Composition, form of production and packaging
Suspension for the / m introduction of white color, opaque.
1 dose (0.5 ml)
L1 protein of the human papilloma virus 120 Ојg,
in t.ch. type 6 20 Ојg
type 11 40 Ојg
type 16 40 Ојg
type 18 20 Ојg
Auxiliary substances: aluminum hydroxyphosphate sulfate amorphous - 225 Ојg, sodium chloride - 9.56 mg, L-histidine - 780 Ојg, polysorbate 80 - 50 Ојg, sodium borate - 35 Ојg, water d / u.
0.5 ml - bottles of glass with a capacity of 3 ml (1) - packs of cardboard.
0.5 ml - bottles of glass with a capacity of 3 ml (10) - packs of cardboard.
0.5 ml - disposable glass syringes with a capacity of 1.5 ml (1) - packings of cellular outline with lid (1) - packs of cardboard.
0.5 ml - disposable glass syringes with a capacity of 1.5 ml (10) - packings of cellular contour with a lid (1) - packs of cardboard.
0.5 ml - disposable glass syringes with a capacity of 1.5 ml (1) with a device for safe administration complete with 1 or 2 sterile needles - packings of cellular outline with lid (1) - packs of cardboard.
0.5 ml - disposable glass syringes with a capacity of 1.5 ml (10) with a device for safe administration complete with 1 or 2 sterile needles - packings of cellular outline with lid (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
PHARMACHOLOGIC EFFECT
Quadrivalent recombinant human papillomavirus (HPV) vaccine.
The effectiveness of Gardasil В® vaccine is mediated by the formation of protective immunity with the development of a humoral and cellular immune response against HPV. 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 В® , leads to the prevention of diseases caused by HPV.
Infection with oncogenic types of HPV is a prerequisite for the development of cervical cancer (squamous and adenocarcinoma) and precancerous dysplastic conditions. In addition, in men and women, HPV causes cancer of the external genitalia and anal canal, significantly increases the risk of developing cancer of the head and neck, especially oropharyngeal cancer, leads to the development of anogenital warts and causes recurrent respiratory papillomatosis in children and adults.
Clinical efficacy. Based on the studies conducted, 24,358 women and girls aged 9 to 45 years and 4055 men and boys aged 9 to 26 years had a high profile of the efficacy and safety of the Gardasil В® vaccine.
In women from 16 to 26 years, the Gardasil В® 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 В® vaccine reduces the risk of developing cervical dysplasia (CIN 1/2/3) and adenocarcinoma in situ (AIS) caused by the most common oncogenic types of HPV that are not included in the vaccine.
In women from 24 to 45 years, the Gardasil В® vaccine was effective in preventing persistent CIN infection (any degree) or anogenital lesions caused by HPV types 6, 11, 16 and 18, in 88.7% of cases.
In young men and men, the Gardasil В® vaccine prevented external genital lesions (anogenital warts and perineal, perianal intraepithelial neoplasia, penile intraepithelial neoplasia 1/2/3) caused by HPV 6,11,16,18 types, in 90.6% of cases, and anal intraepithelial neoplasia (AIN) 1/2/3 in 77.5% of cases.
Immunogenicity. The full course of vaccination leads to the formation of specific antibodies to the four types of HPV - 6, 11, 16 and 18 - more than 98% of the vaccinated. The presence of immunological memory was shown during vaccination of seropositive (at the time of vaccination) women. In addition, women who received an additional dose of Gardasil В® vaccine five years after the completed vaccination course had a rapid and pronounced anamnestic immune response, in which the average geometric antibody titres exceeded the titers obtained one month after the initial vaccination.
In girls and boys from 9 to 15 years, clinical studies were conducted on safety and immunogenicity studies, and on the basis of immune bridging, the effectiveness of the vaccine in adolescents was demonstrated.
PHARMACOKINETICS
Data on the pharmacokinetics of Gardasil В® vaccine are not available.
INDICATIONS
Prevention of the following diseases in girls and women aged 9 to 45:
- cancer of the cervix, vulva, vagina and anal canal caused by HPV 16 and 18 types;
- Anogenital condylomas (condiloma acuminata) caused by HPV types 6 and 11;
- Cervical intraepithelial neoplasia 1/2/3 degree (CIN), cervical adenocarcinoma in situ (AIS) caused by HPV 6, 11, 16 and 18 types;
- intraepithelial neoplasia of the vulva (VIN) and vagina (VaIN) 1/2/3 degree caused by HPV 6, 11, 16 and 18 types;
- intraepithelial neoplasia of the anal canal 1/2/3 degree, caused by HPV 6, 11, 16 and 18 types.
