Priorix-Tetra^® (Lyophilisate) Instructions for Use

Marketing Authorization Holder

GlaxoSmithKline Trading, JSC (Russia)

Manufactured By

GlaxoSmithKline Biologicals, S.A. (Belgium)

Solvent Manufacturer

CATALENT BELGIUM, SA (Belgium)

Labeled By

GlaxoSmithKline Biologicals, s.a. (Belgium)

Or

GlaxoSmithKline Biologicals (France)

Or

SMITHKLINE BEECHAM-BIOMED, LLC (Russia)

Quality Control Release

GlaxoSmithKline Biologicals, s.a. (Belgium)

Or

SMITHKLINE BEECHAM-BIOMED, LLC (Russia)

ATC Code

J07BD54 (Measles virus in combination with mumps, rubella and varicella viruses, live attenuated)

Active Substance

Measles, mumps, rubella, and varicella vaccine (Grouping name)

Dosage Form

Priorix-Tetra®

Lyophilisate for preparation of solution for subcutaneous and intramuscular administration 1 dose: vial 1 dose or 10 doses with solvent

Dosage Form, Packaging, and Composition

Lyophilisate for preparation of solution for subcutaneous and intramuscular administration in the form of a homogeneous porous mass or powder from white with a tint to pale pink in color; after reconstitution with solvent – a clear solution from pink-orange to pink in color; solvent (water for injections) – a clear colorless liquid without visible mechanical inclusions.

Excipients : lactose – 56 mg, sorbitol – 14 mg, mannitol – 14 mg, amino acids – 15 mg.

Solvent water for injections – 0.5 ml.

1 dose – transparent glass vials (1) in a set with 1 syringe (with solvent), 2 injection needles (in plastic containers) – blisters (1) – cardboard packs.
1 dose – transparent glass vials (10) in a set with 10 syringes (with solvent), 20 injection needles (in plastic containers) – cardboard boxes with a divider and protective perforation against unauthorized opening.

Note.
1. The vaccine contains trace amounts of neomycin sulfate (not more than 25 µg/dose).
2. TCID₅₀ – tissue culture infectious dose infecting 50% of the cell culture with cytopathic effect in 50% of the monolayer cells.
3. PFU – plaque-forming unit.

Clinical-Pharmacological Group

Vaccine for the prevention of measles, mumps, rubella and varicella

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

A combined agent containing live attenuated strains of measles virus (Schwarz), mumps virus (RIT4385, derived from Jeryl Lynn), rubella virus (Wistar RA 27/3) and varicella virus (Oka), cultured separately in chicken embryo cell culture (measles and mumps viruses) or in human diploid MRC-5 cells (rubella and varicella viruses).

The seroconversion rate after administration of 2 doses of the vaccine with an interval of 6 weeks to previously unvaccinated children aged 11-23 months was: to measles virus – more than 99%; to mumps virus – 98.8%; to rubella virus – more than 99%; to varicella virus – more than 99%.

Two years after administration of 2 doses of the vaccine, antibody concentrations remained high. Thus, the seroconversion rate for varicella virus was more than 99%, for measles, mumps and rubella viruses more than 99%, more than 90% and 100%, respectively.

With intramuscular or subcutaneous administration of the vaccine, the immunogenicity and safety profile are the same for both routes of administration.

Indications

Prevention of measles, mumps, rubella and varicella in children aged from 12 months to 12 years inclusive.

ICD codes

Dosage Regimen

The vaccine is administered subcutaneously or intramuscularly into the deltoid region of the shoulder or the anterolateral region of the thigh.

To achieve optimal protection against measles, mumps, rubella and varicella, administration of 2 doses of the vaccine is necessary. The recommended minimum interval between vaccinations is 6 weeks and can be extended. The vaccine can be used in accordance with the recommendations of the National Calendar of Preventive Vaccinations of the Russian Federation against measles, rubella and mumps at 12 months and at 6 years.

