ABD - İngilizce - NLM (National Library of Medicine)

protein sciences corporation - influenza a virus a/michigan/45/2015 (h1n1) recombinant hemagglutinin antigen (unii: 69h0yj871t) (influenza a virus a/michigan/45/2015 (h1n1) recombinant hemagglutinin antigen - unii:69h0yj871t) - influenza a virus a/michigan/45/2015 (h1n1) recombinant hemagglutinin antigen 45 ug in 0.5 ml

ABD - İngilizce - NLM (National Library of Medicine)

bavarian nordic a/s - vaccinia virus modified strain ankara-bavarian nordic non-replicating antigen (unii: tu8j357395) (vaccinia virus modified strain ankara-bavarian nordic non-replicating antigen - unii:tu8j357395) - jynneos is a vaccine indicated for prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection. 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 human data on jynneos administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. the effect of jynneos on embryo-fetal and post-natal development was evaluated in four developmental toxicity studies conducted in female rats and rabbits. in two studies, rats were administered a single human dose of jynneos (0.5 ml) once prior to mating and on one or two occasions during gestation. in the third study, rats were administered a single human dose of jynneos (0.5 ml) on two occasions during gestation. in the fourth study, rabbits were ad

ABD - İngilizce - NLM (National Library of Medicine)

wyeth pharmaceutical division of wyeth holdings llc - streptococcus pneumoniae type 1 capsular polysaccharide diphtheria crm197 protein conjugate antigen (unii: 54ec0se5pz) (streptococcus pneumoniae type 1 capsular polysaccharide diphtheria crm197 protein conjugate antigen - unii:54ec0se5pz), streptococcus pneumoniae type 3 capsular polysaccharide diphtheria crm197 protein conjugate antigen (unii: 2vf3v7175u) (streptococcus pneumoniae type 3 capsular polysaccharide diphtheria crm197 protein conjugate antigen - unii:2vf3v7175u), streptococcus pneumoniae type - streptococcus pneumoniae type 1 capsular polysaccharide diphtheria crm197 protein conjugate antigen 2.2 ug in 0.5 ml - in children 6 weeks through 5 years of age (prior to the 6th birthday), prevnar 13® is indicated for: in children 6 years through 17 years of age (prior to the 18th birthday), prevnar 13 is indicated for: 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 prevnar 13 administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. a developmental toxicity study has been performed in female rabbits administered prevnar 13 prior to mating and during gestation. each dose was approximately 20 times the human dose. this study revealed no evidence of harm to the fetus due to prevnar 13 (see 8.1 data). data animal in a developmental toxicity study, female rabbits were administered prevnar 13 by intramuscular injection twice prior to mating (17 days an

ABD - İngilizce - NLM (National Library of Medicine)

a-s medication solutions - streptococcus pneumoniae type 1 capsular polysaccharide diphtheria crm197 protein conjugate antigen (unii: 54ec0se5pz) (streptococcus pneumoniae type 1 capsular polysaccharide diphtheria crm197 protein conjugate antigen - unii:54ec0se5pz), streptococcus pneumoniae type 3 capsular polysaccharide diphtheria crm197 protein conjugate antigen (unii: 2vf3v7175u) (streptococcus pneumoniae type 3 capsular polysaccharide diphtheria crm197 protein conjugate antigen - unii:2vf3v7175u), streptococcus pneumoniae type - streptococcus pneumoniae type 1 capsular polysaccharide diphtheria crm197 protein conjugate antigen 2.2 ug in 0.5 ml - in children 6 weeks through 5 years of age (prior to the 6th birthday), prevnar 13® is indicated for: in children 6 years through 17 years of age (prior to the 18th birthday), prevnar 13 is indicated for: 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 prevnar 13 administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. a developmental toxicity study has been performed in female rabbits administered prevnar 13 prior to mating and during gestation. each dose was approximately 20 times the human dose. this study revealed no evidence of harm to the fetus due to prevnar 13 (see 8.1 data). data animal in a developmental toxicity study, female rabbits were administered prevnar 13 by intramuscular injection twice prior to mating (17 days an

Kanada - İngilizce - Health Canada

biontech manufacturing gmbh - tozinameran; riltozinameran - suspension - 15mcg; 15mcg - tozinameran 15mcg; riltozinameran 15mcg

Singapur - İngilizce - HSA (Health Sciences Authority)

roche singapore pte. ltd. - pralsetinib - capsule - pralsetinib 100.0mg

Yeni Zelanda - İngilizce - Medsafe (Medicines Safety Authority)

bristol-myers squibb (nz) limited - daclatasvir dihydrochloride 33mg equivalent to daclatasvir 30mg - tablet - 30 mg - active: daclatasvir dihydrochloride 33mg equivalent to daclatasvir 30mg excipient: colloidal silicon dioxide croscarmellose sodium lactose magnesium stearate microcrystalline cellulose opadry green - daklinza is indicated in combination with other medicinal products for the treatment of chronic hepatitis c virus (hcv) infection in adults with compensated liver disease (including cirrhosis).

Yeni Zelanda - İngilizce - Medsafe (Medicines Safety Authority)

bristol-myers squibb (nz) limited - daclatasvir dihydrochloride 66mg equivalent to daclatasvir 60mg - tablet - 60 mg - active: daclatasvir dihydrochloride 66mg equivalent to daclatasvir 60mg excipient: colloidal silicon dioxide croscarmellose sodium lactose magnesium stearate microcrystalline cellulose opadry green - daklinza is indicated in combination with other medicinal products for the treatment of chronic hepatitis c virus (hcv) infection in adults with compensated liver disease (including cirrhosis).

Kanada - İngilizce - Health Canada

gilead sciences canada inc - bictegravir (bictegravir sodium); emtricitabine; tenofovir alafenamide (tenofovir alafenamide hemifumarate) - tablet - 50mg; 200mg; 25mg - bictegravir (bictegravir sodium) 50mg; emtricitabine 200mg; tenofovir alafenamide (tenofovir alafenamide hemifumarate) 25mg - hiv integrase inhibitors

ABD - İngilizce - NLM (National Library of Medicine)

blue earth diagnostics - flotufolastat f-18 (unii: 811w19e3ol) (flotufolastat f-18 - unii:811w19e3ol) - posluma is indicated for positron emission tomography (pet) of prostate-specific membrane antigen (psma) positive lesions in men with prostate cancer - with suspected metastasis who are candidates for initial definitive therapy. - with suspected recurrence based on elevated serum prostate-specific antigen (psa) level. none. risk summary posluma is not indicated for use in females. there are no available data on the use of posluma in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted with flotufolastat f 18. radioactive drugs, including posluma, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. risk summary posluma is not indicated for use in females. there are no data on the presence of flotufolastat f 18 in human milk, the effect on the breastfed infant, or the effect on milk production. the safety and effectiveness of posluma have not been established in pediatric patients. among the total number of patients receiving posluma in clinical studies of prostate cancer, 463 (62%) were 65 years of age and older, while 118 (16%) were 75 years of age and older [see clinical studies ( 14.1, 14.2)] . no overall differences in safety or effectiveness were observed between these patients and younger adult patients.