South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

bayer (pty) ltd û isando - tablet - see ingredients - each tablet contains aspirin 500,0 mg

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

bayer (pty) ltd û isando - tablet - see ingredients - each effervescent tablet contains aspirin 500,0 mg

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

elanco australasia pty ltd - enrofloxacin - parenteral liquid/solution/suspension - enrofloxacin antibiotic active 50.0 mg/ml - antibiotic & related - animal - exotic | cat | dog | avian species | bitch | castrate | cat - queen | cat - tom | exotic animals | kitten | puppy | rep - antibiotics - oral, parenteral | infections of the respiratory tract | infections of the urinary tracts | staphylococcus intermedius | wound infections | abscesses | acute respiratory infections | airsacculitis | amoxycillin sensitive bacteria | anaerobic bacterial infection | avian mycoplasmas | bronchiseptica | bronchitis | clavulanic acid sensitive | coccidiosis | coryza | crd | deep pyodermas | dermatoses | diarrhoea | endometritis | enteritis | enzootic pneumonia | escherichia coli | european brood disease | gentamicin sensitive | group d streptococcus | hypermotility | including secondary invaders | infected wounds | infections | klebsiella spp. | lactating | mastitis | pharyngitis | pneumonia | proteus spp. | protozoal infections | pseudomonas aeruginosa | pyometra | salmonellosis | seborrhoeic dermatitis | sinusitis | staphylococcus spp. | systemic bacterial infection | tonsillitis

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

elanco australasia pty ltd - enrofloxacin - oral solution/suspension - enrofloxacin antibiotic active 25.0 mg/ml - antibiotic & related - animal - exotic | cat | dog | avian species | bitch | castrate | cat - queen | cat - tom | exotic animals | kitten | puppy | rep - antibiotics - oral, parenteral | infections of the respiratory tract | infections of the urinary tracts | staphylococcus intermedius | wound infections | abscesses | acute respiratory infections | airsacculitis | amoxycillin sensitive bacteria | anaerobic bacterial infection | avian mycoplasmas | bronchiseptica | bronchitis | clavulanic acid sensitive | coccidiosis | coryza | crd | deep pyodermas | dermatoses | diarrhoea | endometritis | enteritis | enzootic pneumonia | escherichia coli | european brood disease | gentamicin sensitive | group d streptococcus | hypermotility | including secondary invaders | infected wounds | infections | klebsiella spp. | lactating | mastitis | pharyngitis | pneumonia | proteus spp. | protozoal infections | pseudomonas aeruginosa | pyometra | salmonellosis | seborrhoeic dermatitis | sinusitis | staphylococcus spp. | systemic bacterial infection | tonsillitis

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

bayer healthcare llc - antihemophilic factor, human recombinant (unii: p89dr4ny54) (antihemophilic factor, human recombinant - unii:p89dr4ny54) - antihemophilic factor, human recombinant 1000 [iu] in 2.5 ml - kogenate® fs is a recombinant antihemophilic factor indicated for: kogenate fs is not indicated for the treatment of von willebrand disease. kogenate fs is contraindicated in patients who have life-threatening hypersensitivity reactions, including anaphylaxis to mouse or hamster protein or other constituents of the product (sucrose, glycine, histidine, sodium, calcium chloride, polysorbate 80, imidazole, tri-n-butyl phosphate, and copper). there are no data with kogenate fs use in pregnant women to inform on drug-associated risk. animal reproduction studies have not been conducted with kogenate fs. it is also not known whether kogenate fs can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. there is no information regarding the presence of kogenate fs in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for kogenate fs and any potential adverse effects on the breastfed child from kogenate fs or from the underlying maternal condition. safety and efficacy studies have been performed in previously untreated and minimally treated pediatric patients. children, in comparison to adults, present higher factor viii clearance values and, thus, lower half-life and recovery of factor viii. this may be due to differences in body composition.13 account for this difference in clearance when dosing or following factor viii levels in the pediatric population [see clinical pharmacology (12.3)] . routine prophylactic treatment in children ages 0–2.5 years with no pre-existing joint damage has been shown to reduce spontaneous joint bleeding and the risk of joint damage. this data can be extrapolated to ages >2.5–16 years for children who have no existing joint damage [see clinical studies (14)] . clinical studies with kogenate fs did not include patients aged 65 and over. dose selection for an elderly patient should be individualized.

