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

sanofi pasteur inc. - poliovirus type 1 antigen (formaldehyde inactivated) (unii: 0lvy784c09) (poliovirus type 1 antigen (formaldehyde inactivated) - unii:0lvy784c09), poliovirus type 2 antigen (formaldehyde inactivated) (unii: 23je9kdf4r) (poliovirus type 2 antigen (formaldehyde inactivated) - unii:23je9kdf4r), poliovirus type 3 antigen (formaldehyde inactivated) (unii: 459rom8m9m) (poliovirus type 3 antigen (formaldehyde inactivated) - unii:459rom8m9m) - poliovirus type 1 antigen (formaldehyde inactivated) 40 [d'ag'u] in 0.5 ml - ipol vaccine is indicated for active immunization of infants (as young as 6 weeks of age), children, and adults for the prevention of poliomyelitis caused by poliovirus types 1, 2, and 3. (28) it is recommended that all infants (as young as 6 weeks of age), unimmunized children, and adolescents not previously immunized be vaccinated routinely against paralytic poliomyelitis. (29) following the eradication of poliomyelitis caused by wild poliovirus from the western hemisphere (including north and south america) (30), an ipv-only schedule was recommended to eliminate vapp. (7) all children should receive four doses of ipv at ages 2, 4, 6 to 18 months, and 4 to 6 years. opv is no longer available in the us and is not recommended for routine immunization. (7) previous clinical poliomyelitis (usually due to only a single poliovirus type) or incomplete immunization with opv are not contraindications to completing the primary series of immunization with ipol vaccine. children of all ages should have their immuni

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

deseret biologicals, inc. - influenza a virus (unii: r9hh0nde2e) (influenza a virus - unii:r9hh0nde2e), influenza b virus (unii: 1314jz2x6w) (influenza b virus - unii:1314jz2x6w), human adenovirus e serotype 4 strain cl-68578 antigen (unii: fkd3duk39i) (human adenovirus e serotype 4 strain cl-68578 antigen - unii:fkd3duk39i), human adenovirus b serotype 7 strain 55142 antigen (unii: tm54l796sn) (human adenovirus b serotype 7 strain 55142 antigen - unii:tm54l796sn), human herpesvirus 1 (unii: 22g38p19rl) (human herpesvirus 1 - unii:22g - influenza a virus 12 [hp_x] in 1 ml - for temporary relief of symptoms related to general viral infections (such as influenza, epstein-barr virus [ebv], cytomegalovirus [cmv], hepatitis, herpes, or adenovirus) including fever, fatigue, muscle aches and pain, rash, cold sores, swollen glands, headache and confusion.** **these statements are based upon homeopathic principles. they have not been reviewed by the food and drug administration. for temporary relief of symptoms related to general viral infections (such as influenza, epstein-barr virus [ebv], cytomegalovirus [cmv], hepatitis, herpes, or adenovirus) including fever, fatigue, muscle aches and pain, rash, cold sores, swollen glands, headache and confusion.** **these statements are based upon homeopathic principles. they have not been reviewed by the food and drug administration.

