Vaccination Gardasil what. Which is better - Cervarix or Gardasil? Use of the Gardasil vaccine

Starting in 2009, in all clinics, schools and private medical centers, the female population of our country began to offer a new way to prevent cervical cancer - vaccination against (). According to the developed vaccination program, only girls and women of childbearing age from 12 to 50 years. Let's remember this fact. Let us also remember that this virus affects men as often as women, but, oddly enough, they are not in a hurry to vaccinate them.

Viruses that cause the formation of papillomas on the skin and mucous membranes in humans have been known for a very long time as wart viruses. There are about 100 (!) different types of viruses that cause skin warts and mucosal ulcers. They are transmitted by contact and more than 80% of the population of our planet are carriers of this infection. It is believed that in order for the carriage to turn into a disease, a weakening of the body's immune system, stress, etc. are needed. There is also an opinion that some types of papillomas can degenerate into cancer. And in order to prevent this from happening, a preventive vaccination is needed: no virus, no cancer!

At your choice, the programs include two vaccines of the same type of action, but from different foreign manufacturers - Gardasil (manufacturer: & Dohme, the Netherlands) and (manufacturer: Belgium). As the ad says, " GARDASIL and are the only vaccines that protect against cervical cancer and other serious diseases caused by: cervical dysplasia, genital warts, etc. The vaccines are FDA approved and officially registered in the USA, Australia / New Zealand, Canada, Mexico, Brazil in the countries of the European Union».

Read on: " Gardasil was developed in the USA in the early 90s. The quality is confirmed by international clinical studies. The experiments, which lasted for 15 years, culminated in clinical trials, in which more than 21,000 women took part in different countries of the world.».

In private medical centers, these vaccinations were not given free of charge. So, a standard series of three vaccinations cost from 17,000 to 26,000 rubles. In schools and polyclinics, vaccination was financed from the budget. If you multiply these amounts by the number of women who do not want to get cervical cancer, you get a very round sum.

So what actually caused such a touching concern for the female part of the population of our country and a complete disregard for the male? Are these drugs so effective, and most importantly, safe?

Vaccine Gardasil (Gardasil) cripples people

In 2007, independent studies on the topic began to appear.

For example, the major American information portal News Tagit carefully reviewed a study published in the Journal of the American Medical Association (JAMA, August 2007) entitled "Effect of a vaccine with a 16/18 L1 human-like particle in women with a previous infection ". The study aimed to establish the benefit of the vaccine against carrier women (which in fact include all sexually active women regardless of age). This article, reprinted from the Journal of the American Medical Association, can be found in the University of Louisville Documents Archive. The research report can also be found on our website (in case the University of Louisville suddenly "loses" it).

This document contains amazing data on the ineffectiveness of the vaccine. It says that the vaccine against often caused an increase in the amount of the virus and was completely unable to rid the body of most women of it. These shocking results led the study authors to the following sound conclusion, published in the Journal of the American Medical Association:

“There was no significant evidence of a therapeutic effect of the vaccine in the analyzes of women who received all doses of the vaccine, compared with the analyzes of women who had only HPV infection. We found no evidence of vaccine efficacy. Vaccination does not affect the rate of elimination of the virus over a 12-month period. Further studies on the effectiveness of BLA (biologics license application) found that Gardasil can increase the risk of disease by 44.6% in certain people, namely those who are already carriers of the types used in the vaccine.

In other words, it has been found that a vaccine given to a young woman who is already a carrier in a "harmless" state can "activate" the infection and directly lead to the appearance of a precancerous lesion. I.e Vaccine may accelerate development of precancerous lesions in women.

This information was simply withheld from discussion of the Gardasil vaccination policy. The pharmacology politicians called for "saving lives" and claimed that Gardasil was the perfect protection for all women, with absolutely no increase in cancer risk. And these documents show that Gardasil may contribute to a serious increase in the risk of cervical cancer in patients.

The authors of the study found no evidence that the vaccine works at all. This observation led the authors to the damning conclusion that Gardasil is nothing but a grand medical scam.

Researchers have gone out of their way to come up with arguments that would prompt every physician, governor, and public health authority in the United States (and around the world) to reconsider Gardasil vaccination policy. But no one listened to them.

It is difficult to honestly look at these scientific evidence and conclusions and not conclude that the mandatory Gardasil vaccination policy that is being pushed around the world today is based on anything but scientific evidence. According to News Tagit, there are several theories that explain the motivation for such a policy.

financial benefit

Pharmaceutical companies ("Big Pharma") impose mandatory vaccination policies in order to profit from selling more vaccine worldwide. This idea is supported, at least in part, by the fact that Texas Gov. Rick Perry, the first state governor to make such vaccination mandatory, had secret ties to a pharmaceutical company (the top official in Perry's administration worked directly for Gardasil Corporation). ). You can read the true story of Merck and its crimes.

Sheep control

According to this theory, the main purpose of mandatory vaccination is to teach the American people to obey the mandatory drugs. If the introduction of mandatory medicines to some part of the population is successful, then such a policy can be extended to other groups and eventually cover the entire population.

Conspiracy to poison people

This theory, which will disbelieve some readers, suggests that such mandatory vaccinations are introduced to create disease in the future by poisoning people with dangerous chemicals and DNA fragments known to be in vaccines. Poisoning people will affect the future revenues of pharmaceutical companies when new serious diseases appear that require drug "treatment". Many people who support this theory actually believe that AIDS, for example, was created by scientists and then introduced through vaccines into the New York gay population in the late 1980s.

Theories about financial gain are easy to believe, and it is easy to believe in the desire of those in power to have total control over citizens. Let's take a closer look at the third point.

