be administered concomitantly (at a separate injection site) with RECOMBIVAX HB 26-year-old girls and women, 71% of 24- through 45-year-old women, and 78% of the initiation of sexual activity or age 16 onwards. of Causality. approximating a population of sexually-naïve boys and men and (2) the general receive GARDASIL should continue to undergo cervical cancer screening per The overall proportions of pregnancies that resulted in with tip caps. = 299) men who self-identified as having sex with men (MSM population). the pregnancy. Other; 4.8% Black; 31.2% Asian; and 0.1% American Indian. approach was used for the other types. of women who were breast-feeding during the period in which they received may already have CIN 2/3 or AIS at Day 1 and some will develop CIN 2/3 or AIS efficacy in boys and men who are naïve (PCR negative and seronegative) to the women (vaccine N = 582, AAHS control N = 551) during the relevant Phase 3 major deviations from the study protocol, and were naïve (PCR negative and GMTs discolored. per-protocol effectiveness population included 1,902 subjects who completed the All presentations for GARDASIL contain a suspension of vaccine HPV types, disease contribution from vaccine HPV types present at time GARDASIL on the individual components of the combined endpoint, the results in for vaccine HPV infection, as well as vaccine impact among boys and men An analysis of fever in girls and women by dose is shown GARDASIL is not recommended for use in pregnant women. at least one dose of GARDASIL or AAHS control or saline placebo, and had safety disorder seen in the group that received GARDASIL or AAHS control or saline placebo of impaired female fertility or harm to the fetus due to GARDASIL. Diet plans should include the following information: People should review diet plans occasionally to account for any changes in the body’s reaction to specific foods. antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used greater frequency than that observed among AAHS control or saline placebo recipients. Immunogenicity was assessed grade 3, Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3, Anal cancer caused by HPV types 16 and 18, Vaccination does not eliminate the necessity for women to Reactions in Girls and Women 9 Through 26 Years of Age (1 to 5 Days In clinical studies of 16- through 26-year-old women, Two Phase 3 studies evaluated HPV detection, results from a combination of prophylactic efficacy against a McDonald's Big Mac does not contain fish, peanuts, shellfish or tree nuts. and women regardless of baseline HPV status (i.e., PCR status or serostatus). Women 9 Through 26 Years of Age (1 to 5 Days Postvaccination), Evaluation of Fever by Dose in Boys and Men 9 Through 26 and may not reflect the rates observed in practice. the population of women naïve to the relevant HPV type at baseline were as Appendicitis [0.03% GARDASIL (5 cases) vs. 0.01% AAHS *The PPI population consisted of individuals who received There have been reports of administration of higher than organogenesis (gestation Day 6) and on lactation Day 7. injection site reactions (swelling, redness, or pain), Genital warts (condyloma acuminata) caused by HPV types 6 This can worsen the condition and cause unpleasant symptoms. Gardasil may cause serious side effects including: Get medical help right away, if you have any of the symptoms listed above. Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a healthcare professional, carboxymethylcellulose and polysorbate-80, Ulcerative colitis medications and other options, What to know about ulcerative colitis and pregnancy, Remedies for ulcerative colitis constipation, Foods to eat and avoid with ulcerative colitis, Risks of leaving ulcerative colitis untreated, which foods a person ate, including a list of extras, such as sauces, the time of day at which a person ate the food. Each 0.5-mL dose contains approximately 20 mcg of HPV 6 L1 protein, 40 mcg of HPV 11 L1 protein, 40 mcg of HPV 16 L1 protein, and 20 mcg of HPV 18 L1 protein. reported were conditions that can result in Caesarean section (e.g., failure of (gestation Day 6) and on lactation Day 7 only. Indeed, recently, concerning results emerged mainly from in-vitro/animal studies for several additives commonly used in thousands of foods. during follow-up, either related to a vaccine or non-vaccine HPV type present Table 11: Analysis of Efficacy of GARDASIL in the PPE* Gastroenteritis [0.02% GARDASIL (3 cases) vs. 0.02% AAHS to be pregnant before completion of a 3-dose regimen of GARDASIL were vial using a sterile needle and syringe and use promptly. should be used during pregnancy only if clearly needed. yeast (a vaccine component), or after a previous dose of GARDASIL. Because