The vaccine Gardasil В® can provide protection in girls and women aged 9 to 26 years from diseases caused by HPV types that are not part of the vaccine.
The vaccine Gardasil В® is indicated for use in boys and men aged 9 to 26 years for the prevention of the following diseases:
- cancer of the anal canal caused by HPV 16 and 18 types;
- anogenital condylomas (condiloma acuminate), caused by HPV types 6 and 11;
- precancerous, dysplastic conditions and intraepithelial neoplasia of the anal canal 1/2/3 degree caused by HPV 6, 11,16, 18 types.
DOSING MODE
The vaccine Gardasil В® is injected / m into the deltoid muscle or the upper-upper surface of the middle thirds of the thigh.
The vaccine is not intended for intravenous administration.
For all age groups, a single dose of the vaccine 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 - 2 months after the first; the third dose - 6 months after the first.
An accelerated vaccination scheme is possible in which the second dose is administered 1 month after the first vaccination, and the third dose is administered 3 months after the second vaccination.
If the interval between vaccinations is broken, the vaccination course is considered complete if 3 vaccinations are carried out within 1 year.
The need for revaccination is not established.
If the first dose of the GardasilВ® vaccine was used for vaccination, the full course of vaccination should be carried out using the GardasilВ® vaccine.
Before use, the vial / syringe with the vaccine is shaken until a homogeneous turbid suspension is obtained. The loss of homogeneity, the appearance of the included particles and the discoloration of the suspension indicate the unfitness of the vaccine.
A syringe filled with a vaccine is intended only for single use and only for one person.
The vials are opened and the vaccination procedure is carried out with strict adherence to aseptic and antiseptic rules. Place of injection before and after injection is treated with 70% alcohol.
You should enter the entire recommended dose - 0.5 ml.
Regulations for the introduction of the vaccine
Vials with a single dose of vaccine: dial 0.5 ml of a suspension from a vial of a single dose of a vaccine with a sterile needle into a disposable sterile syringe. Enter the entire dose. Remove the vial with the remainder of the vaccine.
Syringes with a single dose of vaccine: enter the entire contents of the syringe completely.
Disposable sterile, pre-filled syringes with a single dose complete with a protective device: for the introduction of the vaccine, a nested needle should be used. If you need 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, which is a prerequisite for the proper functioning of the protective device.
Remove the cap from the end of the syringe. Press both of the anti-rotation protrusions, fix the syringe, and attach the Luer needle by turning it clockwise. Remove the protective cap from the needle.
When carrying out the injection, as indicated above, you should press the piston, firmly holding the syringe under the finger protrusions and insert the entire dose. The needle guard will not work unless the entire dose is administered. 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 slowly pulling them. After the procedure, throw the syringe into a container for sharp objects.
To document the vaccination, detachable labels should be separated by slowly pulling them.
SIDE EFFECT
Adverse reactions that were observed in connection with the introduction of the Gardasil В® vaccine in 1% of cases and more often than those administered placebo.
Determination of the frequency of adverse reactions: very often (? 1/10); often (? 1/100, <1/10); infrequently (? 1/1000, <1/100); rarely (? 1/10 000, <1/1 000); very rarely (<1/10 000).
From the osteomuscular system: often - pain in the limbs.
From the respiratory system: very rarely - bronchospasm .
Common disorders: often - pyrexia.
Local reactions (more often in the group administered with the Gardasil В® vaccine, in comparison with any drug containing an aluminum hydroxylphosphate sulfate amorphous aluminum adjuvant or compared to the placebo group administered), very often redness, pain and swelling; often - itching, bruising. Most local reactions were of mild severity.
During the post-marketing use of the Gardasil В® vaccine, spontaneous information about the development of the following adverse reactions in the vaccine was received, it is not possible to reliably estimate the frequency and association with vaccination.
Infectious and parasitic diseases: cellulite.
From the hemopoietic system and lymphatic system: lymphadenopathy, idiopathic thrombocytopenic purpura.
From the side of the nervous system: dizziness, acute primary idiopathic polyradiculoneuritis, headache, Guillain-Barre syndrome, acute disseminated encephalomyelitis, syncope, sometimes accompanied by tonic-clonic seizures.
From the digestive system: nausea, vomiting.
On the part of the musculoskeletal system: arthralgia, myalgia.
General disorders: asthenia, fatigue, chills, discomfort.
Allergic reactions: hypersensitivity reactions, including anaphylactic / anaphylactoid reactions, bronchospasm and urticaria.
CONTRAINDICATIONS
- hypersensitivity to the active components and excipients of the vaccine;
- when there are 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 with anticoagulants. If a vaccine is needed in this category of patients, the potential benefits of vaccination and the associated risk should be assessed. When vaccinating in such cases, it is necessary to take measures to reduce the risk of post-injection hematoma.