For 20 years, various major world scientific centers have been developing a contraceptive vaccine designed to solve the problem of overpopulation of our planet. The studies were carried out within the framework of the WHO program on reproductive health. They were financed by the Rockefeller Foundation, and controlled by the Population Council, the World Bank, the United Nations Development Program and other global "humanist" organizations. WHO spent about 365 million dollars on these developments, and by the beginning of the 90s, such a vaccine . The essence of the action of this vaccine was as follows:

In the body of a pregnant woman, a special hormone is produced - human chorionic gonadotropin (CGT). Without it, the development of pregnancy is impossible, and a decrease in its level leads to miscarriage. This is a hormone “familiar” to a woman’s body, and antibodies are not produced on it that attack and destroy it. But if, with the help of genetic engineering, this hormone is attached to some foreign protein - for example, a weakened virus - and introduced into the body as a vaccine, then antibodies will be produced against it, like against this virus. The "stranger", consisting of a harmful virus and a beneficial hormone, will be destroyed. Antibodies remain in the body for a long time, so as soon as a woman becomes pregnant, they destroy the CTG that has appeared, and a miscarriage occurs.

A similar tetanus vaccine has been anonymously tested on thousands of women in the poor countries of Latin America, Nicaragua, Mexico. Apparently, the wave of these vaccinations has reached our country. A lot of things match up. Both there and here we are talking only about women of childbearing age, although both men and children are ill. And there, and here the same schedule of vaccinations - three times with a small interval between injections. Both here and there are harsh, frightening advertising of the drug and dubious scientific evidence of its effectiveness.

The population of our country, which has a vast territory and the richest subsoil, greatly hinders the World Elite from managing these reserves. The theory of the "Golden Billion" has long ceased to be a theory and has become a practice. Therefore, to reduce the number of the population, all means are put into action. Agree, it is much more profitable that children are not born at all than to fight with "extra eaters" later. To do this, every year there are "increasingly effective" vaccines "for the prevention of deadly diseases" and hysteria is whipped up about the need for mass vaccination.

Keep this in mind when you are persistently offered to get vaccinated with some new imported supervaccine that will permanently save you from health problems. Think a thousand times why and who needs it.

Rutribune note. The mention of a series of three vaccinations brings to mind the widely published materials last year that exposed the myth of "swine flu". They talked about, among other things, the three-vaccine system.

The first vaccine neutralizes white blood cells (the immune system), the second introduces viruses into the body, and the third reactivates the immune system. In the second stage, the viruses spread throughout the body, but the person does not feel sick because the immune system is inactive. When the immune system is activated again, it attacks the viral cocktail with such force that the body cannot stand it and dies. This syndrome is called "cycotine storm" - an overloaded immune system sends so many antibodies to infected areas that vital organs "burn out".

The epidemic and even almost a pandemic of "swine flu" disappeared as suddenly as it began. Viruses change, but the principle of three vaccinations remains the same. Which makes me think at least.

Quadrivalent human papillomavirus (HPV) vaccine.
Preparation: GARDASIL®
The active substance of the drug: human papillomavirus vaccine, recombinant
ATX encoding: J07BM01
CFG: Vaccine for the prevention of diseases caused by the human papillomavirus
Registration number: LS-002293
Date of registration: 24.11.06
The owner of the reg. credit: MERCK SHARP & DOHME B.V. (Netherlands)

Gardasil release form, drug packaging and composition.

Suspension for i / m administration is opaque, white.

0.5 ml
L1 human papillomavirus proteins
120 mcg
including type 6
20 mcg
type 11
40 mcg
type 16
40 mcg
type 18
20 mcg

Excipients: aluminum in the form of amorphous aluminum hydroxyphosphate-sulphate adjuvant (225 mcg), sodium chloride (9.56 mg), L-histidine (780 mcg), polysorbate 80 (50 mcg), sodium borate (35 mcg), water for injection .

0.5 ml - 3 ml vials (1) - cardboard packs.
0.5 ml - 3 ml vials (10) - cardboard packs.
0.5 ml - disposable syringes with a volume of 1.5 ml (1) with a device for safe injection (or without it), complete with 1 or 2 sterile needles (or without needles) - blister packs (1) - packs of cardboard.
0.5 ml - disposable syringes with a volume of 1.5 ml (6) with a device for safe injection (or without it), complete with 6 or 12 sterile needles (or without needles) - blister packs (1) - packs of cardboard.

The description of the drug is based on the officially approved instructions for use.

Pharmacological action of Gardasil

Quadrivalent human papillomavirus (HPV) vaccine. It is a sterile suspension for IM administration, prepared from a mixture of highly purified virus-like particles (VLP) of recombinant major capsid protein (L1) of HPV types 6, 11, 16 and 18. L1 proteins are produced by separate fermentation in recombinant Saccharomyces cerevisiae CANADE 3C-5 (Strain 1895) and form VHF by self-assembly. HPS for each type are purified and adsorbed on an aluminum-containing adjuvant (amorphous aluminum hydroxyphosphate sulfate).

Conducting a full course of vaccination leads to the formation of specific antibodies to four types of HPV - 6, 11, 16 and 18 - in a protective titer in more than 99% of those vaccinated for a period of at least 36 months in all age groups.

The vaccine is almost 100% effective in preventing HPV types 6, 11, 16 and 18-induced genital cancers, precancerous epithelial dysplasia and genital warts.

Pharmacokinetics of the drug.

Data on the pharmacokinetics of the Gardasil vaccine are not available.

Indications for use:

Prevention of the following diseases caused by human papillomavirus types 6, 11, 16 and 18 in children and adolescents aged 9 to 17 years and in young women aged 18 to 26 years:

Cancer of the cervix, vulva and vagina;

Genital warts (condiloma acuminata);

Prevention of precancerous dysplastic conditions in children and adolescents aged 9 to 17 years and in young women aged 18 to 26 years:

Adenocarcinomas of the cervix in situ (AIS);

Cervical intraepithelial neoplasia grades 2 and 3 (CIN 2/3);

Vulvar intraepithelial neoplasia grades 2 and 3 (VIN 2/3);

Vaginal intraepithelial neoplasia grades 2 and 3 (VaIN 2/3);

Cervical intraepithelial neoplasia grade 1 (CIN 1).

