Priority® (Priorix®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbsplyophilizate for the preparation of a solution for subcutaneous and intramuscular administration
Composition:

1 inoculation dose (0.5 ml) contains:

Name of the component

amount1

Active substances:

Live attenuated measles virus (strain Schwarz), grown in the culture of cells of chick embryos

not less than 3,0 lg TCDs502

Live attenuated mumps virus (strain RIT4385), grown in the culture of cells of chick embryos

not less than 3,7 lg TCDs50

Live attenuated rubella virus (strain Wistar RA 27/3), grown in a diploid culture of human cells MRC-5

not less than 3,0 lg TCDs50

Excipients:

Lactose

Sorbitol

Mannitol

Amino acids

Neomycin sulfate

32 mg

9 mg

8 mg

9 mg

not more than 25 mcg

Solvent:

Water for injections

0.5 ml

Note:

1. Nominal virus titer.

Corresponds to the minimum titre guaranteed by the manufacturer at the expiration date. In order to compensate for the decrease in the virus titer at During the expiry date of the preparation, an excess of Release 1 of the vaccine dose contains at least 3.5 lg TCD50 live attenuated measles virus (strain Schwarz), not less than 4.3 lg TCD50 live attenuated mumps virus (strain RIT4385), not less than 3.5 lg TCD50 live attenuated rubella virus (strain Wistar RA 27/3).

2. TCDs50 - tissue cytopathogenic dose, which causes the death of 50% of monolayer cells.

Description:

Lyophilizate: homogeneous, porous mass from white to slightly pink.

Solvent: transparent, colorless liquid, odorless, free of visible impurities.

The reconstituted drug solution: transparent liquid from pink-orange to pink; visible mechanical inclusions should be absent.

Pharmacotherapeutic group:MIBP vaccine
ATX: & nbsp
  • Measles virus in combination with mumps and rubella viruses - live attenuated
    • Pharmacodynamics:

    Priori® is a lyophilized combination preparation of attenuated vaccine strains of measles virus (Schwarz), mumps (RIT 4385, derived from Jeryl Lynn) and rubella (Wistar RA 27/3) cultivated separately in chicken embryo cells (measles and mumps) and diploid human cells (rubella virus).

    Priority® meets World Health Organization requirements for the production of biological products, requirements for measles, mumps, rubella and live combination vaccines.

    Clinical trials of the Priori® vaccine showed high efficacy of the drug. Antibodies to measles virus were detected in 98%, to the mumps virus in 96.1% and to the rubella virus in 99.3% of the vaccinated.One year after the vaccination, all seropositive persons retained a protective titer of antibodies to measles virus and rubella virus and 88.4% of the mumps virus.

    A certain degree of protection against measles disease can be achieved by administering the vaccine to non-immune individuals within 72 hours after contact with the measles.

    Indications:

    Prevention of measles, mumps and rubella from 12 months of age.

    Contraindications:

    - Symptoms of an allergic reaction after the introduction of vaccines for the prevention of measles, mumps and / or rubella in history:

    - hypersensitivity to neomycin, any other vaccine ingredient and chicken eggs; At the same time, the presence in a history of contact dermatitis caused by neomycin and an allergic reaction to non-anaphylactic chicken eggs is not a contraindication to vaccination;

    - PPrimary and secondary immunodeficiencies. Note: the drug can be administered to people with asymptomatic HIV infection, as well as AIDS patients;

    - pregnancy;

    - Vaccination is postponed until the end of acute manifestations of the disease and exacerbation of chronic diseases. With non-severe acute respiratory infections, acute intestinal diseases, etc.Inoculations can be carried out immediately after the temperature is normalized.

    Pregnancy and lactation:

    Pregnancy

    Pregnant women should not be vaccinated with Priori®.

    At the same time, when using vaccines to prevent measles, mumps or rubella in pregnant women, fetal damage is not documented.

    Even in cases where theoretical risk can not be ruled out, no case of congenital rubella syndrome was registered among 3,500 women who were in early pregnancy during the vaccination with rubella-containing drugs, and they were unaware of the pregnancy.

    Unintentional vaccination of women who are unaware of the pregnancy, drugs containing measles, mumps and rubella components, is not an indication for abortion.

    Do not allow pregnancy within 1 month after vaccination. Women planning a pregnancy should be advised to postpone the onset of pregnancy.