Administration of one dose of the vaccine is allowed for children who have previously received one dose of another combined vaccine for the prevention of measles, rubella and mumps and/or one dose of a vaccine for the prevention of varicella. Administration of one dose of another combined vaccine for the prevention of measles, rubella and mumps and/or one dose of a vaccine for the prevention of varicella after a single dose of this vaccine is also allowed.

Adverse Reactions

Infections and infestations: uncommon – upper respiratory tract infections; rare – otitis media, meningitis, infection caused by Herpes Zoster, measles-like syndrome, mumps-like syndrome (including orchitis, epididymitis and inflammation of the parotid glands).

Blood and lymphatic system disorders: uncommon – lymphadenopathy; rare – thrombocytopenia, thrombocytopenic purpura.

Immune system disorders: rare – allergic reactions (including anaphylactic and anaphylactoid reactions).

Metabolism and nutrition disorders: uncommon – anorexia.

Psychiatric disorders: common – irritability; uncommon – crying, increased excitability, insomnia.

Vascular disorders: rare – vasculitis (including Henoch-Schönlein purpura and Kawasaki syndrome).

Nervous system disorders: rare – febrile seizures, encephalitis, acute cerebrovascular accident, cerebellitis, symptoms resembling cerebellitis (including transient gait disturbance and transient ataxia), Guillain-Barré syndrome, transverse myelitis, peripheral neuritis.

Respiratory, thoracic and mediastinal disorders: uncommon – rhinitis; rare – cough, bronchitis.

Gastrointestinal disorders: uncommon – enlargement of the parotid salivary glands, diarrhea, vomiting.

Musculoskeletal and connective tissue disorders: rare – arthralgia, arthritis.

Skin and subcutaneous tissue disorders: common – rash; rare – erythema multiforme, varicella-like rash.

General disorders and administration site conditions: very common – fever; uncommon – drowsiness, weakness, feeling of tiredness.

Administration site conditions: very common – pain and redness at the injection site; common – swelling at the injection site.

Contraindications

Hypersensitivity to the components of the vaccine in history; severe reaction (temperature above 40°C (104°F), swelling and hyperemia at the injection site more than 8 cm in diameter) or complication to the previous administration of a vaccine for the prevention of measles, rubella, mumps and/or a vaccine for the prevention of varicella; severe deficiency of humoral or cellular immunity (primary or acquired); acute infectious and non-infectious diseases, exacerbation of chronic diseases are temporary contraindications for vaccination – routine vaccinations are carried out 2-4 weeks after recovery or during convalescence or remission. For non-severe acute respiratory viral infections, acute intestinal diseases, vaccinations are carried out immediately after temperature normalization; pregnancy.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy.

Pediatric Use

The drug is approved for use in children and adolescents under the age of 18 years.

Special Precautions

As with the administration of other vaccines, the administration of this vaccine should be postponed in persons with a severe acute febrile condition. However, the presence of minimal signs of infection, such as a “cold”, should not be a reason for withdrawal from vaccination.

After vaccination or sometimes before it, fainting (loss of consciousness) is possible as a psychological reaction to the injection. Before vaccination, it is important to ensure that the patient will not be injured in case of fainting.

As with the parenteral administration of any other vaccines, everything necessary for the management of a rare anaphylactic reaction after vaccine administration and for subsequent observation should be ready. The vaccinated person should be under medical supervision for 30 minutes after vaccination.

If vaccination is carried out within the first 72 hours after contact with an infection caused by the natural measles or varicella virus, protection against varicella or measles may not be complete.

There is an increased risk of febrile reaction and febrile seizures within 5-12 days after the first dose of this vaccine compared with the administration of the measles, rubella and mumps vaccine and the varicella vaccine as 2 separate injections. An increased risk of such events after the second dose was not observed. After administration of the first dose of a vaccine containing a measles component, a high frequency of fever is generally observed. Caution should be exercised when deciding to vaccinate patients with a personal or family history of febrile seizures. For the first dose, immunization by separate administration of the measles, rubella and mumps vaccine and the varicella vaccine should be considered as an alternative. In any case, vaccinated persons should be monitored for fever throughout the entire risk period.

