Instruction for use: Gardasil

Dosage form: Suspension for intramuscular injection

Active substance: The human papillomavirus vaccine is a recurrent (pancreatic) type (types 6, 11, 16, 18)

ATX

J07BM01 The virus of the papilloma (human virus types 6, 11, 16, 18)

Pharmacological group:

Vaccines, serums, phages and toxoids

The nosological classification (ICD-10)

A63.0 Anogenital (venereal) warts: Anogenital warts; Venereal warts; Condylomata genital; Condyloma pointed; Externally pointed genital warts; Externally pointed condyloma; Pointed Condyloma; Flat condyloma

B97.7 Papillomavirus: Human papillomavirus; Asymptomatic selection of human papillomavirus; Papillomavirus infection; The papilloma virus; Upper respiratory tract papillomatosis; Papillomovirus infection; Human papillomaviruses

C51 Malignant neoplasm of vulva: Basal cell carcinoma of vulva; Cancer of the vulva; Carcinoma of the vulva

C52 Malignant neoplasm of vagina: Vaginal carcinoma; Epithelioma of the malignant vagina

C53 Malignant neoplasm of cervix: Intraepithelial neoplasm of cervix uteri; Cervical carcinoma; Cervical cancer

D06 Carcinoma in situ of the cervix uteri

N87 Cervical dysplasia

N89.3 Vaginal dysplasia, unspecified

N90.3 Vulvar disparity, unspecified

Composition and release form

Suspension for intramuscular injection 0.5 ml

L1 proteins of human papillomavirus 120 mcg

(Including type 6 - 20 mcg, type 11 - 40 mcg, type 16 - 40 mcg, type 18 - 20 mcg

Auxiliary substances: aluminum in the form of an aluminum adjuvant hydroxyphosphate-sulfate amorphous - 225 mkg; Sodium chloride - 9.56 mg; L-histidine - 780 mcg; Polysorbate 80 - 50 mcg; Sodium borate - 35 mcg; water for injections

In bottles (3 ml) 0.5 ml each; In a pack of cardboard 1 or 10 bottles; Or in disposable syringes (1.5 ml volume) of 0.5 ml, complete with sterile needles (or without needles), in a contiguous cell pack of 1 or 6 syringes; In a pack of cardboard 1 package.

Description of dosage form

Suspension is opaque, white.

Pharmachologic effect

Mode of action - Antiviral.

Pharmacodynamics

Quadrivalent vaccine against human papillomavirus (HPV). It is a sterile suspension for intravenous administration prepared from a mixture of highly purified virus-like particles (HPV) of recombinant lipid 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 virus-like particles by self-assembly. Virus-like particles for each type are purified and adsorbed on an aluminum-containing adjuvant (amorphous aluminum hydroxyphosphate sulfate).

The full course of vaccination leads to the formation of specific antibodies to the 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 has almost 100% effectiveness in preventing 6, 11, 16 and 18 types of HPV-induced cancers of genital organs, precancerous epithelial dysplasia and genital warts.

Pharmacokinetics

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

Indication of the Gardasil

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

Cancer of the cervix, vulva and vagina;

Genital warts (condyloma acuminata).

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

Cervical adenocarcinoma in situ (AIS);

Cervical intraepithelial neoplasia of degree 2 and 3 (CIN 2/3);

Intraepithelial vulvar neoplasia of degree 2 and 3 (VIN 2/3);

Vaginal intraepithelial neoplasia of degree 2 and 3 (VaIN 2/3);

Cervical intraepithelial neoplasia of degree 1 (CIN 1).

Contraindications

Hypersensitivity to active components and excipients of the vaccine;

The introduction of a subsequent dose of vaccine in the event of symptoms of hypersensitivity;

Relative contraindications - violations of blood clotting due to hemophilia, thrombocytopenia or the use of anticoagulants. If a vaccine is needed, the potential benefits of vaccination and the associated risk should be assessed in this category of patients. When vaccinating in such cases, it is necessary to take measures to reduce the risk of post-injection hematoma.

Application in pregnancy and breastfeeding

Category B by the FDA. Adequate and strictly controlled studies of the safety of Gardasil® in 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 Gardasil® vaccine has an adverse effect on fertility, pregnancy, or fetus.

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

Side effects

After the introduction of the vaccine in some cases, local and general reactions may develop: according to clinical studies, the following adverse events occurred at a frequency of not less than 1% and more often than in the placebo group.

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

General reactions: ≥1% - headache, short-term rise in body temperature; In some cases - gastroenteritis, inflammation of the pelvic organs.

Given the theoretical possibility of developing allergic reactions of immediate type 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.

Interaction

The results of clinical studies show that the Gardasil® vaccine can be administered simultaneously (to another site) with a recombinant hepatitis B 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 use did not affect the immune response to Gardasil® vaccines.

Data on simultaneous use of systemic immunosuppressants and Gardasil® vaccine are not available.

Dosing and Administration

IM, in the deltoid muscle or anterolateral region of the 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.

The recommended course of vaccination consists of 3 doses and is carried out according to the scheme: the first dose - on the appointed day; The second - 2 months after the first; The third - after 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 vaccine is ready for use, no additional dilution or resuspension is required. 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 only for single use and only for one person.

Opening of bottles and the vaccination procedure are carried out with strict adherence to the rules of aseptic and antiseptic. Place of injection before and after injection is treated with 70% alcohol.

You should enter the recommended dose.

Regulations for the introduction of the vaccine

Vials with a single dose of vaccine: dial 0.5 ml of a suspension of a single-dose vial of a vaccine with a sterile needle into a disposable syringe that does not contain preservatives, antiseptics and detergents. Introduce the entire dose. The vial should be discarded 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 it is securely attached to the syringe and its length does not exceed 2.5 cm, this 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, secure 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.

Overdose

There have been reports of cases of administering 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 doses of this vaccine.

Special instructions

The efficacy and safety of Gardasil® for both SC and ID or administration has not been studied, therefore these methods of administration are not recommended.

Gardasil® is not intended for the treatment of cervical, vulvar or vaginal cancer, CIN, VIN or VaIN or active condylomatosis. The drug does not protect against diseases caused by HPV of other types and other etiology.

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

The decision to administer the drug or to postpone vaccination due to a current or recent illness accompanied by fever is largely dependent on the etiology and severity of the disease. A slight increase in temperature and a mild infection of the upper respiratory tract are usually not contraindications for vaccination.

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 Gardasil® vaccine should be administered with caution to patients with thrombocytopenia and any blood clotting disorders, 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 compulsory protection from pregnancy during the vaccination course, 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 on the safety and efficacy of Gardasil® vaccine in adults over 26 years of age.

Use in Pediatrics

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

Complaints on the specific and physical properties of the vaccine and reports on all cases of increased reactogenicity or the development of post-vaccination complications are directed:

- in the Federal Research Institute of Standardization and Control of Medical Biological Preparations named after. L.A. Tarasevich at the address - 119002, Moscow

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

Storage conditions of the drug Gardasil

In the dark place at a temperature of 2-8 ° C (do not freeze).

Keep out of the reach of children.

Shelf life of the drug Gardasil

3 years.

Do not use after the expiry date printed on the package.