    Breastfeeding period

    There are no data on the use of breast-feeding women.Nursing women can be vaccinated if the benefits of vaccination prevail over the possible risk.

    Dosing and Administration:

    Priori® is administered subcutaneously, intramuscular administration of the drug is permissible.

    Priority® you can not enter intravascular.

    The solvent and the reconstituted preparation must be visually inspected before use for the absence of mechanical inclusions and / or change in appearance. If they are detected, the use of a solvent or a reduced preparata. The reconstituted drug is a clear liquid from pink-orange to pink, visible inclusions should be absent.

    Preorix® vaccine should not be mixed in the same syringe with other vaccines. Immediately before use, the contents of the attached width or ampoule with the solvent are added to the vial containing the preparation at a rate of 0.5 ml per 1 dose. A new sterile needle should be used to administer the drug.

    Preparation of the vaccine before administration with the use of a solvent in an ampoule

    The Priori® vaccine needs to be restored by adding the full volume of the solvent from the ampoule to the vial containing the lyophilizate.After adding the solvent to the lyophilizate, shake the resulting mixture well until the lyophilisate is completely dissolved in the solvent (no more than 1 minute). After restoration, the vaccine must be promptly introduced. A new needle should be used to administer the vaccine. For administration, the weight of its contents is removed from the vial of the reconstituted vaccine.

    Preparation of the vaccine before administration with the use of a solvent in a syringe

    The Priori® vaccine needs to be restored by adding the full volume of the solvent from the pre-filled syringe to the vial containing the lyophilizate.

    Attention! The packaging of the Priori® vaccine can be represented by two types of syringes, differing in the way the needle is connected to the syringe nozzle.

    To select the correct method for connecting the needle and syringe, follow the instructions below:

    Type 1 Syringe (see Figure 1).

    Instruction for the preparation of a type I syringe (Figure 1) for use:

    1. Unscrew the protective cap of the syringe by turning it counter-clockwise (while holding the syringe by the cylinder, avoiding contact with the plunger of the syringe).

    2. Twisting motion clockwise arrow, connect the needle to the syringe until you feel them snap into place (see Figure 1).

    3. Remove the protective cap from the needle (in some cases it may be tightly attached to the needle).

    Syringe type 2

    In case the package contains a syringe other than that shown in Figure 1, after removing the protective cap from the syringe nozzle, place the needle on the syringe until it stops, without additional screwing. Add the solvent to the lyophilizate. After the addition of the solvent to the lyophilizate, the resulting mixture should be well shaken until the lyophilizate is completely dissolved in the solvent (no more than 1 minute). After restoration, the vaccine must be promptly introduced. A new needle should be used to administer the vaccine. For the introduction, all the contents are removed from the vial of the reconstituted vaccine. The reconstituted vaccine is used immediately and is not subject to storage. Unused preparation and waste from its use must be destroyed in accordance with the requirements adopted in the Russian Federation.

    Vaccination schedules

    The vaccine dose is 0.5 ml.

    In accordance with the Calendar of Preventive Inoculations of Russia, Priori® is administered to children aged 12 months followed by booster vaccination at the age of 6 years.

    Priori® can be administered to girls at the age of 13 who were not vaccinated or who received only one vaccine with monovalent or combined vaccines against measles, rubella and mumps.

    Side effects:

    Clinical Trials Data

    Undesirable reactionsand, presented below, are listed in accordance with the damage to organs and organ systems and frequency of occurrence. Frequency of occurrence is defined as follows: Often (≥ 1/10), often (≥ 1/100 and <1/10), infrequently (≥ 1/1 000 and <1/100), rarely (≥ 1/10 000 and <I 000), rarely (<1/10 000, including individual cases).

    In controlled clinical trials, signs and symptoms were actively monitored during the 42-day follow-up period. The vaccinated were also asked to report all clinical manifestations during the study time.

    The vaccine safety profile is based on data obtained for 12,000 subjects who received the vaccine as part of clinical trials.

    Frequency of occurrence of undesirable reactions

    Infectious and parasitic diseases

    Often: infections of the upper respiratory tract.

    Infrequent: otitis media.

    Violations of the blood and lymphatic system

    Infrequent: lymphadenopathy.

    Immune system disorders

    Rarely: allergic reactions.

    Disorders from the metabolism and nutrition

    Infrequently: anorexia.