Dosage and method of application of the drug.

Gardasil vaccine is administered intramuscularly into the deltoid muscle or anterolateral thigh. The vaccine is not intended for intravenous administration.

For children and adolescents aged 9 to 17 years and young women aged 18 to 26 years, a single dose of the vaccine is 0.5 ml.

An accelerated vaccination schedule is allowed, in which the second dose is administered 1 month after the first vaccination, and the third dose 3 months after the second vaccination.

If the interval between vaccinations is violated, the vaccination course is considered completed if 3 vaccinations are carried out within 1 year.

The vaccine is ready to use, no further dilution or resuspension is required. Before use, the vial / syringe with the vaccine is shaken until a homogeneous cloudy suspension is obtained. Loss of homogeneity, the appearance of incorporated particles and a change in the color of the suspension indicate the unsuitability of the vaccine.

The syringe filled with the vaccine is for single use only and for one person only.

The opening of the vials and the vaccination procedure is carried out with strict observance of the rules of asepsis and antisepsis. The injection site before and after the injection is treated with 70% alcohol.

Rules for the introduction of the vaccine

Vaccine single dose vials: Draw 0.5 ml of suspension from the single dose vial with a sterile needle into a disposable syringe that does not contain preservatives, antiseptics or detergents. Enter the entire dose. Throw away the vaccine vial.

Syringes with a single dose of vaccine: inject the entire contents of the syringe completely.

Disposable, sterile, single-dose pre-filled syringes complete with safety device: Inserted needle must be used to administer the vaccine. If it is necessary to use a different needle, make sure that the needle is securely attached to the syringe and that its length does not exceed 2.5 cm, which is a prerequisite for the correct operation of the protective device.

Remove the cap from the end of the syringe. Pressing both anti-rotation tabs, secure the syringe, and attach the Luer needle by turning it clockwise. Remove the protective cap from the needle.

When injecting as above, press the plunger while holding the syringe firmly under the finger protrusions and inject the entire dose. The needle guard will not work unless the entire dose has been injected. Remove the needle. Release the plunger and allow the syringe to move up until the entire needle is completely closed. To document the vaccination, separate the removable labels by pulling them slowly. After the end of the procedure, throw the syringe into a sharps container.

Side effects of Gardasil:

After the introduction of the vaccine, in some cases, local and general reactions may develop: according to clinical studies, the following adverse events occurred with a frequency of at least 1% and more often than in the placebo group.

Local reactions: 1% - redness, swelling, soreness and itching at the injection site. The duration of reactions does not exceed 5 days and does not require the appointment of drug therapy.

General reactions: 1% - headache, short-term fever; in some cases - gastroenteritis, inflammation of the pelvic organs.

Given the theoretical possibility of developing immediate allergic reactions in particularly sensitive individuals, after the introduction of the vaccine, it is necessary to provide medical supervision for 30 minutes.

Vaccination should be carried out in a medical facility equipped with anti-shock therapy.

Contraindications to the drug:

Hypersensitivity to the active components and excipients of the vaccine;

If symptoms of hypersensitivity to Gardasil occur, the next dose of the vaccine is contraindicated.

Relative contraindications: bleeding disorders due to hemophilia, thrombocytopenia or while taking anticoagulants. If a vaccine is needed in this category of patients, the potential benefits of vaccination and the risks associated with it should be assessed. When vaccinated in such cases, it is necessary to take measures to reduce the risk of post-injection hematoma formation.

Use during pregnancy and lactation.

Category B. Adequate and strictly controlled studies of the safety of the use of Gardasil during pregnancy have not been conducted. The potential impact of the vaccine on reproductive function in women and on the fetus has not been studied.

There is no evidence that the administration of the Gardasil vaccine has an undesirable effect on fertility, pregnancy or the fetus.

Gardasil vaccine can be administered to women during lactation (breastfeeding).

Special instructions for the use of Gardasil.

The efficacy and safety of Gardasil when administered subcutaneously and intradermally have not been studied, therefore these routes of administration are not recommended.

Gardasil is not intended to treat cancer of the cervix, vulva, or vagina, CIN, VIN, or VaIN, or active condylomatosis. The drug does not protect against diseases caused by HPV of other types and other etiologies.

As with any vaccine, it is always necessary to have the appropriate medicines available for the immediate relief of an anaphylactic reaction.

The decision to administer the drug or to delay vaccination due to a current or recent illness accompanied by fever, to a large extent depends on the etiology of the disease and the severity of the disease. A slight fever and a mild upper respiratory tract infection are not usually contraindications for vaccination.

In individuals with impaired immune system reactivity due to the use of immunosuppressants (systemic corticosteroids, antimetabolites, alkylating drugs, cytotoxic drugs), a genetic defect, HIV infection and other causes, the protective effect may be reduced.

Gardasil vaccine should be administered with caution to patients with thrombocytopenia and any bleeding disorder, as such individuals may bleed after IM injection.

Human Papillomavirus Vaccine, Recombinant -
HPV VACCINE GARDASIL

Registration certificate holder:
MERCK SHARP & DOHME, B.V. manufactured by MERCK & Co., Inc.

Suspension 0.5 ml. for i / m introduction opaque, white.

