Dosage durabolin injection Form suspension for intramuscular injection Quadrivalent vaccine against human papillomavirus (HPV) is a mixture of highly purified virus-like particles (RSPs) recombinant major capsid protein (L1) HPV types 6,11,16 and 18. L1 proteins are produced by separate fermentation of recombinant Saccharomyces cerevisiae CANADA 3C-5 (strain 1895) and TSP form by self-assembly. TSP for each type of purified and adsorbed on aluminum-containing adjuvant (amorphous aluminum gidroksifosfatsulfat). Composition One dose (0.5 ml) contains: Active substance: recombinant antigens: L1 protein of human papillomavirus in the following amounts: Type 6 (20 mg) type 11 (40 mg), type 16 (40 mg), type 18 (20 mg). Excipients: aluminum hydroxyphosphate sulfate amorphous – 225 mg, sodium chloride – 9.56 mg, L-histidine – 0.78 mg, polysorbate-80 – 50 g, sodium borate – 35 mg water for injections.
Preservatives and contains no antibiotics.
Description of the dosage form
. The opaque white suspension Pharmacotherapeutic group MIBP vaccine Code ATC J07BM01 Immunobiologichesky properties of a full course of vaccination leads to the formation of specific antibodies against the four HPV types – 6,11,16 and 18 – more than 99% of vaccinees in the durabolin injection protective titer.Protection against genital cancers, precancerous dysplasia and genital warts, induced by specific HPV types, maintained for at least 54 months after completion of vaccination. Based on studies in women between the ages of 16 and 45 confirmed the high profile of efficacy, safety and immunogenicity of the vaccine Gardasil®. Girls and boys from 9 to 15 years conducted clinical studies investigating the safety and immunogenicity, and efficacy of the vaccine has been shown on the basis of immunological bridging.
The vaccine Gardasil® is indicated for use in children and adolescents aged 9 to 15 years and women 16 to 45 years for the prevention of:
– premalignant dysplastic states (cervical, vulvar and vaginal) and cervical cancer caused by oncogenic types of human papillomavirus ( HPV),
-. genital warts external genitalia (condiloma acuminate) etiologically associated with specific types of HPV vaccine Gardasil® should be applied in accordance with the doctor’s appointment for the prevention of diseases by human durabolin injection papillomavirus types caused 6,11, 16, 18, and to a lesser degree of diseases caused by other HPV types. Contraindications Hypersensitivity to the active components of vaccines and excipients. In the event of hypersensitivity symptoms following administration of the vaccine Gardasil® introduction of subsequent doses of vaccine is contraindicated. Coagulation disorders due to hemophilia, thrombocytopenia or in patients receiving anticoagulants are a relative contraindication to the intramuscular administration of the vaccine Gardasil®, unless the potential benefits of vaccination do not exceed largely associated with it risks. If the choice is made in favor of vaccination, must be taken to reduce the risk of postinjection hematoma. If the patient has an acute severe febrile illness, the administration of Gardasil® vaccine should be postponed. However, the presence of a mild infection or a small rise in body temperature is not a contraindication to vaccination. Dosage and administrationThe vaccine Gardasil® is administered intramuscularly into the deltoid muscle or verhnenaruzhnogo surface of the middle third of the thigh. Do not inject intravenously. Single dose for all age groups of 0, 5 ml. The recommended course of vaccination consists of 3 doses and is held by the scheme (0-2-6 months) . The first dose – on the appointed day, the second dose – 2 months after the first. The third dose – 6 months after the first. allowed scheme vaccination, wherein the second dose is given 1 month after the first dose and the third 3 months after the second vaccination. In case of violation of the interval between vaccination course of vaccination is considered complete if the three vaccinations carried out within 1 year. The need for revaccination has not been established. If the first dose of vaccine Gardasil® vaccine has been used, then the full course of vaccination should be carried out with the use of Gardasil® vaccine. Before use vial / syringe vaccine shaken until a homogeneous turbid suspension. The loss of homogeneity, the presence of impurities and foreign particles, discoloration suspensions indicate unsuitability of the vaccine. The syringe with vaccine is intended for single use only, and only one person. It is necessary to enter all the recommended dose -. 