Gardasil® (Gardasil®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceThe human papillomavirus vaccine is a recurrent (pancreatic) type (types 6, 11, 16, 18)The human papillomavirus vaccine is a recurrent (pancreatic) type (types 6, 11, 16, 18)
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  • Gardasil®
    suspension w / m 
    Merck Sharp and Doum B.V.     Netherlands
  • Cervarix®
    suspension w / m 
    GlaxoSmithKline Trading, ZAO     Russia
    • Dosage form: & nbsp

    suspension for intramuscular injection

    Composition:
    One dose (0.5 ml) contains
    Active substances: recombinant antigens - L1 protein of the papilloma virus
    human in the following amounts: type 6 -20 mcg, type 11-40 mcg, type 16-40 mcg, type 18-20 mcg.
    Excipients: aluminum in the form of aluminum hydroxyphosphate sulfate amorphous - 225 μg, sodium chloride - 9.56 mg. / .- Histidine - 0.78 mg, llorisorbat-80 - 50 μg, sodium borate - 35 μg. water for injection up to 0.5 ml.
    Preservatives and antibiotics does not.
    Description:

    Opaque suspension of white color.

    Quadrivalent vaccine against human papillomavirus (HPV) is a mixture of highly purified virus-like particles (HFV) of a recombinant base capsid protein (L1) HPV types 6, 11, 16 and 18. Proteins L1 are produced by separate fermentation in recombinant Saccharomyces cerevisiae CANADE ЗС-5 (strain 1895) and form the VHF by self-assembly. VHF for each type is purified and adsorbed on an aluminum-containing adjuvant (aluminum hydroxyphosphate sulfate amorphous).

