BCG Vaccine is supplied in a box of one single-dose vial of BCG. In univariate analysis, greater age was significantly associated with a positive booster reaction (P = .003), in both vaccinated and nonvaccinated employees. TICE is a registered trademark of The Board of Trustees of the University of Illinois, used under the license of Organon Teknika Corporation. Your doctor can give you a better idea of what to expect based on your personal medical profile. The catheter is clamped off so the solution stays in your bladder. However, in 1985 there was a 1.1% increase over the previous year. With Modern's Covid-19 vaccine candidate, it has a much more visible advocate: trial volunteer Ian Haydon. {9} Vaccination should be repeated for those who remain tuberculin negative to 5 TU of tuberculin after 2–3 months. {19}, Prior administration of BCG Vaccine has not been associated with a positive interferon gamma release assay (IGRA) test, which are indirect tests for, Although BCG vaccination often causes local reactions, serious or long-term complications are rare. {1} The TICE® strain used in this BCG Vaccine preparation was developed at the University of Illinois from a strain originated at the Pasteur Institute. {3}, BCG vaccination is recommended for infants and children with negative tuberculin skin tests who are (a) at high risk of intimate and prolonged exposure to persistently untreated or ineffectively treated patients with infectious pulmonary tuberculosis and who cannot be removed from the source of exposure and cannot be placed on long-term primary preventive therapy, or (b) continuously exposed to persons with infectious pulmonary tuberculosis who have bacilli resistant to isoniazid and rifampin, and the child cannot be separated from the presence of the infectious patient. Une petite rougeur gonflée et sensible se forme au niveau du point d’injection. Ce vaccin est distribué avec le Programme d’accès spécial de Santé Canada. {3} It is recommended that a Mantoux skin-test be performed prior to BCG vaccination to demonstrate the absence of tuberculous infection. {3} Reactions that can be expected after vaccination include moderate axillary or cervical lymphadenopathy and induration and subsequent pustule formation at the injection site; these reactions can persist for as long as 3 months after vaccination. Est enceinte, ou pense qu'elle pourrait l’être. Global Epidemiology of Tuberculosis. Each type of treatment has potential benefits and side effects to consider. BCG vaccine is contraindicated in patients with a hypersensitivity to any component of the vaccine including monosodium glutamate hypersensitivity and polysorbate 80 hypersensitivity; the vaccine is also contraindicated in patients with an anaphylactic or other allergic reaction to a previous dose of BCG vaccine. {16}, In a 1995 study of vaccine potency, 26 tuberculin negative subjects were vaccinated with BCG Vaccine (TICE® strain) and subsequent tuberculin conversion was monitored. Le vaccin bilié de Calmette et Guérin, le plus souvent dénommé vaccin BCGNote 1, est un vaccin contre la tuberculose. You’ll be advised to limit your fluid intake for four hours prior to the procedure. The most serious complication of BCG vaccination is disseminated BCG infection. Health care workers should be informed about (a) the lack of data regarding the efficacy of preventive therapy for MDR-TB infections and (b) the risks of drug toxicity associated with multi-drug preventive therapy regimens. If live vaccines cannot b… After that, you might need to do it once a month for six months to a year. 112-265. L’anaphylaxie (ou encore choc anaphylactique ou réaction anaphylactique)est une réaction d’hypersensibilité systémique, généralisée, sévère, pouvant engager le pronostic vital. BCG Vaccine (TICE® strain) is indicated for the prevention of tuberculosis in persons not previously infected with M. tuberculosis who are at high risk for exposure. Men should urinate while seated to avoid splashing. Manufactured for: BCG Vaccine has not been evaluated for carcinogenic, mutagenic potentials or impairment of fertility. Lotte A, Wazs-Hockert O, Poisson N, Dumitrescu N, Verron M, Couvet E: BCG Complications. Although the vaccine will not survive in a dry state for long, infection of others is possible. Fatal disseminated BCG infection has occurred at a rate of 0.06–1.56 cases per million doses; these deaths occurred primarily among immunocompromised persons. Other reported clinical experience has not identified differences in response between elderly and younger patients. However, no evidence exists for currently available vaccines to support this concern. Vaccination is recommended only for those who are tuberculin negative to a recent skin test with 5 TU. {9} Despite the conflicting results concerning prevention of pulmonary tuberculosis, it is widely acknowledged that immunization of infants with BCG lowers the risk of disseminated complications of this disease. BCG Vaccine is not a vaccine for the treatment of active tuberculosis. Accidental overdosages if treated immediately with anti-tuberculous drugs have not led to complications. Since BCG strains are resistant to pyrazinamide, this antibiotic should not be used. Watkins SM: Unusual complications of BCG vaccination. Estimates in areas where BCG vaccination is performed at birth indicate that the effectiveness of BCG in preventing childhood TB meningitis or miliary TB exceeds 70%.