0.5 ml of opening the bottle and the procedure of vaccination is carried out in strict compliance with the rules of aseptic and antiseptic. Place before and after the administration of injection treated with 70% alcohol. The use of single-dose vials of vaccine Score 0.5 ml of suspension from the vial with a single dose of vaccine with a sterile needle into a disposable syringe. Enter the entire dose. The bottle with the remains discard the vaccine. Using syringe with a single dose of vaccine Enter the entire contents of the syringe completely.Instructions for use disposable sterile, pre-filled syringes with a single dose, complete with a protective device. Use the enclosed needle for administration of the vaccine. If you want to use another, make sure that the needle is firmly attached to the syringe, and that its length does not exceed 2.5 cm, which is a prerequisite for proper operation of the safety device. Remove the cap from the syringe. Pressing both the anti-rotation projection secure syringe and attach the needle Luer turning clockwise. Remove the protective cap from the needle. During the injection, as described above, press the plunger firmly holding a finger projections syringe and enter the entire dose. No protective device It works, if not the entire dose is injected. Remove the needle. Dip the piston and allow the syringe to move up to the full needle closed. Throw away the syringe into the sharps container. For documenting vaccination separate removable labels, slowly pulling them. Warnings General In deciding whether vaccination is necessary to compare the potential risk from the previous HPV exposure and potential benefit of vaccination. Gardasil® vaccine is not intended for the treatment of diseases: cancer of the cervix, vulva or vagina, of CIN, VINili VaIN or active kondillomatoza and administered solely for preventive purposes. The vaccine is preventive and is designed to prevent infection by HPV types that are not in the patient. The vaccine has no effect on the course of active infection caused by HPV. As with any other vaccine administered, while applying Gardasil® not all vaccinees possible to obtain a protective immune response. The drug does not protect against sexually transmitted diseases through, other etiologies. In this regard, vaccinated patients should be advised to continue the use of other preventive remedies. Subcutaneous and intradermal administration of the vaccine has not been studied and is not recommended. As with the introduction of any injectable vaccine, a health care office you should always have ready the appropriate remedies in case of a rare anaphylactic reaction to the vaccine, and emergency funds, and anti-shock therapy. Immediately after administration of the vaccine within 30 minutes of the patient is carried out under medical surveillance for timely detection of post-vaccination reactions and complications, and emergency relief. In carrying out any vaccination may experience fainting, especially in adolescents and young women. The decision on the introduction of the drug or the postponement of vaccination in connection with current or recent illness accompanied by fever, largely depends on the etiology of the disease and severity. In individuals with impaired reactivity immune system due to use of immunosuppressive therapy (systemic corticosteroids, cytotoxic drugs antimetabolites, alkylating agents), genetic deficiency, infection by human immunodeficiency virus (HIV) and other reasons a protective effect can be reduced. The vaccine Gardasil® be administered with caution to persons with thrombocytopenia and any violations blood clotting, since after intramuscular injection such persons may develop bleeding. The medical staff is obliged to provide all necessary information on vaccination and vaccines to patients, parents and caregivers, including information about the benefits and associated risks. vaccinated should be warned about the need to report to your doctor or nurse about any adverse reactions, and that the vaccination does not replace or supersede routine screening examinations. To achieve effective results the vaccination course should be completed in full if it does not have a contraindication. OverdoseThere have been reports of administration of Gardasil® vaccine at doses higher than recommended. In general, the nature and severity of adverse events in overdose was comparable to that of the introduction of the recommended single dose of durabolin injection vaccine Gardasil®. Side effects The following adverse reactions associated with the vaccine occurred in patients who were administered Gardasil® in 1% of