    Pharmacotherapeutic group:MIBP, vaccine
    ATX: & nbsp

    J.07.B   Vaccines for the prevention of viral infections

    J.07   Vaccines

    Pharmacodynamics:
    IMMUNOBIOLOGICAL PROPERTIES
    The effectiveness of Gardasil® vaccine is mediated by the formation of protective immunity with the development of humoral and cellular immune responses against human papillomavirus. The risk of HPV infection during life, without vaccination, in sexually active people is more than 50%, and it is constantly growing. The course of vaccination with the drug Gardasil® leads to the prevention of diseases caused by HPV.
    Clinical efficacy
    Based on the studies, 24,358 women and girls aged 16 to 45 years and 4055 men and boys aged 16 to 26 years confirmed the high profile of the efficacy and safety of the Gardasil® vaccine.
    In girls and women aged 16 to 26, the Gardasil® vaccine effectively prevented cancer and precancerous dysplastic conditions of the cervix, vulva, vagina, and anogenital warts in 98-100% of cases. An analysis of cross protective efficacy shows that the administration of the Gardasil® vaccine reduces the risk of developing CIN (cervical intraepithelial neoplasia) 1/2/3 and adenocarcinoma in situ (AIS). caused by the most common oncogenic types of HPV that are not included in the vaccine.
    Women 16 to 26 years old, vaccinated with Gardasil® vaccine and included in the protocol effectiveness (PRE) population in the main FUTURE II trial, were further observed in an additional long-term clinical trial for 8 years. During this period, no cases of CIN (of any degree) caused by HPV 6, 11, 16 and 18 types have been reported. In this study, the duration of protection was statistically confirmed by about 6 years.
    In women from 24 to 45 years, the Gardasil® vaccine was effective in preventing persistent infection, CIN (any degree), or anogenital lesions caused by HPV types 6, 11, 16 and 18, in 88.7% of cases.
    Women 24 to 45 years old, vaccinated with the Gardasil® vaccine and included in the protocol effectiveness (PRE) population in the main FUTURE III trial, were further observed in an additional long-term clinical trial for 6 years. During this period, there were no cases of CIN (any degree) and genital warts caused by HPV 6, 11, 16 and 18 types.
    In young men and men, the Gardasil® vaccine prevented HPV infection in types 6, 11, 16 and 18, causing external genital lesions (anogenital warts and perineal, perianal intraepithelial neoplasia,intraepithelial neoplasia of the penis 1/2/3 degree) in 90.6% of cases, as well as anal intraepithelial neoplasia (AIN) of 1/2/3 degree in 77.5% of cases.
    The duration of protection against anal cancer is currently unknown. Men aged 16 to 26 years who were vaccinated with Gardasil® vaccine and included in the protocol effectiveness (PRE) population in the main study (Protocol 020) were further observed in an additional long-term clinical trial. At the same time, no cases of HPV-induced disease (anogenital condylomas caused by HPV 6, 11 types, external genital lesions caused by HPV 6, 11, 16 and 18 types, and AIN of any degree caused by HPV 6, , 11, 16 and 18 types).
    Immunogenicity
    The full course of vaccination leads to the formation of specific antibodies to the four types of HPV (6, 11, 16 and 18) in more than 98% of the vaccinated.
    The presence of immunological memory was shown during vaccination of seropositive (at the time of vaccination) persons. In addition, individuals who received an additional dose of Gardasil® vaccine five years after the completed vaccination course, a rapid and pronounced anamnestic immune response was observed in which the average geometric antibody titres exceeded the titers obtained one month after the first vaccination course.
    In girls and boys from 9 to 15 years, the effectiveness of the vaccine was shown on the basis of immune bridging.
    Girls and boys aged 9 to 15 years vaccinated with Gardasil® vaccine in the main study (Protocol 018) were further observed in an additional long-term clinical trial.
    The Gardasil vaccine also provides protection in girls and women aged 9 to 26 years from CIN diseases (1/2/3 degree) or AIS. called HPV types 31, 33, 52 and 58 types.
    Immune response to a 2-dose vaccination with Gardasil®
    In a clinical study, it was demonstrated that the immune response (at the 7th month after the first dose) in girls aged 9-13 years (n = 259). who received 2 doses of the Gardasil® vaccine (according to the 0-6 month schedule) was no less than the immune response in women aged 16-26 beds (n = 310) who received 3 doses of the Gardasil vaccine (according to the 0-2-6 month schedule .). The duration of immune protection with a 2-dose vaccination with Gardasil was not established.
    Indications:

    The Gardasil® vaccine is indicated for use by girls and women between the ages of 9 and 45 to warn:

    -cray of the cervix, vulva, vagina and anal canal caused by HPV 16 and 18 types;

    -Anogenital Warts (condiloma acuminate), caused by HPV types 6 and 11; -cervical intraepithelial neoplasia 1/2/3 degree (CIN) and cervical adenocarcinoma in situ (AIS), caused by HPV 6, 11, 16 and 18 types;

    -internal epithelial neoplasia of the vulva (VIN) and the vagina (VaIN) 1/2/3 of the degree caused by HPV 6, 11, 16 and 18 types;

    -internal epithelial neoplasia of the anal canal 1/2/3 degree caused by HPV 6, 11, 16 and 18 types.

    The Gardasil® vaccine is indicated for use by boys and men aged 9 to 26 years to prevent:

    - the anal canal caused by HPV 16 and 18 types;

    -Anogenital Warts (condiloma acuminate), caused by HPV types 6 and 11; -predrakovyh, dysplastic conditions and anal intraepithelial neoplasia 1/2/3 extent caused by HPV 6, 11, 16, 18 types.

    Contraindications:

    Hypersensitivity to the active components and excipients of the vaccine. If symptoms of hypersensitivity occur after the administration of the Gardasil® vaccine, the introduction of a subsequent dose of the vaccine is contraindicated.

    Violations of blood clotting due to hemophilia, thrombocytopenia or against the background of taking anticoagulants are the relative a contraindication to intramuscular administration of the Gardasil® vaccine, unless the potential benefits of vaccination exceed, to a large extent, the risks involved.If the choice is made in favor of vaccination, measures should be taken to reduce the risk of post-injection hematoma.