    Disorders of the psyche

    Infrequently: pathological crying, nervousness, insomnia.

    Disturbances from the nervous system

    Rarely: febrile convulsions.

    Disturbances on the part of the organ of sight

    Infrequently: conjunctivitis.

    Disturbances from the respiratory system, chest and mediastinal organs

    Infrequent: bronchitis, cough.

    Disorders from the gastrointestinal tract

    Infrequent: parotid enlargement, diarrhea, vomiting.

    Disturbances from the skin and subcutaneous tissues

    Often: rash.

    General disorders and disorders at the site of administration

    Very often: redness at place of injection, temperature increase (rectal ≥ 38 ° C, axillary cavity / oral cavity ≥ 37.5 ° C).

    Often: soreness and swelling at the injection site, fever (rectal ≥ 39.5 ° C; axillary / oral cavity> 39 ° C).

    In general, the frequency of occurrence of unwanted reactions were similar after the introduction of the first dose of vaccine and booster. However, pain at the injection site according to the frequency categories was observed "Often" after the first vaccination and "Very often" afterrevaccination.

    Post-registration data

    In conditions of mass vaccination, they were additionally registered the following undesirable reactions, which are in temporary connection with the introduction of the vaccine.

    Infectious and parasitic diseases

    Rarely: meningitis, korepodobny syndrome, parotitonodobny syndrome (including orchitis, epididymitis and inflammation of the parotid glands).

    Disturbances from the blood of the lymphatic system

    Rarely: thrombocytopenia, thrombocytopenic purpura.

    Immune system disorders

    Rarely: anaphylactic reactions.

    Disturbances from the nervous system

    Rarely: encephalitis, cerebellitis, symptoms reminiscent of cerebellitis (including transient gait disorder and transient ataxia), Guillain-Barre syndrome, transverse myelitis, peripheral neuritis.

    Vascular disorders

    Rarely: vasculitis (including Henoch-Shonlein purpura and Kawasaki syndrome).

    Disturbances from the skin and subcutaneous and tissueMr.her

    Rarely: erythema multiforme.

    Disturbances from musculoskeletal system and connective tissue

    Rare: arthralgia, arthritis.

    Accidental intravenous administration may cause severe reactions or even shock.Immediate measures taken depend on the severity of the reaction.

    Overdose:

    In the course of post-registrationthere were reports of overdose cases (exceeding the recommended dose by no more than 2 times). There were no adverse reactions due to overdose.

    Interaction:

    Priority® can be administered simultaneously (on the same day) with DTP and ADS vaccines, live and inactivated poliovirus vaccine, a vaccine against H. ifluenzae type b, a hepatitis B vaccine, provided injections are given with individual syringes in different parts of the body. Other live viral vaccines are administered at intervals of at least 1 month.

    Priority® Do not mix with other vaccines in the same syringe.

    Vaccine Priority® can be used to re-vaccinate people previously vaccinated with another combination vaccine against measles, mumps and rubella or with the corresponding mono preparations.

    If a tuberculin test is required, it should be performed before or concomitantly with vaccination, as according to available data live measles vaccines (and possibly mumps) can cause a temporary decrease in the sensitivity of the skin to tuberculin.Due to the fact that such a decrease in sensitivity may last from 4 to 6 weeks, tuberculin diagnostics should not be performed within the specified time period after vaccination in order to avoid false negative results. Patients who have previously received human blood products (immunoglobulins, plasma and others) should be vaccinated for at least three months because of the likelihood of insufficient formation of antibodies to mumps, measles and rubella virus.

    Special instructions:

    Care should be taken when administering the vaccine to people with allergic diseases and convulsions in a personal and family history.

    As with the use of other biological products, due to the possibility of developing allergic reactions of immediate type, the vaccine should be monitored for at least 30 minutes. The grafting rooms should be provided with anti-shock therapy, including adrenaline solution 1:1000.

    After vaccination, or sometimes in front of it, fainting or severe weakness is possible as a psychological reaction to injection. Before vaccination it is important to make sure that the patient does not get injured in the event of a syncope.

    Vaccination of women in childbearing age is carried out in the absence of pregnancy and only if the woman agrees to be protected from conception within 1 month after vaccination. As with any other vaccination, not all vaccinees may have a protective immune response.

