Gardasil

Гардасил Drug photo

The description is actual on 12.08.2014

  • Latin name: Gardasil
  • ATH code: J07BM01
  • Active ingredient: Recombinant antigens: L1 protein of a virus of papilloma of the person of types 6, 11, 16 and 18.
  • Producer: Merc Sharp&Dohme Idea Inc., USA

Structure

In one dose – 0,5 ml contain:

  • Active agents – immunogens, namely recombinant L1 protein antigens of a virus of papilloma of the person in ratios on types: 6 – 20 mkg, type 11 – 40 mkg, type 16 – 40 mkg and type 18 – 20 mkg.
  • Auxiliary components are: adjuvant-aluminum hydroxyphosphate-sulfate of amorphous – 225 mkg, a L-histidine – 0,78 mg, sodium chloride – 9,56 mg, sodium borate – 35 mkg, polysorbate – 80-50 mkg and water for injections.

Release form

Gardasil vaccine in the form of the suspension of opaque white color intended for intramuscular introduction is issued. Drug can be packaged in bottles or one-time (special) syringes.

Pharmacological action

Vaccine for prevention of the diseases caused by a virus of papilloma of the person.

Pharmacodynamics and pharmacokinetics

The L1 proteins which are a part of a vaccine are produced by way of separate fermentation in recombinant Saccharomyces cerevisiae CANADE 3C-5 (the Strain of 1895). As a result by self-assembly form VVCh. Each VVCh type is cleared and adsorbed on aluminum-bearing adjuvant.

If full vaccination is carried out, then specific antibodies to the 4th types of a virus are formed - it is 6, 11, 16 and 18. It occurs almost at 99% vaccinated and at all age groups they remain within 36 months.

The efficiency allowing to prevent cancer diseases of generative organs, precancerous epithelial dysplasias and genital condylomas which cause 4 VPCh types is characteristic of this vaccine nearly 100%.

Gardasil given on pharmacokinetics are absent.

Indications to drug use

As a rule, the vaccine Gardasil is applied as prevention of a number of diseases which are caused by a virus of papilloma of the person of 6, 11, 16 and 18 types. If to make a vaccine to children and teenagers at the age of 9-17, to young women of 18-26 years, then it is possible to avoid education:

Contraindications to use

The main contraindication is:

  • intolerance of active components and fillers of a vaccine and sensitivity to them.

Relative contraindication disturbance of coagulability of blood because of hemophilia, thrombocytopenia, reception of anticoagulants is considered. Therefore when for this category of patients the inoculation Gardasil is carried out, it is necessary to estimate its potential advantages and possible risk.

Side effects

In certain cases after introduction of a vaccine local and general reactions develop, for example:

Duration of reactions can make 5 days. At the same time special medicamentous intervention is not required.

The theoretical possibility of development of imediate-type allergies in the patients possessing special sensitivity demands after vaccination of medical supervision about 30 min.

It is necessary to carry out vaccination only in medical institution where there is an equipment by means of antishock therapy.

The instruction on Gardasil (A way and a dosage)

Gardasil the application instruction recommends to carry out introduction of a vaccine in a deltoid muscle, and sometimes to the anterolateral area of a hip. At the same time it is necessary to remember that this drug is not intended for intravenous administration.

The single dose of a vaccine for children and teenagers of 9-17 years and women of 18-26 years makes 0,5 ml.

The full-fledged course of vaccination includes 3 doses and is carried out according to a certain scheme – 0-2-6 months. That is the first dose is entered into appointed day, following – in 2 months, and the third dose 6 months later after introduction of the first vaccine.

The accelerated scheme when the second dose is entered in 1 month, and a third – 3 months later after the second vaccination is sometimes used. If there is a disturbance of an interval, then the course of vaccination can be considered completed on condition of carrying out three vaccination within one year.

Suspension is ready to use therefore additional cultivation is not required. Before use the bottle or the syringe with a vaccine need to be stirred up that the homogeneous muddy suspension turned out. Insufficient homogeneity, formation of excess particles or discoloration – indicate unfitness of a vaccine.

If the syringe filled with a vaccine is used, then it intends only for single use for one person. At the same time all recommended dose is entered.

To open bottles and to carry out procedure of vaccination it is allowed at strict observance of all rules of an asepsis and antiseptics. Before an injection and after it a skin surface it is necessary to process 70% alcohol.

Overdose

At introduction of a vaccine in the raised doses special character and expressiveness of undesirable symptoms is not revealed.

Interaction

According to results of clinical trials, vaccination by Gardasil along with a recombinant hepatitis B vaccine, but in other site is allowed.

Reception of analgetics, anti-inflammatory drugs, antibiotics, vitamin drugs did not exert impact on efficiency, safety or an immunogenicity of a vaccine.

Also influence on an immune response of a vaccine when using hormonal contraceptives, corticosteroids for inhalation local or parenteral use is noted.

Terms of sale

Drug is released according to the recipe.

Storage conditions

The place for storage of a vaccine has to be protected from light and children. The recommended temperature of 2-8 °C. Freezing of suspension is not allowed.

Period of validity

Drug is good 3 years. If are observed change of physical properties, then suspension is forbidden to be used.

Analogs

Coincidence on the ATH code of the 4th level:

The main analog of this vaccine for prevention of the diseases caused by a virus of papilloma of the person is Tservariks.

Alcohol and Gardasil

During vaccination it is necessary to refrain from alcohol intake.

Zdravzona

  • Gardasil a vaccine against VPCh 0,5ml/doza suspension for introduction No. 1 in oil flakonmerk Sharp and Doum
  • Gardasil a vaccine against VPCh 0,5ml/doza suspension for introduction No. 1 in oil shpritsmerk Sharp and Doum

Drugstore of IFC

  • Gardasil 1fl/1doza (against VPCh 6 11,16,18), Merck Sharp & Dohmeniderlandy
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Section: Gynecologic Antiviral
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