    If a patient has an acute severe febrile illness, the administration of the Gardasil® vaccine should be postponed. However, the presence of an easy infection or a slight increase in body temperature is not a contraindication to vaccination.

    Carefully:

    APPLICATION IN PEDIATRIC PRACTICE

    In children under 9 years of age, the safety and efficacy of Gardasil® vaccine have not been evaluated.

    APPLICATION IN GERIATRIC PRACTICE

    There is no data on the safety and efficacy of Gardasil® vaccine in adults over 45 years of age.

    Pregnancy and lactation:

    There is no evidence that the administration of the Gardasil® vaccine has an adverse effect on fertility, pregnancy or fetus, which would cast doubt on its safety. Specially planned and well-controlled studies in pregnant women have not been conducted. Data on the use of Gardasil vaccine during pregnancy and the potential impact of Gardasil® vaccine on the reproductive function of women and on the fetus in pregnant women is not enough to recommend the use of the vaccine during pregnancy.

    Patients should be warned about the need to protect themselves from pregnancy during the course of vaccination, and when pregnancy occurs, vaccination should be postponed until it is completed.

    Clinical trials that tested the efficacy, immunogenicity, and safety of Gardasil® vaccine in nursing mothers and infants showed that Gardasil® can be administered to nursing women.

    Dosing and Administration:
    The vaccine Gardasil® is injected intramuscularly into the deltoid muscle or upper-upper surface of the middle third of the thigh.
    Do not administer intravenously.
    A single dose of vaccine for all age groups is 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 on the appointed day:
    -The second dose - after 2 months. after the first;
    -the third dose - after 6 months. after the first.
    An accelerated vaccination scheme is possible, in which the second dose is administered after 1 month. after the first vaccination, and the third - after 3 months. after the second vaccination.
    The vaccination course is considered complete, even if the interval between vaccinations is broken, if three vaccinations are carried out within 1 year.
    An alternative 2-dose vaccination schedule (0-6 months) with Gardasil® is allowed in persons aged 9-13 years. In this case, if a second dose is administered earlier than 6 months after the metered dose, it is always necessary to introduce a third dose.
    If the first dose of the Gardasil® vaccine was used for vaccination, the full course of vaccination should be carried out using the Gardasil® vaccine. The need for revaccination is not established.
    Before use, the vial / syringe with the vaccine is shaken until a homogeneous turbid suspension is obtained. Loss of homogeneity, presence of inclusions and foreign particles, discoloration of the suspension testify about
    unfitness vaccine.
    The pre-filled syringe with the vaccine is intended only for single use and only for one person. For each vaccine, the contents of the vaccine vial should be administered using an individual disposable sterile syringe with a sterile needle. It is necessary to enter the entire recommended dose of 0.5 ml.
    The vials are opened and the vaccination procedure is carried out with strict adherence to aseptic and antiseptic rules.The injection site is treated with 70% alcohol before and after injection.
    Use of vials with a single dose of vaccine.
    Insert a sterile needle into a disposable sterile syringe with 0.5 ml of a suspension from a vial of a single dose of vaccine. Enter the entire dose. The vial with the leftovers of the vaccine throw those.
    Use of syringes with a single dose of vaccine.
    Enter the contents of the width completely.
    Instructions for the use of disposable sterile pre-filled syringes with a single dose complete with a protective device
    Use a nested needle to inject the vaccine. If you want to use another needle, make sure that the needle is securely attached to the syringe and that its length does not exceed 2.5 cm. This is a prerequisite for proper operation of the protective device. The syringe is equipped with two removable labels, which can be separated after the injection.
    Remove the cap from the syringe. Press both of the anti-rotation protrusions, secure the syringe and attach the Luer needle by turning it clockwise.
    Remove the protective cap from the needle.
    Prepare for injection as described above. Press the plunger, firmly holding the syringe under the finger ledges, and enter the entire dose.Needle guard HE It will work if you do not enter ALL dose. Remove the needle. Release the piston 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. Dispose of the syringe in a container for sharp objects.
    Side effects:

    Unwanted reactions, whose frequency was at least 1% in those who received the Gardasil® vaccine, and exceeded that of those administered placebo, are listed below in accordance with the organ / class system.