PREGNANCY AND LACTATION
Adequate and strictly controlled studies of the safety of Gardasil in pregnancy have not been conducted.
Data suggesting that the administration of the Gardasil В® vaccine has an adverse effect on fertility, pregnancy or fetus is not available.
Data on the use of Gardasil В® during pregnancy and the potential impact of Gardasil В® vaccine on the reproductive function of women and on the fetus in pregnant women is not enough to recommend the use of the vaccine in pregnancy.
Vaccinated women should be warned about the need to protect themselves from pregnancy during the course of vaccination, and at the onset of pregnancy, vaccination should be postponed until it is completed.
Clinical studies that examined the efficacy, immunogenicity, and safety of the GardasilВ® vaccine in nursing mothers and infants showed that GardasilВ® can be administered to women during lactation (breastfeeding).
APPLICATION FOR CHILDREN
In children under 9 years of age, the safety and efficacy of Gardasil В® vaccine has not been evaluated.
APPLICATION IN ELDERLY PATIENTS
There is no data to assess the safety and efficacy of Gardasil В® vaccine in adults over 45 years of age .
SPECIAL INSTRUCTIONS
When deciding on vaccination, it is necessary to compare the possible risk from previous HPV infection and the potential benefits of vaccination.
Gardasil В® is not intended for the treatment of cervical, vulvar or vaginal cancer, CIN, VIN or VaIN or active condylomatosis and is used exclusively for prophylactic purposes. The vaccine is designed to prevent infection with 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, the GardasilВ® vaccine does not provide a protective immune response to all vaccinees. 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.
The efficacy and safety of Gardasil with subcutaneous and intradermal administration have not been studied, therefore these methods of administration are not recommended.
As with any vaccine, in the treatment and prophylactic office it is always necessary to have appropriate medications for immediate relief of the anaphylactic reaction and the means of emergency and anti-shock therapy.
Immediately after the introduction of the vaccine, the patient should be monitored for 30 minutes to promptly detect post-vaccination reactions and complications and provide 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 immunosuppressants (systemic corticosteroids, antimetabolites, alkylating drugs, cytotoxic drugs), genetic defect, HIV infection and other causes, the protective effect can be reduced.
The vaccine Gardasil В® should be administered with caution to patients with thrombocytopenia and any disorders of blood coagulation, since after an intravenous injection, 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 benefits and the associated risk.
The vaccinated should be warned about the need to inform the doctor or nurse about any unwanted reactions, and that vaccination does not replace or cancel routine screening examinations. To achieve effective results, the vaccination course should be completed completely if there is no contraindication for this.
There is no data to assess the safety and efficacy of Gardasil В® vaccine in adults over 45 years of age .
Use in Pediatrics
In children under 9 years of age, the safety and efficacy of Gardasil В® vaccine has not been evaluated.
Impact on the ability to drive vehicles and manage mechanisms
Studies of the effect of the vaccine on the ability to drive vehicles and work with mechanisms have not been conducted.
Complaints about the specific and physical properties of the vaccine and all cases of increased reactogenicity or the development of postvaccine complications are directed to the representative office of the manufacturer in Russia: "MSD Pharmaceuticals" LLC.
OVERDOSE
There have been reports of cases of administration of the Gardasil В® vaccine at doses exceeding 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 doses of this vaccine.
DRUG INTERACTION
The results of clinical studies show that the Gardasil В® vaccine can be administered simultaneously (to another site) with a recombinant hepatitis B vaccine, a meningococcal vaccine, a diphtheria toxoid conjugate, and an inactivated diphtheria, tetanus, pertussis (acellular component), and polio vaccine.
The use of analgesics, anti-inflammatory drugs, antibiotics and vitamin preparations did not affect the efficacy, immunogenicity and safety of the vaccine.
Hormonal contraceptives, corticosteroids for inhaled local and parenteral administration did not affect the immunogenicity, efficacy and safety of the Gardasil В®vaccine.
Data on simultaneous use of systemic immunosuppressants and Gardasil В® vaccine are not available.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
It is intended for sanitary-preventive and medical-prophylactic establishments.
TERMS AND CONDITIONS OF STORAGE
The vaccine should be stored out of reach of children, protected from light, at a temperature of 2 В° to 8 В° C; Do not freeze. Shelf life - 3 years.
Gardasil В® should be administered as soon as possible after removal from the refrigerator.
Gardasil В® can be kept outside the refrigerator (at a temperature of 25 В° C or lower) for no more than 72 hours.
