Mencevax Acwy instructions for use of the drug

Release form, packaging and composition of the drug Clinical-pharmacological group Pharmaco-therapeutic group Pharmacological action Indications for use Method of administration and doses Side effects Contraindications for use Use in children Special instructions Drug interactions

Registration Certificate Holder:

GlaxoSmithKline Trading, JSC (Russia)

ATX Code:

J07AH05

Active substance:

meningitis polysaccharide vaccine

Dosage form:

Mencevax Acwy

Release form, packaging and composition of the drug Mencevax Acwy

Lyophilisate for preparing a solution for subcutaneous injection

in the form of an amorphous mass or white powder; the attached solvent is transparent, colorless; the prepared solution is transparent, colorless.

Excipients

: lactose (filler).

Solvent:

0.9% sodium chloride solution - 0.5 ml.

The vaccine meets WHO requirements for biological products and meningococcal polysaccharide vaccines.

1 dose - glass bottles (1) complete with solvent (amp.) - cardboard boxes. 1 dose - glass bottles (1) complete with solvent (vial) - cardboard boxes. 1 dose - glass bottles (1) complete with solvent (glass syringes) and needles (1 or 2 pcs.) - blisters (1) - cardboard boxes.

Lyophilisate for preparing a solution for subcutaneous injection

in the form of an amorphous mass or white powder; the attached solvent is transparent, colorless or slightly pinkish in color, with a faint odor of phenol; the prepared solution is transparent, colorless.

Excipients

: lactose (filler).

Solvent:

0.9% sodium chloride solution containing 0.25% phenol (as a preservative) - 5 ml.

The vaccine meets WHO requirements for biological products and meningococcal polysaccharide vaccines.

10 doses - bottles (1) complete with solvent (vial) - cardboard boxes.

Possible adverse reactions

• Impairment of basal metabolism, leading to decreased appetite and weight loss
• Disturbance of the central nervous system is manifested by the following symptoms: increased excitability and irritability, drowsiness, frequent migraines, dizziness, possible fainting.
• Digestive system disorders are manifested by the following symptoms: nausea, single vomiting, bloating, diarrhea.
• Painful sensations in the muscles.
• Joint pain.
• Local reactions: swelling at the site of vaccine administration, fever, redness, pain.
• General reactions of the body: decreased activity, concentration and attention, fatigue.
• Allergic reactions: spotty rashes, urticaria, Quincke's edema, itching.

Adverse reactions vary, but do not entail serious consequences. Treatment depends on the severity of the reaction. Do not self-medicate under any circumstances, consult your family doctor and he will prescribe you medications depending on your symptoms.

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Drug overdose

When the Mencevax vaccine is used correctly and certain doses are administered, an overdose is excluded. In practice, there were such cases, but no significant violations on the part of organs and systems were observed. Changes can be observed, as in side effects.

Mencevax prevents the development of only certain strains of meningococcal infection.

There are a number of specific guidelines:

• In people with HIV or AIDS, or a weakened immune system due to other conditions, the vaccine may not be effective enough to develop active immunity.
• With repeated vaccination, a less persistent immune reaction is possible compared to the initial administration.
• People living in regions with a high probability of developing meningococcal disease are recommended to undergo repeated revaccination, based on data on the duration of the immune response to previous vaccinations.
• After the procedure, the patient should be under the supervision of a doctor for about an hour.
• Driving during the day is not recommended to prevent accidents, as dizziness and fainting are possible.

Cost of Mencevax ACWY

You can buy a vaccination kit at a pharmacy, or order it from a pharmacy warehouse with home delivery. The vaccine corresponds to the price-quality ratio. The price ranges from 3,500 to 6,000 thousand rubles, it depends on the place of purchase.

Meningococcal infection is a serious disease. If there is prevention of this disease, then it should not be neglected. The risks of death are very high due to untimely diagnosis of the disease, since clinical symptoms do not initially manifest themselves, and in the later stages, when the disease is in full swing, it is no longer possible to prevent them. The disease is especially severe in children, so their safety comes first.

Directions for use and doses

Mencevax ACWY is administered subcutaneously once.

