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

teva women's health, inc. - human adenovirus e serotype 4 strain cl-68578 (unii: fkd3duk39i) (human adenovirus e serotype 4 strain cl-68578 - unii:fkd3duk39i) - human adenovirus e serotype 4 strain cl-68578 32000 [tcid_50] - adenovirus type 4 and type 7 vaccine, live, oral is a vaccine indicated for active immunization for the prevention of febrile acute respiratory disease caused by adenovirus type 4 and type 7. adenovirus type 4 and type 7 vaccine, live, oral is approved for use in military populations 17 through 50 years of age. adenovirus type 4 and type 7 vaccine, live, oral should not be administered to pregnant females [see pregnancy (8.1)] . it is not known whether adenovirus type 4 and type 7 vaccine, live, oral can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. naturally occurring infection with adenoviruses has been associated with fetal harm. pregnancy should be avoided for 6 weeks following receipt of vaccine. severe allergic reaction (e.g., anaphylaxis) to any component of adenovirus type 4 and type 7 vaccine, live, oral is a contraindication [see description (11)]. adenovirus type 4 and type 7 vaccine, live, oral should not be administered to individuals incapable of swa

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

grifols usa, llc - human rabies virus immune globulin (unii: 95f619atq2) (human rabies virus immune globulin - unii:95f619atq2) - human rabies virus immune globulin 150 [iu] in 1 ml - rabies vaccine and hyperrab s/d should be given to all persons suspected of exposure to rabies with one exception: persons who have been previously immunized with rabies vaccine and have a confirmed adequate rabies antibody titer should receive only vaccine. hyperrab s/d should be administered as promptly as possible after exposure, but can be administered up to the eighth day after the first dose of vaccine is given. recommendations for use of passive and active immunization after exposure to an animal suspected of having rabies have been detailed by the u.s. public health service advisory committee on immunization practices (acip). [19] every exposure to possible rabies infection must be individually evaluated. the following factors should be considered before specific antirabies treatment is initiated: carnivorous wild animals (especially skunks, foxes, coyotes, raccoons, and bobcats) and bats are the animals most commonly infected with rabies and have caused most of the indigenous cases of human rabies

European Union - English - EMA (European Medicines Agency)

sanofi pasteur - influenza a virus subtype h1n1 haemagglutinin, recombinant, influenza a virus subtype h3n2 haemagglutinin, recombinant, influenza b virus victoria lineage haemagglutinin, recombinant, influenza b virus yamagata lineage haemagglutinin, recombinant - influenza, human - vaccines - supemtek is indicated for active immunization for the prevention of influenza disease in adults.supemtek should be used in accordance with official recommendations.

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)

valneva austria gmbh - covid-19 vaccine (inactivated, adjuvanted, adsorbed) - covid-19 virus infection - vaccines - covid-19 vaccine (inactivated, adjuvanted) valneva is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 18 to 50 years of age. the use of this vaccine should be in accordance with official recommendations.

Malta - English - 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

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

European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals sa - recombinant varicella zoster virus glycoprotein e - herpes zoster - vaccines - shingrix is indicated for prevention of herpes zoster (hz) and post-herpetic neuralgia (phn), in:adults 50 years of age or older;adults 18 years of age or older at increased risk of hz.the use of shingrix should be in accordance with official recommendations.

Singapore - English - HSA (Health Sciences Authority)

msd pharma (singapore) pte. ltd. - human papillomavirus type 11 l1 protein; human papillomavirus type 16 l1 protein; human papillomavirus type 18 l1 protein; human papillomavirus type 31 l1 protein; human papillomavirus type 33 l1 protein; human papillomavirus type 45 l1 protein; human papillomavirus type 52 l1 protein; human papillomavirus type 58 l1 protein; human papillomavirus type 6 l1 protein - injection, suspension - human papillomavirus type 11 l1 protein 40 mcg; human papillomavirus type 16 l1 protein 60 mcg; human papillomavirus type 18 l1 protein 40 mcg; human papillomavirus type 31 l1 protein 20 mcg; human papillomavirus type 33 l1 protein 20 mcg; human papillomavirus type 45 l1 protein 20 mcg; human papillomavirus type 52 l1 protein 20 mcg; human papillomavirus type 58 l1 protein 20 mcg; human papillomavirus type 6 l1 protein 30 mcg

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - meningococcal vaccines group a; meningococcal vaccines group c; meningococcal vaccines group w; meningococcal vaccines group y - powder and solution for solution for injection - meningococcal vaccines group y 5 mcg / 0.5 ml; meningococcal vaccines group w 5 mcg / 0.5 ml; meningococcal vaccines group c 5 mcg / 0.5 ml; meningococcal vaccines group a 10 mcg / 0.5 ml - other meningococcal monovalent purified polysaccharides antigen - other meningococcal monovalent purified polysaccharides antigen - menveo is indicated for active immunization of children (2 years of age and above), adolescents and adults up to the age of 55 years, at risk of exposure to neisseria meningitidis groups a, c, w135 and y, to prevent invasive disease. the use of this vaccine should be in accordance with official recommendations.