    Very often (≥ 1/10); often (≥ 1/100, <1/10); infrequently (≥ 1/1 000, <1/100); rarely (≥ 1/10 000, <1/1 000); very rarely (<1/10 000).

    Disturbances from musculoskeletal and connective tissue

    Often: pain in the extremities.

    General disorders and disorders at the site of administration

    Often: pyrexia.

    The following local reactions were more common in the group administered with the Gardasil® vaccine, compared to any preparations containing an aluminum hydroxylphosphate sulfate amorphous aluminum adjuvant, or compared to a group administered with a placebo solution.

    Very often: redness, pain and swelling.

    Often: itching, bruising.

    Most local reactions were of mild severity.

    Disturbances from the respiratory system, chest and mediastinal organs

    In addition, bronchospasm as serious side effects were very rare.

    During the post-marketing application of the Gardasil® vaccine, spontaneous information about the development of the following undesirable reactions in the vaccine was received, it is not possible to reliably estimate the frequency and association with vaccination. Infectious and parasitic diseases: phlegmon.

    Violations of the blood and lymphatic system: lymphadenopathy, idiopathic thrombocytopenic purpura.

    Disturbances from the nervous system: dizziness, headache, Guillain-Barre syndrome, acute disseminated encephalomyelitis, syncope, sometimes accompanied by tonic-clonic convulsions.

    Disorders from the gastrointestinal tract: nausea, vomiting.

    Disturbances from musculoskeletal and connective tissue: arthralgia, myalgia.

    General disorders and disorders at the site of administration: asthenia, fatigue, chills, discomfort.

    Immune system disorders: hypersensitivity reactions, including anaphylactic / anaphylactoid reactions, bronchospasm and urticaria.

    Overdose:There have been reports of cases of administration of the Gardasil® vaccine at doses in excess of those recommended. In general, the nature and severity of adverse events in an overdose were comparable to those observed with the administration of the recommended single dose of Gardasil® vaccine.
    Interaction:

    Use with other vaccines

    The Gardasil® vaccine can be administered simultaneously (to another recommended body site) with a recombinant hepatitis B vaccine, a meningococcal vaccine conjugated with diphtheria toxoid, and an inactivated diphtheria, tetanus, pertussis (acellular component) vaccine, a polio vaccine (inactivated) .

    Use with common medications

    The use of analgesics, anti-inflammatory drugs, antibiotics and vitamin preparations did not affect the efficacy, immunogenicity and safety of the vaccine.

    Use with hormonal contraceptives

    The use of hormonal contraceptives did not affect the efficacy, immunogenicity and safety of the Gardasil® vaccine.

    Use with steroids

    Inhalation, local and parenteral steroids did not affect the immunogenicity and safety of the Gardasil® vaccine.

    Use with systemic immunosuppressants

    Data on simultaneous use of systemic immunosuppressants and Gardasil® vaccine are not available. In persons taking immunosuppressants (systemic corticosteroids, cytotoxic drugs, antimetabolites, alkylating drugs), the protective effect can be reduced (see "SPECIAL INSTRUCTIONS").

    Special instructions:

    Infection with oncogenic types of HPV is a prerequisite for the development of cervical cancer (squamous and adenocarcinoma), vulvar cancer, vagina, precancerous dysplastic conditions, condyloma. In addition, in men and women, infection with HPV causes cancer of the external genitalia and anal canal. Infection with HPV significantly increases the risk of developing head and neck cancer, especially oropharyngeal cancer, and causes recurrent respiratory papillomatosis in children and adults.