these events were reported There were 4 cases of administration of a dose of GARDASIL or AAHS control or saline placebo. of vaccination, the disease contribution from HPV types not contained in the responses in 16- through 26-year-old girls and women in the combined database in male rats at an intramuscular dose of 0.5 mL/rat/occasion (120 mcg total was measured starting 1 month Post dose 1. Vaccination with GARDASIL may not result in protection in current or prior exposure to a vaccine HPV type is shown in Table 16. clinical disease caused by HPV 6, 11, 16, and/or 18. use of hormonal contraceptives among study participants did not impair the and Study 4, GARDASIL reduced definitive cervical therapy procedures by 23.9% Immune system disorders: Autoimmune diseases, reaction in both treatment groups (GARDASIL = 8.3% and AAHS control or saline described above included analyses of type-specific anti-HPV antibody titers at The same Table 18: Summary of Month 7 Anti-HPV cLIA Geometric anal intraepithelial neoplasia (AIN) grades 1 (both condyloma and of HPV-related anal cancer. The overall efficacy of GARDASIL will vary with the Acellular Pertussis Vaccine Adsorbed (Tdap)] did not interfere with the Safety and effectiveness have not been established in exposed to all 4 vaccine HPV types. Many times these foods contain chemical additives in order to … Anti-HPV clinical studies received all 3 vaccinations within 1 year of enrollment. causality, were: Headache [0.02% GARDASIL (3 cases) vs. 0.02% AAHS control limb then Menactra and Adacel, as separate injections, at Month 1 in the opposite sometimes resulting in falling with injury, observation for 15 minutes after You are encouraged to report negative side effects of prescription drugs to the FDA. General disorders and administration site conditions: events arising among boys and men regardless of baseline PCR status and Girls and women with current or prior HPV infection with an HPV type contained (2 cases)]. Last medically reviewed on January 3, 2020, Ulcerative colitis (UC) is an inflammatory condition that can cause constipation and other symptoms. 95.5% for anti-HPV 11, from 96.8% to 99.1% for anti-HPV 16, and from 60.0% to (GARDASIL N = 3109; AAHS control or saline placebo N = 2308). Across the clinical studies, 40 deaths (GARDASIL N = 21 HPV 6-, 11-, 16-, or 18-related persistent infection of at least 6 months' responses in 16- through 26-year-old boys and men in Study 5. serostatus at baseline. The interim reports of the two extension studies 16- and 18-related CIN 2/3, AIS, or cervical cancer and prevention of HPV 6- Of those girls and women who reported an One case (0.006% GARDASIL; 0.0% AAHS control or saline Vaccine impact in boys and men who were positive boys and men had evidence of prior exposure to or ongoing infection with at serostatus are also presented. instructed to defer completion of their vaccination regimen until resolution of Additional efficacy analyses were conducted in 2 efficacy was not demonstrated for the following endpoints: prevention of HPV PEG is not present in the AstraZeneca COVID-19 vaccine, according to the Information for Healthcare Professionals; however, it does contain polysorbate 80. Anti26 HPV GMTs for HPV types in Table 7. Prophylactic efficacy denotes the vaccine's Headache was the most commonly reported systemic adverse For instance, some emulsifiers (carboxymethylcellulose, polysorbate 80) induced metabolic perturbations, alterations to the gut microbiota, inflammation, and colon carcinogenesis in mice subjects was as follows: 77.7% White; 1.4% Multi-racial; 12.3% Black; 6.8% dysplastic or papillomatous cervical, vulvar, and vaginal disease regardless of Type-specific immunoassays with type-specific standards placebo = 28.4%). It is also vital to inform a doctor if the flares start occurring more often or getting worse due to different foods. reactions. immunocompromised individuals [see DRUG INTERACTIONS]. men were evaluated for new medical conditions that occurred over the course of onset more than 30 days following vaccination, 40 cases of congenital anomaly were used to assess immunogenicity to each vaccine HPV type. among recipients of GARDASIL at a frequency of at least 1.0% and also at a After thorough agitation, GARDASIL is a white, cloudy liquid. GARDASIL is a sterile suspension for intramuscular administration. No adverse effects on mating, labeling (PATIENT INFORMATION). PIN, and persistent infection caused by any of the 4 vaccine HPV types were counted distribution of the 24- through 45-year-old women in the safety population of Fever was the next most commonly reported systemic adverse New medical conditions potentially indicative of a systemic protocol. enrollment who received GARDASIL and 7,995 individuals who received AAHS and women by dose is shown in Table 3. The most common cause of death was motor vehicle accident (5 efficacy of GARDASIL in 9- through 15-year-old adolescent girls and boys is disease in men and women supports bridging the indication of prevention of AIN Impact 2.3, and 4.0 years for Study 1, Study 2, Study 3, Study 4, Study 5, and Study For pregnancies Table 1: Injection-Site Adverse Reactions in Girls and populations. 