TSERVARYKS

Active material: Human papilloma
When ATH: J07BM02
CCF: A vaccine for the prevention of diseases, caused by human papillomavirus
ICD-10 codes (testimony): B97.7, C53
When CSF: 14.03.01.26
Manufacturer: GlaxoSmithKline Trading Company (Russia)

Pharmaceutical form, composition and packaging

Suspension for the / m Homogeneous, opaque, white, without foreign impurities, When defending, divided into 2 layer: upper – transparent colorless liquid, lower – White sediment.

Excipients: 3-O-Dezacil-4′-Monophosphory lipid A, aluminum hydroxide, sodium chloride, sodium dihydrogen phosphate dihydrate, water d / and.

0.5 ml – bottles (1) – packs cardboard.
0.5 ml – bottles (10) – packs cardboard.
0.5 ml – bottles (100) – packs cardboard.
0.5 ml – syringes (1) in the kit with 1 or 2 or without needles – packs cardboard.
0.5 ml – syringes (10) in the kit with 1 or 2 or without needles – packs cardboard.

Pharmacological action

Recombinant adsorbed vaccine for the prevention of diseases, caused by the viruses of human papilloma (HPV), containing adjuvant AS04. It is a mixture of virus -like particles of recombinant surface proteins of VPV types 16 and 18, whose action is enhanced using the adjuvant system AS04.

L1 VPV-16 and HPV-18 proteins were obtained using recombinant baculoviruses of HPV-16 and HPV-18 on Trichoplusia ni cell culture (HI-5 RIX4446). AS04 consists of aluminum of hydroxide and 3-o-Dezacil-4′-monophosphorylipid A (MFL).

In accordance with epidemiological data in most cases, cervical cancer is caused by cancer viruses of human papilloma. HPV-16 and HPV-18 are responsible for the emergence of more 70% cervical cancer cases, And also approximately 50% all cases of the development of cervical intraepithelial lesions around the world.

Clinical efficacy

The effectiveness of the CERVICE^® In relation to HPV-16 and HPV-18 and the consequences related to infection are confirmed by clinical research, included 1113 persons aged 15-25 years. A combined analysis of the results of the study and the subsequent 4-year observation showed:

- 94.7% effectiveness in preventing infection (95% CI: 83.5; 98.9);

- 96.0% effectiveness in relation to cervical infection, Persizing for at least 6 Months (95% CI: 75.2; 99.9);

- 100% effectiveness in relation to cervical infection, Persizing for at least 12 Months (95% CI: 52.2);

- 95.7% efficiency in relation to HPV infection, identified at the stage of cytological disorders* (95% CI: 83.5; 99.5);

- 100% Protection against the development of HPV infection, detected histologically, at the stage CIN1+** (95% CI: 42.4; 100);

- 100% Protection against the development of HPV infection, detected histologically, At the CIN2+*** stage (95% CI: -7.7; 100).

* – infringement, identified cytologically, include atypical flat cells of an unclear value (ASC-US), Low degree of plane -cell intraepithelial lesion (LSIL), high degree of plane -cell intraepithelial lesion (Antiquity) and the presence of atypical flat cells, in which HSIL cannot be excluded(ASC-H).

** Cin1+ – Intraepithelial cervical neoplasia 1 degree and higher.

*** CIN2+ – Intraepithelial cervical neoplasia 2 degree and higher

The vaccine provides cross protection at 40.6 % vaccinated against any manifestations of HPV infection, identified cytologically, caused by other oncogenic types of HPV (95% CI: 14.9; 58.8). The vaccine is effective regarding the development of any CIN2 lesions (Regardless of the type of DNA of the VPV virus) in 73.3% subjects (95% CI: -1.0; 95.2).

Vaccine immunogenicity

A full course of vaccination (scheme 0-1-6 Months) leads to the formation of specific antibodies against HPV-16 and HPV-18, determined by 100% vaccinated through 18 months after the introduction of the last dose of the vaccine in age groups from 10 to 25 years.

The maximum severity of the immune response was noted immediately at the end of the vaccination course (7-her meat). Antibodies were preserved during 4 years of subsequent observation after the introduction of the first dose.

Additionally, the neutralizing ability of the produced antibodies has been proven.

All originally seronagal women, including the age group 46-55 years, became seropositive in the end of the vaccination course (7-her meat), The level of antibodies on 7 the month was at least in 3-4 times higher, than observed in studies on evaluating effectiveness on 18 month after vaccination. The protective level of antibodies was observed through 18 months and remained at the same level during the four -year observation period, Without subsequent reduction.

Women, Initially seropositive in relation to HPV-16 and/or HPV-18, Tservaryks^® caused the production of the same level of antibodies, Like the original seronagent women, At the same time, the titer of antibodies was significantly higher, than produced after an infection.

AS04 adjuvant system causes a longer immune response, surpassing such aluminum salts as adjuvant. The titer of antibodies when using AS04 was at least twice as high for 4 years after the introduction of the first dose, And the number of B-lymphocytes of memory surpassed approximately half for 2 years after the introduction of the first dose.

