Церварикс

General characteristics. Structure:

Suspension for introduction in oil homogeneous, opaque, white color, without foreign inclusions, when upholding divided into 2 layers: upper - transparent colourless liquid, lower - a white deposit.

 0.5 ml (1 dose)
Active ingredient: L1 of a squirrel of a virus of papilloma of the person
     mkg type 16 20
     mkg type 18 20

Excipients: 3-o-dezatsil-4-monophosphoryl a lipid And, aluminum hydroxide, sodium chloride, dihydrophosphate sodium a dihydrate, water for and.

Pharmacological properties:

The recombinant adsorbed vaccine for prevention of the diseases caused by the viruses of papilloma of the person (VPP) containing AS04 adjuvant. Represents mix of virus-like particles of recombinant surface proteins of VPCh of types 16 and 18 which action is strengthened by means of the adjuvant AS04 system.

L1 of a squirrel of VPCh-16 and VPCh-18 are received with use of recombinant bakulovirus of VPCh-16 and VPCh-18 on culture of cells of Trichoplusia ni (Hi-5 Rix4446). AS04 consists of aluminum of hydroxide and 3-O-dezatsil-4-monofosforillipida And (MFL).

According to epidemiological data in most cases cancer of a neck of uterus is caused by oncogenous viruses of papilloma of the person. VPCh-16 and VPCh-18 are responsible for emergence more than 70% of cases of cancer of neck of uterus, and also about 50% of all cases of development of cervical intraepithelial defeats worldwide.

Clinical performance

Tservariks's efficiency concerning VPCh-16 and VPCh-18 and effects connected with infection is confirmed with the clinical trials including 1113 faces at the age of 15-25 years. The combined analysis of results of a research and the subsequent 4 years' observation showed:

— 94.7% efficiency in prevention of infection (95% of CI: 83.5; 98.9);

— 96.0% efficiency concerning a cervical infection, persistent for at least 6 months (95% of CI: 75.2; 99.9);

— 100% efficiency concerning a cervical infection, persistent for at least 12 months (95% of CI: 52.2);

— 95.7% efficiency concerning the VPCh-infection revealed at a stage of cytologic disturbances * (95% of CI: 83.5; 99.5);

— 100% protection against development of the VPCh-infection revealed histologically at CIN1+ stage ** (95% of CI: 42.4; 100);

— 100% protection against development of the VPCh-infection revealed histologically at CIN2+ stage *** (95% of CI:-7.7; 100).

* - the disturbances revealed cytologic include atypical flat cells of not clear value (ASC-US), low extent of planocellular intraepithelial defeat (LSIL), high extent of planocellular intraepithelial defeat (HSIL) and existence of atypical flat cells at which it is impossible to exclude HSIL(ASC-H).

** CIN1 + - an intraepithelial cervical neoplasia of 1 degree above.

*** CIN2 + - an intraepithelial cervical neoplasia 2 degrees above

The vaccine provides cross protection at 40.6% vaccinated concerning any displays of the VPCh-infection revealed cytologic, caused by other VPCh oncogenous types (95% of CI: 14.9; 58.8). The vaccine is effective concerning development of any CIN2 of defeats (regardless of the VPCh virus DNA type) at 73.3% of subjects (95% of CI:-1.0; 95.2).

Vaccine immunogenicity

The full course of vaccination (according to the scheme of 0-1-6 months) leads to formation of specific antibodies against VPCh-16 and VPCh-18 which were defined at 100% vaccinated in 18 months after introduction of the last dose of a vaccine in age groups from 10 to 25 years.

The maximum expressiveness of an immune response was noted upon completion of a vaccination course (the 7th month) at once. Antibodies remained for 4 years of the subsequent observation after introduction of the first dose.

Neutralized ability of the developed antibodies is in addition proved.

All initially seronegative women, including an age group of 46-55 years, became seropositive on end of a course of vaccination (the 7th month), the level of antibodies for 7 months was at least 3-4 times higher, than observed in researches on efficiency assessment for 18 months after vaccination. Protective level of antibodies was observed in 18 months and remained at the previous level during the four-year period of observation, without the subsequent decrease.

At women, initially seropositive concerning VPCh-16 and/or VPCh-18, Tservariks® caused development of the same level of antibodies as at initially seronegative women, at the same time the antiserum capacity was much higher, than developed after the postponed infection

The adjuvant AS04 system causes longer immune response surpassing that when using salts of aluminum as adjuvant. The antiserum capacity when using AS04 a minimum was twice higher within 4 years after introduction of the first dose, and the quantity of V-lymphocytes of memory surpassed approximately twice for 2 years after introduction of the first dose.

