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

sanofi pasteur inc. - neisseria meningitidis group a capsular polysaccharide antigen (unii: 1i86b47ny4) (neisseria meningitidis group a capsular polysaccharide antigen - unii:1i86b47ny4) - neisseria meningitidis group a capsular polysaccharide antigen 50 ug in 0.5 ml

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.

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

pfizer australia pty ltd - pneumococcal purified capsular polysaccharides, quantity: 2.2 microgram; pneumococcal purified capsular polysaccharides, quantity: 4.4 microgram - injection, suspension - excipient ingredients: aluminium phosphate; water for injections; polysorbate 80; diphtheria crm197 protein; succinic acid; sodium chloride - active immunisation for the prevention of pneumococcal disease caused by streptococcus pneumoniae serotypes 1, 3, 4, 5, 6a, 6b, 7f, 9v, 14, 18c, 19a, 19f and 23f in adults and children aged more than 6 weeks of age. the use of prevenar 13 should be guided by official recommendations.

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

trp company - according to homeopathic indications these ingredients provide temporary relief from symptoms of fibromyalgia such as: - muscle pain - fatigue - nerve/soft tissue pain - headache - multiple tender points if tamper evident seal is broken. if symptoms persist for more than 7 days or worsen or if new symptoms occur or if redness or swelling is present because these could be a sign of a serious illness.

Philippines - English - FDA (Food And Drug Administration)

interphil laboratories inc. - dequalinium chloride (for export only) - lozenge (citrus flavor) (for export only) - 250mcg

Philippines - English - FDA (Food And Drug Administration)

interphil laboratories inc. - dequalinium chloride (for export only) - lozenge (citrus flavor) (for export only) - 250mcg

Philippines - English - FDA (Food And Drug Administration)

interphil laboratories inc. - dequalinium chloride (for export only) - lozenge (lemon flavor) (for export only) - 250mcg

Philippines - English - FDA (Food And Drug Administration)

interphil laboratories inc. - dequalinium chloride (for export only) - lozenge (orange flavor) (for export only) - 250mcg

Philippines - English - FDA (Food And Drug Administration)

interphil laboratories inc. - dequalinium chloride (for export only) - lozenge (orange flavor) (for export only) - 250mcg

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

similasan corporation - oyster shell calcium carbonate, crude (unii: 2e32821g6i) (oyster shell calcium carbonate, crude - unii:2e32821g6i), calcium fluoride (unii: o3b55k4yki) (fluoride ion - unii:q80vpu408o), tribasic calcium phosphate (unii: 91d9gv0z28) (calcium cation - unii:2m83c4r6zb), matricaria recutita (unii: g0r4ubi2zz) (matricaria recutita - unii:g0r4ubi2zz), ferrosoferric phosphate (unii: 91gqh8i5f7) (ferrosoferric phosphate - unii:91gqh8i5f7), podophyllum (unii: 2s713a4vp3) (podophyllum - unii:2s713a4vp3) - pain, difficult dentition supports dental development supports dental development, pain, slow dentition swelling, irritability, restlessness, sleeplessness, red cheek/face fussiness or restlessness drooling, chewing on things, irritability according to the homeopathic principles, the active ingredients in this product: - temporarily relieve restlessness & irritability due to painful gums - support dental development