{10-15}. For an adult dosage, 1 mL of Sterile Water for Injection, USP, should be added to one single-dose vial of vaccine. When the vaccine is administered in the upper arm, the lymph node reaction is most likely to occur in the armpit, and less often above the collarbone or in the neck. Oxford Immunotec Ltd, July 2010. Since BCG is a live vaccine, the immune response to the vaccine might be impaired if administered within 30 days of another live vaccine. How does it compare to other treatment options? If a BCG infection is suspected, the physician should consult with an infectious disease expert before therapy is initiated. {3} The greatest known risk factor for developing active TB disease is immunodeficiency, particularly if caused by coinfection with HIV. After the vaccine is prepared, the skin site is cleansed with an alcohol or acetone sponge and allowed to dry thoroughly. More severe local reactions include ulceration at the vaccination site, regional suppurative lymphadenitis with draining sinuses, and caseous lesions or purulent drainage at the puncture site; these manifestations might occur within the 5 months after vaccination and could persist for several weeks. Dans ce cas, la vaccination n'est pas nécessaire. Wash your hands thoroughly, too. Precautions should be taken with respect to infants vaccinated with BCG and exposed to persons with active tuberculosis.{23}. During the same period, 1456 vaccines were administered, with a prevalence of 0.046% adverse reactions; of the patients with these adverse reactions, 45 had local reactions, 18 had lymphadenopathy, 3 had combined local reactio… Field trials of tuberculosis vaccines: How could we have done better? BCG vaccination results in tuberculin skin test reactivity. BCG Vaccine (TICE® strain) is indicated for the prevention of tuberculosis in persons not previously infected with, To avoid cross-contamination, parenteral drugs should not be prepared in areas where BCG Vaccine has been in use. MERCK & CO., INC. After about two hours, the catheter is unclamped so the fluid can be drained. Comme il n’est pas possible de prévenir totalement la survenue d’une anaphylaxie post-vaccinale, les vaccinateurs doivent prendre les mesures préventives a… Caution is advised in attributing a positive skin test to BCG vaccination. Depuis la disparition de la forme multipuncture du vaccin BCG (Monovax) en 2005, un seul vaccin BCG existe : le BCG SSI intradermique, dérivé de la souche danoise Copenhague 33. Then the BCG solution is injected into the catheter. All precautions should be taken for the prevention of allergic or any other side reactions, including understanding the use of the biological and the nature of the adverse reactions that may follow its use. Lorin MI, Hsu KHK, Jacob SC: Treatment of tuberculosis in children. Ce bacille proche de Mycobacterium tuberculosis, responsable de la tuberculose humaine, confère une antig… Please read this leaflet carefully before administering BCG Vaccine. Before administration of BCG Vaccine, health care personnel should inform patients or guardians of the benefits and risks of immunization and inquire about the health status of the patient. These reactions occasionally could occur more than 1 year after vaccination. Although BCG vaccination often causes local reactions, serious or long-term complications are rare. La vaccination est faite par injection par voie intradermique du vaccin BCG. BCG vaccination is reserved for persons who have a reaction of less than 5mm induration after skin testing with 5 TU of PPD tuberculin. The final preparation prior to freeze drying also contains lactose. Some doctors may remove the catheter at this time. {3} The appropriate therapy for systemic BCG infections is discussed in the ADVERSE REACTIONS section. To avoid cross-contamination, parenteral drugs should not be prepared in areas where BCG Vaccine has been in use. Centers for Disease Control and Prevention. Tuberculosis Morbidity – United States, 1998. La note de synthèse de l’OMS actuellement disponible sur ces