Gardasil

Gardasil – the vaccine applied to prevention of the diseases caused by a virus of papilloma of the person.

Form of release and structure

Gardasil release in the form of suspension for intramuscular introduction: white, opaque (on 0,5 ml in glass bottles with a capacity of 3 ml or in glass one-time syringes with a capacity of 1,5 ml complete with 1 or 2 sterile needles and the device for safe introduction or without it, on 1 or 10 bottles or syringes in a cardboard pack).

Active agent is a part of 0,5 ml (1 doses): L1 of squirrels of a virus of papilloma of the person – 0,12 mg, including:

• Type 6 – 0,02 mg;
• Type 11 – 0,04 mg;
• Type 16 – 0,04 mg;
• Type 18 – 0,02 mg.

Auxiliary components: sodium chloride – 9,56 mg, amorphous sulfate hydroxyaluminum phosphate – 0,225 mg, polysorbate of 80 - 0,05 mg, a L-histidine – 0,78 mg, sodium borate – 0,035 mg, water for injections – 0,5 mg.

Suspension does not contain antibiotics and preservatives.

Indications to use

Gardasil appoint for prevention of the diseases caused by the virus of papilloma of the person (VPP).

Girls and women (age from 9 to 45 years):

• Cancer of the proctal channel, vagina, vulva and neck of uterus (caused by VPCh 16 and 18 of types);
• Intra epithelial neoplasia of a vagina (VaIN) and vulva (VIN) 1/2/3 of degree (VPCh 6, 11, 16 and 18 of types);
• Adenocarcinoma of a neck of uterus of in situ (AIS), cervical intra epithelial neoplasia 1/2/3 degrees (CIN) (VPCh 6, 11, 16 and 18 of types);
• Condyloma acuminata (anogenitalny condylomas) (VPCh 6 and 11 of types);
• Intra epithelial neoplasia of proctal channel 1/2/3 of degree (VPCh 6, 11, 16 and 18 of types).

At girls and women (age from 9 to 26 years) Gardasil can provide protection against the diseases caused by VPCh, which are not a part of a vaccine of types.

Boys and men (age from 9 to 26 years):

• Condyloma acuminata (anogenitalny condylomas) (VPCh 6 and 11 of types);
• Cancer of the proctal channel (VPCh 16 and 18 of types);
• Precancerous, dysplastic states and intra epithelial neoplasia of proctal channel 1/2/3 of degree (VPCh 6, 11,16, 18 of types).

Contraindications

Contraindication to Gardasil's use is hypersensitivity to drug components.

At development of symptoms of hypersensitivity to drug introduction of the subsequent doses of a vaccine is contraindicated.

Relative contraindication to performing therapy are disturbances of coagulability of blood because of thrombocytopenia, hemophilia or against the background of reception of anticoagulants. In case of need uses of a vaccine for this category of patients it is necessary to estimate potential advantages of vaccination with the interfaced risk. At vaccination in these cases it is necessary to take measures for reduction of risk of formation of a post-injection hematoma.

Data on efficiency and safety of use of Gardasil for children are younger than 9 years and 45 years are more senior than adults are absent.

Route of administration and dosage

Gardasil it is necessary to enter intramusculary into a verkhnenaruzhny surface of an average third of a hip or a deltoid muscle. The vaccine is not intended for intravenous administration.

The single dose of Gardasil for all age groups makes 0,5 ml.

The recommended vaccination course – 3 doses, it is necessary to carry out it according to the scheme (0-2-6 months):

• 1 dose – in appointed day;
• 2 dose – 2 months later after introduction of the first;
• 3 dose – 6 months later after introduction of the first.

Carrying out the accelerated scheme of vaccination (0-1-3 months) is possible.

At disturbances of a break between inoculations the course of vaccination can be considered complete if 3 vaccination were entered during 1 year.

Need for carrying out a revaccination was not established.

If for performing vaccination the first dose of Gardasil was used, then and the full course of vaccination needs to be conducted, using this drug.

Before introduction packaging (syringe/bottle) with a vaccine should be stirred up before receiving a homogeneous muddy suspension. During the losing homogeneity, emergence of the included particles and discoloration of suspension it is impossible to enter a vaccine.

