Приорикс

Приорикс – the live attenuirovanny combined vaccine applied to prevention of such diseases as measles, epidemic parotitis and a rubella.

Form of release and structure

Dosage form – lyophilisate for preparation of solution for intramuscular and hypodermic introduction: homogeneous porous mass from white till white-pinkish color (on 1 dose in glass bottles, 1 bottle complete with 1 syringe of solvent and injection cannulas (1-2 pieces) in a blister strip packaging, 1 packaging in a pack cardboard; on 1 dose in glass bottles, in a cardboard box 1 bottle complete with 1 ampoule of solvent or 100 bottles with 100 ampoules of solvent (in a separate box); on 10 doses in dark glass bottles, in a cardboard box of 50 bottles complete with 50 ampoules of solvent (in a separate box)).

Active agents as a part of 1 dose of a vaccine:

• Attenuirovanny vaccinal virus strain of epidemic parotitis (RIT4385, derivative Jeryl Lynn) – at least 4,3 _lgttsd50;
• Attenuirovanny vaccinal virus strain of measles (Schwarz) – a minimum
  3,5 _lgttsd50;
• Attenuirovanny vaccinal virus strain of a rubella (Wistar RA 27/3) – at least 3,5 _lgttsd50.

As excipients are used: Mannitolum, sorbitol, amino acids, lactose and Neomycinum sulfate.

Solvent represents water for injections (0,5 ml).

The vaccine of Prioriks conforms to requirements of World Health Organization for production of biological drugs, and also requirements to the live combined vaccines, vaccines against epidemic parotitis, measles and a rubella.

Indications to use

Приорикс it is applied to vaccination of children from 12-month age against measles, a rubella and epidemic parotitis.

Contraindications

• Pregnancy;
• Immunodeficiencies (both primary, and secondary), except for patients with an asymptomatic infection of the human immunodeficiency virus (HIV) and patients with a syndrome of the acquired immune deficit (AIDS);
• Acute diseases and exacerbation of chronic diseases (except for not heavy acute respiratory viral infections and acute intestinal diseases – in these cases vaccination can be carried out right after normalization of body temperature);
• Allergic reactions to the previous Prioriks's introduction;
• Hypersensitivity to any component of a vaccine, Neomycinum or eggs (at the same time existence in the history of a disease of allergic reaction to eggs of not anaphylactic character, or the contact dermatitis caused by Neomycinum is not a contraindication to an inoculation).

Route of administration and dosage

Приорикс enter on 1 dose (0,5 ml), usually subcutaneously, but it is possible to do also an intramuscular injection.

According to the Russian Calendar of preventive inoculations, Prioriks enter to children at the age of 12 months, carry out a revaccination in 6 years. Besides, girls can be vaccinated at the age of 13 years if they were not imparted earlier or received only 1 inoculation the monovalent or combined vaccine against epidemic parotitis, a rubella and measles.

Rules of preparation of solution:

• With lyophilisate enter the enclosed solvent just before an inoculation into a bottle;
• Carefully stir up a bottle for full dissolution of powder, but no more than 1 minute. Ready solution represents transparent liquid from light orange till light-red color. If the vaccine looks differently or has foreign particles, it is not used;
• For introduction use a new sterile needle. At a drug intake from multidose packaging the new syringe and a needle it is necessary to use every time.

The dissolved lyophilisate in multidose packaging can be to use within 1 working day (i.e. at most within 8 hours) on condition of its storage at a temperature of 2-8 ºС (in the refrigerator). It is necessary to extract solution from a bottle with strict observance of rules of an asepsis.

Side effects

The profile of safety of a vaccine of Prioriks is based on the data obtained for 12 thousand people who received drug within clinical trials. Events were registered within 42 days after an inoculation:

• Infections: often (≥1%, <10%) – upper respiratory tract infections; sometimes (≥0,1%, <1%) – average otitis;
• System of a hemopoiesis: sometimes – a lymphadenopathy;
• Alimentary system: sometimes – diarrhea, increase in parotid glands, vomiting, anorexia;
• Central nervous system: sometimes – sleeplessness, nervousness, unusual crying; seldom (≥0,01%, <0,1%) – febrile spasms;
• Immune system: seldom – allergic reactions;
• Respiratory system: sometimes – cough, bronchitis;
• Dermatological reactions: often – skin rash;
• Organ of sight: sometimes – conjunctivitis;
• Local reactions: very often (≥10%) – reddening in a drug injection site; often – morbidity and hypostasis;
• General reactions: very often – fervescence to 37,5 ºС and is a little higher (or rectal to 38 ºС), is frequent – fervescence more than 39 ºС (or rectal to 39,5 ºС).

In the conditions of mass vaccination the following side effects were registered:

• Infections: meningitis;
• Central nervous system: cross myelitis, encephalitis, peripheral neuritis, syndrome to Giyena-Barra (acute primary idiopathic polyneuritis);
• Immune system: anaphylactic reactions;
• Musculoskeletal system: arthritis, arthralgia;
• System of a hemopoiesis: Werlhof's disease, thrombocytopenia;
• Dermatological reactions: mnogoformny erythema;
• Others: a syndrome of Kawasaki, passing painful short-term hypostasis of testicles, a korepodobny syndrome, and also the states reminding parotitis.

At accidental intravenous administration development of heavy reactions and even shock is possible.

Special instructions

Intravenous administration of a vaccine is strictly forbidden!

Before Prioriks's introduction it is necessary to be convinced that the disinfecting agent (for example, alcohol) evaporated from the surface of skin and a stopper of a bottle as this substance can inactivate attenuated viruses as a part of a vaccine.

Extra care should be observed at administration of drug to persons with spasms and allergic diseases in the anamnesis, including family. After an inoculation such patients at least within 30 minutes have to be under observation of the doctor. At the same time the means of antishock therapy including solution of Epinephrinum (adrenaline) 1:1000 shall be provided in an inoculative office.

During a lactation drug can be used after careful assessment of a ratio of advantages/risks.

Women of childbearing age should do an inoculation after the test confirming lack of pregnancy. Within 3 months after vaccination it is necessary to apply reliable methods of contraception.

Medicinal interaction

Приорикс it is possible to enter in one day with the following vaccines: ADS, AKDS, against Haemophilus influenzae type b, against hepatitis B, the live and inactivated poliomyelitic vaccine. An important condition – administration of drugs in different body parts different syringes.

Any other live virus vaccine can be entered with the minimum interval of 1 month.

Приорикс it is impossible to mix in one syringe with other vaccines.

This means can be applied to revaccination at persons who were vaccinated by a monovalent vaccine against epidemic parotitis, a rubella and measles or other corresponding combined vaccine earlier.

In need of conducting tuberkulinovy test it should be put either along with vaccination, or in 6 weeks after it as clumsy vaccinal process (and, perhaps, parotitis) can cause temporary decrease in sensitivity of skin because of what obtaining false-negative result of tuberkulinovy test is possible.

Terms and storage conditions

To store and transport (both a vaccine, and solvent) at a temperature of 2-8 ºС. Solvent which is packed separately from a vaccine can be stored and transported at a temperature of 2-25 ºС. Not to freeze. To protect from children.

Vaccine period of validity – 2 years, solvent – 5 years.