vaccins a été publiée en 2004. To avoid cross-contamination, parenteral drugs should not be prepared in areas where BCG Vaccine has been prepared. Serious side effects from the BCG vaccine, such as a serious allergic reaction (anaphylactic reaction), are very rare. Si vous ou votre enfant avez effectué un test tuberculinique qui s'est révélé positif. Tuberculin skin test reactivity as a result of BCG vaccination cannot be readily differentiated from reactivity following exposure to tuberculosis. Un vaccin est une préparation biologique prophylactique d'un ou de plusieurs antigènes microbiens, qui stimule le système immunitaire d'un organisme vivant afin d'y développer une immunité adaptative protectrice et relativement durable contre l'agent infectieux d'une maladie infectieuse particulière [1]. Prior administration of BCG Vaccine has not been associated with a positive interferon gamma release assay (IGRA) test, which are indirect tests for M. tuberculosis infection (including disease) and are intended for use in conjunction with risk assessment, radiography and other medical and diagnostic evaluations.{20,21}. Persons administering vaccines should take necessary precautions to minimize risk for spreading disease. This upward trend continued through 1992, when the incidence was 10.5 cases per 100,000 population. Professional Postgraduate Services, International, Japan, 1987:73-79. Generic Name: bacillus calmette-guerin For example, in 1987 there were only 2 adverse reactions to BCG vaccine that were reported in all of Canada [1]. Let it stand for about 20 minutes before flushing. © 2005-2020 Healthline Media a Red Ventures Company. For six hours after each treatment, you’ll have to be very careful when you urinate to avoid transmitting BCG to others. In infants less than 1 month old, the dosage of BCG Vaccine should be reduced by one-half, by using 2 mL of Sterile Water for Injection, USP at 4-25°C (39-77°F) when reconstituting. 0,05 mg de la souche vivante atténuée de Mycobacterium bovis; 2. For a pediatric dosage, 2 mL of Sterile Water for Injection, USP, should be added to one single-dose vial of vaccine (see DOSAGE AND ADMINISTRATION). Guerin C: The history of BCG. Disinfect the urine by adding 2 cups of bleach into the toilet. Fatal disseminated BCG disease has occurred at a rate of 0.06–1.56 cases per million doses of vaccine administered; these deaths occurred primarily among immunocompromised persons. Am J Public Health 1986;76:783-786. Trois ampoules de verre du vaccin contre le choléra, Paris, France, 1924. Acute, localized irritative toxicities of BCG may be accompanied by systemic manifestations, consistent with a "flu-like" syndrome. Chemotherapy or radiation therapy may also be recommended. 0,0006 % de Polysorbate 80. The main use of BCG is for vaccination against tuberculosis.BCG vaccine can be administered after birth intradermally. Boston, Little Brown and Company; 1996; pp. Ce vaccin est destiné à lutter contre la tuberculose, sévère maladie respiratoire due au Bacille de Koch.Il n'est plus obligatoire pour les enfants depuis 2007. Multiple puncture devices may be obtained separately from the Merck Order Management Center, 351 North Sumneytown Pike, North Wales, PA 19454-2505, Telephone number: 800-MERCKRX (800-637-2579). What’s the survival rate for people with bladder cancer, and how good of a predictive model are these statistics? The left arm is recommended by the World Health Organization (WHO). MERCK & CO., INC., Whitehouse Station, NJ 08889, USA, Manufactured by: Organon Teknika Corporation LLC, Durham, NC 27712, USA, a subsidiary of Centers for Disease Control and Prevention. Bull WHO 1986;64:247-258. Available for Android and iOS devices. Reactions that can be expected after vaccination include moderate axillary or cervical lymphadenopathy and induration and subsequent pustule formation at the injection site; these reactions can persist for as long as 3 months after vaccination. Meta-analysis of the published literature. Last updated on Sep 1, 2020. The vaccine is to be administered after fully explaining the risks and benefits to the vaccinee, parent, or guardian. It’s not useful for later stage bladder cancer that has spread into or beyond the bladder lining, or to other tissues and organs. BCG is a liquid drug that can be deposited directly into your bladder through a catheter. It’s made from a weakened strain of Mycobacterium bovis, a vaccine for tuberculosis. NEJM 1997;337:315-320. No further immunisation should be given in the arm used for BCG immunisation for at least three months because of the risk of regional lymphadenitis. {26} If the vaccination response is allowed to progress it can still be treated successfully with anti-tuberculous drugs but complications can include regional adenitis, lupus vulgaris, subcutaneous cold abscesses, ocular lesions, and others.