Gardasil vaccine suspension 1dose 0,5ml

VACCINE Gardasil SUSP. DOSE 0.5ML

Description

Vaccine against human papillomavirus quadrivalent recombinant (types 6,11,16,18)

Human Papillomavirus (Types 6,11,16,18) quadrivalent recombinant Vaccine

Dosage form

intramuscular suspension

Quadrivalent vaccine against human papillomavirus (HPV) is a mixture of highly purified virus-like particles (HF) of recombinant basic capsid protein (L1) of HPV types 6,11,16 and 18. L1 proteins are produced by separate fermentation in recombinant Saccharomyces cerevisiae CANADA 3C-5 Strain 1895) and form the high pass through self-assembly. The AMP for each type is purified and adsorbed onto an aluminum-containing adjuvant (amorphous hydroxyphosphate aluminum sulphate).

Composition

One dose (0.5 ml) contains:
Active substances: recombinant antigens: L1 protein of human papillomavirus in the following quantities: type 6 (20 mcg), type 11 (40 mcg), type 16 (40 mcg), type 18 (20 mcg).
Excipients: aluminum hydroxyphosphate amorphous sulfate - 225 μg, sodium chloride - 9.56 mg, L-histidine - 0.78 mg, polysorbate-80 - 50 μg, sodium borate - 35 μg, water for injection.
Preservatives and antibiotics does not contain.

Opaque suspension of white color.

Mibp vaccine

Conducting a full course of vaccination leads to the formation of specific antibodies to four types of HPV - 6,11,16 and 18 - in protective titer in more than 99% of those vaccinated. Protection against genital cancers, precancerous dysplasias, and genital warts induced by specific types of HPV was maintained for at least 54 months after the completed course of vaccination.
Based on the studies conducted in women aged 16 to 45, a high profile of the efficacy, safety and immunogenicity of the Gardasil © vaccine has been confirmed. Clinical studies of safety and immunogenicity were conducted in girls and boys from 9 to 15 years old, and the effectiveness of the vaccine was shown on the basis of immune bridging.

The vaccine Gardasil © is indicated for use in children and adolescents aged 9 to 15 years and women from 16 to 45 years to prevent:
- precancerous dysplastic conditions (cervix, vulva and vagina) and cervical cancer caused by oncogenic types of human papillomavirus (HPV),
- Genital warts of the external genitalia (condiloma acuminate) are etiologically associated with specific types of HPV.
Gardasil © vaccine should be used in accordance with the prescription of a physician for the prevention of diseases caused by human papillomavirus types 11, 16, 18, and to a lesser extent, diseases caused by other types of HPV.

Contraindications

Hypersensitivity to the active ingredients and vaccine adjuvants.If symptoms of hypersensitivity occur after administration of Gardasil vaccine, administration of a subsequent dose of the vaccine is contraindicated.
Coagulation dysfunction due to hemophilia, thrombocytopenia, or in the presence of anticoagulants are a relative contraindication to the intramuscular administration of Gardasil © vaccine, unless the potential benefits of vaccination do not significantly exceed the associated risks. If the choice is made in favor of vaccination, it is necessary to take measures to reduce the risk of post-injection hematoma.
If a patient has an acute severe febrile illness, the administration of Gardasil © vaccine should be postponed. However, the presence of a mild infection or a slight increase in body temperature is not a contraindication to vaccination.