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

bayer healthcare pharmaceuticals inc. - riociguat (unii: ru3fe2y4xi) (riociguat - unii:ru3fe2y4xi) - riociguat .5 mg - adempas is indicated for the treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (cteph), (who group 4) after surgical treatment, or inoperable cteph, to improve exercise capacity and who functional class [see clinical studies (14.1)]. adempas is indicated for the treatment of adults with pulmonary arterial hypertension (pah), (who group 1), to improve exercise capacity, who functional class and to delay clinical worsening. efficacy was shown in patients on adempas monotherapy or in combination with endothelin receptor antagonists or prostanoids. studies establishing effectiveness included predominately patients with who functional class ii–iii and etiologies of idiopathic or heritable pah (61%) or pah associated with connective tissue diseases (25%) [see clinical studies (14.2)] . based on data from animal reproduction studies, adempas may cause fetal harm when administered to a pregnant woman and is contraindicated in females who are pregnant. adempas was consistently

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

bayer healthcare llc - antihemophilic factor, human recombinant (unii: p89dr4ny54) (antihemophilic factor, human recombinant - unii:p89dr4ny54) - antihemophilic factor, human recombinant 250 [iu] in 2.5 ml - kovaltry is not indicated for the treatment of von willebrand disease. kovaltry is contraindicated in patients who have a history of hypersensitivity reactions to the active substance, to any of the excipients, or to mouse or hamster proteins [see description (11)]. there are no data with kovaltry use in pregnant women to inform on drug-associated risk. animal reproduction studies have not been conducted using kovaltry. it is not known whether kovaltry can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. there is no information regarding the presence of kovaltry in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for kovaltry and any potential adverse effects on the breastfed infant from kovaltry or from the underlying maternal condition. safety and efficacy studies with kovaltry have been performed in 51 pediatric ptps ≤12 years of age and 43 pediatric pups/mtps <6 years of age [see clinical studies (14)]. body weight adjusted clearance of factor viii in children ≤12 years of age is higher than in adults and adolescents. consider higher or more frequent dosing in children to account for this difference in clearance [see clinical pharmacology (12.3)] . clinical studies with kovaltry did not include patients aged 65 and over to determine whether or not they respond differently from younger patients. however, clinical experience with other factor viii products has not identified differences between the elderly and younger patients. as with any patient receiving recombinant factor viii, dose selection for an elderly patient should be individualized.

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

bayer healthcare llc - damoctocog alfa pegol (unii: by4tsk952y) (damoctocog alfa pegol - unii:by4tsk952y) - jivi, antihemophilic factor (recombinant), pegylated-aucl, is a recombinant dna-derived, factor viii concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with hemophilia a (congenital factor viii deficiency) for: limitations of use jivi is not indicated for use in children < 12 years of age due to greater risk for hypersensitivity reactions [see use in specific populations (8.4)] . jivi is not indicated for use in previously untreated patients (pups). jivi is not indicated for the treatment of von willebrand disease. jivi is contraindicated in patients who have a history of hypersensitivity reactions to the active substance, polyethylene glycol (peg), mouse or hamster proteins, or other constituents of the product [see description (11)]. there are no data with jivi use in pregnant women to inform on drug-associated risk. animal developmental and reproductive toxicity studies have not been conducted with jivi. it is not known whether jivi can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. there is no information regarding the presence of jivi in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for jivi and any potential adverse effects on the breastfed infant from jivi or from the underlying maternal condition. the safety and effectiveness in patients below the age of 12 have not been established. jivi is not indicated for use in previously untreated patients. jivi is not indicated for use in children below 12 years of age [see clinical studies (14)] .  in completed clinical studies with 73 pediatric previously treated patients (ptps) < 12 years of age (44 ptps < 6 years, 29 ptps 6 to < 12 years), adverse reactions due to immune response to peg were observed in children less than 6 years of age. in 23% of subjects in the age group < 6 years of age, loss of drug effect due to neutralizing anti-peg igm antibodies during the first 4 exposure days (eds) was observed. in 7% of the subjects < 6 years of age, loss of drug effect was combined with hypersensitivity reactions [see warnings and precautions (5.3)] . clinical studies of jivi did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease and other drug therapy.

Ireland - English - HPRA (Health Products Regulatory Authority)

bayer limited - praziquantel pyrantel embonate - tablets - 230/20.0 milligram - feline - endoparasiticide

Ireland - English - HPRA (Health Products Regulatory Authority)

bayer limited - febantel pyrantel embonate praziquantel - tablets - canine - endoparasiticide