United States - English - NLM (National Library of Medicine)

a-s medication solutions - human papillomavirus type 6 l1 capsid protein antigen (unii: 61746o90dy) (human papillomavirus type 6 l1 capsid protein antigen - unii:61746o90dy), human papillomavirus type 11 l1 capsid protein antigen (unii: z845vhq61p) (human papillomavirus type 11 l1 capsid protein antigen - unii:z845vhq61p), human papillomavirus type 16 l1 capsid protein antigen (unii: 6lte2dnx63) (human papillomavirus type 16 l1 capsid protein antigen - unii:6lte2dnx63), human papillomavirus type 18 l1 capsid protein antigen (unii: j2d279pem5) (human papillomavirus type 18 l1 capsid protein antigen - unii:j2d279pem5), human papillomavirus type 31 l1 capsid protein antigen (unii: 53jil371ns) (human papillomavirus type 31 l1 capsid protein antigen - unii:53jil371ns), human papillomavirus type 33 l1 capsid protein antigen (unii: 759rac446c) (human papillomavirus type 33 l1 capsid protein antigen - unii:759rac446c), human papillomavirus type 45 l1 capsid protein antigen (unii: 68s8vcn34f) (human papillomavirus type 45 l1 capsid protein antigen - unii:68s8vcn34f), human papillomavirus type 52 l1 capsid protein antigen (unii: 55644w68fd) (human papillomavirus type 52 l1 capsid protein antigen - unii:55644w68fd), human papillomavirus type 58 l1 capsid protein antigen (unii: 94y15hp7lf) (human papillomavirus type 58 l1 capsid protein antigen - unii:94y15hp7lf) - gardasil® 9 is a vaccine indicated in girls and women 9 through 45 years of age for the prevention of the following diseases: - cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by human papillomavirus (hpv) types 16, 18, 31, 33, 45, 52, and 58 - genital warts (condyloma acuminata) caused by hpv types 6 and 11 and the following precancerous or dysplastic lesions caused by hpv types 6, 11, 16, 18, 31, 33, 45, 52, and 58: - cervical intraepithelial neoplasia (cin) grade 2/3 and cervical adenocarcinoma in situ (ais) - cervical intraepithelial neoplasia (cin) grade 1 - vulvar intraepithelial neoplasia (vin) grade 2 and grade 3 - vaginal intraepithelial neoplasia (vain) grade 2 and grade 3 - anal intraepithelial neoplasia (ain) grades 1, 2, and 3 gardasil 9 is indicated in boys and men 9 through 45 years of age for the prevention of the following diseases: - anal, oropharyngeal and other head and neck cancers caused by hpv types 16, 18, 31, 33, 45, 52, and 58 - genital warts (condyloma acuminata) caused by hpv types 6 and 11 and the following precancerous or dysplastic lesions caused by hpv types 6, 11, 16, 18, 31, 33, 45, 52, and 58: - anal intraepithelial neoplasia (ain) grades 1, 2, and 3 the oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing hpv-related anogenital disease [see clinical studies (14.5)]. continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. - vaccination with gardasil 9 does not eliminate the necessity for vaccine recipients to undergo screening for cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers as recommended by a health care provider. - gardasil 9 has not been demonstrated to provide protection against disease caused by: hpv types not covered by the vaccine [see description (11)], hpv types to which a person has previously been exposed through sexual activity. - hpv types not covered by the vaccine [see description (11)], - hpv types to which a person has previously been exposed through sexual activity. - not all vulvar, vaginal, anal, oropharyngeal and other head and neck cancers are caused by hpv, and gardasil 9 protects only against those vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by hpv 16, 18, 31, 33, 45, 52, and 58. - gardasil 9 is not a treatment for external genital lesions; cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers; cin; vin; vain; or ain. - vaccination with gardasil 9 may not result in protection in all vaccine recipients. hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose of gardasil 9 or gardasil [see description (11)]. pregnancy exposure registry there is a pregnancy exposure registry to monitor pregnancy outcomes in women exposed to gardasil 9 during pregnancy. to enroll in or obtain information about the registry, call merck sharp & dohme llc at 1-800-986-8999. risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. there are no adequate and well-controlled studies of gardasil 9 in pregnant women. available human data do not demonstrate