Egyesült Államok - angol - NLM (National Library of Medicine)

glaxosmithkline biologicals sa - corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) (unii: irh51qn26h) (corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) - unii:irh51qn26h), clostridium tetani toxoid antigen (formaldehyde inactivated) (unii: k3w1n8yp13) (clostridium tetani toxoid antigen (formaldehyde inactivated) - unii:k3w1n8yp13), bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated) (unii: 8c367iy4ey) (bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated) - unii:8c367iy4ey), bordetella pertussis pertactin antigen (formaldehyde inactivated) (unii: i05o535nv6) (bordetella pertussis pertactin antigen (formaldehyde inactivated) - unii:i05o535nv6), bordetella pertussis toxoid antigen (formaldehyde, glutaraldehyde inactivated) (unii: qsn5xo8zsu) (bordetella pertussis toxoid antigen (formaldehyde, glutaraldehyde inactivated) - unii:qsn5xo8zsu), 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) - corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) 25 [iu] in 0.5 ml - a single dose of kinrix is indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (dtap) vaccine series and the fourth dose in the inactivated poliovirus vaccine (ipv) series in children aged 4 through 6 years (prior to the seventh birthday) whose previous dtap vaccine doses have been with infanrix (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) and/or pediarix [diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis b (recombinant) and inactivated poliovirus vaccine] for the first 3 doses and infanrix for the fourth dose. severe allergic reaction (e.g., anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, pertussis- or poliovirus-containing vaccine, or to any component of kinrix, including neomycin and polymyxin b, is a contraindication to administration of kinrix [see description (11)] . because of the uncertainty as to which component of the vaccine might be responsible, no further vaccination with any of these components should be given. alternatively, such individuals may be referred to an allergist for evaluation if immunization with any of these components is considered. encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous dose of a pertussis-containing vaccine that is not attributable to another identifiable cause is a contraindication to administration of any pertussis-containing vaccine, including kinrix. progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy, is a contraindication to administration of any pertussis-containing vaccine, including kinrix. pertussis vaccine should not be administered to individuals with such conditions until a treatment regimen has been established and the condition has stabilized. safety and effectiveness of kinrix in children younger than 4 years and children aged 7 to 16 years have not been evaluated. kinrix is not approved for use in persons in these age groups.

Egyesült Államok - angol - NLM (National Library of Medicine)

sanofi pasteur inc. - clostridium tetani toxoid antigen (formaldehyde inactivated) (unii: k3w1n8yp13) (clostridium tetani toxoid antigen (formaldehyde inactivated) - unii:k3w1n8yp13), corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) (unii: irh51qn26h) (corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) - unii:irh51qn26h), bordetella pertussis toxoid antigen (glutaraldehyde inactivated) (unii: f4tn0ipy37) (bordetella pertussis toxoid antigen (glutaraldehyde inactivated) - unii:f4tn0ipy37 - clostridium tetani toxoid antigen (formaldehyde inactivated) 5 [lf] in 0.5 ml - adacel® is a vaccine indicated for: - active booster immunization against tetanus, diphtheria and pertussis. adacel is approved for use in individuals 10 through 64 years of age. immunization during the third trimester of pregnancy to prevent pertussis in infants younger than 2 months of age. a severe allergic reaction (e.g., anaphylaxis) after a previous dose of any tetanus toxoid, diphtheria toxoid or pertussis containing vaccine or any other component of this vaccine is a contraindication to administration of adacel. [see description (11). ] because of uncertainty as to which component of the vaccine may be responsible, none of the components should be administered. alternatively, such individuals may be referred to an allergist for evaluation if further immunizations are to be considered. encephalopathy (e.g., coma, prolonged seizures, or decreased level of consciousness) within 7 days of a previous dose of a pertussis containing vaccine not attributable to another identifiable cause is a contraindicatio

Egyesült Államok - angol - NLM (National Library of Medicine)

sanofi pasteur inc. - clostridium tetani toxoid antigen (formaldehyde inactivated) (unii: k3w1n8yp13) (clostridium tetani toxoid antigen (formaldehyde inactivated) - unii:k3w1n8yp13), corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) (unii: irh51qn26h) (corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) - unii:irh51qn26h) - clostridium tetani toxoid antigen (formaldehyde inactivated) 5 [lf] in 0.5 ml - tenivac® is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria in persons 7 years of age and older. a severe allergic reaction (e.g., anaphylaxis) after a previous dose of tenivac or any other tetanus toxoid or diphtheria toxoid-containing vaccine or any other component of this vaccine is a contraindication to administration of tenivac. [see description (11) .] because of uncertainty as to which component of the vaccine may be responsible, none of the components should be administered. alternatively, such individuals may be referred to an allergist for evaluation if further immunizations are to be considered. 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. there are no adequate and well-controlled studies of tenivac administration in pregnant women in the u.s. there are insufficient human data from tenivac administered during pregnancy to establish the presence or absence of a vaccine-associated risk. a developmental toxicity study has been performed in female rabbits administered a single human dose of tenivac prior to mating and during gestation. this study revealed no evidence of harm to the fetus due to tenivac. (see animal data ) data animal data in a developmental toxicity study, female rabbits received a single human dose (0.5 ml) of tenivac by intramuscular injection 17 and 10 days prior to mating, and on gestation days 6 and 29. no adverse effects on pre-weaning development up to post-natal day 35 were observed. there were no vaccine-related fetal malformations or variations observed. it is not known whether tenivac components are excreted in human milk. data are not available to assess the effect of administration of tenivac on breastfed infants or on milk production/excretion. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tenivac and any potential adverse effects on the breastfed child from tenivac or from the underlying maternal condition. for preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine. tenivac is not approved for use in infants and children younger than 7 years of age. safety and effectiveness of tenivac in this age group have not been established. in one clinical study, (tdc01) 449 participants 65 years of age and over, including 192 participants who were 75 years of age and over received a dose of tenivac. a lower proportion of participants 65 years of age and over had a pre-vaccination seroprotective level of antibody to tetanus toxoid and diphtheria toxin compared to adolescents and adults less than 65 years of age. the proportion of participants 65 years of age and over with a seroprotective level of antibody following tenivac was marginally lower for tetanus and lower for diphtheria compared to younger participants. in general, rates of solicited adverse events were not higher in participants 65 years of age and over compared to younger participants. [see adverse reactions (6) , clinical pharmacology (12.1), and clinical studies (14.2) .]