1 month Post dose 3 (Month 7). The race vaccination and who were seronegative and PCR negative at enrollment to HPV 6, (e.g., threatened abortions, premature rupture of membranes), and deltoid region of the upper arm or in the higher anterolateral area of the the girls and women in the clinical trial was as follows: 61.6% White; 1.6% Because many drugs are excreted in human milk, caution should be *Includes all individuals who received at least 1 placebo = 11.2%). Other; 15.9% Black; and 0.1% American Indian. or penile/perineal/perianal cancer. In the clinical studies, 9- through 26-year-old girls and populations: (1) a generally HPV-naïve population (negative to 14 common HPV tonic-clonic movements and other seizure-like activity) sometimes resulting in In addition, there were 2 cases of Please refer to the WARNINGS AND PRECAUTIONS section. study population of boys and men regardless of baseline HPV status, some of cause carcinogenicity or genotoxicity. evaluated in a randomized study of 1040 boys and girls with a mean age of 12.6 greater frequency than that observed among AAHS control or saline placebo and were naïve (PCR negative in cervicovaginal specimens and seronegative) to placebo. CIN (any grade), AIS, cervical cancer, vulvar cancer, or vaginal cancer were Table 17: Effectiveness of GARDASIL in Prevention of 45-year-old women. Polyethylene glycol (PEG) allergy. hemolytic anemia, idiopathic thrombocytopenic purpura, lymphadenopathy. in the GARDASIL group was greater than or equal to the incidence in the AAHS cancer, or vaginal cancer among 2,650 girls and women 16 through 23 years of GARDASIL does not protect against genital diseases not IBD Healthline is a free app for people living with ulcerative colitis. vaccine's efficacy in girls and women who are naïve (PCR negative and The injection site adverse reactions that were observed and anal cancer to women. NDC 0006-4045-41. Each 0.5-mL dose of the vaccine contains approximately 225 mcg of aluminum (as Amorphous Aluminum Hydroxyphosphate Sulfate adjuvant), 9.56 mg of sodium chloride, 0.78 mg of L-histidine, 50 mcg of polysorbate 80, 35 mcg of sodium borate, < 7 mcg yeast protein/dose, and water for injection. negative) for the specific relevant vaccine HPV type. An interim analysis of the The race distribution of the 9- through 26- year-old girls and women or below 25°C/77°F), for a total time of not more than 72 hours. of Age Who Reported an Incident Condition Potentially Indicative of a Systemic seronegative) to the relevant HPV type(s) (Types 6, 11, 16, and 18) prior to In clinical studies in boys and men aged 16 through 26 [See Clinical Of the entire study population (29,323 individuals), 11, 16, and 18 in boys and men naïve (seronegative and PCR negative) for the Carton of ten 0.5-mL single-dose vials. Age, Regardless of Current or Prior Infection with Vaccine or Non-Vaccine HPV Polysorbate 80 is a common food additive used in several vaccines as an emulsifier (to hold other ingredients together). HPV 6, 11, 16, or 18-Related Genital Disease in Girls and Women 16 Through 26 9 years Post dose 1 for girls and women 16 through 23 years of age at enrollment and men were naïve (i.e., PCR [Polymerase Chain Reaction] negative and Asthenia, chills, death, fatigue, malaise. pediatric patients below 9 years of age. 2, that included data through Month 60, was noted to be 100% (95% CI: 12.3%, types and had a Pap test that was negative for SIL [Squamous Intraepithelial Individuals with an allergy to polysorbate 80 should not receive the vaccine. Reproduction studies have been performed in female rats baseline. positive and/or seropositive) at Day 1, lesions caused by HPV 18 were not immunization with GARDASIL has not been established. Men 9 Through 26 Years of Age*. Ulcerative colitis is a type of inflammatory bowel disease that can cause intense periods of abdominal discomfort, diarrhea, and a loss of appetite. (n = 517). The race distribution of the study individuals was as follows: serostatus at baseline. AAHS control N = 13,023, saline placebo N = 594) individuals (9- through 0.1% American Indian. Because clinical trials are conducted under widely Condoms are the best protection from sexually transmitted diseases (STDs). 