vaccine-associated increase in risk of major birth defects and miscarriages when gardasil 9 is administered during pregnancy. in one developmental toxicity study, 0.5 ml of a vaccine formulation containing between 1 and 1.5 –fold of each of the 9 hpv antigen types was administered to female rats prior to mating and during gestation. in a second study, animals were administered a single human dose (0.5 ml) of gardasil 9 prior to mating, during gestation and during lactation. these animal studies revealed no evidence of harm to the fetus due to gardasil 9 [see data] . data human data in pre-licensure clinical studies of gardasil 9, women underwent pregnancy testing immediately prior to administration of each dose of gardasil 9 or control vaccine (gardasil). (data from gardasil are relevant to gardasil 9 because both vaccines are manufactured using the same process and have overlapping compositions.) subjects who were determined to be pregnant were instructed to defer vaccination until the end of their pregnancy. despite this pregnancy screening regimen, some subjects were vaccinated very early in pregnancy before human chorionic gonadotropin (hcg) was detectable. an analysis was conducted to evaluate pregnancy outcomes for pregnancies with onset within 30 days before or after vaccination with gardasil 9 or gardasil. among such pregnancies, there were 62 and 55 with known outcomes (excluding ectopic pregnancies and elective terminations) for gardasil 9 and gardasil, respectively, including 44 and 48 live births, respectively. the rates of pregnancies that resulted in a miscarriage were 27.4% (17/62) and 12.7% (7/55) in subjects who received gardasil 9 or gardasil, respectively. the rates of live births with major birth defects were 0% (0/44) and 2.1% (1/48) in subjects who received gardasil 9 or gardasil, respectively. a five-year pregnancy registry enrolled 2,942 women who were inadvertently exposed to gardasil within one month prior to the last menstrual period (lmp) or at any time during pregnancy, 2,566 of whom were prospectively followed. after excluding elective terminations (n=107), ectopic pregnancies (n=5) and those lost to follow-up (n=814), there were 1,640 pregnancies with known outcomes. rates of miscarriage and major birth defects were 6.8% of pregnancies (111/1,640) and 2.4% of live born infants (37/1,527), respectively. these rates of assessed outcomes in the prospective population were consistent with estimated background rates. in two postmarketing studies of gardasil (one conducted in the u.s., and the other in nordic countries), pregnancy outcomes among subjects who received gardasil during pregnancy were evaluated retrospectively. among the 1,740 pregnancies included in the u.s. study database, outcomes were available to assess the rates of major birth defects and miscarriage. among the 499 pregnancies included in the nordic study database, outcomes were available to assess the rates of major birth defects. in both studies, rates of assessed outcomes did not suggest an increased risk with the administration of gardasil during pregnancy. animal data developmental toxicity studies were conducted in female rats. in one study, animals were administered 0.5 ml of a vaccine formulation containing between 1 and 1.5 –fold of each of the 9 hpv antigen types 5 and 2 weeks prior to mating, and on gestation day 6. in a second study, animals were administered a single human dose (0.5 ml) of gardasil 9, 5 and 2 weeks prior to mating, on gestation day 6, and on lactation day 7. no adverse effects on pre- and post-weaning development were observed. there were no vaccine-related fetal malformations or variations. risk summary available data are not sufficient to assess the effects of gardasil 9 on the breastfed infant or on milk production/excretion. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for gardasil 9 and any potential adverse effects on the breastfed child from gardasil 9 or from the underlying maternal condition. for preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine. safety and effectiveness have not been established in pediatric patients below 9 years of age. the safety and effectiveness of gardasil 9 have not been evaluated in a geriatric population, defined as individuals aged 65 years and over. the immunologic response to gardasil 9 may be diminished in immunocompromised individuals [see drug interactions (7.1)] .