Dosage and administration

Gardasil © vaccine is injected intramuscularly into the deltoid muscle or the outer outer surface of the middle third of the thigh.
Do not administer intravenously.
Single dose for all age groups is 0.5 ml.
The recommended vaccination course consists of 3 doses and is carried out according to the scheme (0-2-6 months):
The first dose is on the appointed day.
The second dose - 2 months after the first.
The third dose - 6 months after the first.
A vaccination schedule is allowed, in which the second dose is administered 1 month after the first vaccination, and the third 3 months after the second vaccination. In case of violation of the interval between vaccinations, the vaccination course is considered complete if three vaccinations are carried out within 1 year.
The need for revaccination is not installed.
If the first dose of Gardasil © vaccine was used for vaccination, then the full vaccination course should be carried out using the Gardasil © vaccine.
Before use, the vial / syringe with vaccine is shaken until a homogeneous turbid suspension is obtained. The loss of homogeneity, the presence of inclusions and foreign particles, discoloration of the suspension indicate the unsuitability of the vaccine.
The vaccine syringe is intended for single use only and for only one person. You should enter the entire recommended dose of 0.5 ml.
The opening of the bottles and the vaccination procedure is carried out in strict compliance with the rules of asepsis and antisepsis. The injection site before and after the injection is treated with 70% alcohol.
Use of single dose vaccine vials
Take 0.5 ml of the suspension from the vial with a single dose of vaccine with a sterile needle into a disposable syringe. Enter the entire dose. Discard the bottle of vaccine residues.
Use of single dose vaccine syringes
Fill in the entire contents of the syringe.
Instructions for use of disposable sterile, pre-filled syringes with one dose complete with a safety device.
Use an inserted needle to administer the vaccine. If you want to use another, make sure that the needle is securely attached to the syringe and that its length does not exceed 2.5 cm, which is a prerequisite for the correct operation of the protective device.
Remove the cap from the syringe. Pressing both of the projections against the rotation of the protrusion, fasten the syringe, and attach the Luer needle by turning it clockwise. Remove the protective cap from the needle.
When performing the injection, as indicated above, press down on the plunger, firmly holding the syringe under the finger projections and inject the entire dose. The safety device will not work unless an ALL dose is entered. Remove the needle. Lower the plunger and allow the syringe to move up until the needle is completely closed. Throw the syringe into the sharps container.
To document vaccinations, remove the removable labels by slowly pulling them.

General When addressing the issue of vaccination, it is necessary to compare the possible risk of previous infection with HPV and the potential benefits of vaccination. Gardasil © vaccine is not intended to treat diseases of the cervix, vulvar or vaginal cancer, CIN, VIN or VaIN, or active condylomatosis and is administered exclusively for prophylactic purposes. The vaccine is prophylactic and is intended to prevent infection with those types of HPV that the patient does not have. The vaccine does not affect the course of active infections caused by HPV. As with the introduction of any other vaccine, when using Gardasil ©, not all vaccinees can obtain a protective immune response. The drug does not protect against sexually transmitted diseases of a different etiology.
Therefore, vaccinated patients should be advised to continue using other prophylactic agents.
Subcutaneous and intradermal administration of the vaccine has not been studied and therefore is not recommended.
As with the introduction of any injectable vaccine, in the treatment-and-prophylactic treatment room, you should always have the appropriate medicines ready in case of a rare anaphylactic reaction to the administration of the vaccine and means of emergency and anti-shock therapy. Immediately after the introduction of the vaccine, a patient is under medical observation for 30 minutes in order to timely detect post-vaccination reactions and complications and provide emergency care. Any vaccination can cause syncope, especially in adolescents and young women.
The decision to administer the drug or delay vaccination due to a current or recent illness with an elevated temperature is more dependent on the etiology of the disease and its severity.
In individuals with impaired immune system reactivity, due to the use of immunosuppressive therapy (systemic corticosteroids, cytotoxic antimetabolites, alkylating agents), a genetic defect, infection with the human immunodeficiency virus (HIV) and other causes, the protective effect can be reduced.
Gardasil © vaccine should be administered with caution to individuals with thrombocytopenia and any blood clotting abnormalities, since after intramuscular injection, such individuals may develop bleeding.
Medical personnel are required to provide all necessary information on vaccination and vaccine to patients, parents and guardians, including information on the benefits and risks involved.
Vaccinated should be warned about the need to inform the doctor or nurse about any adverse reactions, as well as the fact that vaccination does not replace or cancel routine screening examinations. To achieve effective results, the course of vaccination must be completed completely, unless there are contraindications for this.

There have been reports of cases of administration of the vaccine Gardasil © in doses exceeding the recommended. In general, the nature and severity of adverse events in overdose were comparable to those with the introduction of the recommended single doses of Gardasil © vaccine.

