Priorix lyophilized powder for injection 1 dose single-dose vial with solvent in a syringe + 2 needles




The Priorix™ vaccine is indicated for active immunization to prevent measles, mumps, and rubella.
Composition
Active ingredients: Measles, Mumps, Rubella vaccine. One dose of reconstituted vaccine, 0.5 ml, contains:
not less than 10 3.0 TCD50 of live attenuated measles virus (Schwarz strain); not less than 10 3.7 TCD50 of live attenuated mumps virus (RIT 4385 strain); not less than 10 3.0 TCD50 of live attenuated rubella virus (Wistar RA 27/3 strain).Excipients: amino acids, anhydrous lactose, mannitol, sorbitol.
Solvent - water for injections.
Neomycin sulfate is present as a residue from the manufacturing process.
Contraindication
The Priorix™ vaccine is contraindicated:
persons with increased systemic sensitivity to neomycin or any other component of the vaccine (however, previous contact dermatitis to neomycin is not a contraindication); persons with signs of hypersensitivity after previous administration of measles, mumps and/or rubella vaccine; persons with severe humoral or cellular immunodeficiency (primary or acquired), for example, with severe combined immunodeficiency, agammaglobulinemia and AIDS or symptomatic HIV infection or age-related percentage of CD4 + T-lymphocytes in children under 12 months: CD4 + <25%; aged 12-35 months: CD4 + <20%; aged 36-59 months: CD4 + <15%; pregnant women (pregnancy should be avoided for at least one month after vaccination); As with other vaccines, the administration of Priorix™ should be postponed for individuals with fever (however, the presence of minor infections such as a cold should not lead to the postponement of vaccination).Method of application
A single dose of reconstituted vaccine (0.5 ml) is recommended for immunization of children over 12 months of age.
When carrying out immunization in Ukraine, contraindications and interactions with other drugs should be guided by the current regulatory documents of the Ministry of Health of Ukraine.
The vaccine should be administered according to the recommended schedule according to official guidelines. Priorix™ is intended for subcutaneous injection, although it can be administered intramuscularly in the deltoid region or the anterior thigh.
The vaccine should be administered subcutaneously to patients with bleeding disorders (e.g., thrombocytopenia or coagulation disorders).
Application features
Children
There are no data on the safety and efficacy of the Priorix™ vaccine in children under 9 months of age.
Drivers
"Priorix™" has no or negligible influence on the ability to drive and use machines.
Overdose
According to post-marketing surveillance, there have been reports of overdose (in doses that were 2 times higher than the recommended). No adverse reactions associated with this overdose were observed.
Side effects
The most common adverse reactions after administration of Priorix™ vaccine were redness at the injection site, temperature ≥ 38 °C (rectal) or ≥ 37.5 °C (axillary/oral).
Interaction
Priorix™ should not be mixed with other medicines and vaccines in the same syringe.
Storage conditions
Store at 2°C to 8°C. Protect from light. Do not freeze. Keep out of reach of children. The solvent can be stored in the refrigerator or at room temperature.
Shelf life - 2 years.
The reconstituted vaccine should be used immediately. If the reconstituted vaccine is not used immediately, it should be stored in a refrigerator at 2°C to 8°C and used within 8 hours of reconstitution for single-use packaging.
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