European Union - English - EMA (European Medicines Agency)

pfizer europe ma eeig - neisseria meningitidis group a polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group c polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group w-135 polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group y polysaccharide conjugated to tetanus toxoid - meningitis, meningococcal - vaccines - nimenrix is indicated for active immunisation of individuals from the age of 6 weeks against invasive meningococcal diseases caused by neisseria meningitidis group a, c, w-135, and y.

European Union - English - EMA (European Medicines Agency)

novartis vaccines and diagnostics s.r.l. - influenza virus surface antigens (haemagglutinin and neuraminidase) of strain a/viet nam/1194/2004 (h5n1) - influenza, human, immunization, disease outbreaks - vaccines, - active immunisation against h5n1 subtype of influenza a virus., this indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing a/vietnam/1194/2004 (h5n1)-like strain., prepandemic influenza vaccine (h5n1) novartis vaccines and diagnostic should be used in accordance with official recommendations.,

European Union - English - EMA (European Medicines Agency)

novartis vaccines and diagnostics s.r.l. - influenza virus surface antigens (haemagglutinin and neuraminidase) of strain a/viet nam/1194/2004 (h5n1) - influenza, human - vaccines - active immunisation against h5n1 subtype of influenza a virus.; this indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing a/vietnam/1194/2004 (h5n1)-like strain.; prepandemic influenza vaccine (h5n1) novartis vaccines and diagnostic should be used in accordance with official recommendations.

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

bioproperties pty. ltd. - marek's disease - misc. vaccines or anti sera - marek's disease vaccine-general active 0.0 p - immunotherapy - poultry | breeders | broiler | chickens | chicks | chooks | day old chicks | hatchlings | layers - vaccine | equine rotavirus

Malta - English - Malta Medicines Authority

biotest pharma gmbh landsteinerstrasse 5, 63303 dreieich, germany - human plasma, protein - solution for infusion - human plasma protein 200 g/l - blood substitutes and perfusion solutions

European Union - English - EMA (European Medicines Agency)

resilience biomanufacturing ireland limited - influenza vaccine (whole virion, inactivated) containing antigen of: a/vietnam/1203/2004 (h5n1) - influenza, human; immunization; disease outbreaks - vaccines - prophylaxis of influenza in an officially declared pandemic situation. pandemic influenza vaccine should be used in accordance with official guidance.

Canada - English - Health Canada

merck canada inc - recombinant human papillomavirus type 6 l1 protein; recombinant human papillomavirus type 11 l1 protein; recombinant human papillomavirus type 16 l1 protein; recombinant human papillomavirus type 18 l1 protein - suspension - 20mcg; 40mcg; 40mcg; 20mcg - recombinant human papillomavirus type 6 l1 protein 20mcg; recombinant human papillomavirus type 11 l1 protein 40mcg; recombinant human papillomavirus type 16 l1 protein 40mcg; recombinant human papillomavirus type 18 l1 protein 20mcg - vaccines

United States - English - NLM (National Library of Medicine)

grifols usa, llc - albumin human (unii: zif514rvzr) (albumin human - unii:zif514rvzr) - albumin human 12.5 g in 50 ml - for restoration and maintenance of circulating blood volume where hypovolemia is demonstrated and colloid use is appropriate. when hypovolemia is long standing and hypoalbuminemia exists accompanied by adequate hydration or edema, 20-25% albumin solutions should be used.1,2,3 acute liver failure is a special situation in which both hypovolemia and hypoalbuminemia can be present. human albumin grifols® 25% can be used in such cases.1 human albumin grifols 25% may be of value in the treatment of shock or hypotension in renal dialysis patients.1 preoperative dilution of blood using albumin and crystalloid can be used in cardiopulmonary bypass procedures. albumin also may be used in the priming fluid.4,5,6 human albumin grifols 25% may be used to treat peripheral edema in patients with acute nephrosis who are refractory to cyclophosphamide, corticosteroid therapy or diuretics.1,2,7 human albumin grifols 25% may be indicated for subjects with hypoalbuminemia who are critically ill and/or actively bleeding. when

Canada - English - Health Canada

merck canada inc - recombinant human papillomavirus type 6 l1 protein; recombinant human papillomavirus type 11 l1 protein; recombinant human papillomavirus type 16 l1 protein; recombinant human papillomavirus type 18 l1 protein; recombinant human papillomavirus type 31 l1 protein; recombinant human papillomavirus type 33 l1 protein; recombinant human papillomavirus type 45 l1 protein; recombinant human papillomavirus type 52 l1 protein; recombinant human papillomavirus type 58 l1 protein - suspension - 30mcg; 40mcg; 60mcg; 40mcg; 20mcg; 20mcg; 20mcg; 20mcg; 20mcg - recombinant human papillomavirus type 6 l1 protein 30mcg; recombinant human papillomavirus type 11 l1 protein 40mcg; recombinant human papillomavirus type 16 l1 protein 60mcg; recombinant human papillomavirus type 18 l1 protein 40mcg; recombinant human papillomavirus type 31 l1 protein 20mcg; recombinant human papillomavirus type 33 l1 protein 20mcg; recombinant human papillomavirus type 45 l1 protein 20mcg; recombinant human papillomavirus type 52 l1 protein 20mcg; recombinant human papillomavirus type 58 l1 protein 20mcg - vaccines