Priorix - Instructions For Using The Vaccine, Reviews After Vaccination

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Priorix

Priorix: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacodynamics and pharmacokinetics
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application of pregnancy and lactation
10. 10. Drug interactions
11. 11. Analogs
12. 12. Terms and conditions of storage
13. 13. Terms of dispensing from pharmacies
14. 14. Reviews
15. 15. Price in pharmacies

Latin name: Priorix

ATX code: J07BD52

Active ingredient: Strain Schwartz + Strain RIT 43/85 + Strain Wistar RA 27/3 + Neomycin B sulfate

Producer: GlaxoSmithKline Biologicals, sa (Belgium)

Description and photo updated: 2018-19-07

Priorix is a live attenuated combination vaccine used to prevent diseases such as measles, mumps and rubella.

Release form and composition

Dosage form - lyophilisate for preparation of a solution for intramuscular and subcutaneous administration: a homogeneous porous mass from white to white-pinkish color (1 dose in glass vials, 1 vial complete with 1 syringe of solvent and needles for injection (1-2 pcs.) in a contour acheikova package, 1 package in a cardboard box; 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); 10 doses in dark glass bottles, in a cardboard box 50 vials complete with 50 ampoules of solvent (in a separate box)).

Active substances in 1 dose of Priorix vaccine:

• Attenuated mumps vaccine strain (RIT4385, Jeryl Lynn derivative) - at least 4.3 lgTCD ₅₀;

• Attenuated measles virus vaccine strain (Schwarz) - at least

  3.5 lgTCD ₅₀;

• Attenuated rubella vaccine strain (Wistar RA 27/3) - minimum 3.5 lgTCD ₅₀.

Used as auxiliary substances: mannitol, sorbitol, amino acids, lactose and neomycin sulfate.

The solvent is water for injection (0.5 ml).

Priorix vaccine meets the requirements of the World Health Organization for the production of biological products, as well as the requirements for live combination vaccines, vaccines against mumps, measles and rubella.

Pharmacodynamics and pharmacokinetics

As a result of clinical trials, the high efficiency of the Priorix vaccine was revealed. Antibodies to rubella virus were found in 99.3% of vaccinated patients, in 98% - to measles virus and 96.1% - to mumps virus. 12 months after vaccination, the protective titer of antibodies to measles and rubella viruses remained in all seropositive individuals, and to mumps virus - in 88.4% of patients.

Indications for use

According to the instructions, Priorix is used to vaccinate children from 12 months of age against measles, rubella and mumps.

Contraindications

• Pregnancy;
• Immunodeficiencies (both primary and secondary), with the exception of patients with asymptomatic human immunodeficiency virus (HIV) infection and patients with acquired immune deficiency syndrome (AIDS);
• Acute diseases and exacerbation of chronic diseases (with the exception of mild acute respiratory viral infections and acute intestinal diseases - in these cases, vaccination can be carried out immediately after normalization of body temperature);
• Allergic reactions to the previous administration of Priorix;
• Hypersensitivity to any component of the vaccine, neomycin or chicken eggs (it is not a contraindication to vaccination if there is a history of an allergic reaction to chicken eggs of a non-anaphylactic nature, or contact dermatitis caused by neomycin).

Instructions for the use of Priorix: method and dosage

The vaccine is administered in 1 dose (0.5 ml), usually subcutaneously, but intramuscular injection can also be given.

According to the Russian Calendar of Preventive Vaccinations, Priorix is administered to children at the age of 12 months, revaccination is performed at the age of 6. In addition, girls can be vaccinated at age 13 if they have not previously been vaccinated or have received only 1 vaccine with monovalent or combination mumps, rubella and measles vaccines.

Solution preparation rules:

• The supplied solvent is introduced into the vial with the lyophilisate immediately before inoculation;
• Shake the bottle thoroughly to completely dissolve the powder, but not more than 1 minute. The finished solution is a clear liquid from light orange to light red. If the vaccine looks different or has foreign particles, do not use it;
• A new sterile needle is used for injection. When taking a drug from a multi-dose package, a new syringe and needle must be used each time.

Dissolved lyophilisate in multi-dose packaging can be used within 1 working day (ie maximum within 8 hours), provided it is stored at a temperature of 2-8 ° C (in a refrigerator). It is necessary to remove the solution from the vial with strict adherence to the rules of asepsis.

