Гардасил®

General characteristics. Structure:

Active ingredient: 120 mkg of L1 of protein of a virus of papilloma of the person (including: 20 mkg of type 6, 40 of mkg of type 11, 40 of mkg of type 16, 20 of mkg of type 18).

Excipients: aluminum hydroxyphosphate sulfate amorphous, sodium chloride, a L-histidine, polysorbate 80, sodium borate, water for injections.

Does not contain preservatives and antibiotics.

Kvadrivalentny recombinant vaccine against the virus of papilloma of the person (VPP).

Pharmacological properties:

Pharmacodynamics. Immunological efficacy of Gardasil® is mediated by formation of protective immunity with development of a humoral and cellular immune response against VPCh. Risk of infection of VPCh during life, without vaccination, sexually active people have more than 50%, and it constantly grows. Carrying out a course of vaccination by the drug Gardasil®, leads to prevention of the diseases caused by VPCh.

Infection with the VPCh oncogenous types is an indispensable condition of development of cancer of neck of uterus (planocellular and adenocarcinomas) and precancerous dysplastic states. Besides, at men and women of VPCh is the reason of cancer of external genitals and the proctal channel, considerably increases risk of development of cancer of bodies of the head and neck, especially stomatopharynx cancer, leads to development of anogenitalny condylomas and causes a recurrent respiratory papillomatosis of children and adults.

Clinical performance. On the basis of the conducted researches at 24 358 women and girls from 9 to 45 years and at 4055 men and boys from 9 to 26 years the high profile of efficiency and safety of the vaccine Gardasil® was confirmed.

At women from 16 to 26 years the vaccine Gardasil® effectively prevented cancer and precancerous dysplastic conditions of a neck of uterus, vulva, vagina, and also anogenitalny condylomas in 98-100% of cases. The analysis of cross protective efficiency shows that introduction of the vaccine Gardasil® promotes decrease in risk of development of a dysplasia of a neck of uterus (CIN 1/2/3) and adenocarcinoma of in situ (AIS) caused most by the VPCh widespread oncogenous types which are not a part of a vaccine.

At women from 24 to 45 years the vaccine Gardasil® was effective for prevention of a persistent infection of CIN (any degree) or anogenitalny damages caused by VPCh 6, 11, 16 and 18 types in 88.7% of cases.

At young men and men the vaccine Gardasil® prevented the outside genital defeats (anogenitalny condylomas and a perineal, perianal intra epithelial neoplasia, an intra epithelial neoplasia of a penis 1/2/3 degrees) caused by VPCh of 6,11,16,18 types in 90.6% of cases, and also a proctal intra epithelial neoplasia (AIN) 1/2/3 of degree in 77.5% of cases.

Immunogenicity. Carrying out a full course of vaccination leads to formation of specific antibodies to four VPCh types - 6, 11, 16 and 18 - more than at 98% vaccinated. Existence of immunological memory at vaccination seropositive (at the time of vaccination) women was shown. Besides, at women who received an additional dose of the vaccine Gardasil® in five years after a complete course of vaccination the bystry and expressed anamnestic immune response at which average geometrical antiserum capacities exceeded the credits received in a month after primary immunization was observed.

At girls and boys from 9 to 15 years clinical trials of studying of safety and an immunogenicity were conducted, and on the basis of an immune bridzhing immunological efficacy at teenagers was shown.

Pharmacokinetics. The vaccines Gardasil® given on pharmacokinetics are absent.

Indications to use:

Prevention of the following diseases at girls and women aged from 9 up to 45 years:

— cancer of a neck of uterus, vulva, vagina and the proctal channel caused by VPCh 16 and 18 of types;

— anogenitalny condylomas (condiloma acuminata) caused by VPCh 6 and 11 of types;

— a cervical intra epithelial neoplasia 1/2/3 degrees (CIN), an adenocarcinoma of a neck of uterus of in situ (AIS) caused by VPCh 6, 11, 16 and 18 of types;

— the intra epithelial neoplasia of a vulva (VIN) and a vagina (VaIN) 1/2/3 of degree caused by VPCh 6, 11, 16 and 18 of types;

— the intra epithelial neoplasia of proctal channel 1/2/3 of degree caused by VPCh 6, 11, 16 and 18 of types.

