase of the vaccine from pharmacy from its storage in the refrigerator or vaccination.
This vaccine should not be frozen.
POSSIBLE ADVERSE EFFECTS (summary)
Injection site reaction: pain, redness, swelling or pressure sensitivity.
For infants and children under 10 years of age:
  • very common: unusual crying, drowsiness, loss of appetite, diarrhea, vomiting, irritability, rash, fever;
  • rarely: Kawasaki syndrome (which can result in fever, rash, swelling of the hands and feet, lymph nodes).
Most commonly in adults and adolescents over 11 years of age: nausea, muscle or joint pain, headache, malaise.


GLOSSARY (summary)


antecedent
Affection healed or always in evolution. The antecedent may be personal or family. The background is the history of a person's health.


anticoagulant
Medication that prevents blood from coagulating and therefore prevents clots from forming in the blood vessels.
Anticoagulants are used to treat or prevent phlebitis, pulmonary embolism, certain infarcts. They also prevent the formation of clots in the heart during rhythm disorders such as atrial fibrillation or in the case of an artificial heart valve.
There are two main types of anticoagulants:
  • oral anticoagulants, which block the action of vitamin K (antivitamin K, or AVK) and whose effectiveness is controlled by a blood test: INR (formerly TP);
  • injectable anticoagulants derived from heparin, the efficacy of which can be controlled by the blood assay of anti-Xa activity, Howell's Time (TH) or Cephalin Kaolin Time (TCK) depending on the products used. A regular dosage of blood platelets is necessary throughout the life of a heparin derivative.


germ
A general term that refers to all microscopic organisms likely to cause infection: bacteria, viruses, parasites, fungi.


IM
Abbreviation for intramuscular. See this term.


intramuscular
route or injectionInjection of a drug into a muscle, usually at the buttock. The effect of the drug, which only gradually passes into the bloodstream, is delayed but prolonged. A good prior disinfection of the skin is necessary, because this deep injection exposes to a risk of abscess. The pain caused by the bite depends mainly on the nature of the product used. This route of administration is contraindicated in hemophiliacs and in people undergoing anticoagulant therapy because it exposes them to a risk of hematoma of the buttock.
Abbreviation: IM.


meningitis
Inflammation due most often to an infection of the outer envelopes of the brain called meninges. Meningitis may be due to a virus; their evolution is usually favorable. Some bacteria, such as meningococcus, Haemophilus influenzae type b, may be responsible for severe meningitis that may leave sequelae. One should think of meningitis in the case of a permanent headache with nausea, a high fever and an unusual state of prostration in a child: urgent medical examination is then necessary. Fortunately, in most cases, it is a commonplace flu.


allergic reactions
Reaction due to hypersensitivity of the organism to a drug. Allergic reactions can take a wide variety of aspects: urticaria, angioedema, eczema, eruption of pimples resembling measles, etc. Anaphylactic shock is a generalized allergic reaction that causes discomfort due to a sudden drop in blood pressure.


vaccine
An injectable solution for immunizing the organism against a virus or bacterium.
There are several kinds of vaccines:
  • Live attenuated vaccines: the germ contained in the vaccine is alive but unable to cause the disease (BCG, measles, rubella, mumps, etc.).
  • Vaccines prepared from killed germs: the most immunizing parts of the virus or bacteria are used to prepare the vaccine (polio vaccines, hepatitis vaccines, etc.).
  • Vaccines containing neutralized (inactivated) toxins: in the case of tetanus, it is a toxin secreted by the germ that is responsible for the severity of the disease; the vaccine allows immunization against this toxin.

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