1 immunizing dose = 0.5 ml of dissolved vaccine.

Rules for prepared solution for subcutaneous injection

Before use, the vaccine is dissolved with the supplied solvent at the rate of 0.5 ml per dose. Shake the bottle thoroughly until the contents are completely dissolved for 1 minute. The dissolved drug is a clear, colorless solution. If it looks different, or if there are foreign particles, the vaccine is not used. After diluting the lyophilisate with a solvent, the vaccine should be used immediately.

It is allowed to store the solution in a bottle containing 10 doses in the refrigerator for no more than 8 hours. The solution should be protected from direct sunlight.

A new sterile needle must be used to administer the drug. When using a vaccine in a multi-dose package, a new syringe and needle must be used to withdraw the drug each time. The dissolved drug in a multi-dose package should be used during the working day. The drug should be removed from the bottle with strict adherence to aseptic rules.

Under no circumstances should Mencevax ACWY vaccine be administered intravenously.

Mencevax

Vaccination schedule : Once for children over 2 years of age and adults.
Revaccination after 2 years. The Mencevax ACWY vaccine is a lyophilized preparation of purified polysaccharides of Neisseria meningitidis (meningococcus) serogroups A, C, W135 and Y. The Mencevax ACWY vaccine meets the WHO requirements for biological products and meningococcal vaccines.

Dosage form Lyophilisate for the preparation of a solution for subcutaneous administration, complete with a solvent.

Composition 0.5 ml (1 dose) of the dissolved vaccine contains 50 μg of each polysaccharide of serogroups A, C, W135 and Y.

Excipients: Vaccine: lactose. Solvent: 0.9% sterile sodium chloride solution contains 0.25% phenol as a preservative

Immunobiological properties The Mencevax ACWY vaccine causes the production of bactericidal antibodies against meningococci of serogroups A, C, W135 and Y.

Administration of one dose of 0.5 ml of the Mencevax ACWY vaccine causes the production of a significant amount of bactericidal antibodies against meningococcal serogroups A, C, W135 and Y in approximately 95% of immunized individuals. Polysaccharide A is known to be immunogenic in children over 6 months of age. The rate of seroconversion in children vaccinated before the age of 2 years is reduced for the polysaccharide antigen of serogroup C and, to a lesser extent, for the polysaccharide antigens of serogroups W135 and Y.

Indications Mencevax ACWY vaccine is indicated for the active immunization of adults and children aged 2 years against meningococcal meningitis caused by meningococcal serogroups A, C, W135 and Y. This vaccine is especially recommended for people who are at high risk of infection, such as those living in areas where the infection is endemic or highly endemic, or visits such areas. It is also recommended for persons living in closed communities or in contact with patients with meningitis caused by meningococci of serogroups A, C, W135 and Y.

Contraindications The Mencevax ACWY vaccine should not be administered to people with known hypersensitivity to any of its components, as well as to people who have shown signs of hypersensitivity after previous administrations of this vaccine.

Dosage and administration regimen One immunizing dose - 0.5 ml of dissolved vaccine.

Method of administration The Mencevax ACWY vaccine is intended for subcutaneous administration only. Under no circumstances should the Mencevax ACWY vaccine be administered intravenously.

Before use, the vaccine should be dissolved with the supplied solvent at the rate of 0.5 ml per dose. Shake the bottle thoroughly until the contents are completely dissolved. The dissolved drug is a clear, colorless solution. If it looks different, or if there are foreign particles, the vaccine is not used. A new sterile needle must be used to administer the drug. When using a vaccine in a multi-dose package, a new syringe and needle must be used to withdraw the drug each time. The drug must be removed from the vial under strict aseptic technique in order to prevent contamination.

Side effects Mencevax ACWY vaccine may cause erythema, mild induration, tenderness or pain at the injection site. It is extremely rare for vaccinated individuals to experience headache, general malaise, fever, allergic reactions, including anaphylactoid reactions, and drowsiness.

Interaction with other drugs The Mencevax ACWY vaccine can be administered simultaneously with other vaccines, and the drugs must be injected with different syringes into different parts of the body. The Mencevax ACWY vaccine cannot be mixed with other vaccines.