{27}. Centers for Disease Control and Prevention. Your doctor will help you work through your options and decide on the best treatment for you. When comparing BCG to other bladder cancer treatments, it’s important to remember that treatment isn’t the same for everybody. Elle peut concerner tous les patients et tous les vaccins. L’apparition d’une réaction cutanée locale est normale après vaccination par le BCG. ); Tuberculosis. The patient should be advised that the vaccine contains live organisms. 9 Des lignes directrices révisées relatives à la vaccination par le BCG des nourrissons exposés au risque d’infection par le VIH ont été publiées séparément en 2007. BCG Vaccine administration should not be attempted in individuals with severe immune deficiency disease. There were 3 deaths from tuberculosis in the control group that were less than 2.5 years of age (all had miliary tuberculosis with meningitis), with one death in the vaccinated group (meningitis). TB is a serious infection that affects the lungs and sometimes other parts of the body, such as the bones, joints and kidneys. Men can pass BCG to their partner during sex. In: Rosenthal SR (ed): BCG Vaccine: Tuberculosis-Cancer. Usually you have BCG into the bladder if you have a high risk of early bladder cancer coming back or spreading into the deeper layers of your bladder. As with any vaccine, immunization with BCG Vaccine may not protect 100% of susceptible individuals. BCG Vaccine for percutaneous use is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis. Do not administer INTRAVENOUSLY, SUBCUTANEOUSLY, INTRAMUSCULARLY, OR INTRADERMALLY. Although BCG vaccination often results in local adverse effects, serious or long-term complications are rare. {19} A separate sterile multiple puncture device must be used for each patient and appropriately discarded after use. JAMA 1997;278:833-837. In: Rom, WN, Garay, SM (eds. All rights reserved. {22} After use, any unused vaccine and all materials exposed to the product should be immediately placed in a biohazard container and disposed of in an appropriate manner. Ce processus, appelé séroconversion, est progressif.. Habituellement, la protection apportée par le vaccin contre une maladie est présente entre deux et trois semaines après la vaccination pour les vaccins nécessitant une seule injection comme la grippe, l’hépatite A ou la fièvre jaune. An intact immune system is a prerequisite for BCG vaccination. Tuberculosis (TB) is primarily an airborne communicable disease caused by the bacterium, Mycobacterium tuberculosis. Efficacy of BCG Vaccine in the prevention of tuberculosis. This agent contains live bacteria and should be protected from direct sunlight. Twenty-one (21) out of 22 converted to PPD positive at a level greater than 5mm for a skin test conversion rate of 95%.{17}. The most serious complication of BCG vaccination is disseminated BCG infection. The infant who died in the vaccinated group had not converted to a positive purified protein derivative (PPD) skin test at 6 months of age and was never subsequently revaccinated. Any unusual adverse reactions should be reported to the health care provider. Tubercle 1963;44:247-250. Administration should be by the percutaneous route with the multiple puncture device as described below. This treatment only affects cells inside the bladder. Clinical trials patients are usually faceless. fever that doesn’t respond to aspirin or other fever reducers. Il est préparé à partir d'une souche atténuée de bacille tuberculeux bovin (Mycobacterium bovis) vivant qui a perdu sa virulence sur l'homme par culture spéciale sur des milieux artificiels pendant des années. It’s important that you follow your doctor’s instructions for what to do before and after the procedure. However, symptoms such as fever of 103°F or greater, or acute localized inflammation persisting longer than 2–3 days suggest active infections, and evaluation for serious infectious complication should be considered. Certain immunosuppressants, antimicrobial therapies, and radiation therapies can interfere with BCG treatment. Data on file, Organon Teknika Corporation LLC, Durham, NC. Vaccination should not be required for employment or for assignment of HCWs in specific work areas. L'administration de Vaccin BCG SSI pourrait entraîner une réaction importante au site d'injection. National Geographic Recommended for you The sterile, single-use multiple puncture device is for use with the BCG Vaccine only. Copyright © 2011-2019 Merck Sharp & Dohme B.V., a subsidiary of Merck & Co., Inc. The diagnosis of tuberculosis was made following a review of chest X-ray