Priorix^® (Lyophilisate) Instructions for Use

ATC Code

J07BD52 (Measles virus in combination with mumps and rubella viruses, live attenuated)

Active Substance

Measles, mumps and rubella virus vaccine live (Ph.Eur.)

Clinical-Pharmacological Group

Vaccine for the prevention of measles, mumps and rubella

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

A live combined attenuated vaccine against measles, mumps and rubella. The attenuated vaccine strains of measles virus (Schwarz), mumps virus (RIT 4385, derived from Jeryl Lynn) and rubella virus (Wistar RA 27/3) are cultured separately in chicken embryo cell culture (measles and mumps viruses) and human diploid cells (rubella virus).

Clinical studies have shown high efficacy of the Priorix^® vaccine. Antibodies to the measles virus were detected in 98% of vaccinated individuals, to the mumps virus in 96.1%, and to the rubella virus in 99.3%. One year after vaccination, all seropositive individuals maintained a protective antibody titer against measles virus and rubella virus, and in 88.4% – against 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 a measles patient.

Pharmacokinetics

Pharmacokinetic data for the Priorix^® preparation are not available.

Indications

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

ICD codes

Dosage Regimen

Lyophilisate

The vaccine is administered subcutaneously in a dose of 0.5 ml; intramuscular administration of the vaccine is also permitted. Intravenous administration of the vaccine is not allowed!

In accordance with the Russian Preventive Vaccination Calendar, Priorix^® is administered to children at the age of 12 months followed by revaccination at the age of 6 years. Furthermore, Priorix^® can be administered to girls at 13 years of age who have not been previously vaccinated or have received only 1 vaccination with monovalent or combined vaccines against measles, rubella and mumps.

Rules for solution preparation

Immediately before use, add the contents of the supplied syringe or ampoule with solvent to the vial with the preparation at the rate of 0.5 ml per 1 dose. Shake the vial thoroughly until completely dissolved. The dissolution time of the preparation should not exceed 1 minute. The dissolved preparation is a clear liquid from light orange to light red in color. If the solution looks different or contains foreign particles, the vaccine should not be used.

A new sterile needle should be used for administration of the preparation. When using the vaccine in a multi-dose package, a new syringe and needle should be used each time for withdrawal.

The dissolved preparation in a multi-dose package should be used during the working day (within no more than 8 hours) provided it is stored in a refrigerator (at a temperature from 2°C (35.6°F) to 8°C (46.4°F)). The preparation should be withdrawn from the vial under strict aseptic conditions.

Under no circumstances should the Priorix^® vaccine be administered intravenously.

Adverse Reactions

Definition of frequency of adverse reactions: very common (≥10%), common (≥1%, <10%), uncommon (≥0.1%, <1%), rare (≥0.01%, <0.1%), very rare (<0.01%).

The safety profile of the vaccine is based on data obtained from 12,000 individuals who received the vaccine in clinical trials. Events were actively recorded for 42 days after vaccination.

Infections: common – upper respiratory tract infections; uncommon – otitis media.

From the hematopoietic system: uncommon – lymphadenopathy.

From the digestive system: uncommon – parotid gland enlargement, diarrhea, vomiting, anorexia.

From the CNS: uncommon – unusual crying, nervousness, insomnia; rare – febrile seizures.

From the respiratory system: uncommon – cough, bronchitis.

Dermatological reactions: common – rash.

From the immune system: rare – allergic reactions.

From the organ of vision: uncommon – conjunctivitis.

Local reactions: very common – redness at the injection site; common – pain and swelling at the injection site.

General reactions very common – fever (rectal ≥38°C (100.4°F); axillary/oral: ≥37.5°C (99.5°F)); common – fever (rectal ≥39.5°C (103.1°F); axillary/oral >39°C (102.2°F)).

Overall, the profile of adverse reactions was similar after the first dose of the vaccine and after revaccination. However, pain at the injection site was observed in 1-10% of cases after the first vaccination, and in more than 10% of cases after revaccination.

In the context of mass vaccination, the following adverse reactions, temporarily associated with vaccine administration, have been reported.

