Description
Release form
Solution for intramuscular administration.
Packaging
bottle 0.5 ml.
Pharmacological action
Combined preparation containing B vitamins and lidocaine.
Neurotropic B vitamins have a beneficial effect on inflammatory and degenerative diseases of the nerves and the motor apparatus. They are not used to eliminate deficient conditions, but in high doses they have analgesic properties, enhance blood flow, normalize the nervous system and the process of hematopoiesis (vitamin B12).
Thiamine (Vitamin B1) plays a key role in carbohydrate metabolism, which is crucial in the metabolic processes of nerve tissue, as well as in the Krebs cycle, with subsequent participation in the synthesis of thiamine pyrophosphate and ATP. Pyridoxine (vitamin B6) is involved in the metabolism of proteins, and partly in the metabolism of carbohydrates and fats. The physiological function of both vitamins (B1 and B6) is the potentiation of each other s actions, manifested in a positive effect on the nervous, neuromuscular and cardiovascular systems.
Cyanocobalamin (vitamin B12) is involved in the synthesis of the myelin sheath, stimulates hematopoiesis, reduces pain associated with damage to the peripheral nervous system, and stimulates nucleic acid metabolism via activation of folic acid.
Lidocaine – a local anesthetic, causes all types of local anesthesia.
Indications
– prevention of invasive meningococcal infection caused by N. meningitidis serogroups A, C, Y and W-135 in people aged 2 years to 55 years.
Use during pregnancy and lactation
Animal studies have not revealed a negative effect of Menactra vaccine on pregnancy and feto-fetal development of the fetus, childbirth and postnatal development. Due to the fact that vaccine studies in pregnant women have not been conducted, and the post-marketing experience with its use is limited, The introduction of a vaccine to pregnant women is recommended only if absolutely necessary, such as during an outbreak of meningococcal infection, before traveling to an endemic area, and only after assessing the ratio of benefit and risk of vaccination. It is currently unknown whether the active ingredients in the vaccine are able to pass into breast milk. However, it was previously shown that antibodies to polysaccharides are found in young mice that were breast-fed.
In studies in mice, there was no adverse effect on the postnatal development of offspring receiving maternal antibodies with milk and the production of which was induced by the introduction of Menactra vaccine. At the same time, the effects in children of the first year of life whose mothers were immunized with Menactra vaccine during breastfeeding, not investigated. Before deciding to immunize a nursing woman, it is necessary to assess the risks and benefits of this immunization.
Special instructions
Vaccination is especially indicated for the following groups at high risk for meningococcal infection:
– for people who have had direct contact with patients infected with serogroup A, C meningococci, Y or W-135 (in the family or in closed institutions)
– for people with deficiency of sperlkp and complement components and
complement components – for people with functional or anatomical asplenia
– for tourists and people traveling to areas that are hyperendemic for meningococcal infection, such as Africa, Sub-Saharan
– employees of research, industrial and clinical laboratories who are regularly exposed to N. meningitidis, which are in solutions capable of forming
aerosol – for students of various universities, and especially after living constituents in dormitories in hotels or apartment type
– recruits and recruits.
It is forbidden to administer the Menactra vaccine intravenously, subcutaneously or intradermally, since data on the safety and effectiveness of the vaccine for subcutaneous intravenous and intradermal administration are absent.
Do not mix Menactra vaccine in the same syringe with other vaccines or drugs.
The use of the vaccine in patients with thrombocytopenia or blood clotting disorders has not been studied. As with other vaccines administered intramuscularly, the benefit-risk ratio of the vaccine should be evaluated in individuals with an increased risk of bleeding during intramuscular injection.
The risk of developing Guillain-Barr © Syndrome (GBS) after Menactra vaccination was evaluated in a post-marketing retrospective cohort study. Cases of GBS development, characterized by the presence of a time relationship with the introduction of Menactra vaccine, are described. Persons who have previously been diagnosed with GBS may be at increased risk for developing this condition after the administration of Menactra vaccine. The decision to use the Menactra vaccine in this situation should be made after assessing the potential benefits and risks.
The vaccine is not intended for the prevention of meningitis caused by other microorganisms or for the prevention of invasive meningococcal infection caused by meningococcal serogroup B.
In individuals with impaired immune status, as well as during immunosuppressive therapy, a reduced immune response to the introduction of Menactra vaccine may be observed.
As with any vaccination, not all 100% vaccinated can have protective immunity.
Before using the vaccine, the healthcare provider or attending physician must inform the patient, his parents, guardians, or other responsible adults about the possible benefits and risks to the patient associated with the vaccine.
Influence on the ability to drive vehicles and control mechanisms
No studies have been conducted to examine the effect of the vaccine on the ability to drive cars and other mechanisms.
Composition
1 dose (0. 5 ml)
monovalent meningococcal conjugates polysaccharides Neisseria meningitidis serogroup A * 4 g
monovalent meningococcal conjugates polysaccharides Neisseria meningitidis serogroup C * 4 ug
monovalent meningococcal conjugates polysaccharides Neisseria meningitidis serogroup Y * 4 ug
monovalent meningococcal conjugates polysaccharides Neisseria meningitidis serogroup W-135 * 4 mcg
* each polysaccharide is conjugated to diphtheria toxoid. The inoculated dose of diphtheria toxoid protein is about 48 mcg.