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

glaxosmithkline biologicals sa - hepatitis a virus strain hm175 antigen (formaldehyde inactivated) (unii: 5bfc8lz6lq) (hepatitis a virus strain hm175 antigen (formaldehyde inactivated) - unii:5bfc8lz6lq), hepatitis b virus subtype adw2 hbsag surface protein antigen (unii: 9gcj1l5d1p) (hepatitis b virus subtype adw2 hbsag surface protein antigen - unii:9gcj1l5d1p) - hepatitis a virus strain hm175 antigen (formaldehyde inactivated) 720 [iu] in 1 ml - twinrix is indicated for active immunization against disease caused by hepatitis a virus and infection by all known subtypes of hepatitis b virus. twinrix is approved for use in persons 18 years of age or older. severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis a-containing or hepatitis b-containing vaccine, or to any component of twinrix, including yeast and neomycin, is a contraindication to administration of twinrix [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 twinrix in pregnant women in the u.s. available data do not suggest an increased risk of major birth defects and miscarriage in women who received twinrix within 28 days prior to conception or during pregnancy (see data) . a developmental toxicity study was performed in female rats administered twinrix prior to mating and during gestation (0.2 ml at each occasion). this study revealed no adverse effects on fetal or pre-weaning development (see data) . data human data: a pregnancy exposure registry was maintained from 2001 to 2015. the registry prospectively enrolled 245 women who received a dose of twinrix during pregnancy or within 28 days prior to conception. after excluding induced abortions (n = 6, including one of a fetus with congenital anomalies), those lost to follow-up (n = 142), those with exposure in the third trimester (n = 1), and those with an unknown exposure timing (n = 9), there were 87 pregnancies with known outcomes with exposure within 28 days prior to conception, or in the first or second trimesters. miscarriage was reported for 9.6% of pregnancies with exposure to twinrix prior to 20 weeks gestation (8/83). major birth defects were reported for 3.8% of live born infants whose mothers were exposed within 28 days prior to conception or during the first or second trimester (3/80). the rates of miscarriage and major birth defects were consistent with estimated background rates. in pre- and post-licensure clinical studies of twinrix, 45 pregnant women were inadvertently administered twinrix following their last menstrual period. among such pregnancies, after excluding elective terminations (n = 1) and those lost to follow-up (n = 1), there were 43 pregnancies with known outcomes all with exposure in the first trimester. miscarriage was reported in 16% of pregnancies (7/43) and major birth defects were reported in 2.6% of live births (1/38). the rates of miscarriage and major birth defects were consistent with estimated background rates. animal data: in a developmental toxicity study, female rats were administered twinrix by intramuscular injection on day 30 prior to mating and on gestation days 6, 8, 11, and 15. the total dose was 0.2 ml (divided) at each occasion (a single human dose is 1 ml). no adverse effects on pre-weaning development up to post-natal day 25 were observed. there were no fetal malformations or variations. risk summary there is no information regarding the presence of twinrix in human milk, the effects on the breastfed child, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for twinrix and any potential adverse effects on the breastfed child from twinrix or from the underlying maternal condition. for preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine. safety and effectiveness in pediatric patients younger than 18 years have not been established. clinical studies of twinrix did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects [see clinical studies (14.1, 14.3)] .

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

deseret biologicals, inc. - influenza a virus a/singapore/gp1908/2015 ivr-180a (h1n1) antigen (propiolactone inactivated) (unii: 9jwn7vdq7n) (influenza a virus a/singapore/gp1908/2015 ivr-180a (h1n1) hemagglutinin antigen (propiolactone inactivated) - unii:u6c4gj6wzg), influenza a virus a/hong kong/4801/2014 x-263b (h3n2) antigen (propiolactone inactivated) (unii: 3dzy3q314e) (influenza a virus a/hong kong/4801/2014 x-263b (h3n2) hemagglutinin antigen (propiolactone inactivated) - unii:c2c4da5k06), influenza b virus b/brisbane/60/20 - influenza a virus a/singapore/gp1908/2015 ivr-180a (h1n1) antigen (propiolactone inactivated) 12 [hp_x] in 1 ml - for temporary relief of symptoms related to general viral infection (such as influenza, epstein-barr virus [ebv], cytomegalovirus [cmv], hepatitis, herpes, or adenovirus) including fever, fatigue, muscle aches and pain, rash, cold sores, headache and confusion.** **these statements are based upon traditional homeopathic principles. they have not been reviewed by the food and drug administration. for temporary relief of symptoms related to general viral infection (such as influenza, epstein-barr virus [ebv], cytomegalovirus [cmv], hepatitis, herpes, or adenovirus) including fever, fatigue, muscle aches and pain, rash, cold sores, headache and confusion.** **these statements are based upon traditional homeopathic principles. they have not been reviewed by the food and drug administration.

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

a-s medication solutions - poliovirus type 1 antigen (formaldehyde inactivated) (unii: 0lvy784c09) (poliovirus type 1 antigen (formaldehyde inactivated) - unii:0lvy784c09), poliovirus type 2 antigen (formaldehyde inactivated) (unii: 23je9kdf4r) (poliovirus type 2 antigen (formaldehyde inactivated) - unii:23je9kdf4r), poliovirus type 3 antigen (formaldehyde inactivated) (unii: 459rom8m9m) (poliovirus type 3 antigen (formaldehyde inactivated) - unii:459rom8m9m) - ipol vaccine is indicated for active immunization of infants (as young as 6 weeks of age), children, and adults for the prevention of poliomyelitis caused by poliovirus types 1, 2, and 3. (28) it is recommended that all infants (as young as 6 weeks of age), unimmunized children, and adolescents not previously immunized be vaccinated routinely against paralytic poliomyelitis. (29) following the eradication of poliomyelitis caused by wild poliovirus from the western hemisphere (including north and south america) (30), an ipv-only schedule was recommended to eliminate vapp. (7) all children should receive four doses of ipv at ages 2, 4, 6 to 18 months, and 4 to 6 years. opv is no longer available in the us and is not recommended for routine immunization. (7) previous clinical poliomyelitis (usually due to only a single poliovirus type) or incomplete immunization with opv are not contraindications to completing the primary series of immunization with ipol vaccine. children of all ages should have their immuni

