New Zealand - Tiếng Anh - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - hepatitis a vaccine 50 u/ml - suspension for injection - 50 u/ml - active: hepatitis a vaccine 50 u/ml excipient: aluminium as amorphous aluminium hydroxyphosphate sulphate borax sodium chloride water for injection - vaqta is indicated for active pre-exposure prophylaxis against disease caused by hepatitis a virus. primary immunisation should be given at least 2 weeks prior to expected exposure to hav. vaccination is recommended in children 12 months of age and older, adolescents, and adults who are at risk of contracting or spreading infection or who are at risk of life-threatening disease if infected, including but not limited to: · travellers to endemic or outbreak areas · frequently affected communities - members residing in any community with one or more recorded outbreaks within the last five years · daycare - children and staff of daycare centres as well as their parents, siblings, and other contacts · military personnel prior to departure for endemic or outbreak areas · persons for whom hepatitis a is an occupational hazard - health-care workers - staff and residents of orphanages, chronic care hospitals and mental health care facilities - sewage workers · haemophiliacs and other recipients of therapeutic blood products · persons who test positive for hepatitis c virus and have diagnosed liver disease · food handlers · consumers of high-risk foods e.g. raw shellfish · persons at increased risk of the disease due to their sexual practices - homosexually-active males - persons who repeatedly contract sexually transmitted diseases · human immunodeficiency virus (hiv)-infected adults · users of illicit injectable drugs vaqta will not prevent hepatitis caused by infectious agents other than hepatitis a virus.

Ai-len - Tiếng Anh - HPRA (Health Products Regulatory Authority)

sanofi pasteur msd ltd - pneumococcal polysaccharide serotype 1, pneumococcal polysaccharide type 2 (2), pneumococcal polysaccharide type 3 (3), pneumococcal polysaccharide serotype 4, pneumococcal polysaccharide serotype 5, pneumococcal polysaccharide serotype 6b, pneumococcal polysaccharide serotype 7f, pneumococcal polysaccharide type 8 (8), pneumococcal polysaccharide type 9n, pneumococcal polysaccharide serotype 9v, pneumococcal polysaccharide type 20 (20), pneumococcal oligosaccharide serotype 18c, pneumococcal polysaccharide - solution for injection in pre-filled syringe - 25/0.5 microgram/ml - pneumococcal vaccines - it is recommended for active immunisation against disease caused by the pneumococcal serotypes included in the vaccine

Vương quốc Anh - Tiếng Anh - myHealthbox

novartis vaccines and diagnostics - neisseria meningitidis group c (strain c11) oligosaccharide, corynebacterium diphtheriae crm197 protein , adsorbed on aluminium - suspension for injection - 10micrograms, 12.5 to 25.0micrograms, 0.3 to 0.4mg al 3+ - meningococcal vaccines - active immunisation of children from 2 months of age, adolescents and adults, for the prevention of invasive disease caused by neisseria meningitidis group c.

Vương quốc Anh - Tiếng Anh - myHealthbox

novartis vaccines and diagnostics - neisseria meningitidis group c (strain c11) oligosaccharide, corynebacterium diphtheriae crm197 protein , adsorbed on aluminium - suspension for injection - 10micrograms, 12.5 to 25.0micrograms, 0.3 to 0.4mg al 3+ - meningococcal vaccines - active immunisation of children from 2 months of age, adolescents and adults, for the prevention of invasive disease caused by neisseria meningitidis group c.

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

novartis vaccines and diagnostics s.r.l. - neisseria meningitidis group a capsular oligosaccharide diphtheria crm197 protein conjugate antigen (unii: 3o44u6xyqk) (neisseria meningitidis group a capsular oligosaccharide diphtheria crm197 protein conjugate antigen - unii:3o44u6xyqk) - neisseria meningitidis group a capsular oligosaccharide diphtheria crm197 protein conjugate antigen 10 ug in 0.5 ml