The vaccine Gardasil® can provide protection at girls and women aged from 9 up to 26 years from the diseases caused by VPCh of the types which are not a part of a vaccine.

The vaccine Gardasil® is shown to use for boys and men aged from 9 up to 26 years for prevention of the following diseases:

— cancer of the proctal channel caused by VPCh 16 and 18 of types;

— anogenitalny condylomas (condiloma acuminate) caused by VPCh 6 and 11 of types;

— precancerous, dysplastic states and the intra epithelial neoplasia of proctal channel 1/2/3 of degree caused by VPCh 6, 11,16, 18 of types.

Route of administration and doses:

The vaccine Gardasil® is entered in oil into a deltoid muscle or a verkhnenaruzhny surface of an average third of a hip.

The vaccine is not intended for in/in introductions. For all age groups the single dose of a vaccine makes 0,5 ml.

The recommended course of vaccination consists of 3 doses and is carried out according to the scheme (0-2-6 months): the first dose – in appointed day; the second dose – in 2 months after the first; the third dose – in 6 months after the first.

The accelerated scheme of vaccination at which the second dose is entered in 1 month after the first inoculation, and the third – in 3 months after the second inoculation is allowed.

At disturbance of an interval between inoculations the course of vaccination is considered complete if 3 vaccination are carried out during 1 year.

Need of carrying out a revaccination is not established. If for vaccination the first dose of the vaccine Gardasil® was used, then and the full course of vaccination should be conducted with use of the vaccine Gardasil®.

Before the use the bottle/syringe with a vaccine is stirred up before receiving a homogeneous muddy suspension. Homogeneity loss, emergence of the included particles and discoloration of suspension testify to unfitness of a vaccine.

The syringe filled with a vaccine is intended only for disposable and only at one person.

Opening of bottles and the procedure of vaccination are carried out at strict observance of rules of an asepsis and antiseptics. The injection site before and after an injection is processed by 70% alcohol.

It is necessary to enter all recommended dose - 0,5 ml.

Rules of introduction of a vaccine. Bottles with a single dose of a vaccine: to gain 0,5 ml of a suspension from a bottle with a single dose of a vaccine a sterile needle in the one-time sterile syringe. To enter all dose. To throw out a bottle from the remains of a vaccine.

Syringes with a single dose of a vaccine: to enter all contents of the syringe completely.

The one-time sterile, previously filled syringes with a single dose complete with the protection device: for introduction of a vaccine it is necessary to use the enclosed needle. In need of use of other needle it is necessary to be convinced that the needle reliably joins the syringe and that its length does not exceed 2.5 cm that is a necessary condition for the correct operation of the protection device.

To remove a cap from the end of the syringe. Having pressed both interfering rotation of a ledge, to fix the syringe and to attach Lyuer's needle turn clockwise. To remove a protective cap from a needle.

When carrying out an injection as it is stated above, it is necessary to press the piston, strong holding the syringe under manual ledges and to enter all dose. The protection device of a needle will not work if all dose is not entered. To take a needle. To release the piston and to allow the syringe to move up to full closing of all needle. For documentation of vaccination to separate removable labels, having slowly pulled them. After the end of a procedure to throw out the syringe in a container for sharp objects.

For documentation of vaccination it is necessary to separate removable labels, having slowly pulled them.

Features of use:

Use at pregnancy and feeding by a breast. Adequate and strictly controlled researches of safety of use of Gardasil at pregnancy were not conducted.

This, testimonial that introduction of the vaccine Gardasil® makes undesirable impact on fertility pregnancy or on a fruit is not available.

And about potential impact of the vaccine Gardasil® on reproductive function of the woman and on a fruit pregnant women have not enough data on use of the vaccine Gardasil® at pregnancy to recommend use of a vaccine at pregnancy.