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

glaxosmithkline australia pty ltd - hepatitis b surface antigen recombinant, quantity: 20 microgram/ml; hepatitis a virus antigen, quantity: 720 elisa unit/ml - injection, suspension - excipient ingredients: aluminium hydroxide hydrate; aluminium phosphate; polysorbate 20; water for injections; neomycin sulfate; monobasic sodium phosphate; trometamol; sodium chloride; dibasic sodium phosphate heptahydrate; formaldehyde solution; acetic acid; leucine; phenylalanine; methionine; lysine hydrochloride; isoleucine; valine; histidine; threonine; tryptophan; alanine; arginine; proline; tyrosine; serine; sodium acetate; dibasic potassium phosphate; magnesium chloride hexahydrate; glycine - twinrix (720/20) is indicated for active immunisation against hepatitis a and hepatitis b virus infection in adults and children from 1 year of age. twinrix junior (360/10) is indicated for use in children aged 1 to 15 years. twinrix (720/20) is indicated for active immunisation against hepatitis a and hepatitis b virus infection in adults and children from 1 year of age. twinrix junior (360/10) is indicated for use in children aged 1 to 15 years.

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

glaxosmithkline australia pty ltd - hepatitis b surface antigen recombinant, quantity: 20 microgram/ml; hepatitis a virus antigen, quantity: 720 elisa unit/ml - injection, suspension - excipient ingredients: trometamol; aluminium hydroxide hydrate; sodium chloride; polysorbate 20; neomycin sulfate; water for injections; formaldehyde solution; aluminium phosphate; dibasic sodium phosphate heptahydrate; monobasic sodium phosphate; acetic acid; leucine; phenylalanine; methionine; lysine hydrochloride; isoleucine; valine; histidine; threonine; tryptophan; alanine; arginine; proline; tyrosine; serine; sodium acetate; dibasic potassium phosphate; magnesium chloride hexahydrate; glycine - twinrix (720/20) is indicated for active immunisation against hepatitis a and hepatitis b virus infection in adults and children from 1 year of age. twinrix junior (360/10) is indicated for use in children aged 1 to 15 years. twinrix (720/20) is indicated for active immunisation against hepatitis a and hepatitis b virus infection in adults and children from 1 year of age. twinrix junior (360/10) is indicated for use in children aged 1 to 15 years.

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - purified hepatitis b antigen - suspension for injection - purified hepatitis b antigen 20 mcg / 1 ml - hepatitis b, purified antigen - hepatitis b, purified antigen - engerix b is indicated for active immunisation against hepatitis b virus infection (hbv) caused by all known subtypes in non immune subjects .. the 20 µg dose vaccine in 1.0 ml suspension is intended for use in subjects 16 years of age and above. the 10 µg dose vaccine in 0.5 ml suspension is intended for use in subjects up to and including 15 years of age, including neonates. the categories within the population to be immunised are determined on the basis of official recommendations.it can be expected that hepatitis d will also be prevented by immunisation with engerix b as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis b infection.

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - purified hepatitis b antigen - suspension for injection - purified hepatitis b antigen 10 mcg / 0.5 ml - hepatitis b, purified antigen - hepatitis b, purified antigen - engerix b is indicated for active immunisation against hepatitis b virus infection (hbv) caused by all known subtypes in non immune subjects . the 20 µg dose vaccine in 1.0 ml suspension is intended for use in subjects 16 years of age and above. the 10 µg dose vaccine in 0.5 ml suspension is intended for use in subjects up to and including 15 years of age, including neonates. the categories within the population to be immunised are determined on the basis of official recommendations.it can be expected that hepatitis d will also be prevented by immunisation with engerix b as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis b infection.

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

dispensing solutions, inc. - hepatitis a virus strain hm175 antigen (formaldehyde inactivated) (unii: 5bfc8lz6lq) (hepatitis a virus strain hm175 antigen (formaldehyde inactivated) - unii:5bfc8lz6lq) - hepatitis a virus strain hm175 antigen (formaldehyde inactivated) 1440 [iu] in 1 ml - havrix® is indicated for active immunization against disease caused by hepatitis a virus (hav). havrix is approved for use in persons 12 months of age and older. primary immunization should be administered at least 2 weeks prior to expected exposure to hav. severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis a-containing vaccine, or to any component of havrix, including neomycin, is a contraindication to administration of havrix [see description (11)] . pregnancy category c animal reproduction studies have not been conducted with havrix. it is also not known whether havrix can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. havrix should be given to a pregnant woman only if clearly needed. it is not known whether havrix is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when havrix is administered to a nursing woman. the safety and effectiveness of havrix, doses of 360 el.u. or 720 e