cases and more than in patients administered placebo. Very often (> 10.1); Often (≥1 / 100, <1/10); Uncommon (≥1 / 1000, <1/100); Rare (≥1 / 10,000, <1/1 000); Very rare (<1/10 000) – Musculoskeletal disorders and damage to the connective tissue. Often: . Pain in the limbs – Systemic reactions and injection site reactions. Often: . Pyrexia – The following local reactions occurred in the group administered with Gardasil® compared with any preparations containing the adjuvant aluminum hydroxyphosphate sulfate amorphous, or compared with the group administered the placebo solution. Very often, redness, pain and swelling. often: . itching, bruising Most local reaction was mild. Furthermore, bronchospasm, as serious side effects are very rare . During post-marketing use of Gardasil® vaccine was more spontaneous about adverse reactions reports. Since the reports of these reactions came on their own population, it is not possible to reliably estimate their frequency or establish a causal relationship with the vaccine. – Disorders of the blood and lymphatic system : lymphadenopathy, idiopathic purpura. – Disorders of the nervous system : dizziness, acute primary idiopathic polyradiculitis, headache, Guillain-Barre syndrome, acute disseminated encephalomyelitis, syncope sometimes accompanied by tonic-clonic seizures. – F eludochno-intestinal disorders: . nausea, vomiting – musculoskeletal disorders I:. arthralgia, myalgia – General reaction: asthenia, fatigue , chills, discomfort. – immune system disorders: . hypersensitivity reactions, including anaphylactic / anaphylactoid reactions, bronchospasm, and urticariaInteractions with other medicinal products The use of other vaccines vaccine Gardasil® may be administered simultaneously (in another area) with a recombinant hepatitis B vaccine, vaccine meningococcal conjugated to diphtheria toxoid and inactivated vaccine against diphtheria, tetanus, pertussis (acellular component), poliomyelitis. The use of a common drug application of analgesics, anti-inflammatory drugs, antibiotics and vitamin supplements did not affect the effectiveness, immunogenicity and safety of the vaccine. The use of a hormonal contraceptives The use of hormonal contraceptives did not affect the efficacy, safety and immunogenicity of Gardasil® vaccine. The use of steroids inhaled, topical and parenteral steroids do not affect the safety and immunogenicity of Gardasil® vaccine. The durabolin injection use of systemic immunosuppressants data on concomitant use of systemic immunosuppressants and Gardasil® vaccine no. pregnancy and lactation There is no evidence that the administration of Gardasil® vaccine has an adverse effect on fertility, pregnancy or the fetus, and are forced to doubt its safety. Specially-designed and well-controlled studies in pregnant women have not been conducted.Data on the use of Gardasil® vaccine during pregnancy and the potential impact of Gardasil® vaccine to women’s reproductive function and on the fetus in pregnant women is not enough to recommend the use of the vaccine during pregnancy. It should warn patients about the need to prevent pregnancy during the vaccination course, and when pregnancy occurs vaccination should be delayed until it is completed. Clinical trials, during which examined the effectiveness, safety and immunogenicity of Gardasil® vaccine in lactating mothers and infants, showed that Gardasil® vaccine can be administered to lactating women. Paediatric use in children under the age of 9 years safety and efficacy of Gardasil® vaccine has not been evaluated. Use in geriatrics no data to assess the safety and efficacy of Gardasil® vaccine in adults older than 45 years. Effects on ability to drive a car Research influence on the ability to drive and operate with mechanisms not carried out. Form Product vial Primary packaging : 1 dose (0.5 ml) was placed into a sterile vial (capacity of 3 ml), and the tubular glass type 1. Bottle cork chlorobutyl stopper with durabolin injection Teflon coating for aluminum run-in and snap-on plastic lid is closed. 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) of borosilicate glass. A syringe with a device for safe injection (or without it), equipped with a polycarbonate adapter protective bromobutyl cap and piston closed stopper made of butyl rubber coated with silicone. 1, a disposable sterile, pre-filled syringe, complete with one or two sterile needles (with or without needle) placed in blisters with a lid. Secondary packaging : 1 or 10 single-use sterile syringes, sealed in blisters with a lid, in a carton box together with instructions for use. shelf life 3 years.