Excipients: aluminum in the form of amorphous aluminum hydroxyphosphate-sulphate adjuvant (225 mcg), sodium chloride (9.56 mg), L-histidine (780 mcg), polysorbate 80 (50 mcg), sodium borate (35 mcg), water for injection . Susp. d / i / m administration 120 mcg / 0.5 ml (1 dose): vial. 1 or 10 pcs., syringes 1 or 6 pcs. - LS-002293, 24.11.06

INSTRUCTIONS FOR USE

Gardasil is used for vaccination to prevent diseases caused by the human papillomavirus. You can buy Gardasil and get vaccinated in our clinic in Moscow. Make an appointment with a gynecologist and get advice on indications and possible contraindications!

pharmachologic effect
Quadrivalent human papillomavirus (HPV) vaccine. Gardasil vaccine is a sterile IM suspension prepared from a mixture of highly purified virus-like particles (VLPs) of recombinant HPV types 6, 11, 16 and 18 major capsid protein (L1). L1 proteins are produced by separate fermentation in recombinant Saccharomyces cerevisiae CANADE 3C -5 (Strain 1895) and form VHF by self-assembly. HPS for each type are purified and adsorbed on an aluminum-containing adjuvant (amorphous aluminum hydroxyphosphate sulfate).

Carrying out a full course of vaccination with Gardasil leads to the formation of specific antibodies to four types of HPV - 6, 11, 16 and 18 - in a protective titer for the cervix in women in more than 99% of those vaccinated for a period of at least 36 months in all age groups. It has almost 100% effectiveness in preventing genital cancers caused by HPV types 6, 11, 16 and 18, precancerous epithelial dysplasia and genital warts.

USE OF GARDASIL

1. Prevention of the following diseases caused by human papillomavirus types 6, 11, 16 and 18 in children and adolescents aged 9 to 17 years and in young women aged 18 to 26 years:

Cancer of the cervix, vulva and vagina;
- genital warts (condiloma acuminata);

2. Prevention of precancerous dysplastic conditions in children and adolescents aged 9 to 17 years and in young women aged 18 to 26 years:

Adenocarcinomas of the cervix in situ (AIS);
- cervical intraepithelial neoplasia grades 2 and 3 (CIN 2/3);
- intraepithelial neoplasia of the vulva 2 and 3 degrees (VIN 2/3);
- intraepithelial neoplasia of the vagina 2 and 3 degrees (VaIN 2/3);
- cervical intraepithelial neoplasia grade 1 (CIN 1).

Gardasil vaccine is administered intramuscularly into the deltoid muscle or anterolateral thigh. Not intended for intravenous administration. For children and adolescents aged 9 to 17 years and young women aged 18 to 26 years, a single dose is 0.5 ml.

  1. Gardasil is only an intramuscular vaccine. The injection site is the deltoid muscle or the thigh area (the upper outer surface of the middle third).
  2. "Gardasil" is applied three times. Enter 0.5 ml on the day of vaccination initially and again in the same dosage on the 2nd and 6th month from the first day.
  3. There is also an accelerated course in which Gardasil is administered again a month later, and then again three months after the second vaccination.
  4. A course completed within a year is considered completed, even if the intervals are violated.

The Gardasil vaccine is ready to use, no further dilution or resuspension is required. Before use, the vial / syringe with the vaccine is shaken until a homogeneous cloudy suspension is obtained. The loss of homogeneity, the appearance of included particles and a change in the color of the suspension indicate its unsuitability. The filled syringe is intended for single use only and for one person only. The opening of the vials and the vaccination procedure is carried out with strict observance of the rules of asepsis and antisepsis. The injection site before and after the injection is treated with 70% alcohol. The entire recommended dose should be administered.

Introduction rules
Vaccine single dose vials: Draw 0.5 ml of suspension from the single dose vial with a sterile needle into a disposable syringe that does not contain preservatives, antiseptics or detergents. Enter the entire dose. Throw away the vaccine vial.

Side effect
After the introduction of the Gardasil vaccine, in some cases, local and general reactions may develop: according to clinical studies, the following adverse events occurred with a frequency of at least 1% and more often than in the placebo group.

Local reactions: ≥1% - redness, swelling, soreness and itching at the injection site. The duration of reactions does not exceed 5 days and does not require the appointment of drug therapy. General reactions: ≥ 1% - headache, short-term fever; in some cases - gastroenteritis, inflammation of the pelvic organs. Given the theoretical possibility of the development of immediate allergic reactions in particularly sensitive individuals, after administration, it is necessary to provide medical supervision for 30 minutes. Vaccination with Gardasil should be carried out in a medical facility equipped with anti-shock therapy.

RESTRICTIONS

Contraindications:
- Hypersensitivity to the active components and excipients of the vaccine;
- in the event of symptoms of hypersensitivity to Gardasil, the introduction of a subsequent dose of the vaccine is contraindicated.

Relative contraindications: bleeding disorders due to hemophilia, thrombocytopenia or while taking anticoagulants. If a vaccine is needed in this category of patients, the potential benefits of vaccination and the risks associated with it should be assessed. When vaccinating Gardasil in such cases, it is necessary to take measures to reduce the risk of post-injection hematoma formation.

Use of the Gardasil vaccine during pregnancy and lactation
Category B. Adequate and well-controlled studies of the safety of the use of Gardasil during pregnancy have not been conducted. The potential effect of the vaccine on reproductive function in women and on the fetus has not been studied. There is no evidence that the administration of the Gardasil vaccine has an undesirable effect on fertility, pregnancy or the fetus. According to experts, Gardasil can be administered to women during lactation (breastfeeding).

special instructions
The efficacy and safety of subcutaneous and intradermal administration have not been studied, therefore these routes of administration are not recommended. The Gardasil vaccine is not intended to treat cancer of the cervix, vulva or vagina, CIN, VIN or VaIN, or active condylomatosis. The drug does not protect against diseases caused by HPV of other types and other etiologies.

As with any vaccine, it is always necessary to have the appropriate medicines available for the immediate relief of an anaphylactic reaction. The decision to administer the drug or to delay vaccination with Gardasil due to a current or recent illness accompanied by fever, to a large extent depends on the etiology of the disease and severity. Slight fever and mild upper respiratory tract infection are not usually contraindications for use.