The measles and mumps viruses that are part of the vaccine are grown in chicken embryo cell cultures, so the vaccine may contain trace amounts of egg protein. In persons with a history of anaphylactic, anaphylactoid or other immediate-type reactions (e.g., generalized urticaria, oropharyngeal edema, difficulty breathing, hypotension or shock) to egg protein, the risk of developing immediate-type hypersensitivity reactions after vaccine administration may be high, although such reactions have been observed very rarely. When vaccinating persons who have previously developed anaphylactic shock after eating eggs, strict precautions should be observed, and drugs for the management of anaphylactic shock should be in close proximity in case such a reaction develops.

There have been no reports of transmission of vaccine measles, rubella and mumps viruses from vaccinated persons to unvaccinated contacts who have not had measles, rubella, mumps, or have not received a full course of vaccination against these diseases, although it has been established that rubella virus can be isolated from the pharynx for 7-28 days after vaccination with the maximum degree of virus isolation approximately on the 11th day. It has been shown that in some cases, transmission of the vaccine strain of varicella virus from vaccinated persons with a rash to seronegative contacts may occur. Transmission of the vaccine strain of varicella virus to seronegative contacts from vaccinated persons in the absence of a rash in the latter cannot be ruled out.

As with any vaccination, a protective immune response may not develop in all persons who have been vaccinated. As with the use of other varicella vaccines, cases of varicella have been observed in persons vaccinated with this vaccine. Such cases of varicella are usually mild, with a small number of rash elements and less pronounced fever compared to cases of varicella in unvaccinated persons.

After primary vaccination with live attenuated measles, rubella and mumps vaccines, cases of exacerbation and relapse of the disease have been recorded in persons with thrombocytopenia. In such cases, a thorough assessment of the risks and benefits of immunization with this vaccine should be carried out.

After primary vaccination with live attenuated measles, rubella and mumps vaccines, cases of exacerbation and relapse of the disease have been recorded in persons with thrombocytopenia. In such cases, a thorough assessment of the potential risk and expected benefit of immunization with this vaccine should be carried out.

Vaccination of persons with immunodeficiency conditions should be carried out with caution and only if, in the opinion of the physician, the expected benefit outweighs the potential risk.

In persons with immunodeficiency conditions who are not contraindicated for vaccination, as well as in immunocompetent patients, an adequate immune response may not develop, respectively, some of the vaccinated may become infected with measles, mumps, rubella or varicella, despite properly performed vaccination. Persons with immunodeficiency conditions should be carefully monitored for signs of measles, mumps, rubella or varicella.

There are reports of isolated cases of dissemination of varicella virus with involvement of internal organs after vaccination with a vaccine containing the Oka strain, mainly in immunodeficient patients.

Drug Interactions

If this vaccine is used simultaneously with another vaccine for parenteral administration, the vaccines are administered at different sites on the body.

If a tuberculin test is necessary, it should be performed before or simultaneously with vaccination, since, according to available data, combined vaccines for the prevention of measles, rubella and mumps can cause a temporary decrease in skin sensitivity to tuberculin. Since such a decrease in sensitivity can persist for up to 6 weeks, tuberculin diagnostics should not be performed during this period of time after vaccination to avoid false-negative results.

Patients who have received human gamma globulin or have undergone a blood transfusion should postpone vaccination for at least 3 months due to the possible ineffectiveness of vaccination due to passively acquired antibodies.

Within 6 weeks after each vaccination, the use of salicylic acid derivatives should be avoided, since there are reports of the development of Reye’s syndrome with the use of salicylic acid derivatives against the background of an infection caused by the wild strain of varicella virus.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.