Malta - English - Medicines Authority

sanofi pasteur 14 espace henry vallée , 69007 lyon, france - pertactin, pertussis toxoid, diphtheria toxoid, filamentous haemagglutinin, fha, fimbriae types, and, tetanus toxoid - suspension for injection - pertactin 3 µg pertussis toxoid 2.5 µg diphtheria toxoid filamentous haemagglutinin (fha) 5 µg fimbriae types 2 and 3 5 µg tetanus toxoid - vaccines

Israel - English - Ministry of Health

merck sharp & dohme (israel - 1996) company ltd, israel - hpv type 11 l1 protein; hpv type 16 l1 protein; hpv type 18 l1 protein; hpv type 31 l1 protein; hpv type 33 l1 protein; hpv type 45 l1 protein; hpv type 52 l1 protein; hpv type 58 l1 protein; hpv type 6 l1 protein - suspension for injection - hpv type 58 l1 protein 20 mcg / 0.5 ml; hpv type 52 l1 protein 20 mcg / 0.5 ml; hpv type 45 l1 protein 20 mcg / 0.5 ml; hpv type 33 l1 protein 20 mcg / 0.5 ml; hpv type 31 l1 protein 20 mcg / 0.5 ml; hpv type 18 l1 protein 40 mcg / 0.5 ml; hpv type 16 l1 protein 60 mcg / 0.5 ml; hpv type 11 l1 protein 40 mcg / 0.5 ml; hpv type 6 l1 protein 30 mcg / 0.5 ml - papillomavirus (human types 6, 11, 16, 18, 31, 33, 45, 52, 58) - gardasil 9 is indicated for active immunisation of individuals at the age of 9-45 years old against the following hpv diseases:• premalignant lesions and cancers affecting the cervix, vulva, vagina and anus caused by vaccine hpv types• genital warts (condyloma acuminata) caused by specific hpv types.

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

bioproperties pty. ltd. - mycoplasma synoviae strain ms-h vaccine, living - misc. aural, ophthalmic, oro/naso pharyngeal - mycoplasma synoviae strain ms-h vaccine, living vaccine-general active 105.7 ccu/dose - immunotherapy - poultry broilers (meat for human consum) | poultry layers (eggs for human consump) | poultry pullets (growing chook) | breeding - airsacculitis | chronic respiratory disease | infectious synovitis | vaccine | equine rotavirus | ms

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - neisseria meningitidis serogroup b recombinant lipidated- factor h binding protein subfamily a, quantity: 60 microgram; neisseria meningitidis serogroup b recombinant lipidated- factor h binding protein subfamily b, quantity: 60 microgram - injection, suspension - excipient ingredients: water for injections; aluminium phosphate; histidine; sodium chloride; polysorbate 80 - trumenba is indicated in individuals 10 years and older for active immunisation to prevent invasive meningococcal disease caused by neisseria meningitidis serogroup b.

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

grifols usa, llc - .alpha.1-proteinase inhibitor human (unii: f43i396ois) (.alpha.1-proteinase inhibitor human - unii:f43i396ois) - .alpha.1-proteinase inhibitor human 1000 mg in 20 ml - prolastin-c is an alpha1 -proteinase inhibitor (human) (alpha1 -pi) indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe hereditary deficiency of alpha1 -pi (alpha1 -antitrypsin deficiency). prolastin-c increases antigenic and functional (anti-neutrophil elastase capacity, anec) serum levels and antigenic lung epithelial lining fluid levels of alpha1 -pi. limitations of use - the effect of augmentation therapy with any alpha1 -pi, including prolastin-c, on pulmonary exacerbations and on the progression of emphysema in alpha1 -pi deficiency has not been conclusively demonstrated in randomized, controlled clinical trials. - clinical data demonstrating the long-term effects of chronic augmentation or maintenance therapy with prolastin-c are not available. - prolastin-c is not indicated as therapy for lung disease in patients in whom severe alpha1 -pi deficiency has not been established. prolastin-c is contraindicated in: - iga deficient patients w

