Gardasil vaccine against human papillomavirus (types 6, 11, 16, 18) kvadrivalentny recombinant.

by

Indications

Vaktsin Gardasil's

it is shown to use to girls and women aged from 9 up to 45 years for prevention of the diseases caused by HPV 6, 11, 16, 18 types, including cervical cancer, a vulva, a vagina and cancer of the anal channel; precancerous and dysplastic states; genital condylomas; the infections caused by human papillomavirus

to Vaktsin Gardasil's

it is shown for prevention of such diseases:

• cervical cancer, vulvas, vaginas and cancer of the anal channel caused by HPV of types 16 and 18;
• genital condylomas (Condyloma acuminata) caused by HPV of types 6 and 11, both the infections and the subsequent precancerous or dysplastic states caused by HPV of types 6, 11, 16 and 18;
• cervical intra epithelial neoplasia 2 and 3 degrees (CIN 2/3) and adenocarcinoma of a neck of the uterus in situ (AIS);
• cervical intra epithelial neoplasia of 1 degree (CIN 1);
• intra epithelial neoplasia of a vulva 2 and 3 degrees (VIN 2/3);
• intra epithelial neoplasia of a vagina 2 and 3 degrees (VaIN 2/3);
• intra epithelial neoplasia of a vulva of 1 degree (VIN 1) and intra epithelial neoplasia of a vagina of 1 degree (VaIN 1);
• intra epithelial neoplasia of anal channel (AIN) 1, 2 and 3 of degrees.

by Vaktsin Gardasil's

it is also shown to girls and women aged from 9 up to 26 years for prevention of a cervical intra epithelial neoplasia (CIN) connected with HPV of types 31, 33, 52 and 58, or adenocarcinomas of a neck of the uterus in situ (AIS).

by Vaktsin Gardasil's

it is shown to use to boys and men aged from 9 up to 26 years for prevention of the diseases and infections caused by HPV of types 6, 11, 16 and 18:

• cancer of the anal channel caused by HPV of types 16 and 18;
• genital condylomas (Condyloma acuminata) caused by HPV of types 6 and 11.

to Vaktsin's

it is also shown for prevention of the precancerous and dysplastic states caused by HPV of types 6, 11, 16 and 18:

• intra epithelial neoplasia of anal channel (AIN) 1, 2 and 3 of degrees.

Structure

• active ingredient: papillomavirus (human types 6, 11, 16, 18).

One dose (0.5 ml) contains

:

• active ingredients: recombinant antigens: L1 of squirrels of human papillomavirus in the following quantities: type 6 – 20 mkg, type 11 – 40 mkg, type 16 – 40 mkg, type 18 – 20 mkg;
• other components: aluminum in the form of adjuvant of aluminum of hydroxyphosphate of sulfate, amorphous; sodium chloride; L-histidine; polysorbate 80; sodium borate; water for injections.

Contraindication

Hypersensitivity to active ingredients or any component of vaccine, including heavy allergic reactions to yeast.

to Persons at whom the symptoms demonstrating hypersensitivity after introduction of a dose of Gardasil develop introduction of the following dose of vaccine is contraindicated to

.

As well as concerning other vaccines, use of vaccine of Gardasil it is necessary to postpone in the presence at the patient of the acute disease which is followed by fever. Presence of a slight infection, such as insignificant upper respiratory tract infection or subfebrile temperature, is not a contraindication for vaccination.

Side reactions

were More often observed by

following side reactions: side reactions in the place of an injection (77.1% vaccinated within 5 days after any visit for performing vaccination) and headaches (16.6% vaccinated). These side reactions usually were light or moderate intensity.

Route of administration

to Vaktsin should be entered by an intramuscular injection. The desirable injection site is the deltoid muscle of a shoulder or the anterolateral site of an upper part of a hip.

Drug cannot be administered intravenously. Hypodermic and intracutaneous methods of administration of medicament were not studied; such methods of introduction are not recommended.

Children aged from 9 up to 13 years inclusive Gardasil can be applied according to the scheme of two doses (on 0.5 ml: 0 and 6 months).

If the second dose is entered earlier, than in 6 months after the first, it is necessary to enter the third dose surely.

to

It is alternative, Gardasil it is possible to apply according to the three-dose scheme (0.5 ml: 0, 2 and 6 months). The second dose should be entered at least in 1 month after the first, and a third – at least in 3 months after the second dose. All three doses should be entered during 1 year.

Children are more senior than 14 years and adults Gardasil it is necessary to apply according to the three-dose scheme (0.5 ml: 0, 2 and 6 months). The second dose should be entered at least in 1 month after the first, and a third – at least in 3 months after the second dose. All three doses should be entered during 1 year.

Gardasil should be applied according to official recommendations.

to the Persons who received the first dose of the vaccine Gardasil recommends to finish

a full course of an inoculation the vaccine Gardasil.

Need of use of a booster dose is not established to

.

Use during pregnancy or feeding by a breast

These uses of the vaccine Gardasil during pregnancy did not indicate

Feature of use

security of use of drug. However these data are not enough to recommend use of the vaccine Gardasil during pregnancy. It is necessary to postpone vaccination to completion of pregnancy.

Gardasil the women nursing can apply

.

Children

Safety and efficiency of use of Gardasil are not established to children up to 9 years by

, there are no data.

Ability to influence speed of response at control of motor transport or other mechanisms

Research of influence on ability to run motor transport or to work with other mechanisms were not carried out by

.

messages about vaccine injection cases Gardasil in the doses exceeding recommended Were p>

. In general, the profile of side reactions at overdose was comparable to a profile at introduction of the recommended single doses of the vaccine Gardasil.

Storage conditions

to Store

at a temperature from 2 to 8 With in the place protected from light. Not to freeze. To store out of children's reach.