Excipients: sodium chloride – 4.35 mg, sodium hydrogen phosphate – 0.348 mg, sodium dihydrogen phosphate monohydrate – 0.352 mg, water d / i – up to 0.5 ml.
Dosage and administration
Vaccination is carried out once in a dose of 0.5 ml.
The vaccine should be administered intramuscularly, preferably into the deltoid muscle of the shoulder.
Precautions for use
Before the vaccine is introduced, the necessary precautions must be taken to prevent serious adverse reactions, which include studying the patient’s vaccination history, elucidation of contraindications for immunization and assessment of the patient s current state of health
The vaccine is administered under the supervision of a medical professional, and in the office where the vaccination is carried out, the necessary means of anti-shock therapy should be available (for example, solutions of epinephrine hydrochloride (1: 1000) and glucocorticosteroids for injection).
Fainting has been reported after the administration of Menactra vaccine. It is necessary to provide measures to prevent injuries associated with fainting, as well as medical care in connection with fainting.
Side effects
The nature and frequency of the side effects identified in the studies varied depending on the age of the vaccinees. In clinical trials, in children aged 2 to 10 years, pain and redness at the injection site, irritability, diarrhea, drowsiness, anorexia in adolescents from 11 to 18 years old and in adults from 18 to 55 years were most often observed soreness at the injection site, headache and increased fatigue. The incidence of the following side effects is classified according to the recommendations of the World Health Organization (WHO) and includes the following categories: very often:? 10% often:? 1% and <10% infrequently:? 0.1% and <1% rarely:? 0 01% and <0.1% are very rare: <0.01% the frequency is unknown: cannot be determined according to available data. Children 2 to 10 years old Most of the reported local and general reactions observed 7 days after vaccination were mild. In addition, the following disorders were noted: From the side of metabolism and nutrition Very often or often: decreased appetite From the nervous system Very often or often: drowsiness From the gastrointestinal tract Very often: diarrhea Often: vomiting From skin and subcutaneous tissue Often: rash, urticaria From the musculoskeletal and connective tissue Often: arthralgia General disorders and disorders at the injection site Very often: pain and tightness at the injection site Very often or often: irritability, redness at the injection site, swelling at the injection site, fever Persons aged 11-55 years Most of the recorded local and general reactions observed within 7 days after vaccination, were light. In addition, the following disorders were noted: From the side of metabolism and nutrition Very often or often: decreased appetite From the nervous system Very often: headache From the gastrointestinal tract Very often or often: diarrhea Often: vomiting Co sides of the skin and subcutaneous tissue Often: rash From the musculoskeletal and connective tissue Very often: arthralgia General disorders and disorders at the injection site Very often: pain, tightness, redness and swelling at the injection site, increased fatigue, general malaise Often: chills, fever In the post-marking period, additional information was received on the following adverse events after administration of the drug (currently the frequency of development of these phenomena and their causal relationship with the use of Menactra vaccine cannot be determined): On the part of the immune system Hypersensitivity reactions, such as anaphylactic shock, anaphylactoid reactions, stridor respiration, difficulty in Haniyeh, edema of the upper respiratory tract, urticaria, skin redness, itching. lowering blood pressure. From the nervous system Guillain-Barré Syndrome (GBS). paresthesia, loss of consciousness (due to dysregulation of the autonomic nervous system), dizziness, convulsions, facial paralysis, acute disseminated encephalomyelitis, transverse myelitis. From the musculoskeletal and connective tissue myalgia Post-marketing study The risk of GBS after the Menactra vaccine was assessed as part of a retrospective cohort study in the United States that used an electronic health care database of 9 578 688 patients aged 11-18, of which 1,431,906 (15%) received Menactra vaccine. None of the patients described in 72 reports of medically confirmed cases of GBS received the Menactra vaccine within 42 days before the onset of symptoms. Another 129 potential cases of GBS were not medically confirmed or were excluded from the analysis due to lack or insufficiency of medical information. As part of the analysis, taking into account the missing data, the estimated additional risk of GBS varied from 0 to 5 additional cases of GBS per 1,000,000 vaccinated within 6 weeks after vaccination. Drug Interactions The Menactra vaccine was used simultaneously with the polysaccharide vaccine for the prevention of typhoid fever and with an adsorbed vaccine containing tetanus and diphtheria toxoids intended for use in adults (Td) in people aged 18-55 years and 11-17 years old, respectively. BCG vaccine should not be used concomitantly with Menactra vaccine. Vaccines must always be administered to different parts of the body using separate syringes for each of them. Storage Conditions At 2 to 8 ° C. Do not freeze. Keep out of reach of children. Freezing drug should not be used. Expiration 2 years. Active ingredient Vaccine for the prevention of diphtheria, pertussis, poliomyelitis, Y and W-135) was conjugated to diphtheria toxoid lekarstvennaja form Solution for Sanofi Pasteur S.A., France