results and clinical findings. All staff who give vaccinations are trained to treat allergic reactions. Le vaccin BCG est utilisé pour l'immunisation active contre la tuberculose, en particulier pour protéger les jeunes enfants des formes graves de tuberculosedont certaines méningites. Elle se transforme progressivement en petite vésicule qui peut s’ulcérer et devenir purulente après 2 à 4 semaines. Doctors have been using this method of treating superficial bladder cancer for 40 years. One death was attributed to tuberculosis in the vaccinated group with 6 deaths in the controls, or a reduction of 83%. transurethral resection of bladder tumor (TURBT). On individuals whose skin tends to form keloids, there may be slightly more visible evidence of the vaccination. Six months afterwards there is usually no visible sign of the vaccination, though on occasion, a faintly discernible pattern of the points from the multiple puncture device may be visible. The initial skin lesions usually appear within 10–14 days and consist of small red papules at the site. La vaccination par Vaccin BCG SSI induit une réponse immunitaire à médiation cellulaire qui confère un niveau de protection va riable contre l'infection à Mycobacterium tuberculosis .La réaction à la tuberculine devient positive 6 semaines après vaccination.Une réponse … BCG treatment is more effective than TURBT alone or TURBT with chemotherapy in preventing recurrence. Reconstitution should result in a uniform suspension of the bacilli. provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. The Role of BCG Vaccine in the Prevention and Control of Tuberculosis in the United States. À l'âge de 4 à 6 ans, on administre une deuxièm… 35-43. There were 639 families in which there was a sibling in both the control and vaccination groups. The vaccine is to be administered after fully explaining the risks and benefits to the vaccinee, parent, or guardian. The BCG vaccine protects against tuberculosis, which is also known as TB. Our website services, content, and products are for informational purposes only. Littleton, MA, PSG Publishing Co., Inc. 1980; pp. {24,25} The most frequent disseminated infection is BCG osteomyelitis (0.01 to 43 cases per million doses of vaccine administered) which usually occurs 4 months to 2 years after vaccination. Il s’agit d’une complication exceptionnelle de la vaccination, estimée à moins de 1 cas/100000 doses. HCWs considered for BCG vaccination should be counseled regarding the risks and benefits associated with both BCG vaccinations and TB preventive therapy. A vaccinated person should be tuberculin skin tested 2–3 months after BCG administration, and the test results, in millimeters of induration, should be recorded in the person's medical record. BCG is appropriate for noninvasive (stage 0) and minimally invasive (stage 1) bladder cancers. Healthline Media does not provide medical advice, diagnosis, or treatment. You have to hold the medicine in your bladder. Using aseptic methods, 1 mL of Sterile Water for Injection, USP at 4-25°C (39-77°F), is added to one vial of vaccine (see Pediatric Dose below for pediatric use). Although over 2 billion people have been immunized with BCG, and it is currently an officially recommended vaccine in more than 180 countries, excluding the U.S., the efficacy of BCG as a vaccine against tuberculosis remains controversial. As seen in Table 3, BCG vaccination affected the booster reaction no matter what definition of the booster effect (≥10 or ≥15 mm) was considered. Major changes to the best practice guidance include 1) more descriptive characterization of anaphylactic allergy and 2) incorporation of protocols for managing adverse reactions. Romanus V: Tuberculosis in bacillus Calmette-Guerin immunized and unimmunized children in Sweden: a ten-year evaluation following the cessation of general bacillus Calmette-Guerin immunization of the newborn in 1975. Each vial contains 1 to 8 × 108 CFU, which is equivalent to approximately 50 mg (wet weight), as lyophilized (freeze-dried) powder, NDC 0052-0603-02. The most controversial aspect of BCG is the variable efficacy found in different clinical trials, which appears to depend on geography. Disposable needles and the multiple puncture device should be discarded as biohazardous waste in labeled, puncture-proof containers to prevent inadvertent needlestick injury or reuse. The intensity and duration of the local reaction depends on the depth of penetration of the multiple puncture device and individual variations in patients' tissue reactions. The papules reach maximum diameter (about 3 mm) after 4 to 6 weeks, after which they may scale and then slowly subside. Enarson, D, Murray, JF. It’s generally well-tolerated. They should be informed about (a) the variable data concerning the efficacy of BCG vaccination, (b) the interference with the diagnosis of newly acquired M. tuberculosis infections in BCG-vaccinated persons, and (c) the potential serious complications associated with BCG vaccination of immunocompromised individuals. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Adverse reactions to BCG vaccine appear to be grossly underreported. MMWR 47(13):253-257. Lancet 1995;333:561-563. Children with a family history of immune deficiency disease should not be vaccinated; if they are, an infectious disease specialist should be consulted and anti-tuberculous therapy administered if clinically indicated.{18}. The vaccination site should be kept clean until the local reaction has disappeared. Conversion from a negative to a positive skin test may be considered a surrogate indicator of potency and immunization efficacy of BCG Vaccines; however, the correlation between PPD conversion and vaccine effectiveness has not been established. Caution: Federal law restricts this device to sale by or on the order of a physician. In a prospective trial using the TICE® strain of BCG Vaccine, Rosenthal, et al., studied 1,716 vaccinated and 1,665 non-vaccinated infants, all born at the Cook County Hospital in Chicago and followed for 12–23 years. If you have any sign of serious infection, seek immediate medical attention. Negative cultures do not necessarily rule out infection. BCG Vaccination Against Tuberculous in Chicago: a Twenty-year Study Statistically Analyzed. Sometimes, TURBT isn’t an option, as would be the case in later stage bladder cancer. Il s’agit d’un vaccin vivant atténué : il contient des germes vivants du bacille, modifiés afin qu’ils ne puissent plus induire la maladie. Immunotherapy is used to prompt the immune system into attacking cancer cells. Antimicrobial or immunosuppressive agents may interfere with the development of the immune response and should be used only under medical supervision. Last medically reviewed on September 27, 2017. BCG has been used to treat noninvasive bladder cancer for a long time. You’ll be asked to urinate just before the procedure so you’ll be able to hold the medication in your bladder for several hours. BCG vaccination can cause a false positive Mantoux test, although a very high-grade reading is usually due to active disease.. A separate needle and syringe should be used for each application. Does the BCG vaccine for TB help with COVID-19 (coronavirus)? {3}, BCG vaccination is not recommended for HCWs in settings in which the risk for M. tuberculosis transmission is low.{3}. In 1993, there was a 5.2% decrease over 1992 with a rate of 9.8 cases per 100,000 population. Dosage Form: injection, powder, lyophilized, for solution. BCG Vaccine contains live bacteria and should be used with aseptic technique. Avoid forceful agitation which may cause clumping of the mycobacteria. A review of each patient's immunization records to include history on reactions to immunizations should be completed prior to vaccination. BCG Vaccine for prevention of tuberculosis should not be given to persons (a) whose immunologic responses are impaired because of HIV infections, congenital immunodeficiency such as chronic granulomatous disease or interferon gamma receptor deficiency, leukemia, lymphoma, or generalized malignancy or (b) whose immunologic responses have been suppressed by steroids, alkylating agents, antimetabolites, or radiation. The medium in which the TICE® BCG organism is grown for preparation of the freeze-dried cake is composed of the following ingredients: glycerin, asparagine, citric acid, potassium phosphate, magnesium sulfate, and iron ammonium citrate. Le ROR offre une triple protection contre la rougeole, les oreillons et la rubéole. Tidjani O, Amedone A, ten Dam HG: The protective effect of BCG vaccination of the newborn against childhood tuberculosis in an African community. Clinical studies of BCG Vaccine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Comstock, GW. Colditz GA, Brewer TF, Berkey CS et al. {8} The reasons for the wide range of effectiveness seen in these studies are unknown but may be attributed to the following: vaccination was not allocated randomly in observational studies; there were differences in BCG strains, methods, and routes of administration; and there were differences in the characteristics of the populations and environments in which the vaccines were studied. The bacteria in the BCG vaccine may sometimes cause a slowly developing infection and enlarge the lymph node near the injection site. : Brief report: meningitis due to iatrogenic BCG infection in two immunocompromised children.
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