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

wyeth pharmaceutical division of wyeth holdings llc - neisseria meningitidis group b recombinant lp2086 a05 protein variant antigen (unii: 583wcd0izi) (neisseria meningitidis group b recombinant lp2086 a05 protein variant antigen - unii:583wcd0izi), neisseria meningitidis group b recombinant lp2086 b01 protein variant antigen (unii: 7mbd4k530d) (neisseria meningitidis group b recombinant lp2086 b01 protein variant antigen - unii:7mbd4k530d) - neisseria meningitidis group b recombinant lp2086 a05 protein variant antigen 60 ug in 0.5 ml - trumenba is indicated for active immunization to prevent invasive disease caused by neisseria meningitidis serogroup b. trumenba is approved for use in individuals 10 through 25 years of age. severe allergic reaction (e.g. anaphylaxis) to any component of trumenba [see description (11)] . 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 trumenba in pregnant women. available human data on trumenba administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. two developmental toxicity studies were performed in female rabbits administered trumenba prior to mating and during gestation. the dose was 0.5 ml at each occasion (a single human dose is 0.5 ml). these studies revealed no evidence of harm to the fet

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

novo nordisk - antihemophilic factor, human recombinant (unii: p89dr4ny54) (antihemophilic factor, human recombinant - unii:p89dr4ny54) - antihemophilic factor, human recombinant 62.5 [iu] in 1 ml - novoeight, antihemophilic factor (recombinant), is a human antihemophilic factor (human blood coagulation factor viii (fviii)) indicated for use in adults and children with hemophilia a for: novoeight is not indicated for the treatment of von willebrand disease. novoeight is contraindicated in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis, to novoeight or its components (including traces of hamster proteins). risk summary as hemophilia mainly affects males, there are no adequate and well-controlled studies using novoeight in pregnant women to determine whether there is a drug-associated risk. animal reproduction studies have not been conducted with novoeight. in the u.s. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. there is no reliable data on the incidences specific to the hemophilia a population. risk summary there is no information regarding the prese

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

grifols usa, llc - .alpha.1-proteinase inhibitor human (unii: f43i396ois) (.alpha.1-proteinase inhibitor human - unii:f43i396ois) - .alpha.1-proteinase inhibitor human 1000 mg in 20 ml - prolastin® -c liquid is an alpha1 -proteinase inhibitor (human) (alpha1 -pi) indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe hereditary deficiency of alpha1 -pi (alpha1 -antitrypsin deficiency). limitations of use - the effect of augmentation therapy with any alpha1 -pi, including prolastin-c liquid, on pulmonary exacerbations and on the progression of emphysema in alpha1 -pi deficiency has not been conclusively demonstrated in randomized, controlled clinical trials.    - clinical data demonstrating the long-term effects of chronic augmentation or maintenance therapy with prolastin-c liquid are not available. - prolastin-c liquid is not indicated as therapy for lung disease in patients in whom severe alpha1 -pi deficiency has not been established. prolastin-c liquid is contraindicated in: - iga deficient patients with antibodies against iga, due to the risk of severe hypersensitivity. - patients with a history of anaphylaxis or other sever

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

saol therapeutics - human varicella-zoster immune globulin (unii: 33t61iwl27) (human varicella-zoster immune globulin - unii:33t61iwl27) - varizig® [varicella zoster immune globulin (human)] is indicated for post-exposure prophylaxis of varicella in high risk individuals. high risk groups include: - immunocompromised children and adults, - newborns of mothers with varicella shortly before or after delivery, - premature infants, - neonates and infants less than one year of age, - adults without evidence of immunity, - pregnant women. varizig administration is intended to reduce the severity of varicella. administer varizig as soon as possible following varicella zoster virus (vzv) exposure, ideally within 96 hours for greatest effectiveness. - there is no convincing evidence that varizig reduces the incidence of chickenpox infection after exposure to vzv. - there is no convincing evidence that established infections with vzv can be modified by varizig administration. - there is no indication for the prophylactic use of varizig in immunodeficient children or adults when there is a past history of varicella, unless the patient is undergoing bone m

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

glaxosmithkline biologicals sa - recombinant respiratory syncytial virus pre-fusion f protein (unii: m739eb7427) (recombinant respiratory syncytial virus pre-fusion f protein - unii:m739eb7427) - arexvy is indicated for active immunization for the prevention of lower respiratory tract disease (lrtd) caused by respiratory syncytial virus in individuals 60 years of age and older. do not administer arexvy to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of arexvy [see description (11)] . 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. arexvy is not approved for use in persons <60 years of age. in a clinical study that enrolled pregnant individuals who received an investigational unadjuvanted rsv vaccine that contained the same rsvpref3 antigen as arexvy, an increase in preterm births was observed compared to pregnant individuals who received placebo (sucrose reconstituted with saline). data in a randomized controlled clinical trial that enroll