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

pfizer laboratories div pfizer inc - raxtozinameran (unii: n36vhk46pr) (raxtozinameran - unii:n36vhk46pr) - comirnaty is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (covid-19) caused by severe acute respiratory syndrome coronavirus 2 (sars-cov-2) in individuals 12 years of age and older. do not administer comirnaty to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of comirnaty [see description (11)] or to individuals who had a severe allergic reaction (e.g., anaphylaxis) following a previous dose of a pfizer-biontech covid-19 vaccine.       risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the us 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. available data on comirnaty administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. a developmental toxicity study has been performed in female rats administered the equivalent of a single human dose of comirnaty [encoding the viral spike (s) glycoprotein of sars-cov-2 wuhan-hu-1 strain (original)] on 4 occasions, twice prior to mating and twice during gestation. these studies revealed no evidence of harm to the fetus due to the vaccine (see animal data) . clinical considerations disease-associated maternal and/or embryo/fetal risk pregnant individuals infected with sars-cov-2 are at increased risk of severe covid-19 compared with non-pregnant individuals. data animal data in a developmental toxicity study, 0.06 ml of a vaccine formulation containing the same quantity of nucleoside-modified messenger ribonucleic acid (mrna) (30 mcg) and other ingredients included in a single human dose of comirnaty [encoding the viral spike (s) glycoprotein of sars-cov-2 wuhan-hu-1 strain (original)] was administered to female rats by the intramuscular route on 4 occasions: 21 and 14 days prior to mating, and on gestation days 9 and 20. no vaccine-related adverse effects on female fertility, fetal development, or postnatal development were reported in the study. risk summary it is not known whether comirnaty is excreted in human milk. data are not available to assess the effects of comirnaty on 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 comirnaty and any potential adverse effects on the breastfed child from comirnaty 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 comirnaty in individuals 12 through 17 years of age is based on safety and effectiveness data in this age group and in adults [see adverse reactions (6) and clinical studies (14.1)] . the safety and effectiveness of comirnaty in individuals younger than 12 years of age have not been established. evidence from clinical studies in individuals 6 months through 4 years of age strongly suggests that a single dose of comirnaty would be ineffective in individuals younger than 6 months of age. of the total number of comirnaty recipients in study 2 as of march 13, 2021 (n = 22,026), 20.7% (n = 4,552) were 65 years of age and older and 4.2% (n = 925) were 75 years of age and older [see clinical studies (14.1)] . in study 4, of 5081 recipients who received comirnaty as the first booster dose, 23.1% (n = 1175) were 65 years of age and older and 5.2% (n = 265) were 75 years of age and older. in study 5, of 726 recipients who received pfizer-biontech covid-19 vaccine, bivalent as the second booster dose, 21.9% (n = 159) were 65 years of age and older and 4.8% (n = 35) were 75 years of age and older. no overall differences in safety or effectiveness were observed between these recipients and younger recipients. the centers for disease control and prevention has published considerations related to covid-19 vaccination for individuals who are moderately to severely immunocompromised (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html).

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

moderna us, inc. - cx-038839 omicron (xbb.1.5) (unii: 4f9qrs7zv2) (cx-038839 omicron (xbb.1.5) - unii:4f9qrs7zv2) - spikevax is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (covid-19) caused by severe acute respiratory syndrome coronavirus 2 (sars-cov-2) in individuals 12 years of age and older. do not administer spikevax to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of spikevax [see description (11)] or to individuals who had a severe allergic reaction (e.g., anaphylaxis) following a previous dose of a moderna covid-19 vaccine. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to spikevax during pregnancy. women who are vaccinated with spikevax during pregnancy are encouraged to enroll in the registry by calling 1-866-moderna (1-866-663-3762). 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 pregnancie

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

newton laboratories, inc. - influenza a virus (unii: r9hh0nde2e) (influenza a virus - unii:r9hh0nde2e), influenza b virus (unii: 1314jz2x6w) (influenza b virus - unii:1314jz2x6w), measles virus (unii: ht3r7c012q) (measles virus - unii:ht3r7c012q), human sputum, bordetella pertussis infected (unii: u364v64hun) (human sputum, bordetella pertussis infected - unii:u364v64hun), aconitum napellus (unii: u0nq8555jd) (aconitum napellus - unii:u0nq8555jd), aluminum oxide (unii: lmi26o6933) (aluminum oxide - unii:lmi26o6933), antimony potassium - vaccination - illness formulated for vaccinations and viral-related symptoms such as headache, site pain, irritability and other reactions.

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

newton laboratories, inc. - measles virus (unii: ht3r7c012q) (measles virus - unii:ht3r7c012q), human sputum, bordetella pertussis infected (unii: u364v64hun) (human sputum, bordetella pertussis infected - unii:u364v64hun), aconitum napellus (unii: u0nq8555jd) (aconitum napellus - unii:u0nq8555jd), aluminum oxide (unii: lmi26o6933) (aluminum oxide - unii:lmi26o6933), antimony potassium tartrate (unii: dl6oz476v3) (antimony cation (3+) - unii:069647rpt5), arsenic trioxide (unii: s7v92p67ho) (arsenic cation (3+) - unii:c96613f5av), bapt - vaccination - illness formulated for vaccinations and viral-related symptoms such as headache, site pain, irritability and other reactions.

