Description overdue on 08/12/2014
- Latin name: Gardasil
- ATC code: J07BM01
- Active substance: Recombinant antigens: L1-protein of human papilloma virus types 6, 11, 16 and 18.
- Manufacturer: Merc Sharp & Dohme Idea Inc., USA
- Composition
- Product form
- Pharmacological action
- Pharmacodynamics and pharmacokinetics
- Indications for use of the drug
- Contraindications
- Side effects
- Instructions on Gardasil (method and dosage)
- Overdose
- Cooperation
- Terms of sale
- Storage conditions
- Shelf life
- Analogs
- With alcohol
- Reviews
- The Truth About Gardasil
- Price, where to buy
Composition
In a single dose - 0, 5 ml contain:
- Active substances - immunogens Namely recombinant antigens L1-protein of human papillomavirus in the proportions by type: 6 - 20 g, type 11 - 40 ug, type 16 - 40 micrograms and the type of 18 - 20 mg.
- Auxiliary components include aluminum hydroxyphosphate adjuvant sulfate amorphous - 225 g, L-histidine, - 0, 78 mg of sodium chloride - 9, 56 mg, sodium borate - 35 mg, polysorbate - 80-50 g and water for injection.
Product form
Gardasil vaccine is produced in a slurry of opaque white color intended for intramuscular administration. The preparation may be packaged in vials or disposable (special) syringes.
Pharmacological action
A vaccine for the prevention of diseases caused by human papilloma virus.
Pharmacodynamics and pharmacokinetics
Included in the vaccine L1 proteins are produced in a way separate fermentation of recombinant Saccharomyces cerevisiae CANADE 3C-5 (Strain 1895). As a result, by the self-assembly to form RSPs. Each type of TSP was purified and adsorbed onto the aluminum adjuvant.
If it is a complete vaccination, the specific antibodies are produced to the 4 types of the virus - is 6, 11, 16 and 18. It occurs in almost 99% of the vaccinated and in all age groups, they are stored for 36 months.
For the vaccine is characterized by almost 100% efficiency, allowing to prevent genital cancers, precancerous epithelial dysplasia and genital warts Which cause 4 HPV types.
The data on the pharmacokinetics of Gardasil available.
Indications for use of the drug
Typically, the vaccine Gardasil is used as prevention of diseases, which cause human papilloma virus 6, 11, 16 and 18. If you make a vaccine for children and adolescents aged 9-17 years, 18-26 years, young women, it is possible to avoid:
- Cancer of the cervix, vagina and vulva;
- genital warts;
- cervix adenocarcinoma and various types of genital neoplasia.
Contraindications
The main contraindication is:
- intolerant active ingredients and excipients vaccine and sensitivity to them.
It is considered a relative contraindication bleeding disorder due to hemophilia, thrombocytopenia, receiving anticoagulants. So when for this category of patients is performed Gardasil vaccination, it is necessary to evaluate its potential benefits and risks.
Side effects
In some cases, after the introduction of the vaccine develop local and general reactions, such as:
- redness;
- puffiness;
- pain;
- irritation;
- headache;
- fever and so on.
The reaction time may be 5 days. It does not require special medical attention.
The theoretical possibility of Allergies immediate type in patients having particular sensitivity, requires medical supervision after vaccination of about 30 minutes.
It should only be vaccinated in a medical facility, where there is a means of antishock therapy equipment.
Instructions on Gardasil (method and dosage)
The introduction of the vaccine Gardasil application instructions to run in the deltoid muscle, and sometimes in the anterolateral area of the thigh. It should be remembered that this drug is not intended for intravenous administration.
A single dose of the vaccine for children and adolescents 9-17 years and women 18-26 years of age is 0, 5 ml.
A full course of vaccination consists of 3 doses and is performed by a specific scheme - 0-2-6 months. That is, the first dose is administered on the appointed day, the next - after 2 months and the third dose 6 months after the first vaccine.
Sometimes an accelerated schedule, when a second dose is administered at 1 month, and the third - 3 months after the second vaccination. If the event of a breach of the interval, the course of vaccination can be considered complete, subject to three vaccinations within one year.
A suspension ready for use, so further dilution is required. Before using the vial or syringe with vaccine should be shaken to obtain a homogeneous turbid slurry. Lack of homogeneity, education, extra particles or color change - indicate the unsuitability of the vaccine.
If you are using a syringe filled with vaccine, it is intended for single use only for one person. This introduces all the recommended dose.
Reveals bottles and carry out the procedure of vaccination is permitted under strict aseptic and antiseptic rules. Prior to injection and after the skin surface must be treated with 70% alcohol.
Overdose
With the introduction of the vaccine in high doses did not reveal special nature and severity of undesirable symptoms.
Cooperation
According to the results of clinical trials, vaccination with Gardasil may be in conjunction with a recombinant vaccine Hepatitis B But in the other portion.
Receiving analgesics, anti-inflammatories, antibiotics, vitamins It has no impact on efficacy, safety and immunogenicity of the vaccine.
It is also not marked effect on the immune response of the vaccine when used hormonal contraceptives, corticosteroids for inhaled topical or parenteral use.
Terms of sale
The drug prescription.
Storage conditions
A place to store the vaccine should be protected from light and kids. The recommended temperature of 2-8 ° C. Freezing a slurry is not allowed.
Shelf life
The product is fit for 3 years. If observed change in physical properties, the slurry must not be used.
Analogs
The main analog of this vaccine to prevent diseases caused by papillomavirus man It is Cervarix .
Alcohol and Gardasil
During vaccination against the use of alcohol need to abstain.
Reviews of Gardasil
It should be noted that one of the most talked about products is just the vaccine Gardasil, reviews of which are found in various medical and women's forums and specialized sites. At the same time the views of users of the drug varies greatly and often develops into the most heated discussions.
Testimonials about Gardasil also wear a different character, although most of them still are supporters of vaccination. Doctors report the results of numerous clinical studies that confirm the importance of this vaccination, but vaccination should be only after consultation with a specialist and is strictly a medical institution.
Cervarix and Gardasil - which is better?
This question bothers many women who are willing to be vaccinated, or simply interested in the topic. Experts say that since both vaccines have the same composition and patterns of use, and the effectiveness of the vaccine has no special differences.
The Truth About Gardasil
Online you can find many discussions about the various vaccines, including Gardasil. According to some women, this medication is designed specifically American scientists, and its use is infertility and the development of other diseases of the human reproductive system.
However, such disputes erupted over the other vaccines. Often people do not even realize what is the vaccine and do not know the features of its action.
As shown by clinical studies and the comments of experts, certain types of vaccinations Human Papillomavirus It is a real breakthrough in the prevention of cervical cancer.
Of course, we should not exclude the development of undesirable symptoms, but the frequency of their occurrence is commensurate with the administration of other vaccines. This usually arise those side effects, which are specified in the instruction, i.e. weakness, swelling, and pain at the injection site, headaches, nausea and the like.
A more serious phenomenon is the development of syndrome Guillain-Barre Which is characterized by lesions of the peripheral nerves, accompanied by numbness and muscle weakness. Usually patients recover completely, but the recovery process may be delayed.
Also noted sporadic deaths on the background of the introduction of Gardasil, but all of them occurred in patients diabetes or meningitis.
However, representatives of many international medical organizations and agencies are confident that the benefits of Gardasil is much higher than the risk of adverse events.
Price Gardasil, where to buy
Pharmacies can buy the vaccine in vials or syringes. The price of Gardasil in a form does not have significant differences. For example, in Moscow, the price of the vaccine in the vial is 6353 rubles, and in the syringe - 6567 rubles.
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