The vaccinated women should be warned about need of protection from pregnancy during a vaccination course, and at pregnancy approach vaccination should be postponed until its end.

Clinical trials during which efficiency, an immunogenicity and safety of the vaccine Gardasil® at nursing mothers and babies was studied showed that women can enter the vaccine Gardasil® in the period of a lactation (breastfeeding).

Use for children. At children aged up to 9 years safety and immunological efficacy of Gardasil® was not estimated.

Use for elderly patients. Adults have no data on assessment of safety and immunological efficacy of Gardasil® 45 years are more senior.

Special instructions. At the solution of a question of vaccination it is necessary to compare possible risk from the previous infection VPCh and potential advantage of vaccination.

Гардасил® it is not intended for cancer therapy of a neck of uterus, a vulva or a vagina, CIN, VIN or VaIN or an active condylomatosis and it is applied only with the preventive purpose. The vaccine is intended for prevention of infection with the VPCh that types which the patient does not have. The vaccine does not exert impact on the course of the active infections caused by VPCh. As well as at introduction of any other vaccine, at use of the vaccine Gardasil® not at all vaccinated it is possible to receive a protective immune response. Drug does not protect from diseases, sexually transmitted, other etiology. In this regard, the vaccinated patients should recommend to continue use of other prophylactics of protection.

Efficiency and Gardasil's safety at hypodermic and intradermal introduction were not studied therefore these ways of introduction are not recommended.

As well as at introduction of any vaccine, in a treatment-and-prophylactic office it is always required to have the corresponding medicines for immediate stopping of anaphylactic reaction and means of emergency and antishock treatment.

Directly after introduction of a vaccine it is necessary to watch a condition of the patient within 30 min. for the purpose of early detection of postvaccinal reactions and complications and rendering the emergency medical care. When performing any vaccination the syncope, especially at teenagers and young women can be observed.

The decision on administration of drug or on a vaccination delay in connection with the current or recent disease which is followed by the increased temperature to a large extent depends on an etiology of a disease and severity.

At persons with the broken reactivity of immune system owing to use of immunodepressants (the system corticosteroids, antimetabolites alkylating drugs, cytotoxic drugs), genetic defect, HIV infection and other reasons the protective effect can be lowered.

The vaccine Gardasil® should be entered with care to patients with thrombocytopenia and any disturbances of a blood coagulation as after an injection in oil at such persons bleeding can develop.

The medical personnel are obliged to provide all necessary information on vaccination and a vaccine to patients, parents and trustees, including information on advantages and the interfaced risk.

Vaccinated should be warned about need to report to the doctor or the nurse about any undesirable reactions, and also that vaccination does not replace and does not cancel routine screening surveys. For achievement of effective results the course of vaccination has to be complete completely if for this purpose there are no contraindications.

Adults have no data on assessment of safety and immunological efficacy of Gardasil® 45 years are more senior.

Use in pediatrics. At children aged up to 9 years safety and immunological efficacy of Gardasil® was not estimated.

Influence on ability to driving of motor transport and to control of mechanisms. Researches of influence of a vaccine on ability to control of motor transport and work with mechanisms were not conducted.

Claims for specific and physical properties of a vaccine and about all cases of the increased reactogenicity or development of postvaccinal complications send to the address of representative office of the producer in the territory of Russia: LLC MSD Pharmasyyutikals.

It is intended for sanitary and preventive and treatment and prevention facilities.

Side effects:

Side reactions which were observed in connection with introduction of the vaccine Gardasil® to 1% of cases and more often than at persons to whom entered placebo.

Determination of frequency of side reactions: very often (≥1/10); often (≥1/100, <1/10); infrequently (≥ 1/1000, <1/100); seldom (≥1/10 000, <1/1 000); very seldom (<1/10 000).

From a musculoskeletal system: often - extremity pain.

From respiratory system: very seldom - a bronchospasm.

General frustration: often - a pyrexia.