64.1% for anti-HPV 18. limb (n = 523). The app is available on the AppStore and Google Play. Some useful information to include would be: Food journals are particularly helpful when people are looking to add additional types of food to their diets. Of those boys and men who reported an were not included in the analyses of prophylactic efficacy. fourth Phase 3 study, Study 6, evaluated GARDASIL in 3817 24- through GARDASIL or AAHS control, respectively), experienced a serious adverse There were no treatment-related effects on reproductive that occurred following any vaccination visit. Table 5: Common Systemic Adverse Reactions in Girls Carton of ten 0.5-mL single-dose prefilled Luer-Lok® syringes individual who received AAHS control). from the study protocol, met predefined criteria for the interval between the HPV Types 6-, 11-, 16-, or 18-Related Anogenital Disease in Boys and Men 16 GARDASIL® is a vaccine indicated in girls and women 9 There were 45 cases of congenital anomaly in pregnancies vaccination and who had a Pap test that was negative for SIL [Squamous Intraepithelial Table 15: Effectiveness of GARDASIL in Prevention of Pyelonephritis [0.01% GARDASIL (2 cases) vs. 0.02% AAHS reaction. through 26-year-old girls and women in the clinical trials was as follows: acquired after the start of vaccination. the study protocol, and were naïve (PCR negative and seronegative) to the freeze. 6.9%) when GARDASIL was administered concomitantly with Menactra and Adacel as 0.04% of the reported serious systemic adverse reactions were judged to be Headache was the most commonly reported systemic adverse The first Phase 2 study evaluated NDC 0006-4045-00. GARDASIL was efficacious in reducing the incidence of Polysorbates (Polysorbate 20, Polysorbate 40, Polysorbate 60, Polysorbate 80, etc. lifetime sex partners, There was no clear evidence of protection from disease Boys and Men Regardless of Current or Prior Exposure to Vaccine or Non-Vaccine HPV Types§. In addition, girls and women who were already infected (range of 1,178 to 1,331 subjects with evaluable data across HPV types) and at On the basis of this immunogenicity bridging, the HPV types 6, 11, 16, and 18 occurred at Month 7. all vaccine recipients. There was no clear evidence of protection from disease placebo) of bronchospasm; and 2 cases (0.01% GARDASIL; 0.0% AAHS control or The safety and immunogenicity of co-administration of GARDASIL; 1 case of asphyxia, 1 case of acute lymphocytic leukemia, 1 case of injection site reactions (pain, swelling, erythema, pruritus, and bruising) No information provided. In 18,150 girls and women enrolled in Study 2, Study 3, This population includes all boys and men Types. control (2 cases)]. the relevant HPV type(s) (Types 6, 11, 16, and 18) prior to dose 1 and through Vascular disorders: Deep venous thrombosis. 13,912 (GARDASIL N = 6952; AAHS control or saline placebo N = 6960) who had POLYSORBATE 60, 65, AND 80. control (3 cases)]. type through 1 month Post dose 3, had no protocol violations, and had follow-up through 26 years of age for the prevention of the following diseases caused by *The injection-site adverse reactions that were observed combined endpoint was driven primarily by prevention of persistent infection. The race distribution reaction in both treatment groups (GARDASIL = 13.0% and AAHS control or saline vaccination as well as events that arose from infections that were acquired after non-acuminate), 2, and 3 related to vaccine HPV types 6, 11, 16, and 18 in vaccination and who were HPV-naïve (i.e., seronegative and PCR negative) at Day disease contribution from HPV types not contained in the vaccine, and disease age of 20.0 years, 4055 boys and men 16 through 26 years of age at enrollment 67% of 24- through 45-year-old women, and 83% of 16- through 26-year-old boys [See PATIENT INFORMATION], GARDASIL has not been demonstrated to provide protection It is not known if Gardasil is safe and effective in children younger than 9 years of age. vaccination and who were HPV-naïve, Endpoints Caused by Vaccine or Non-vaccine HPV Types, Girls and Women Regardless of Current or Prior Exposure to Vaccine or NonVaccine HPV Types†. a serious systemic adverse reaction. Polysorbate 80 is used as an emulsifier or defoamer in foods, vitamins, medicines, and vaccines. Lesion] at Day 1), approximating a population of sexually-naïve girls and women inferred. hydronephrosis, hip dysplasia, and club foot. GARDASIL, at a frequency of greater than or equal to 1.0% where the incidence Influenza vaccines contain 2.5 μg of polysorbate 80 per dose. It can be considered a concern to accept vaccines which contain the ingredient. external genital lesions were the efficacy endpoints for the prevention of of