Infections meningitis.

From the hematopoietic system thrombocytopenia, thrombocytopenic purpura.

From the CNS: transverse myelitis, acute primary idiopathic polyneuritis (Guillain-Barré syndrome), peripheral neuritis, encephalitis.

Dermatological reactions: erythema multiforme.

From the immune system: anaphylactic reactions.

From the musculoskeletal system: arthralgia, arthritis.

From the body as a whole: Kawasaki syndrome.

Encephalitis has been reported with a frequency of less than 1 case per 10 million doses, which is significantly lower than in natural diseases (measles: 1/1000-1/2000; rubella: 1/6000).

In rare cases, conditions resembling mumps with a shortened incubation period cannot be ruled out. In isolated cases, transient painful short-term testicular swelling has been noted.

In isolated cases, vaccinated individuals developed a measles-like syndrome.

Accidental intravenous administration may cause severe reactions, even shock. In such cases, appropriate emergency medical care is required.

Contraindications

• Primary and secondary immunodeficiencies (however, the preparation can be used in individuals with asymptomatic HIV infection, as well as in AIDS patients);
• Acute diseases and exacerbations of chronic diseases (vaccination is allowed immediately after temperature normalization in cases of mild ARVI, acute intestinal diseases);
• Pregnancy;
• Allergic reactions to previous administration of the preparation;
• Hypersensitivity to neomycin, any other ingredient of the vaccine and chicken eggs (however, a history of contact dermatitis caused by neomycin and an allergic reaction to chicken eggs of a non-anaphylactic nature is not a contraindication to vaccination).

Use in Pregnancy and Lactation

The Priorix^® vaccine is contraindicated for use during pregnancy.

The vaccine may be used during breastfeeding after assessing the expected benefit and potential risk.

Vaccination of women of childbearing age is carried out in the absence of pregnancy and only if the woman agrees to use contraception for 3 months after vaccination.

Special Precautions

Caution should be exercised when administering the vaccine to individuals with allergic diseases and a personal or family history of seizures. It should be taken into account that after vaccine administration, due to the possible risk of immediate-type allergic reactions, the patient should be under medical supervision for 30 minutes. Vaccination sites should be equipped with anti-shock therapy means, including a 1:1000 solution of epinephrine (adrenaline).

Before administration of the vaccine, it should be ensured that alcohol or other disinfecting agent has evaporated from the skin surface and the vial stopper, as these substances may inactivate the attenuated viruses in the vaccine.

Overdose

There have been no reports of overdose with the Priorix^® preparation to date.

Drug Interactions

The Priorix^® vaccine can be administered simultaneously (on the same day) with DTP and ADS vaccines, live and inactivated poliovirus vaccine, Haemophilus influenzae type b vaccine, hepatitis B vaccine, provided the preparations are injected with different syringes into different parts of the body. Other live viral vaccines should be administered at an interval of at least 1 month.

Priorix^® should not be mixed with other vaccines in the same syringe.

Priorix^® can be used for revaccination in individuals previously vaccinated with another combined measles, mumps and rubella vaccine or the corresponding monovalent preparations.

If a tuberculin test is necessary, it should be performed either simultaneously with vaccination or 6 weeks after it, since the measles (and possibly mumps) vaccination process can cause a temporary decrease in skin sensitivity to tuberculin, which will lead to a false negative result.

Storage Conditions

The vaccine in a set with solvent should be stored and transported at a temperature from 2°C (35.6°F) to 8°C (46.4°F).

The vaccine packaged separately from the solvent should be stored and transported at a temperature from 2°C (35.6°F) to 8°C (46.4°F).

The solvent packaged separately from the vaccine should be stored and transported at a temperature from 2°C (35.6°F) to 25°C (77°F); freezing of the solvent is not allowed.

The vaccine and solvent should be stored out of the reach of children.

Shelf Life

The shelf life of the vaccine is 2 years, the shelf life of the solvent is 5 years.

Dispensing Status

The vaccine is dispensed by prescription.

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.