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - pneumococcal polysaccharide serotype 1; pneumococcal polysaccharide serotype 10a; pneumococcal polysaccharide serotype 11a; pneumococcal polysaccharide serotype 12f; pneumococcal polysaccharide serotype 14; pneumococcal polysaccharide serotype 15b; pneumococcal polysaccharide serotype 18c; pneumococcal polysaccharide serotype 19 f; pneumococcal polysaccharide serotype 19a; pneumococcal polysaccharide serotype 22f; pneumococcal polysaccharide serotype 23f; pneumococcal polysaccharide serotype 3; pneumococcal polysaccharide serotype 33f; pneumococcal polysaccharide serotype 4; pneumococcal polysaccharide serotype 5; pneumococcal polysaccharide serotype 6a; pneumococcal polysaccharide serotype 6b; pneumococcal polysaccharide serotype 7f; pneumococcal polysaccharide serotype 8; pneumococcal polysaccharide serotype 9v - suspension for injection - pneumococcal polysaccharide serotype 23f 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 19 f 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 14 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 9v 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 7f 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 6b 4.4 mcg / 0.5 ml; pneumococcal polysaccharide serotype 5 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 4 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 1 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 3 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 6a 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 18c 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 19a 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 33f 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 22f 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 15b 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 12f 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 11a 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 10a 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 8 2.2 mcg / 0.5 ml - pneumococcus, purified polysaccharides antigen conjugated - prevenar 20 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.

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

seqirus pty ltd - coxiella burnetii, quantity: 5 microgram/ml - injection - excipient ingredients: sodium chloride; monobasic sodium phosphate dihydrate; thiomersal; water for injections; dibasic sodium phosphate dodecahydrate - q-vax is indicated for the immunisation of susceptible adults at identifiable risk of infection with q fever. abattoir workers (and those closely associated with the meat industry), farmers, veterinarians, stockyard workers, shearers, animal transporters and many others exposed to cattle, sheep or goats or their products should be considered for vaccination. note: q fever has also occurred among persons culling and processing kangaroos and laboratory personnel handling potentially infected veterinary specimens, or visiting abattoirs, are at risk.

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

newton laboratories, inc. - influenza a virus (unii: r9hh0nde2e) (influenza a virus - unii:r9hh0nde2e), influenza b virus (unii: 1314jz2x6w) (influenza b virus - unii:1314jz2x6w), measles virus (unii: ht3r7c012q) (measles virus - unii:ht3r7c012q), human sputum, bordetella pertussis infected (unii: u364v64hun) (human sputum, bordetella pertussis infected - unii:u364v64hun), aconitum napellus (unii: u0nq8555jd) (aconitum napellus - unii:u0nq8555jd), aluminum oxide (unii: lmi26o6933) (aluminum oxide - unii:lmi26o6933), antimony potassium - influenza a virus 30 [hp_x] in 1 ml - formulated for vaccinations and viral-related symptoms such as fever, inflammation, pain, fatigue and skin discomfort. vaccination - illness formulated for vaccinations and viral-related symptoms such as fever, inflammation, pain, fatigue and skin discomfort.

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

newton laboratories, inc. - influenza a virus (unii: r9hh0nde2e) (influenza a virus - unii:r9hh0nde2e), influenza b virus (unii: 1314jz2x6w) (influenza b virus - unii:1314jz2x6w), measles virus (unii: ht3r7c012q) (measles virus - unii:ht3r7c012q), human sputum, bordetella pertussis infected (unii: u364v64hun) (human sputum, bordetella pertussis infected - unii:u364v64hun), aconitum napellus (unii: u0nq8555jd) (aconitum napellus - unii:u0nq8555jd), aluminum oxide (unii: lmi26o6933) (aluminum oxide - unii:lmi26o6933), antimony potassium - influenza a virus 30 [hp_x] in 1 g - formulated for vaccinations and viral-related symptoms such as fever, inflammation, pain, fatigue and skin discomfort. vaccination - illness formulated for vaccinations and viral-related symptoms such as fever, inflammation, pain, fatigue and skin discomfort.

Philippines - English - FDA (Food And Drug Administration)

msd animal health (phils.), inc.; distributor: msd animal health (phils.), inc. - needle free intradermal vaccination device (vet.) - battery-operated intra-dermal vaccination device - n/a

New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - chadox1-s 100 gvp/ml (gvp = giga viral particles; equivalent to not less than to 5.0 x 10^8 infectious units per ml);  ;  ;   - solution for injection - active: chadox1-s 100 gvp/ml (gvp = giga viral particles; equivalent to not less than to 5.0 x 10^8 infectious units per ml)       excipient: disodium edetate dihydrate ethanol histidine histidine hydrochloride monohydrate magnesium chloride hexahydrate polysorbate 80 sodium chloride sucrose water for injection - covid-19 vaccine astrazeneca is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 18 years of age and older. the use of this vaccine should be in accordance with official recommendations.