Local reactions (is more often in group which entered the vaccine Gardasil® in comparison with any drugs containing hydroxyphosphate aluminum adjuvant sulfate amorphous or in comparison with group which entered placebo solution) very often - reddening, pain and a swelling; often - an itch, a hematoma. The majority of local reactions were easy severity.

During post-registration use of the vaccine Gardasil® spontaneous information on development in vaccinated following side reactions arrived, authentically it is not possible to estimate the frequency of which and communication with an inoculation.

Infectious and parasitic diseases: cellulitis.

From system of a hemopoiesis and lymphatic system: lymphadenopathy, idiopathic Werlhof's disease.

From a nervous system: dizziness, acute primary idiopathic polyradiculoneuritis, a headache, a syndrome to Giyena-Barra, the acute disseminated encephalomyelitis, a syncope which sometimes is followed by toniko-clonic spasms.

From the alimentary system: nausea, vomiting.

From a musculoskeletal system: arthralgia, mialgiya.

General frustration: adynamy, fatigue, fever, discomfort.

Allergic reactions: hypersensitivity reactions, including anaphylactic/anaphylactoid reactions, a bronchospasm and a small tortoiseshell.

Interaction with other medicines:

Results of clinical trials show that the vaccine Gardasil® can be entered at the same time (into other site) with a recombinant vaccine against hepatitis B, a vaccine meningococcal, conjugated with a diphtherial anatoxin and with the inactivated vaccine against diphtheria, tetanus, whooping cough (an acellular component), poliomyelitis.

Use of analgetics, antiinflammatory drugs, antibiotics and vitamin drugs did not influence efficiency, an immunogenicity and safety of a vaccine.

Hormonal contraceptives, corticosteroids for inhalation topical and parenteral administration did not influence an immunogenicity, efficiency and safety of the vaccine Gardasil®.

Data on simultaneous use of system immunodepressants and the vaccine Gardasil® are absent.

Contraindications:

— hypersensitivity to active components and fillers of a vaccine;

— at emergence of symptoms of hypersensitivity to Gardasil introduction of the subsequent dose of a vaccine is contraindicated.

Relative contraindications: disturbances of coagulability of blood owing to hemophilia, thrombocytopenia or against the background of reception of anticoagulants. In need of use of a vaccine for this category of patients it is necessary to estimate potential advantages of vaccination and the risk interfaced to it. At vaccination in such cases it is necessary to take measures for decrease in risk of formation of a post-injection hematoma.

Overdose:

There are messages on cases of introduction of the vaccine Gardasil® in the doses exceeding recommended. In general character and expressiveness of the undesirable phenomena at overdose were comparable to those at introduction of the recommended single doses of this vaccine.

Storage conditions:

The vaccine should be stored in the unavailable to children, protected from light place, at a temperature from 2 °C to 8 °C; not to freeze. A period of validity - 3 years. Гардасил® it is necessary to enter as soon as possible after extraction from the refrigerator. Гардасил® it is possible to hold out of the refrigerator (at a temperature of 25 °C or below) no more than 72 h.

Issue conditions:

According to the recipe

Packaging:

0.5 ml - bottles glass with a capacity of 3 ml (1) - packs cardboard.
0.5 ml - bottles glass with a capacity of 3 ml (10) - packs cardboard.
0.5 ml - syringes one-time glass with a capacity of 1.5 ml (1) - planimetric strip packagings with a cover (1) - packs cardboard.
0.5 ml - syringes one-time glass with a capacity of 1.5 ml (10) - planimetric strip packagings with a cover (1) - packs cardboard.
0.5 ml - syringes one-time glass with a capacity of 1.5 ml (1) with the device for safe introduction complete with 1 or 2 sterile needles - planimetric strip packagings with a cover (1) - packs cardboard.
0.5 ml - syringes one-time glass with a capacity of 1.5 ml (10) with the device for safe introduction complete with 1 or 2 sterile needles - planimetric strip packagings with a cover (1) - packs cardboard.