Spanyolország - angol - HMA (Heads of Medicines Agencies)

ceva salud animal - clostridium chauvoei 90 %, clostridium novyi alpha toxoid 3.5 iu/ml, clostridium perfringens a 1.1 iu/ml, clostridium perfringens type c toxoid 10 iu/ml, clostridium perfringens type d toxoid 5 iu/ml, clostridium septicum 2.5 iu/ml, clostridium sordelli 100 %, clostridium tetani toxoid 2.5 iu/ml - suspension for injection - sheep food - clostridium vaccine

Olaszország - angol - HMA (Heads of Medicines Agencies)

ceva salud animal - clostridium chauvoei 90 %, clostridium novyi alpha toxoid 3.5 iu/ml, clostridium perfringens a 1.1 iu/ml, clostridium perfringens type c toxoid 10 iu/ml, clostridium perfringens type d toxoid 5 iu/ml, clostridium septicum 2.5 iu/ml, clostridium sordelli 100 %, clostridium tetani toxoid 2.5 iu/ml - suspension for injection - sheep food - clostridium vaccine

Ausztrália - angol - APVMA (Australian Pesticides and Veterinary Medicines Authority)

intervet australia pty limited - clostridium haemolyticum; clostridium perfringens type b toxoid; clostridium perfringens type c toxoid; clostridium chauvoei whole cell culture; clostridium novyi tybe b toxiod and inactivated cells; clostridium perfringens type d toxoid; clostridium septicum - toxoid; clostridium tetani - toxoid; thiomersal; aluminium (adjuvant) - misc. vaccines or anti sera - clostridium haemolyticum vaccine-toxoid active 21.2 tcp u/ml; clostridium perfringens type b toxoid vaccine-toxoid active 30.6 tcp u/ml; clostridium perfringens type c toxoid vaccine-toxoid active 15.3 tcp u/ml; clostridium chauvoei whole cell culture vaccine-microbial active 30.0 %ferm/ml; clostridium novyi tybe b toxiod and inactivated cells vaccine-toxiod active 5.95 tcp u/ml; clostridium perfringens type d toxoid vaccine-toxoid active 55.3 tcp u/ml; clostridium septicum - toxoid vaccine-toxoid active 6.4 tcp u/ml; clostridium tetani - toxoid vaccine-toxoid active 3.0 lf u/ml; thiomersal mercury other 0.15 mg/ml; aluminium (adjuvant) mineral-aluminium other 0.0 mg/ml - immunotherapy - cattle | lamb | sheep | beef | bos indicus | bos taurus | bovine | buffalo | bull | bullock | calf | cow | dairy cow | ewe | hei - black disease | blackleg | dysentery | enterotoxaemia (pulpy kidney) | haemorrhagic enterotoxaemia | malignant oedema | post parturient gangrene | swelled head | tetanus | tick fever - bovine babesiosis | babesia bigemina | babesia bovis | clostridium perfringens type d | red water | redwater | tetanus vaccination

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - collagenase clostridium histolyticum -

Egyesült Államok - angol - NLM (National Library of Medicine)

sanofi pasteur inc. - clostridium tetani toxoid antigen (formaldehyde inactivated) (unii: k3w1n8yp13) (clostridium tetani toxoid antigen (formaldehyde inactivated) - unii:k3w1n8yp13) - clostridium tetani toxoid antigen (formaldehyde inactivated) 5 [lf] in 0.5 ml

Egyesült Államok - angol - NLM (National Library of Medicine)

endo pharmaceuticals inc. - collagenase clostridium histolyticum (unii: 9x7o8v25it) (collagenase clostridium histolyticum - unii:9x7o8v25it) - collagenase clostridium histolyticum 0.9 mg - xiaflex is indicated for the treatment of adult patients with dupuytren’s contracture with a palpable cord. xiaflex is indicated for the treatment of adult men with peyronie’s disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. xiaflex is contraindicated in: - the treatment of peyronie’s plaques that involve the penile urethra due to potential risk to this structure. - patients with a history of hypersensitivity to xiaflex or to collagenase used in any other therapeutic application or application method [see warnings and precautions (5.4)] . pregnancy category b there are no adequate and well-controlled studies of xiaflex in pregnant women. because animal reproduction studies are not always predictive of human response, xiaflex should be used during pregnancy only if clearly needed. risk summary based on animal data, xiaflex is not predicted to increase the risk for major developmental abnormalities in humans. human data human pharmacokinetic studies

Ausztrália - angol - APVMA (Australian Pesticides and Veterinary Medicines Authority)

intervet australia pty limited - clostridium haemolyticum - unknown - clostridium haemolyticum vaccine-toxoid active 0.0 - active constituent