Vaccinates should be advised to use contraception during the course, to report any adverse reactions to their doctor or nurse, and that it does not replace or replace routine HPV screening or testing. To achieve effective results, the course of administration must be completed completely, if there are no contraindications for this.

Pediatric use
The safety and efficacy of Gardasil vaccine has not been evaluated in children under 9 years of age.

Overdose
There are reports of cases of administration at dosages exceeding those recommended. In general, the nature and severity of adverse events were comparable to those with the introduction of the recommended single doses.

drug interaction
The results of clinical studies show that the Gardasil vaccine can be administered simultaneously (at a different site) with the recombinant hepatitis B vaccine. The use of analgesics, anti-inflammatory drugs, antibiotics and vitamin preparations did not affect efficacy, immunogenicity and safety. Hormonal contraceptives, corticosteroids for inhaled local and parenteral use did not affect the immune response. Data on the simultaneous use of systemic immunosuppressants are not available.

Terms and conditions of storage
The drug should be stored out of the reach of children, protected from light, at a temperature of 2 ° to 8 ° C; do not freeze. Shelf life - 3 years. Do not use if there is a visual change in the physical properties of the suspension.

GARDASIL IN MOSCOW

You can get an HPV vaccination course at our medical center. Preliminary consultation with a gynecologist before vaccination is recommended. The price to buy and make the Gardasil vaccine (1 injection) in our center from 01/20/2019. is 12,500 rubles.

Gynecologists say that Gardasil protects against papilloma and cervical cancer in almost 100% of cases. Thousands of people who received the vaccine tolerated it well and did not get HPV. Whether the drug works and how safe it is for health will become clear only after several decades of experience using the vaccine. Is it worth it now to vaccinate - everyone decides for himself.

Gardasil: instructions for use and reviews

Latin name: Gardasil

ATX Code: J07BM01

Active substance: recombinant antigens - L1 protein of human papillomavirus types 6, 11, 16 and 18

Manufacturer: Merck Sharp & Dohme Idea Inc. (USA)

Description and photo update: 14.08.2019

Gardasil is a vaccine used to prevent diseases caused by the human papillomavirus.

Release form and composition

Gardasil is produced in the form of a suspension for intramuscular injection: white, opaque (0.5 ml each in 3 ml glass vials or in 1.5 ml disposable glass syringes, complete with 1 or 2 sterile needles and a device for safe injection or without it , 1 or 10 vials or syringes in a carton box).

The composition of 0.5 ml (1 dose) includes the active substance: L1 human papillomavirus protein - 0.12 mg, including:

  • Type 6 - 0.02 mg;
  • Type 11 - 0.04 mg;
  • Type 16 - 0.04 mg;
  • Type 18 - 0.02 mg.

Auxiliary components: sodium chloride - 9.56 mg, amorphous aluminum hydroxyphosphate sulfate - 0.225 mg, polysorbate 80 - 0.05 mg, L-histidine - 0.78 mg, sodium borate - 0.035 mg, water for injection - 0.5 mg .

The suspension does not contain antibiotics and preservatives.

Pharmacological properties

Pharmacodynamics

Immunobiological properties

Gardasil vaccine forms protective immunity with the development of cellular and humoral immune responses against the human papillomavirus (HPV). For sexually active people who are not vaccinated, the lifetime risk of HPV infection exceeds 50%, and this figure is constantly increasing. The course of vaccination with Gardasil contributes to the prevention of diseases caused by HPV.

Clinical Efficiency

In the course of studies conducted with the involvement of more than 24,000 girls and women aged 16–45 years and more than 4,000 boys and men aged 16–26 years, the high safety and efficacy of the drug were confirmed.

In women aged 16–26 years, Gardasil effectively prevented precancerous dysplastic conditions and cancer of the cervix, vagina, vulva, and also prevented the appearance of anogenital warts in 98–100% of cases. Based on the analysis of data on the cross-protective efficacy of Gardasil, it was concluded that it is effective in reducing the risk of developing adenocarcinoma in situ and grade 1/2/3 cervical intraepithelial neoplasia caused by common oncogenic types of human papillomavirus that are not part of the vaccine.

Further, over the course of 8 years, an additional long-term clinical study of women vaccinated with Gardasil aged 16–26 years, who were part of the protocol efficacy population (PPE), that is, 3 vaccinations during the year, was conducted additional to the main FUTURE II study. The results show no cases of cervical intraepithelial neoplasia of any grade caused by human papillomavirus types 18, 16, 11, or 6. The duration of protection in this study was statistically confirmed at 6 years.

For women aged 24–45 years, in 88.7% of cases, the effectiveness of the Gardasil vaccine was recorded in the prevention of persistent infection, cervical intraepithelial neoplasia of any degree, or anogenital lesions caused by human papillomavirus 18, 16, 11 or 6 types.

For women vaccinated with Gardasil aged 24–45 years, who were part of the protocol efficacy population (PPE), then for 6 years, in addition to the main FUTURE III study, a long-term clinical study was conducted. During this period, there were no cases of cervical intraepithelial neoplasia of any degree or genital warts caused by human papillomavirus 18, 16, 11 or 6 types.

The use of the Gardasil vaccine in men and boys in 90.6% of cases contributed to the prevention of infection with HPV types 18, 16, 11 or 6, which causes external genital lesions (penis intraepithelial neoplasia grades 1-3, perineal and perianal intraepithelial neoplasia, anogenital warts), and in 77.5% of cases it prevented grade 1–3 anal intraepithelial neoplasia.