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

The procedure of vaccination and opening of bottles need to be carried out at strict observance of rules of antiseptics and an asepsis. Before and after an injection an injection site it is necessary to process 70% alcohol.

It is necessary to enter all recommended single dose (0,5 ml).

Side effects

During Gardasil's use there can be following disturbances (> 10% – very often;> 1% and 0,1% and 0,01% and <0,1% – редко; <0,01% – очень редко):

• Respiratory system: very seldom – a bronchospasm;
• Musculoskeletal system: often – extremity pain;
• Local reactions: very often – reddening, a swelling and pain; often – a hematoma, an itch (in most cases local reactions proceeded in easy severity);
• General frustration: often – a pyrexia.

At post-registration use Gardasila arrived spontaneous information on development in vaccinated following side effects, to authentically estimate communication with an inoculation and which frequency are not possible:

• Nervous system: a headache, a syndrome to Giyena-Barra, dizziness, the acute primary idiopathic polyradiculoneuritis, acute disseminated encephalomyelitis, a syncope which in certain cases is followed by toniko-clonic spasms;
• Lymphatic system and system of a hemopoiesis: idiopathic Werlhof's disease, lymphadenopathy;
• Musculoskeletal system: mialgiya, arthralgia;
• Alimentary system: vomiting, nausea;
• Parasitic and infectious diseases: cellulitis;
• Allergic reactions: hypersensitivity reactions (including anaphylactoid/anaphylactic reactions), a small tortoiseshell and a bronchospasm;
• General frustration: fever, adynamy, discomfort, fatigue.

Special instructions

At the solution of a question of need of performing vaccination it is necessary to compare possible risk from previous VPCh infection with potential advantage of its carrying out.

Gardasil is not intended for cancer therapy of a neck of uterus, a vagina or a vulva, CIN, VaIN or VIN or an active condylomatosis. Use of drug is possible only with the preventive purpose. The vaccine is intended for prevention of infection with the VPCh types which the patient does not have. The vaccine does not exert impact on a course of the active infections caused by VPCh.

As well as at introduction of any other vaccine, at Gardasil's use the protective immune response manages to be received not at all vaccinated. From the sexually transmitted diseases having other etiology, drug does not protect. Because of it the vaccinated patients need to recommend to continue use of other prophylactics of protection.

Hypodermic and intradermal administration of drug is not recommended that is connected with lack of data on safety and efficiency of use of drug these ways.

In a treatment-and-prophylactic office in which vaccination is carried out there have to be medicines for immediate stopping of anaphylactic reaction and means of antishock and emergency treatment.

For 30 minutes after introduction of a vaccine it is necessary to watch a condition of the patient for early detection of postvaccinal reactions and complications, and also rendering the emergency medical care. When performing vaccination development of a faint, in particular at young women and teenagers is possible.

The decision on Gardasil's introduction or on a vaccination delay because of the flowing or recently postponed disease proceeding with the increased temperature is defined by an etiology of a disease and severity.

At the broken reactivity of immune system because of use of immunodepressants (system corticosteroids, antimetabolites alkylating and cytotoxic drugs), genetic defects, HIV infection and other reasons the protective effect can be lowered.

Gardasil patients need to enter with care with thrombocytopenia and any disturbances of a blood coagulation as after carrying out an intramuscular injection at such patients bleeding can develop.

Before vaccination the medical personnel have to provide all necessary information on a vaccine to patients, trustees and parents, including data on advantages and the interfaced risk.

It is necessary to report about any undesirable reactions to the doctor. Vaccination does not replace routine screening surveys. In the absence of contraindications for achievement of effective results the course of vaccination should be completed completely.

Medicinal interaction

Gardasil it is possible to enter jointly (into other site) with a recombinant vaccine against hepatitis B, a vaccine meningococcal, conjugated with a diphtherial anatoxin and with the inactivated vaccine against poliomyelitis, tetanus, diphtheria, whooping cough (an acellular component).

Terms and storage conditions

To store in protected from light, the place, unavailable to children, at a temperature of 2-8 °C, not to freeze.

Period of validity – 3 years.

After extraction from the refrigerator Gardasil it is necessary to enter as soon as possible. Out of the refrigerator (at a temperature of 25 °C or below) it is possible to hold drug not longer than 72 hours.