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

physicians total care, inc. - estrogens, conjugated synthetic b (unii: 8l6lak9btr) (estrogens, conjugated synthetic b - unii:8l6lak9btr) - estrogens, conjugated synthetic b 0.9 mg - enjuvia tablets are indicated in the: - treatment of moderate to severe vasomotor symptoms associated with menopause. - treatment of moderate to severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal atrophy, associated with menopause. when prescribing solely for the treatment of moderate to severe vaginal dryness and pain with intercourse, topical vaginal products should be considered. enjuvia tablets should not be used in women with any of the following conditions: - undiagnosed abnormal genital bleeding. - known, suspected, or history of cancer of the breast. - known or suspected estrogen-dependent neoplasia. - active deep vein thrombosis, pulmonary embolism or a history of these conditions. - active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction). - liver dysfunction or disease. - known hypersensitivity to the ingredients of enjuvia tablets. - known or suspected pregnancy. there is no indication for enjuvia in pregnancy

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

merck sharp & dohme corp. - haemophilus influenzae type b capsular polysaccharide meningococcal outer membrane protein conjugate antigen (unii: luy6p8763w) (haemophilus influenzae type b capsular polysaccharide meningococcal outer membrane protein conjugate antigen - unii:luy6p8763w) - haemophilus influenzae type b capsular polysaccharide meningococcal outer membrane protein conjugate antigen 1 g in 1 g

United States - English - 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.

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

physicians total care, inc. - estrogens, conjugated (unii: iu5qr144qx) (estrogens, conjugated - unii:iu5qr144qx) - estrogens, conjugated 0.3 mg - premarin therapy is indicated in the: - treatment of moderate to severe vasomotor symptoms due to menopause. - treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. when prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. - treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. - treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease. - treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). - prevention of postmenopausal osteoporosis. when prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate. (see clinical studies .) the mainstays for decreasing the risk of postmenopausal osteoporosis are weight-b

United States - English - 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.

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

u.s. pharmaceuticals - estrogens, conjugated (unii: iu5qr144qx) (estrogens, conjugated - unii:iu5qr144qx), bazedoxifene acetate (unii: j70472ud3d) (bazedoxifene - unii:q16tt9c5bk) - estrogens, conjugated 0.45 mg - duavee is indicated in women with a uterus for: - use duavee for the shortest duration consistent with treatment goals and risks for the individual woman. postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary. - when prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medication should be carefully considered. duavee is contraindicated in women with any of the following conditions: - undiagnosed abnormal uterine bleeding - known, suspected, or past history of breast cancer - known or suspected estrogen-dependent neoplasia - active deep venous thrombosis, pulmonary embolism, or history of these conditions - active arterial thromboembolic disease (for example, stroke, myocardial infarction) or history of these conditions - hypersensitivity (for example, anaphylaxis, angioedema) to estrogens, bazedoxifene, or any ingredients -

Canada - English - Health Canada

pfizer canada ulc - conjugated estrogens; bazedoxifene (bazedoxifene acetate) - tablet (immediate and extended release) - 0.45mg; 20mg - conjugated estrogens 0.45mg; bazedoxifene (bazedoxifene acetate) 20mg - estrogen agonist-antagonists

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

virbac (australia) pty ltd - manganese as disodium manganese edta; copper as copper disodium edta; selenium as sodium selenite; zinc as zinc disodium edta - parenteral liquid/solution/suspension - manganese as disodium manganese edta chelating agent active 10.0 g/l; copper as copper disodium edta mineral-copper active 10.0 g/l; selenium as sodium selenite mineral-selenium active 3.0 g/l; zinc as zinc disodium edta mineral-zinc active 40.0 g/l - nutrition & metabolism

Israel - English - Ministry of Health

sanofi israel ltd - conjugated to tetanus protein; diphtheria toxoid; filamentous haemagglutinin (fha); haemophilus influenzae type b polysaccharide; pertussis toxoid (pt); polio type i (mohoney); polio type ii ( m.e.f.1); polio type iii (saukett); tetanus toxoid - powder and suspension for suspension for injection - polio type iii (saukett) 32 du / 0.5 ml; polio type ii ( m.e.f.1) 8 du / 0.5 ml; polio type i (mohoney) 40 du / 0.5 ml; filamentous haemagglutinin (fha) 25 mcg / 0.5 ml; pertussis toxoid (pt) 25 mcg / 0.5 ml; tetanus toxoid 40 iu / 0.5 ml; diphtheria toxoid 30 iu / 0.5 ml; haemophilus influenzae type b polysaccharide 10 mcg / 0.5 ml; conjugated to tetanus protein 18-30 mcg / 0.5 ml - diphtheria-hemophilus influenzae b-pertussis-poliomyelitis-tetanus - active immunisation against diphtheria, tetanus, pertussis, poliomyelitis and invasive infections caused by haemophilus influenzae type b (meningitis, septicaemia, cellulitis, arthritis, epiglottitis, …)• for primary vaccination in infants.• for booster in children who have previously received a primary vaccination with this vaccine or a diphtheria-tetanus-whole-cell or acellular pertussis poliomyelitis vaccine, whether mixed or not with freeze-dried conjugate haemophilus influenzae type b vaccine.

European Union - English - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - pneumococcal polysaccharide conjugate vaccine (adsorbed) - pneumococcal infections - pneumococcus, purified polysaccharides antigen conjugated - vaxneuvance is indicated for active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by streptococcus pneumoniae in infants, children and adolescents from 6 weeks to less than 18 years of age.vaxneuvance is indicated for active immunisation for the prevention of invasive disease and pneumonia caused by streptococcus pneumoniae in individuals 18 years of age and older. see sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes.the use of vaxneuvance should be in accordance with official recommendations.