The duration of protection against anal cancer is currently unknown. Gardasil-vaccinated males aged 16-26 years who were followed up in the main study (Protocol 020) and assigned to the Protocol Efficacy Population (PPE) were further followed by an additional long-term clinical study. In this category of patients, no cases of diseases caused by HPV (anogenital warts, external genital lesions and anal intraepithelial neoplasia of any degree) have been recorded for 6 years.

Immunogenicity

As a result of a full course of vaccination, more than 98% of those vaccinated develop specific antibodies to four types of HPV (types 18, 16, 11 and 6).

When vaccinating seropositive patients, the presence of immunological memory was recorded. Along with this, in individuals who received an additional dose of the vaccine 5 years after the full course of vaccination, a rapid, pronounced anamnestic immune response was noted, in which the values ​​of the geometric mean antibody titers exceeded those obtained 1 month after the first course of vaccination.

The effectiveness of the vaccine in boys and girls aged 9–15 years was shown based on the method of immune bridging. After vaccination in the main study (according to Protocol 018), boys and girls aged 9–15 years were followed up in an additional long-term clinical study.

The Gardasil vaccine has been shown to protect women and girls 9–26 years of age against cervical intraepithelial neoplasia grades 1–3 or adenocarcinoma in situ caused by HPV types 58, 52, 33 and 31.

Immune response to two-dose vaccination with Gardasil

In a clinical study, it was demonstrated that in girls 9–13 years old (n = 259) who received 2 doses of Gardasil (scheme 0–6 months) at 7 months after the first dose, the immune response was not lower than in women 16–26 years old (n = 310) who received 3 doses of Gardasil (schedule 0–2–6 months). The duration of immune protection in the case of two-dose vaccination with Gardasil has not been established.

Pharmacokinetics

Data on the pharmacokinetics of Gardasil are not available.

Indications for use

According to the instructions, Gardasil is prescribed for the prevention of diseases caused by the human papillomavirus (HPV).

Girls and women (ages 9 to 45):

  • Cancer of the anal canal, vagina, vulva and cervix (caused by HPV types 16 and 18);
  • Vaginal intraepithelial neoplasia (VaIN) and vulva (VIN) grade 1/2/3 (HPV types 6, 11, 16 and 18);
  • Adenocarcinoma of the cervix in situ (AIS), cervical intraepithelial neoplasia grade 1/2/3 (CIN) (HPV types 6, 11, 16 and 18);
  • Intraepithelial neoplasia of the anal canal 1/2/3 degree (HPV types 6, 11, 16 and 18).

In girls and women (age 9 to 26 years), Gardasil may provide protection against HPV diseases not included in the vaccine types.

Boys and men (ages 9 to 26):

  • Condyloma acuminata (anogenital warts) (HPV types 6 and 11);
  • Cancer of the anal canal (HPV 16 and 18 types);
  • Precancerous, dysplastic conditions and intraepithelial neoplasia of the anal canal 1/2/3 degree (HPV 6, 11.16, 18 types).

Contraindications

Contraindication to the use of Gardasil is hypersensitivity to the components of the drug.

With the development of symptoms of hypersensitivity to the drug, the introduction of subsequent doses of the vaccine is contraindicated.

Relative contraindications to therapy are blood clotting disorders due to thrombocytopenia, hemophilia, or while taking anticoagulants. If a vaccine is needed in this category of patients, the potential benefits of vaccination with associated risks should be assessed. When vaccinated in these cases, measures should be taken to reduce the risk of post-injection hematoma formation.

Data on the efficacy and safety of the use of Gardasil in children under 9 years of age and adults over 45 years of age are not available.

Instructions for use Gardasil: method and dosage

Gardasil should be injected intramuscularly into the upper outer surface of the middle third of the thigh or deltoid muscle. The vaccine is not intended for intravenous administration.

A single dose of Gardasil for all age groups is 0.5 ml.

  • 1 dose - on the appointed day;
  • 2nd dose - 2 months after the first dose;
  • 3rd dose - 6 months after the first dose.

An accelerated vaccination schedule (0-1-3 months) is possible.

In case of violations of the interval between Gardasil vaccinations, the vaccination course can be considered completed if 3 vaccinations have been administered within 1 year.

The need for revaccination has not been established.

If the first dose of Gardasil was used for vaccination, then the full course of vaccination should be carried out using this drug.

Before administration, the packaging (syringe/vial) with the vaccine should be shaken until a homogeneous cloudy suspension is obtained. In case of loss of homogeneity, the appearance of incorporated particles and a change in the color of the suspension, the vaccine should not be administered.

The vaccine-filled syringe with Gardasil is intended for single use only and only in one person.

The vaccination procedure and opening of the vials must be carried out with strict observance of the rules of antisepsis and asepsis. Before and after the injection, the injection site should be treated with 70% alcohol.

Side effects

During the use of Gardasil, the following disorders may occur (> 10% - very often; > 1% and 0.1% and 0.01% and<0,1% – редко; <0,01% – очень редко):

  • Respiratory system: very rarely - bronchospasm;
  • Musculoskeletal system: often - pain in the extremities;
  • Local reactions: very often - redness, swelling and pain; often - hematoma, itching (in most cases, local reactions proceeded in mild severity);
  • General disorders: often - pyrexia.

During the post-registration use of Gardasil, spontaneous information was received about the development of the following side effects in the vaccinated, it is not possible to reliably assess the relationship with the vaccine and the frequency of which is not possible:

There are data on cases of administration of Gardasil at a dose exceeding the recommended one. At the same time, the severity and nature of adverse events were comparable to similar effects when using the recommended single doses of Gardasil.

special instructions

When deciding whether to vaccinate, the potential risk of a previous HPV infection should be weighed against the potential benefit of vaccination.

Gardasil is not intended for the treatment of cervical, vaginal or vulvar cancer, CIN, VaIN or VIN, or active condylomatosis. The use of the drug is possible only for prophylactic purposes. The vaccine is designed to prevent infection with HPV types that the person does not have. The vaccine does not affect the course of active infections caused by HPV.