Indications to use:

— prevention of cancer of neck of uterus at women from 10 to 25 years;

— prevention of the acute and persistent infections caused by VPCh, cellular disturbances, including development of atypical flat cells of not clear value (ASC-US), intraepithelial cervical neoplaziya (CIN), precancerous damages (CIN2+) caused by the oncogenous viruses of papilloma of the person (VPP) at women from 10 to 25 years.

Route of administration and doses:

Церварикс® enter in oil, into the area of a deltoid muscle. Церварикс® under no circumstances it is impossible to enter intravenously or vnutrikozhno.

Before use the vaccine needs to be checked visually for lack of foreign particles and it is good to stir up the syringe or a bottle to receive opaque suspension of whitish color. If the vaccine does not match the provided description or contains foreign particles, it should be destroyed.

Schemes of vaccination

The recommended single dose for girls is more senior than 10 years and women are made by 0.5 ml.

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

Need of a revaccination is so far not established.

Features of use:

Церварикс® it is necessary to apply with care at thrombocytopenia or disturbances of coagulant system of blood as during introduction in oil developing of bleedings is possible.

There are no data on an opportunity п / to Tservariks's introduction now.

It is improbable that Tservariks® can cause regression of defeats, and also prevent progressing of the disease caused by VPCh-16 and/or VPCh-18, which was available prior to vaccination in this connection use of a vaccine is for this purpose not shown. Clinical data demonstrate that Tservariks® is safe and иммуногенен at appointment to persons, seropositive concerning VPCh-16 and/or VPCh-18 of types in which at a cytologic research signs of intraepithelial defeat are not found or there are only atypical flat cells of not clear value (ASC-US).

Vaccination does not prevent the infection and diseases caused by the VPCh some types.

Vaccination is method of primary prevention and does not cancel need of carrying out regular inspections at the doctor (secondary prevention).

Due to a possibility of development in rare instances anaphylactic reaction, vaccinated has to be under medical observation within 30 min., and rooms for medical procedures have to be provided with means of antishock therapy.

At patients with immunodeficiency, for example, at HIV infection, the adequate immune response can be not reached.

Influence on ability to driving of motor transport and to control of mechanisms

Special researches about influence of a vaccine on abilities to driving or work with mechanisms were not conducted. However it is necessary to consider a clinical condition of patients and a profile of undesirable reactions.

Side effects:

In controlled researches of the vaccine Tservariks® pain in the place of an injection most often was registered.

The undesirable reactions given below are grouped in systems of bodies and frequency of occurrence: very often (≥10%), it is frequent (≥1%, but <10%), sometimes (≥0.1%, but <1%), is rare (≥0.01%, but <0.1%), is very rare (<0.01%), including separate messages.

From TsNS: very often - a headache; sometimes - dizziness.

From the alimentary system: often - nausea, vomiting, diarrhea, pains in a stomach.

From skin and its appendages: often - an itch, rash, urticaria.

From a musculoskeletal system and connecting fabric: very often - a mialgiya; often - an arthralgia; seldom — muscular weakness.

Infectious complications: sometimes - upper respiratory tract infections.

From an organism in general and connected with an injection site: very often - the feeling of fatigue, local reactions including pain, reddening, a swelling; often - fever (≥38 °C); sometimes - the other reactions in an injection site including consolidation, decrease in local sensitivity, an itch.

Interaction with other medicines:

Data on Tservariks's interaction with other vaccines at their simultaneous use are absent.

During clinical trials it was established that about 60% of the women receiving the vaccine Tservariks® applied oral contraceptives. Data on negative influence of contraceptives on immunological efficacy of Tservariks® are absent.

It is supposed that at the patients receiving immunodepressants, the adequate immune response can be not reached.

Contraindications:

— hypersensitivity to any of vaccine components;

— hypersensitivity reactions on the previous Tservariks's introduction.

Tservariks's introduction has to be postponed at persons with the acute feverish state caused including an exacerbation of chronic diseases.

 

Use of the drug TSERVARIKS® at pregnancy and feeding by a breast

Controlled researches on use of the vaccine Tservariks® at pregnancy and during feeding by a breast were not conducted.

In pilot studies data on a possible negative impact of a vaccine on formation of a fruit or post-natal development were not obtained. Nevertheless, vaccination by Tservariks at pregnancy it is recommended to postpone and carry out it after the delivery.

In pilot studies on animals it was shown that allocation of antibodies to vaccine antigens with milk is possible.

Overdose:

So far about cases of overdose it was not reported.

Storage conditions:

It is necessary to store and transport drug at a temperature from 2 ° to 8 °C; not to freeze. To store in the place, unavailable to children. A period of validity - 3 years.

Issue conditions:

According to the recipe

Packaging:

• сусп. for introduction of 40 mkg in oil / 0.5 ml (1 dose): фл. 1, 10 or 100

• сусп. for introduction of 40 mkg in oil / 0.5 ml (1 dose): syringes 1 or 10