Special instructions As with the use of other vaccines, the administration of the Mencevax ACWY vaccine should be postponed in persons with acute severe febrile illness. However, mild infection is not a contraindication for immunization. Mencevax ACWY vaccine does not protect against meningococcal meningitis caused by meningococci belonging to serogroups other than A, C, W135 and Y. When administered to immunocompromised individuals, this vaccine may not produce an effective immune response. The seroconversion rate in children vaccinated before 2 years of age is reduced for serogroup C polysaccharide antigen and, to a lesser extent, for serogroup A, W135 and Y polysaccharide antigens. It should be noted, however, that the seroconversion rate for serogroup A polysaccharide antigen quite satisfactory in children aged 6 months and older. As with all injectable vaccines, you should always have supplies available to treat anaphylactic reactions that may occur after receiving the Mencevax ACWY vaccine. Vaccinated persons must be under medical supervision for 30 minutes after administration of the vaccine.

Pregnancy and lactation Currently, there is no data on the use of this vaccine in pregnant women, as well as data on its effect on the reproductive system of laboratory animals. Based on theoretical premises, one should refrain from administering the Mencevax ACWY vaccine to pregnant women, unless such women are at high risk of infection.

Release form

• 1 dose of vaccine in a vial along with 0.5 ml of solvent in an ampoule and instructions for use in a cardboard box.
• 1 dose of vaccine in a vial along with 0.5 ml of solvent in an ampoule in a plastic blister. 1 blister along with instructions for use in a cardboard box.
• 1 dose of vaccine in a vial along with 0.5 ml of solvent in a vial and instructions for use in a cardboard box.
• 1 dose of vaccine in a vial along with 0.5 ml of solvent in a glass syringe with 1 or 2 needles is packaged in a plastic blister. 1 blister along with instructions for use in a cardboard box.
• 1 dose of vaccine per vial. 100 bottles each along with instructions for use in a cardboard box.
• 0.5 ml of solvent per ampoule. 100 ampoules in a cardboard box.
• 10 doses of vaccine in a dark glass bottle. 50 bottles each along with instructions for use in a cardboard box.
• 5 ml of solvent in a bottle. 50 bottles in a cardboard box.

Storage conditions The vaccine is stored and transported at a temperature of 2° to 8°C. The solvent is stored and transported at temperatures from 2° to 25°C. Freezing is not allowed. After diluting the lyophilisate with a solvent, the vaccine should be used immediately. The solution can be stored in the refrigerator for no more than 8 hours. The solution should be protected from direct sunlight. Shelf life: 2 years.

special instructions

Mild infection is not a contraindication for immunization. Mencevax ACWY vaccine does not protect against meningococcal meningitis caused by meningococci belonging to serogroups other than A, C, W135 and Y. When administered to immunocompromised individuals, the vaccine may not produce an effective immune response. As with When administering all injectable vaccines, you should always have the necessary equipment and medications available to treat anaphylactic reactions that may occur after administration of Mencevax ACWY. Vaccinated persons should be under medical supervision for 30 minutes after administration of the vaccine.

Indications and contraindications

Indications for vaccination:

• For prophylactic purposes to prevent meningococcal infection. Applicable for children over two years of age, adolescents and adults.
• For persons who are in closed organized groups (children's groups, military units, factory shops, student dormitories)
• For people living in or visiting countries with an increased risk of developing the disease
• For medical staff working in purulent-septic departments of hospitals.

Contraindications are:

• Allergy to vaccine components, as well as a hypersensitive reaction to a previous administration of the drug.
• Acute diseases associated with an infectious agent in the peak stage, after treatment, vaccination can be carried out.
• Acute diseases not associated with an infectious agent.
• Chronic diseases in the form of exacerbation or in the stage of decompensation.
• At high temperatures of unknown origin.

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During pregnancy or breastfeeding, the Mencevax vaccine is used if its effectiveness outweighs the risk of functional and organic disorders in the fetus. But there is not enough data on the use of the ACWY vaccine to draw a conclusion about its effect on the condition of the fetus in the womb or the child during breastfeeding.