As with the introduction of any other vaccine, with the use of Gardasil, a protective immune response can not be obtained in all vaccinated people. From sexually transmitted diseases that have a different etiology, the drug does not protect. Because of this, vaccinated patients should be advised to continue the use of other prophylactic remedies.

Subcutaneous and intradermal administration of the drug is not recommended, due to the lack of data on the safety and efficacy of the drug in these ways.

In the treatment and prevention room where vaccination is carried out, there should be medicines for the immediate relief of an anaphylactic reaction and anti-shock and emergency therapy.

Within 30 minutes after the introduction of the vaccine, it is necessary to monitor the patient's condition for the timely detection of post-vaccination reactions and complications, as well as the provision of emergency medical care. During vaccination, syncope may develop, especially in young women and adolescents.

The decision to administer Gardasil or to delay vaccination due to a current or recent illness with fever is determined by the etiology of the disease and the severity of the disease.

With impaired reactivity of the immune system due to the use of immunosuppressants (systemic corticosteroids, antimetabolites, alkylating and cytotoxic drugs), genetic defects, HIV infection and other causes, the protective effect may be reduced.

Gardasil should be administered with caution to patients with thrombocytopenia and any bleeding disorders, since such patients may develop bleeding after intramuscular injection.

Before vaccination, medical personnel should provide all necessary information about the vaccine to patients, caregivers and parents, including data on benefits and associated risks.

Any adverse reactions should be reported to the doctor. Routine screening examinations are not a substitute for vaccination. In the absence of contraindications to achieve effective results, the course of vaccination should be completed completely.

Use during pregnancy and lactation

Data on the undesirable effects of the Gardasil vaccine on fertility, pregnancy and fetal health are not available. There are no specially designed and well-controlled studies of the use of the vaccine in pregnant women. Data on the use of Gardasil during pregnancy and on the possible impact of the vaccine on the reproductive function of women and on the fetus is not enough to recommend its use in pregnant women.

The patient should be warned about the need to protect against pregnancy during the course of vaccination, and if pregnancy occurs, vaccination should be stopped before it is completed.

Clinical trials of the efficacy, immunogenicity and safety of the vaccine in lactating women and infants have shown that Gardasil can be used during lactation.

Application in childhood

In childhood, the Gardasil vaccination should be done with caution. The safety and efficacy of the vaccine in children under 9 years of age have not been evaluated.

Use in the elderly

Gardasil should be used with caution in the elderly. The safety and efficacy of the vaccine in people over 45 years of age have not been evaluated.

drug interaction

Gardasil can be co-administered (at a different site) with a recombinant hepatitis B vaccine, a meningococcal vaccine conjugated with diphtheria toxoid, and an inactivated polio, tetanus, diphtheria, pertussis vaccine (cell-free component).

Analogues

The analogue of Gardasil is Cervarix.

Terms and conditions of storage

Store in a place protected from light, out of the reach of children at a temperature of 2-8 ° C, do not freeze.

Shelf life - 3 years.

Once removed from the refrigerator, Gardasil should be administered as soon as possible. Out of the refrigerator (at a temperature of 25 ° C or below), you can keep the drug for no longer than 72 hours.

Terms of dispensing from pharmacies

Released by prescription. It is intended for treatment-and-prophylactic and sanitary-and-prophylactic institutions.

It affects almost half of the world's population. Due to its vital activity, skin growths form on the body. They have a different shape and differ in structure: single warts, papillomas, condylomas and clusters of multiple formations. Differences in appearance are caused by the activity of different types of viruses.

Viruses enter the body in various ways:

  • Contact-household (through household items - dishes, things, objects; handshakes, kisses).
  • Vertical (during the transmission of viruses during childbirth from a sick mother to a child).
  • During sexual intercourse.
  • If the rules of personal hygiene are not observed (use of other people's towels, toothbrushes).

The growths formed on various parts of the body look unaesthetic and create a lot of inconvenience. But the main thing is that such neoplasms can pose a serious danger to health, and in some cases, human life.

Important! Papillomas that appear on various parts of the body carry a potential danger. Benign neoplasms can be reborn and take on a malignant character, cause oncological diseases.

The most potentially dangerous strains are recognized HPV 16 and 18, the infection of which occurs during sexual contact. Vaccination is used to protect against their vital activity.

Two vaccines are used for vaccinations, which protect against HPV 16 and 18. These strains are capable of causing cervical cancer under certain circumstances.

Vaccination also helps to cope with other papillomavirus varieties that also pose a serious threat to human health, for example, HPV 6 and HPV 11. These viruses in most cases contribute to the appearance of anogenital condylomas - formations that appear in the anus, and in most cases affect the body of men. The degeneration of cells can in this case lead to the appearance of rectal cancer.

As an inoculation from HPV vaccines are used

  • Gardasil
  • Cervarix

Both vaccines are quite effective. They contain oncogenes and non-oncogenic strains of HPV. The immune system, in response to their effects, produces killer cells that destroy the DNA of papillomavirus cells.

Attention! Timely vaccination against HPV is the most effective method of preventing the formation of cervical cancer and rectal cancer!

Oncology of the reproductive system is very common. In most cases, cervical cancer is incurable and fatal. There is no other effective way to deal with the problem, how to get vaccinated against HPV.

In most countries, such vaccination is mandatory.

The vaccine is administered intramuscularly. Make three injections in several stages with breaks.

Important! If pregnancy occurs during the interval between vaccinations, subsequent vaccinations are carried out after childbirth..

Both drugs are effective and safe for preventing HPV. Which remedy is better?

be careful

The presence of papillomas, warts, warts, moles and spines on the body is the first sign of malignant melanoma!