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

sanofi pasteur inc. - haemophilus influenzae type b strain 1482 capsular polysaccharide tetanus toxoid conjugate antigen (unii: flv5i5w26r) (haemophilus influenzae type b strain 1482 capsular polysaccharide tetanus toxoid conjugate antigen - unii:flv5i5w26r) - haemophilus influenzae type b strain 1482 capsular polysaccharide tetanus toxoid conjugate antigen 10 ug in 0.5 ml - acthib® is a vaccine indicated for the prevention of invasive disease caused by haemophilus influenzae (h. influenzae) type b. acthib is approved for use in children 2 months through 5 years of age. severe allergic reaction (e.g., anaphylaxis) after a previous dose of any h. influenzae type b or tetanus toxoid-containing vaccine or any component of the vaccine is a contraindication to administration of acthib vaccine [see description (11)] . acthib is not approved for use in individuals 6 years of age and older. no human or animal data are available to assess vaccine-associated risks in pregnancy. acthib is not approved for use in individuals 6 years of age and older. human or animal data are not available to assess the impact of acthib on milk production, its presence in breast milk, or its effects on the breastfed infant. safety and effectiveness of acthib have not been established in infants below the age of 6 weeks and children and adolescents 6 years of age and older [see dosage and administration (2.1)] .

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

glaxosmithkline biologicals sa - haemophilus influenzae type b strain 20752 capsular polysaccharide tetanus toxoid conjugate antigen (unii: c9r35m8xv6) (haemophilus influenzae type b strain 20752 capsular polysaccharide tetanus toxoid conjugate antigen - unii:c9r35m8xv6) - haemophilus influenzae type b strain 20752 capsular polysaccharide tetanus toxoid conjugate antigen 10 ug in 0.5 ml - hiberix is indicated for active immunization for the prevention of invasive disease caused by haemophilus influenzae (h. influenzae) type b. hiberix is approved for use in children aged 6 weeks through 4 years (prior to fifth birthday). severe allergic reaction (e.g., anaphylaxis) after a previous dose of any h. influenzae type b- or tetanus toxoid-containing vaccine or any component of the vaccine is a contraindication to administration of hiberix [see description (11)] . safety and effectiveness of hiberix in children younger than 6 weeks and in children aged 5 to 16 years have not been established.