The following adverse reactions associated with the vaccine were found in people who were given Gardasil © in 1% of cases and more often than in people who were given a placebo.
Very often (≥1 / 10); Often (≥1 / 100, <1/10); Infrequently (≥1 / 1 000, <1/100); Rarely (≥1 / 10 000, <1/1 000); Very rare (<1/10 000)
- Musculoskeletal disorders and connective tissue damage.
Often: pain in the limbs.
- General reactions and reactions at the injection site.
Often: pyrexia.
- The following local reactions occurred in the group that was injected with Gardasil © compared with any preparations containing aluminum hydroxyphosphate adjuvant amorphous sulfate, or compared to the group in which the placebo solution was administered.
Very often: redness, pain and swelling.
Often: itching, hematoma.
Most local reactions were mild.
In addition, bronchospasms, as serious side effects, were very rare.
There were several spontaneous reports of adverse reactions during post-registration use of the Gardasil © vaccine. Since reports of these reactions were received at the will of the population, it is not possible to reliably estimate their frequency or establish a causal relationship with the use of the vaccine.
- Blood and lymphatic system disorders: lymphadenopathy, idiopathic purpura.
- Nervous system disorders: dizziness, acute primary idiopathic polyradiculoneuritis, headache, Guillain-Barré syndrome, acute disseminated encephalomyelitis, fainting, sometimes accompanied by tonic-clonic convulsions.
- Gastrointestinal disorders: nausea, vomiting.
- Musculoskeletal injuries: arthralgia, myalgia.
- General reactions: asthenia, fatigue, chills, discomfort.
- Immune system disorders: hypersensitivity reactions, including anaphylactic / anaphylactoid reactions, bronchospasm and urticaria.

Use with other vaccines
Gardasil © vaccine can be administered simultaneously (in a different area) with a recombinant hepatitis B vaccine, a meningococcal vaccine conjugated with diphtheria toxoid and an inactivated diphtheria, tetanus vaccine, whooping cough (cell-free component), polio.
Use with common drugs
The use of analgesics, anti-inflammatory drugs, antibiotics and vitamin preparations did not affect the efficacy, immunogenicity and safety of the vaccine.
Use with hormonal contraceptives
The use of hormonal contraceptives did not affect the efficacy, immunogenicity and safety of the Gardasil © vaccine.
Use with steroids
Inhalation, topical and parenteral steroids did not affect the immunogenicity and safety of the Gardasil © vaccine.
Use with systemic immunosuppressants
Data on the simultaneous use of systemic immunosuppressants and Gardasil © vaccine are not available.

There is no evidence that the administration of the Gardasil © vaccine has an undesirable effect on fertility, pregnancy or the fetus, and which would cast doubt on its safety.
Specially planned and well-controlled studies in pregnant women have not been conducted. Data on the use of Gardasil © vaccine during pregnancy and on the potential impact of Gardasil © vaccine on the reproductive function of women and on the fetus in pregnant women is not enough to recommend the use of the vaccine during pregnancy.
Patients should be warned about the need to prevent pregnancy during the course of vaccination, and when pregnancy occurs, vaccination should be postponed until completion.
Clinical trials in which to test the effectivenessThe immunogenicity and safety of Gardasil © vaccine in nursing mothers and infants have shown that Gardasil © vaccine can be administered to nursing women.

In children aged 9 years, the safety and efficacy of the vaccine Gardasil © was not evaluated.

There are no data to assess the safety and efficacy of Gardasil © vaccine in adults over 45 years of age.

Studies of the impact on the ability to drive, as well as work with the mechanisms was not carried out.

Vial Primary packaging: 1 dose (0.5 ml) placed in a sterile vial (with a capacity of 3 ml) and tubular glass type 1. The bottle is sealed with a chlorbutyl cork with a Teflon coating, under the aluminum running-in and closed with a snap-on plastic lid.
Secondary packaging: 1 or 10 bottles in a carton box together with instructions for use.
Disposable syringe Primary packaging: 1 dose (0.5 ml) in a disposable sterile syringe (1.5 ml capacity) made of borosilicate glass. The syringe with a device for safe insertion (or without it) is equipped with a polycarbonate adapter, a protective bromobutyl cap and a piston with a closed butyl rubber stopper, covered with silicone.
1 disposable sterile, pre-filled, syringe complete with 1 or 2 sterile needles (or without needles) placed in a blister box with a lid.
Secondary packaging: 1 or 10 disposable sterile syringes, sealed in a blister box with a lid, in a carton box together with instructions for use.

At a temperature of 2 to 8 ° C, in a dark place.
Do not freeze.
Keep out of the reach of children.