We hasten to warn you, most medicines "treat" warts, papillomas, moles, etc. - this is a complete deception of marketers who wind up hundreds of percent on drugs whose effectiveness is zero. They do not cure the disease, but only mask the symptoms.

The pharmacy mafia earns a lot of money by deceiving sick people.

But what to do? How to be treated if there is deceit everywhere? Doctor of Medical Sciences Anatoly Makhson conducted own investigation and found a way out of this situation. AT this article The doctor also told how to 100% protect yourself from melanoma, for only 149 rubles!
Read the article in the official source on link.

The opinion of doctors about the most effective methods of treating warts and papillomas

Anatoly Nakhimovich Makhson, the chief physician of the Moscow City Hospital No. 62, describes his vision on this matter.
Medical practice: more than 40 years.

“I have been treating papillomas and warts in people for many years. I tell you as a doctor, papillomas along with HPV and warts can lead to really serious consequences if they are not dealt with.

Everyone has human papillomavirus on whose body there are papillomas, moles, warts and other pigmented formations. According to rough estimates, 80-85% of the world's population has it. By themselves, they are not dangerous. The problem is that an ordinary papilloma can become melanoma at any time.

These are incurable malignant tumors that kill a person in just a few months and from which there is no escape.

Unfortunately, in Russia and the CIS countries, pharmacy corporations sell expensive drugs that only relieve symptoms, thereby putting people on one drug or another. That is why in these countries there is such a high percentage of cancer and so many people suffer from "non-working" drugs.

The only drug that I want to advise, and it is also officially recommended by WHO for the treatment of papillomas and warts, is Papinol. This drug is the only remedy that has an effect not only on external factors (that is, it removes papillomas), but also acts on the virus itself. At the moment, the manufacturer has managed not only to create a highly effective tool, but also to make it available to everyone. In addition, within the framework of the federal program, every resident of the Russian Federation and the CIS can receive it for 149 rubles.

Vaccine Gardasil

Gardasil is included in the register of medicines (RLS). This drug is an effective means of preventing papillomaviruses. In addition to protecting against HPV16 and 18, it also fights against HPV 6 and 11. Since viruses enter the body through unprotected intercourse, it is recommended to vaccinate before puberty. The country of manufacture of the drug is the United States.

Important! The drug does not treat papillomavirus already present in the body. The remedy is a measure for the prevention of papillomatosis!

Vaccination Gardasil 9

In addition to the widely used 4-valent version of Gardasil, which is used to protect against and 18, responsible for the occurrence of cervical cancer, and HPV 6 and 11, the latest 9-valent version of the vaccine is used. According to the instructions, it also protects against these strains and against HPV 31, 33, 45, 52 and 58. These types of viruses are responsible for approximately 25% of diseases of the human reproductive system. Thus, the nine-valent vaccine is able to fight papillomavirus more effectively.

Gardasil: what the instructions for use say

The drug is available as a milky suspension for intramuscular injection. It contains active substances: papilloma protein type 6, 11, 16 and 18 in small quantities. It also contains amorphous sulfate, sodium chloride, L-histidine, water for injection polysorbate-80 and sodium borate. After a full course of vaccination, the human body produces antibodies to these viruses. Protection against oncological diseases of intimate organs and the formation of genital warts persists for a long time after the completion of the vaccination course. How to inject Gardasil?

The vaccine is given to children and adolescents from 9 to 15 years of age. Gardasil can also be used by women aged 16 to 45 years for the prevention of precancerous conditions of the cervix and external genital organs (vagina and vulva). The vaccine can also be used for men. Its use prevents the formation of genital warts and other genital formations (anogenital growths, perineal neoplasia and penile neoplasia).

Possible Side Effects of Gardasil

The instructions for the medicine indicate the possible consequences of the use of Gardasil:

  1. Chills, dizziness and headache, cuts, disorders of the autonomic system, fainting.
  2. The appearance of allergic reactions (urticaria) to the components of the drug up to anaphylactic shock.
  3. Redness, swelling, itching at the injection site and hematoma formation, pain in the extremities.
  4. Violation of the gastrointestinal tract.
  5. Stomach ache.

It is not possible to assess the reliability of reviews about the existing complications after the introduction of the vaccine and to establish a relationship between them. Does vaccination with Gardasil cause infertility?

There has not been a full study of the health of vaccinated women, so there is no basis for confirming such an assumption.

Which is better - Cervarix or Gardasil?

Cervarix is ​​the second vaccine used to prevent cancer of the reproductive system.

Both vaccines are intended to protect against papillomaviruses. They do not contain live or dead viruses, only their man-made shells. Both vaccines are administered as injections and given in courses.

Side effects are the same for Cervarix and Gardasil and are quite rare. Basically, there is swelling and a small hematoma at the injection site, itching and pain at the injection site.

In fact, these drugs practically do not differ from each other and are analogues. The only difference is that Cervarix is ​​able to protect against more HPV strains and has fewer negative reviews. In any case, the decision to use a particular vaccine should be made by the attending physician.

Important! You can't make the decision to vaccinate yourself! Consultation with the attending physician is obligatory!

The current negative reviews about the use of Gardasil and Cervarix are encouraging many doctors to look for an alternative to the use of such vaccinations. For this, drugs are prescribed that protect against HPV, but do not have serious consequences.

If there is an allergic reaction to the components of Gardasil or Cervarix, the doctor may prescribe treatment with other medicines:

  • Immunomax (injections used in courses).
  • Ferrovir (injections).
  • Allokin-alpha (intramuscular injections).
  • In addition to intramuscular injections, ointments and gels (Panavir), immunomodulating agents in the form of tablets (Isoprinosine, Kagocel), rectal and vaginal suppositories (Betadine, Kipferon, Viferon) can be used. Where to find out?

Important! Only both means - Gardasil and Cervarix are analogues of each other! No other HPV vaccine has yet been invented!



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