Pharmacokinetics

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Testimony

- prevention of cervical cancer in women from women 10 to 25 years;

- prevention of acute and chronic infections, called HPV, cellular disorders, including the development of atypical flat cells of an unclear value (ASC-US), intraepithelial cervical neoplasia (CIN), precancerous defeats (CIN2+), human papillomas caused by oncogenic viruses (HPV) In women from 10 to 25 years.

Dosage regimen

Tservaryks^® injected i / m, in the area of the deltoid muscle. Tservaryks^® under no circumstances can be administered intravenously or intradermal.

Before using the vaccine, it is necessary to visually check for the absence of extraneous particles and shake the syringe or bottle well, to get an opaque whiten suspension. If the vaccine does not correspond to the above description or contains extraneous particles, It should be destroyed.

Vaccination schemes

The recommended dose for single Girls older 10 years and women is 0.5 ml.

The primary immunization scheme includes the introduction of three doses of the vaccine according to the scheme 0-1-6 months.

The need for revaccination to date has not been established.

Side effect

In controlled studies of the Vaccine Cervvarix^® most often recorded pain in the injection site.

Adverse reactions, below, grouped by organs and frequency of occurrence: Often (≥10%), often (≥1%, but <10%), sometimes (≥0.1%, but <1%), rarely (≥0.01%, but <0.1%), rarely (<0.01%), including isolated reports.

CNS: Often – headache, feeling tired; sometimes – dizziness.

From the digestive system: often – nausea, vomiting, diarrhea, abdominal pains.

On the part of the skin and its appendages: often – itch, rash, hives.

Musculoskeletal system and connective tissue: Often – myalgia; often – arthralgia; rarely - muscle weakness.

Infectious complications: sometimes – upper respiratory tract infection.

On the part of the body as a whole and associated with the place of introduction: Often – feeling tired, Local reactions, Including pain, redness, swelling; often – fever (≥38°C); sometimes – Other reactions at the place of introduction, including seal, decrease in local sensitivity, itch.

Contraindications

- increased sensitivity to any of the components of the vaccine;

- reactions of increased sensitivity to the previous introduction^®.

Introduction of Certain Current^® must be delayed in persons with an acute feverish state, caused including. exacerbation of chronic diseases.

Pregnancy and lactation

Controlled studies on the use of the Vaccine Cervvarix^® During pregnancy and during breastfeeding, no.

IN experimental studies There was no data on the possible negative impact of the vaccine on the formation of the fetus or postnatal development. Nonetheless, Vaccination with ceremonies^® During pregnancy, it is recommended to postpone and conduct it after childbirth.

IN experimental studies on animals have shown, that it is possible to secrete antibodies to antigens of a vaccine with milk.

Cautions

Tservaryks^® should be used with caution for thrombocytopenia or disorders of the blood coagulation system, Since bleeding may occur during the/m of administration.

There is currently no data on the possibility of p/to the introduction of ceremonies^®.

Unlikely, that ceremonies^® can cause regression of lesions, and also prevent the progression of the disease, called HPV-16 and/or HPV-18, available before the start of vaccination, In this connection, the use of the vaccine for this purpose is not shown. Clinical data indicate, that ceremonies^® Safe and immunogenic when appointing persons, seropositive in relation to HPV-16 and/or HPV-18 types, In which, during a cytological study, signs of intraepithelial lesion were not found or there are only atypical flat cells of an unclear value (ASC-US).

Vaccination does not prevent infection and disease, due to some types of HPV.

Vaccination is the method of primary prevention and does not cancel the need for regular examinations by a doctor (secondary prevention).

In connection with the possibility of developing anaphylactic reaction in rare cases, vaccinated must be under medical supervision during 30 m, and procedural rooms should be provided with anti -shock therapy.

In patients with immunodeficiency conditions, eg, with HIV infection, adequate immune response may not be achieved.

Effects on ability to drive vehicles and management mechanisms

Special studies on the influence of the vaccine on the ability to drive a car or work with mechanisms were not carried out. However, the clinical condition of the patients and the profile of undesirable reactions should be taken into account.

Overdose

Until now, cases of overdose have not been reported.

Drug Interactions

Data on the interaction of ceremonies^® with other vaccines with their simultaneous use are absent.

During clinical studies, it was established, roughly 60% Women, who received the ceremonies of the Vaccine^®, They used oral contraceptives. Data on the negative impact of contraceptives on the effectiveness of the Vaccine Cervvarix^® no.

Expected, that patients, receiving immunosuppressants, adequate immune response may not be achieved.

Conditions of supply of pharmacies

Packaging, contains 1 syringe or bottle, Vocated the recipe.

Packaging, contains 10 or 100 syringes or bottles, Designed for medical institutions.

Conditions and terms

The drug should be stored and transported at a temperature of 2 ° to 8 ° C; Do not freeze. Keep out of the reach of children. Shelf life – 3 year.