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

glaxosmithkline biologicals sa - neisseria meningitidis group a capsular oligosaccharide diphtheria crm197 protein conjugate antigen (unii: 3o44u6xyqk) (neisseria meningitidis group a capsular oligosaccharide diphtheria crm197 protein conjugate antigen - unii:3o44u6xyqk) - neisseria meningitidis group a capsular oligosaccharide diphtheria crm197 protein conjugate antigen 10 ug in 0.5 ml - menveo is a vaccine indicated for active immunization to prevent invasive meningococcal disease caused by neisseria meningitidis serogroups a, c, y, and w-135 in individuals 2 months through 55 years of age. menveo does not prevent n. meningitidis serogroup b infections. do not administer menveo to individuals with a severe allergic reaction (e.g., anaphylaxis) to a previous dose of menveo, to any component of this vaccine, or to any other diphtheria toxoid-containing vaccine. [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 menveo in pregnant women in the u.s. there was a pregnancy exposure registry conducted from 2014-2017 that included 82 subjects. available data do not suggest an increased risk of major birth defects and miscarriage in women who received menveo within 28 days prior to conception or during pregnancy (see data) . a developmental toxicity study was performed in female rabbits administered 0.5 ml (at each occasion) of menveo prior to mating and during gestation. a single human dose is 0.5 ml. this study revealed no adverse effects on fetal or pre-weaning development (see data) . data human data: a pregnancy exposure registry (2014 to 2017) included 82 pregnancies with known outcomes with exposure within 28 days prior to conception or during pregnancy. miscarriage was reported for 12.2% of pregnancies with exposure to menveo within 28 days prior to conception or during pregnancy (10/82). major birth defects were reported for 3.6% of live born infants whose mothers were exposed within 28 days prior to conception or during pregnancy (2/55). the rates of miscarriage and major birth defects were consistent with estimated background rates. animal data: in a developmental toxicity study, female rabbits were administered menveo by intramuscular injection on days 29, 15, and 1 prior to mating and on gestation days 7 and 20. the total dose was 0.5 ml at each occasion (a single human dose is 0.5 ml). no adverse effects on pre-weaning development up to postnatal day 29 were observed. there were no vaccine-related fetal malformations or variations observed. risk summary it is not known whether the vaccine components of menveo are excreted in human milk. data are not available to assess the effects of menveo in 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 menveo and any potential adverse effects on the breastfed child from menveo or from the underlying maternal condition. for preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine. safety and effectiveness of menveo in children aged younger than 2 months have not been established. safety and effectiveness of the one-vial presentation of menveo in children aged younger than 10 years have not been established. [see dosage and administration (2).] for children 2 months through 9 years of age, only the two-vial presentation is approved for use. [see dosage and administration (2).] safety and effectiveness of menveo in adults aged 65 years and older have not been established.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - measles virus, quantity: 3 tcid50; mumps virus, quantity: 4.3 tcid50; rubella virus, quantity: 3 tcid50; live varicella vaccine, quantity: 3.99 pfu - injection, powder for - excipient ingredients: potassium chloride; hydrolysed gelatin; urea; neomycin; sodium bicarbonate; albumin; sodium chloride; sucrose; monobasic sodium phosphate; dibasic sodium phosphate; phenolsulfonphthalein; monosodium glutamate monohydrate; monobasic potassium phosphate; dibasic potassium phosphate; sorbitol; glucose monohydrate; magnesium sulfate heptahydrate; ferric nitrate nonahydrate; dibasic sodium phosphate dihydrate; sodium pyruvate; folic acid; calcium pantothenate; inositol; choline chloride; nicotinamide; pyridoxine hydrochloride; thiamine hydrochloride; riboflavine; cystine; tyrosine; arginine; glycine; histidine; isoleucine; leucine; lysine; methionine; phenylalanine; threonine; tryptophan; serine; valine; glutamine; calcium chloride dihydrate; water for injections; ascorbic acid; polysorbate 80; adenine sulfate dihydrate; adenosine triphosphate disodium; adenosine phosphate; cholesterol; deoxyribose; glutathione; guanine hydrochloride monohydrate; sodium hypoxanthine; ribose; sodium acetate; thymine; uracil; sodium xanthine; dl-alanine; arginine hydrochloride; dl-aspartic acid; cysteine hydrochloride; cystine dihydrochloride; dl-glutamic acid; histidine hydrochloride; hydroxyproline; dl-leucine; lysine hydrochloride; dl-methionine; dl-phenylalanine; proline; dl-serine; dl-threonine; dl-tryptophan; tyrosine disodium; dl-valine; biotin; ergocalciferol; menadione; nicotinic acid; aminobenzoic acid; pyridoxal hydrochloride; retinol acetate; dl-alpha-tocopheryl phosphate disodium - proquad is indicated for simultaneous immunisation against measles, mumps, rubella and varicella in individuals 12 months through 12 years of age.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - measles virus, quantity: 3 tcid50; rubella virus, quantity: 3 tcid50; mumps virus, quantity: 4.3 tcid50; live varicella vaccine, quantity: 3.99 pfu - injection, powder for - excipient ingredients: monobasic sodium phosphate; sodium bicarbonate; albumin; hydrolysed gelatin; sucrose; phenolsulfonphthalein; monobasic potassium phosphate; neomycin; potassium chloride; urea; sorbitol; dibasic potassium phosphate; monosodium glutamate monohydrate; sodium chloride; dibasic sodium phosphate; glucose monohydrate; magnesium sulfate heptahydrate; ferric nitrate nonahydrate; dibasic sodium phosphate dihydrate; sodium pyruvate; folic acid; calcium pantothenate; inositol; choline chloride; nicotinamide; pyridoxine hydrochloride; thiamine hydrochloride; riboflavine; cystine; tyrosine; arginine; glycine; histidine; isoleucine; leucine; lysine; methionine; phenylalanine; threonine; tryptophan; serine; valine; glutamine; calcium chloride dihydrate; water for injections; ascorbic acid; polysorbate 80; adenine sulfate dihydrate; adenosine triphosphate disodium; adenosine phosphate; cholesterol; deoxyribose; glutathione; guanine hydrochloride monohydrate; sodium hypoxanthine; ribose; sodium acetate; thymine; uracil; sodium xanthine; dl-alanine; arginine hydrochloride; dl-aspartic acid; cysteine hydrochloride; cystine dihydrochloride; dl-glutamic acid; histidine hydrochloride; hydroxyproline; dl-leucine; lysine hydrochloride; dl-methionine; dl-phenylalanine; proline; dl-serine; dl-threonine; dl-tryptophan; tyrosine disodium; dl-valine; biotin; ergocalciferol; menadione; nicotinic acid; aminobenzoic acid; pyridoxal hydrochloride; retinol acetate; dl-alpha-tocopheryl phosphate disodium - proquad is indicated for simultaneous immunisation against measles, mumps, rubella and varicella in individuals 12 months through 12 years of age.