GARDASIL

Active material: L1 proteins of human papilloma virus
When ATH: J07BM01
CCF: A vaccine for the prevention of diseases, caused by human papillomavirus
ICD-10 codes (testimony): A63.0, B97.7, C51, C53
At KFU: 14.03.01.26
Manufacturer: MERCK SHARP & DOHME B.V.. (Netherlands)

Pharmaceutical form, composition and packaging

Suspension for the / m opaque, white.

Excipients: aluminum in the form of an adjuvant aluminum hydroxyphosphate sulfate of amorphous (225 g), sodium chloride (9.56 mg), L-histidine (780 g), polysorbate 80 (50 g), sodium borate (35 g), water d / and.

0.5 ml – vials 3 ml (1) – packs cardboard.
0.5 ml – vials 3 ml (10) – packs cardboard.
0.5 ml – Disposable syringes with volume 1.5 ml (1) With a device for safe introduction (or without it), in the kit with 1 or 2 sterile needles (or without a needle) – packings Valium planimetric (1) – packs cardboard.
0.5 ml – Disposable syringes with volume 1.5 ml (6) With a device for safe introduction (or without it), in the kit with 6 or 12 sterile needles (or without a needle) – packings Valium planimetric (1) – packs cardboard.

Pharmacological action

Quadrivalent vaccine against the human papilloma virus (HPV). It is a sterile suspension for in/m introducing, prepared from a mixture of highly purified virus -like particles (VVC) Recombinant basic capsid protein (L1) HPV types 6, 11, 16 and 18. L1 proteins are produced by separate fermentation in the recombinant Saccharmyces cerevisiae Canade 3C-5 (Strain 1895) and form an EV through self -assembly. IVF for each type are cleansed and adsorbed on an aluminum -containing adjuvant (Amorphic hydroxyphosphatceulfate aluminum).

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 more than 99% vaccinated for a period of at least 36 months in all age groups.

The vaccine has practically 100% effectiveness in preventing induced 6, 11, 16 and 18 types of HPV cancer of the genital organs, precancerous epithelial dysplasias and genital warts.

Pharmacokinetics

Data on pharmacokinetics of the Gardasil vaccine^® no.

Testimony

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

- Cervical cancer, vulva and vagina;

- Genital condylomas (Condiloma Accuminata);

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 intra -epithelial neoplasia 2 and 3 degrees (Sin 2/3);

- intra -epithelial neoplasia of Vulva 2 and 3 degrees (VIN 2/3);

- intra -epithelial neoplasia of the vagina 2 and 3 degrees (VaIN 2/3);

- cervical intra -epithelial neoplasia 1 degrees (CIN 1).

Dosage regimen

Vaccinu Gardasil^® Enter in/m into the deltoid muscle or anterolateral thigh. The vaccine is not intended for ivation.

To children and adolescents between the ages of 9 to 17 years and young women aged 18 to 26 years The single dose of the vaccine is 0.5 ml.

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

Accelerated vaccination scheme is allowed, in which the second dose is introduced through 1 month after the first vaccination, And the third - through 3 month after the second vaccination.

In case of violation of the interval between vaccinations, the vaccination course is considered complete, if 3 vaccination was carried out during 1 year.

The vaccine is ready for use, additional breeding or reservation is not required. Before use, the bottle/syringe with the vaccine is shaken until a homogeneous muddy suspension is obtained. Loss of homogeneity, the appearance of the on particles and a change in the color of the suspension indicate the unsuitability of the vaccine.

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

Opening the bottles and the vaccination procedure are carried out with strict observance of the rules of aseptic and antiseptics. The place of administration before and after the injection is treated 70% alcohol.

The entire recommended dose should be entered.

Rules for introducing a vaccine

Blacks with a single dose of vaccine: dial 0.5 ml suspended a bottle with a single dose of a vaccine with a sterile needle into a disposable syringe, not containing preservatives, antiseptics and detergents. Introduce the entire dose. A bottle with the remains of the vaccine throw away.

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

Disposable sterile, pre -filled syringes with a single dose complete with a protective device: To introduce a vaccine, the nested needle should be used. If you need to use another needle, make sure, that the needle firmly joins the syringe and that its length does not exceed 2.5 cm, what is a necessary condition for the proper operation of the protective device.

Remove the cap from the end of the syringe. Pressing both of the ledges that prevent the rotation, Fix the syringe, and attach Luer's needle with turning clockwise. Delete a protective cap from a needle.

During injection, as stated above, should be pressed on the piston, Holding the syringe tightly under the fingeren ledges and enter the entire dose. The protective device of the needle will not work, if the whole dose is not entered. Extract the needle. Let the piston and let the syringe move up until the entire needle closes. To document vaccination, separate removable labels, Pulling them slowly. After the end of the procedure, throw the syringe into a container for sharp objects.