Side effects

The safety profile of the vaccine is based on data obtained for 12 thousand people who received the drug in clinical trials. Events were recorded within 42 days of the Priorix vaccination:

• Infections: often (≥1%, <10%) - upper respiratory tract infections; sometimes (≥0.1%, <1%) - otitis media;
• Hematopoietic system: sometimes - lymphadenopathy;
• Digestive system: sometimes - diarrhea, enlargement of the parotid glands, vomiting, anorexia;
• Central nervous system: sometimes - insomnia, nervousness, unusual crying; rarely (≥0.01%, <0.1%) - febrile convulsions;
• Immune system: rarely - allergic reactions;
• Respiratory system: sometimes - cough, bronchitis;
• Dermatological reactions: often - skin rash;
• Organ of vision: sometimes - conjunctivitis;
• Local reactions: very often (≥10%) - redness at the injection site; often - soreness and swelling;
• General reactions: very often - an increase in body temperature up to 37.5 ºС and slightly higher (or rectal up to 38 ºС), often - an increase in body temperature more than 39 ºС (or rectal up to 39.5 ºС).

In a mass vaccination setting, the following side effects have been reported:

• Infections: meningitis;
• Central nervous system: transverse myelitis, encephalitis, peripheral neuritis, Guillain-Barré syndrome (acute primary idiopathic polyneuritis);
• Immune system: anaphylactic reactions;
• Musculoskeletal system: arthritis, arthralgia;
• Hematopoietic system: thrombocytopenic purpura, thrombocytopenia;
• Dermatological reactions: erythema multiforme;
• Others: Kawasaki syndrome, transient painful short-term testicular edema, measles-like syndrome, and conditions resembling parotitis.

In case of accidental intravenous administration, severe reactions and even shock may develop.

Overdose

No cases of overdose with Priorix vaccine have been reported.

special instructions

Intravenous vaccine administration is strictly prohibited!

Before administering the vaccine, make sure that the disinfecting agent (eg alcohol) has evaporated from the surface of the skin and the bottle cap, as this substance can inactivate the attenuated viruses in the vaccine.

Particular care should be taken when administering the drug to persons with a history of convulsions and allergic diseases, including family history. After vaccination, such patients should be under medical supervision for at least 30 minutes. At the same time, anti-shock therapy means must be provided in the vaccination room, including a solution of epinephrine (adrenaline) 1: 1000.

During lactation, the drug can be used after a careful assessment of the benefit / risk ratio.

For women of childbearing age, the vaccine should be done after a pregnancy test. For 3 months after vaccination, you must use reliable methods of contraception.

Application during pregnancy and lactation

The vaccine is prohibited during pregnancy.

During lactation, the use of the drug is possible after assessing the expected benefits to the mother and the potential risk to the child.

Women of childbearing age are only vaccinated if they are not pregnant. You must use reliable contraceptive methods for 3 months after the vaccine was given.

Drug interactions

Priorix can be administered on the same day with the following vaccines: ADS, DPT, against Haemophilus influenzae type b, against hepatitis B, live and inactivated poliomyelitis vaccine. An important condition is the introduction of drugs into different parts of the body with different syringes.

Any other live virus vaccine can be given at least 1 month apart.

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

This agent can be used for booster vaccination in individuals who have previously been vaccinated with a monovalent mumps, rubella and measles vaccine or other appropriate combination vaccine.

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

Analogs

An analogue of Priorix is the live attenuated vaccine against measles, mumps and rubella.

Terms and conditions of storage

Store and transport (both vaccine and diluent) at 2-8 ºС. The diluent, which is packed separately from the vaccine, can be stored and transported at a temperature of 2-25 ° C. Do not freeze. Keep out of the reach of children.

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

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Priorix

Reviews of the Priorix vaccine are both positive (about 60% of all responses) and negative (about 40% of reviews). This is due to the fact that with any vaccination complications are possible, and in some cases, serious (extremely rare).

The advantage of Priorix, in comparison with domestic vaccines, is a single administration. Russian-made analogs are introduced twice. For allergy sufferers, the disadvantage of the vaccine is its production on the basis of chicken eggs (the domestic vaccine is made using quail eggs).

Price for Priorix in pharmacies

The average price for the Priorix vaccine is 310 rubles (the cost of 1 bottle of solvent). In some pharmacies, the price of the drug is slightly lower - about 280 rubles.

However, it is rather problematic to buy a vaccine in a pharmacy chain. In order to purchase a vaccine, you must contact a specialized vaccination center.

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!