Gardasil suspension 0.5ml/dose 0.5ml (1 dose), vial 1pc

Composition

One dose (0.5 ml) contains:

Active substances-immunogens:

Recombinant antigens:

L1-human papillomavirus protein in the following ratios: type 6 (20 mcg), Type 11 (40 mcg), Type 16 (40 mcg), Type 18 (20 mcg).

Auxiliary substances:

Aluminum in the form of an adjuvant-aluminum hydroxyphosphate – sulfate amorphous -225 mcg,

sodium chloride -9.56 mg,

L-histidine -0.78 mg,

polysorbate-80-50 mcg,

sodium borate-35 mcg,

water for injection.

Pharmacological action

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 Gardasil vaccine is almost 100% effective in preventing genital cancers, precancerous epithelial dysplasia, and genital warts caused by HPV types 6,11,16, and 18.

Indications

-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: – Cervical adenocarcinomas in situ (AIS). – Cervical intraepithelial neoplasia of 2 and 3 degrees (CIN 2/3). – Grade 2 and 3 intraepithelial neoplasia of the vulva (VIN 2/3). – Intraepithelial neoplasia of the vagina of 2 and 3 degrees (VaIN 2/3). – Grade 1 cervical intraepithelial neoplasia (CIN 1).

Use during pregnancy and lactation

There were no specifically planned and well-controlled studies in pregnant women.

The potential effects of the vaccine on female reproductive function and on the fetus in pregnant women have not been studied.

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

The vaccine can be administered to nursing women.

Contraindications

Hypersensitivity to active ingredients and excipients of the vaccine.

If symptoms of hypersensitivity occur after the introduction of Gardasil vaccine, the introduction of a subsequent dose of the vaccine is contraindicated.

Blood clotting disorders due to hemophilia, thrombocytopenia, or while taking anticoagulants are a relative contraindication to intramuscular use of the vaccine. Gardasil, unless the potential benefits of vaccination significantly outweigh the risks associated with it.

If the choice is made in favor of vaccination, measures should be taken to reduce the risk of post-injection hematoma formation.

Side effects

After the introduction of the vaccine, local and general reactions may develop in some cases: according to clinical studies, their combined frequency does not exceed 0.1%.

Local reactions are expressed in 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.

The most characteristic common reactions are headache, a short-term increase in body temperature. Isolated cases of gastroenteritis and pelvic inflammatory disease have been reported.

Taking into account the theoretical possibility of developing immediate allergic reactions in particularly sensitive individuals, it is necessary to ensure medical supervision of vaccinated persons for 30 minutes.

Vaccination sites should be provided with anti-shock therapy.

How to take, course of use and dosage

Gardasil is administered intramuscularly to the deltoid muscle or anterolateral thigh area.

Do not administer intravenously.

A single dose of the 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 month): The first dose is taken on the appointed day. The second dose is given 2 months after the first one. The third dose is given 6 months after the first one.

An accelerated vaccination schedule is allowed, in which the second dose is administered after 1 month, and the third-3 months after the first vaccination. In case of violation of the interval between vaccinations, the vaccination course is considered completed if three vaccinations are carried out within 1 year.

Overdose

There are reports of cases of Gardasil vaccine use at doses exceeding the recommended dose.

In general, the nature and severity of adverse events in overdose were comparable to those with the recommended single doses of this vaccine.

Special instructions

Subcutaneous and intradermal use of the vaccine has not been studied and is therefore not recommended.

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

As with any injectable vaccine, you should always have appropriate medications ready in case of a rare anaphylactic reaction to the introduction of the vaccine.

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

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

Gardasil should be administered with caution to individuals with thrombocytopenia and any blood clotting disorders, as such individuals may develop bleeding after intramuscular injection.

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

Vaccinated persons should be warned about the need to protect themselves from pregnancy during the course of vaccination, about the need to inform the doctor or nurse about any adverse 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 are no contraindications for this.

Form of production

Suspension for intramuscular use

Storage conditions

Store in a dark place, at a temperature of 2-8 °C (do not freeze)

Shelf life

3 years

Active ingredient

Human papillomavirus vaccine quadrivalent, recombinant (types 6,11,16,18)

Conditions of release from pharmacies

By prescription

Dosage form

suspension for injection