Side effect

After the introduction of the vaccine in some cases, local and general reactions may develop: According to clinical research, the following unwanted phenomena were found with a frequency of at least 1% And more often, than placebo.

Local reactions: ≥1% – redness, swelling, soreness and itching at the place of introduction. The duration of reactions does not exceed 5 day and does not require the prescription of drug therapy.

Common reactions: ≥ 1% – headache, transient increase of body temperature; In some cases - gastroenteritis, pelvic inflammation.

Given the theoretical possibility of developing allergic reactions of immediate type in particularly sensitive persons, After the introduction of the vaccine, it is necessary to provide medical supervision during 30 m.

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

Contraindications

- increased sensitivity to active components and fillers of the vaccine;

- in case of symptoms of increased sensitivity to Gardasil^® The introduction of the subsequent dose of the vaccine is contraindicated.

Relative contraindications: blood coagulation due to hemophilia, thrombocytopenia or against the background of anticoagulant. If it is necessary to use the vaccine in this category of patients, the potential advantages of vaccination and the risk associated with it should be evaluated. When vaccinating in such cases, it is necessary to take measures to reduce the risk of the formation of a post -injection hematoma.

Pregnancy and lactation

Category B. Adequate and strictly controlled safety research on the application of Gardalay^® during pregnancy was conducted. The potential effect of the vaccine on the reproductive function in women and the fetus was not studied.

Data, testifying, that the introduction of the Gardasil vaccine^® has an undesirable effect on fertility, Pregnancy or on the fetus is not available.

Vaccinu Gardasil^® can be introduced to women during lactation (breast-feeding).

Cautions

The effectiveness and safety of Gardasil^® With subcutaneous and intradermal introduction were not studied, Therefore, these methods of introduction are not recommended.

Gardasil^® not intended for the treatment of cervical cancer, Vulva or vagina, CIN, Vin or Vain or active condylomatosis. The drug does not protect against diseases, caused by HPV other types and other etiologies.

As with the introduction of any vaccine, It is always necessary to have appropriate drugs for immediate relief of the anaphylactic reaction.

The decision to introduce the drug or on a delay in vaccination in connection with the current or recent disease, accompanied by fever, largely depends on the etiology of the disease and severity. A slight increase in temperature and a mild infection of the upper respiratory tract are usually not contraindications for vaccination.

In persons 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 of the protective effect can be reduced.

Vaccinu Gardasil^® should be administered with caution to patients with thrombocytopenia and any blood coagulation disorders, since after the injection, such persons may develop bleeding.

Medical personnel are obliged to provide all the necessary information on vaccination and vaccine to patients, Parents and guardians, including information about the advantages and conjugated risk.

Vaccinated should be warned of the need to protect from pregnancy during the course of vaccination, about the need to inform a doctor or nurse about any undesirable reactions, as well as, that vaccination does not replace and does not cancel routine screening examinations. To achieve effective results, the vaccination course must be completed completely, If there are no contraindications for this.

There is no data on the security and efficiency of the Gardasil vaccine^® in adults over 26 years.

Use in Pediatrics

In children in Up to 9 years Safety and effectiveness of the Gardasil vaccine^® not yet rated.

Claims The specific and physical properties of the vaccine and about all cases of increased reactogenicity or the development of post -vaccination complications are directed:

- at the FSUN state research institute standardization and control of medical biological drugs to them. L.A.. Tarasevich at the address 119002 Moscow, per. Sivcev Vražek, 41, tel./fax: (495)241-39-22;

- to the representative office of the manufacturer in Russia and the CIS countries: “Merck Sharp and Dom Idea, Inc.”, Switzerland.

Overdose

There are reports about cases of the introduction of the Gardasil vaccine^® doses, than recommended. In general, the nature and severity of unwanted phenomena during an overdose were comparable to those with the introduction of the recommended one -time doses of this vaccine.

Drug Interactions

The results of clinical studies show, that the Gardican vaccine^® It may be administered simultaneously (to another site) with a recombinant vaccine against hepatitis in.

The use of analgesics, anti -inflammatory drugs, antibiotics and vitamin drugs did not affect the effectiveness, immunogenicity and security of the vaccine.

Hormonal contraceptives, Corticosteroids for inhalation local and parenteral use did not affect the immune response to Gardasil vaccines^®.

Data on the simultaneous use of systemic immunosuppressants and Gardasil vaccines^® no.

Conditions of supply of pharmacies

The drug is released under the prescription.

A set of six disposable sterile syringes or 10 vials are intended for sanitary-preventive and medical institutions.

Conditions and terms

The vaccine should be stored inaccessible to children, protected from light, at a temperature of from 2 ° to 8 ° C.; Do not freeze. Shelf life – 3 year. Do not use with visual changes in the physical properties of the suspension.