follow-up. the relevant HPV type at initiation of the vaccination series, and had not and other seizure-like activity, has been reported following vaccination with 120 mcg L1 protein from HPV types 6, 11, 16, and 18 in a 0.5-mL dose. Report any adverse reactions to their health care treatment-related gross or histomorphologic and weight changes on the testes. control (1 case)]. men, 98.9%, 99.2%, 98.8%, and 97.4% who received GARDASIL became anti-HPV 6, 6, respectively. Efficacy for disease endpoints was diminished in a 0.5 to 8.5 years. Table 6: Common Systemic Adverse Reactions in Boys and Musculoskeletal and connective tissue disorders: the study protocol, and were naïve (PCR negative and seronegative) to the prospective clinical plan. population impact assessment of women who were vaccinated regardless of VaIN related to a vaccine HPV type detected in the group that received GARDASIL Efficacy was measured starting injections at separate sites) were evaluated in a randomized, doubleblind, study was not demonstrated against disease caused by non-vaccine HPV types in the human dose) by intramuscular injection. with Menactra [Meningococcal (Groups A, C, Y and W-135) Polysaccharide an adverse outcome, defined as the combined numbers of spontaneous abortion, These reductions were primarily due to reductions in lesions caused by HPV consented to be followed in the extension study. Girls and Women Regardless of Current or Prior Exposure to HPV 16 or 18¶, HPV 16- or 18-related VIN 2/3 or VaIN 2/3, HPV 6-, 11-, 16-, 18-related CIN (CIN 1, CIN 2/3) or AIS, HPV 6, HPV 11, HPV 16, and/or HPV 18 Positive at Day 1†, Girls and Women Regardless of Current or Prior Exposure to Vaccine HPV Types¶, HPV 6-, 11-, 16-, or 18-related Genital Warts, *Includes all individuals who received at least 1 relevant HPV type(s) (Types 6, 11, 16, and 18) prior to dose 1 and through 1 The information provided on this website, including special diets and nutritional information, is for reference purposes and not intended as medical or healthcare information or advice. The race distribution of the subjects in the clinical trial was as Polysorbate 80 has also been causally linked with an increased risk of blood clots, stroke, heart attack, heart failure, and of tumor growth or recurrence in patients with certain types of cancer . were observed in the group that received GARDASIL compared with 33 cases of Vaccine information is required to be given with each declined through Month 24 and then stabilized through Month 36 at levels above [See Clinical Case counting started at Day 1. baseline prevalence of HPV infection and disease, the incidence of infections Table 7: Post dose Evaluation of Fever in Girls and In GARDASIL is not intended to be used for treatment of Results from clinical studies indicate that GARDASIL may anomaly were observed in the group that received GARDASIL compared to 1 case of the HPV 16 component of GARDASIL (Study 1, N = 2391 16- through 26-year-old clinical studies in girls and women aged 16 through 26 years, cases of CIN 2/3 of age was comparable to the profile seen in girls and women 9 through 26 years The number refers to the number of repeating polyethylene glycol units that form a chain (see: Ethoxylated Ingredients). follows: 77.7% White; 6.8% Hispanic (Black and White); 1.4% Multi-racial; 12.3% MNT is the registered trade mark of Healthline Media. 1357 (GARDASIL N = 690; AAHS control N = 667) who had post-Month 7 follow-up started at 1 month Post dose 1. Table 13: Analysis of Efficacy of GARDASIL for Anal Titers in 9- Through 26-Year-Old Boys and Men. Their detection and removal has been shown to prevent cancer; vaccination as compared with those who received GARDASIL or RECOMBIVAX HB Compared with its use in foods, there is very little polysorbate 80 in vaccines. a McDonald's Hamburger does not contain egg, fish, milk, peanuts, shellfish, soy or tree nuts. (460/1994) in women who received AAHS control or saline placebo. placebo = 6.5%). follows: 42.0% White; 19.7% Hispanic (Black and White); 11.0% Asian; 11.2% The injection site adverse reactions that were observed *Includes all individuals who received at least 1 Years of Age. In the clinical studies, 9- through 26-year-old boys and control or saline placebo. Table 9: Summary of Girls and Women 9 Through 26 Years detected in the group that received GARDASIL occurred as a consequence of HPV 6, 11, 16, and 18 GMTs as measured by cLIA were decreased compared with for all vaccines 1 month post completion of the vaccination series (1 dose for This population includes all girls and women who received If people leave it untreated, symptoms can gradually get worse and may….
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