    Are common. When deciding on vaccination, it is necessary to compare the possible risk from previous HPV infection and the potential benefits of vaccination. The vaccine Gardasil® is not intended for the treatment of the following diseases: cancer of the cervix, vulva or vagina, CIN, VIN, VaIN or active condylomatosis - and is administered exclusively for prophylactic purposes. The vaccine is prophylactic and is designed to prevent infection by those types of HPV that the patient does not have. The vaccine has no effect on the course of active infections caused by HPV. As with any other vaccine, with the use of the preparation Gardasil® not all vaccinees can get a protective immune response. The drug does not protect against sexually transmitted diseases, another etiology. In this regard, vaccinated patients should be encouraged to continue using other preventive protective equipment.

    Subcutaneous and intradermal administration of the vaccine has not been studied and is therefore not recommended. As with the introduction of any vaccine, it is always necessary to have appropriate medicines in the treatment-and-prophylactic room in case of a rare anaphylactic reaction to the introduction of the vaccine and the means of emergency and anti-shock therapy. Immediately after the introduction of the vaccine within 30 minutes the patient ismedical supervision for the purpose of timely detection of postvaccinal reactions and complications and provision of emergency medical care. In any vaccination, syncope may occur, especially in adolescents and young women.

    The decision to administer the drug or postpone the vaccination due to a current or recent illness accompanied by fever is largely dependent on the etiology of the disease and severity.

    In people with impaired reactivity of the immune system due to the use of immunosuppressant therapy (systemic corticosteroids, cytotoxic drugs, antimetabolites, alkylating drugs), genetic defect, infection with the human immunodeficiency virus (HIV) and other causes, the protective effect may be reduced (see "INTERACTION WITH OTHER DRUGS PREPARATIONS "), Gardasil® vaccine should be administered with caution to persons with thrombocytopenia and any disorders of blood coagulation, since after intramuscular injection in such individuals may develop bleeding.

    Medical personnel are required to provide all necessary vaccine and vaccine information to patients, parents and caregivers, including information on the benefits and associated risks.

    Vaccinated should be warned about the need to report to your doctor or nurse about any adverse reactions and that the vaccination does not replace or supersede routine screening examinations. To achieve effective results, the vaccination course should be completed completely if there is no contraindication for this.

    Effect on the ability to drive transp. cf. and fur:

    Studies of the impact on the ability to drive a car, as well as working with mechanisms were not conducted.

    Form release / dosage:

    Suspension for intramuscular injection.

    Packaging:

    Bottle

    Primary packaging: 1 dose (0.5 ml) in a sterile vial (3 ml capacity) made of borosilicate tubular glass, type E The bottle is sealed with a chlorobutyl stopper Teflon coating under aluminum rolling and closed with a snap-in plastic cover.

    Secondary packaging: 1 or 10 bottles in a cardboard box together with instructions for use.

    Disposable syringe

    Primary packaging: 1 dose (0.5 ml) in a disposable sterile syringe (with a capacity of 1.5 ml) of borosilicate glass, type I. A syringe with a device for safe administration (or without it) is equipped with a polycarbonate adapter, a protective bromobutyl cap and a piston closed with a cork of butyl rubber, coated with silicone.

    1 disposable sterile pre-filled syringe complete with 1 or 2 sterile needles (or without needles) is placed in a contour mesh package with a lid.

    Secondary packaging: 1 or 10 disposable sterile syringes, sealed in a contoured cell pack with a lid, in a cardboard pack together with instructions for use.

    Storage conditions:

    At a temperature of 2 to 8 ° C, in a dark place.

    Do not freeze.

    Keep out of the reach of children.

    Gardasil® should be administered as soon as possible after removal from the refrigerator. Gardasil® can be outside the refrigerator (at a temperature of 25 ° C or lower) for not more than 72 hours.

    Shelf life:

    3 years. Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-002293
    Date of registration:24.08.2011 / 21.08.2017
    Expiration Date:Unlimited
    The owner of the registration certificate:Merck Sharp and Doum B.V.Merck Sharp and Doum B.V. Netherlands
    Manufacturer: & nbsp
    Representation: & nbspMSD Pharmaceuticals Ltd.MSD Pharmaceuticals Ltd.
    Information update date: & nbsp15.03.2017
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