    In children under 12 months of age, a protective immune response to the measles component of the vaccine may not be sufficient due to the possible retention of maternal antibodies to measles virus in them. However, this should not be grounds for excluding the use of the vaccine Priority® in infants (<12 months), because in some situations, such as high-risk groups, vaccination is indicated. In such cases, revaccination should be performed after reaching the age of 12 months.

    After primary vaccination in people with thrombocytopenia were recorded cases of exacerbation and re-manifestation of the disease, and therefore the decision to appoint a vaccine Priority® such patients should be taken on an individual basis, taking into account the risk and benefit assessment and only after consultation of the specialized doctor.

    Data on the use of the drug Priority® people with immunodeficiency status are limited, so vaccination should be carried out with caution and only if, in the opinion of the doctor, the benefit exceeds the risk (for example, persons with asymptomatic HIV infection).

    In persons with immunodeficient conditions that are not contraindicated in vaccination (the section "Contraindications"), as in immunocompetent patients, a proper immune response may not develop, so some of the vaccinated may become infected with measles, mumps or rubella, despite the correct vaccination. Persons with immunodeficiency conditions should be carefully monitored for signs of measles, mumps and rubella.

    The transmission of measles and mumps virus from vaccinated limes to unvaccinated contacts has not been recorded. There are cases of pharyngeal discharge of the rubella virus 7-28 days after vaccination with a release peak at about the 11th day. Nevertheless, there is no evidence to support the transmission of the released vaccine virus to unvaccinated contact persons.

    Before the introduction of the vaccine,that alcohol or other disinfectant has evaporated from the surface of the skin and the vial plug, since these substances can inactivate attenuated viruses in the vaccine.

    Form release / dosage:

    Lyophilizate for the preparation of solution for subcutaneous and intramuscular injection, 1 dose (0.5 ml).

    Packaging:

    Lyophilizate

    1 dose of vaccine in a vial of transparent glass type I (Heb, F.). corked with rubber stopper and aluminum cap for running in, equipped with a protective plastic lid.

    Solvent

    For 0.5 ml in a vial of transparent glass type I (Hept. F.).

    For 0.5 ml in a syringe of transparent glass type I (Heb.). The nozzle of the syringe is hermetically sealed with a protective rubber cap or sealed with a sealed rubber stopper with a protective screw cap.

    Completeness

    1 bottle with lyophilizate, 1 ampoule with a solvent in a blister, closed with a film. For 1 blister with instructions for use in a cardboard bundle.

    1 bottle with lyophilizate, 1 syringe with solvent complete with 1 needle in a separate plastic container with cannula, closed with a plastic cap, in a blister, covered with a film. For 1 blister with instructions for use in a cardboard bundle.

    1 bottle with lyophilizate, 1 syringe with solvent complete with 2 needles in separate plastic containers with cannula, closed plastic caps, in a blister, covered with a film. 1 blister with instructions for use in a cardboard box.

    100 bottles with lyophilizate with instructions for use in a cardboard box. Solvent separately: 100 ampoules in a cardboard box.

    Storage conditions:

    Lyophilizate

    Store at a temperature of 2 to 8 ° C. Do not freeze.

    Keep in a dark place.

    Solvent

    Store at a temperature of 2 to 25 ° C. Do not freeze.

    Kit (lyophilizate, solvent, with needles or without needles)

    Store at a temperature of 2 to 8 ° C. Do not freeze.

    Keep in a dark place. Keep out of the reach of children place.

    CONDITIONS OF TRANSPORTATION

    Lyophilizate

    Transport at a temperature of 2 to 8 ° C. Do not freeze.

    Solvent

    Transport at a temperature of 2 to 25 ° C. Do not freeze.

    Kit (lyophilizate, solvent, with needles or without needles)

    Transport at a temperature of 2 to 8 ° C. Do not freeze.

    Shelf life:

    Lyophilizate: 2 years.

    Solvent: 5 years.

    The shelf life of the kit is indicated by the shortest shelf life of one of the components.

    Do not use after the expiration date stated on the package.

    Expiration date is the last day of the month indicated on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:П N015888 / 01
    Date of registration:09.06.2009 / 21.07.2015
    The owner of the registration certificate:GlaxoSmithKline Trading, ZAO GlaxoSmithKline Trading, ZAO Russia
    Manufacturer: & nbsp
    Representation: & nbspGlaxoSmithKline Trading, ZAOGlaxoSmithKline Trading, ZAO
    Information update date: & nbsp16.12.2015
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