Gardasil, 0.5 ml/dose 0.5 ml (1 dose)

A full course of vaccine results in a protective titer of specific antibodies to the four types of HPV – 6, 11, 16, and 18 – in more than 99% of those vaccinated for at least 36 months in all age groups.

The Gardasil vaccine is virtually 100% effective in preventing genital cancers, precancerous epithelial dysplasia and genital condylomas induced by HPV types 6, 11, 16 and 18.

Indications

– The prevention of the following diseases caused by human papilloma virus types 6, 11, 16 and 18 in children and teenagers aged 9 to 17 years and young women aged 18 to 26 years:
– Cancer of the cervix, vulva and vagina.
– Genital condyloma (condiloma acuminata).

– The prevention of precancerous dysplastic conditions in children and adolescents aged 9 to 17 years and in young women aged 18 to 26 years:
– Adenocarcinoma of the cervix in situ (AIS).
– Cervical intraepithelial neoplasia of 2nd and 3rd degree (CIN 2/3).
– 2nd and 3rd degree vulvar intraepithelial neoplasia (VIN 2/3).
– 2nd and 3rd degree vaginal intraepithelial neoplasia (VaIN 2/3).
– 1st degree cervical intraepithelial neoplasia (CIN 1).

Composition

One dose (0.5 ml) contains:

Active substances-immunogens:

Recombinant antigens:

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

Auxiliary substances:

Aluminum as adjuvant-aluminum hydroxyphosphate-sulfate amorphous -225 µg,

sodium chloride -9.56 mg,
.

L-histidine -0.78 mg,

polysorbate – 80 – 50 µg,

sodium borate – 35 µg,

water for injection.

How to take, the dosage

The Gardasil vaccine is given intramuscularly into the deltoid muscle or the anterolateral thigh area.

Do not give intravenously.

The 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 months):
First dose – on the appointed day.
The second dose is 2 months after the first.
The third dose is 6 months after the first.

An accelerated vaccination schedule is allowed, in which the second dose is administered 1 month later and the third dose 3 months after the first vaccination.
If the interval between vaccinations is violated, the vaccination course is considered complete if three vaccinations are carried out within 1 year.

Special Instructions

The subcutaneous and intradermal administration of the vaccine has not been studied and therefore is not recommended.

The Gardasil vaccine is not designed to treat: cervical, vulvar or vaginal cancer, CIN, VIN or VaIN, or active condylomatosis. The drug does not protect against diseases caused by other types of HPV and other etiologies.

As with any injectable vaccine, you should always have appropriate medications on hand in case a rare anaphylactic reaction to the vaccine develops.

The decision to administer or delay vaccination due to an ongoing or recent febrile illness depends largely on the etiology and severity of the illness. A mild fever and a mild upper respiratory infection are not usually a contraindication to vaccination.

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

The Gardasil vaccine should be administered with caution to persons with thrombocytopenia and any blood clotting disorders, since bleeding may occur after an intramuscular injection in these individuals.

The medical staff must provide all relevant information about the vaccination and vaccine to patients, parents and caregivers, including information about the benefits and associated risks.

Vaccinated persons should be warned about the need to prevent pregnancy during the vaccination course, the need to report any adverse reactions to the doctor or nurse, and that vaccination does not replace or cancel routine screening exams. For effective results, the vaccination course must be completed in its entirety, unless there are contraindications.

Contraindications

Hypersensitivity to the active ingredients and excipients of the vaccine.

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

Perhaps clotting disorders due to hemophilia, thrombocytopenia or anticoagulants are relative contraindications to intramuscular administration of Gardasil vaccine unless the potential benefits of vaccination greatly outweigh the risks involved.

If vaccination is chosen, measures should be taken to reduce the risk of post-injection hematoma.

Side effects

After the introduction of the vaccine in individual cases local and general reactions may occur: according to the data of clinical studies, their cumulative incidence does not exceed 0.1%.

Local reactions are expressed as redness, swelling, pain and itching at the injection site.The duration of reactions does not exceed 5 days and does not require the prescription of medical therapy.

The most common common reactions are headache, short-term increase in body temperature. Individual cases of gastroenteritis and pelvic inflammation have been reported.

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

The vaccination sites must be provided with anti-shock therapy.

Overdose

There have been reports of doses of Gardasil administered in excess of the recommended doses.

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

Pregnancy use

There have been no specifically designed and well-controlled studies in pregnant women.

Potential effects of the vaccine on female fertility and on the fetus in pregnant women have not been studied.

There is no evidence that vaccine administration has adverse effects on fertility, pregnancy or the fetus.

The vaccine can be given to breastfeeding women.