IAE Pharmaceuticals Corp. - search results

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

respisure one mycoplasma hyopneumoniae vaccine

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

respisure mycoplasma hyopneumoniae vaccine

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

m+pac mycoplasma hyopneumoniae inactivated vaccine for pigs

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

fabhalta- iptacopan capsule

novartis pharmaceuticals corporation - iptacopan hydrochloride (unii: xw5ck7c6yh) (iptacopan - unii:8e05t07z6w) - fabhalta is indicated for the treatment of adults with paroxysmal nocturnal hemoglobinuria (pnh). fabhalta is contraindicated: - in patients with serious hypersensitivity to iptacopan or any of the excipients. - for initiation in patients with unresolved serious infection caused by encapsulated bacteria, including streptococcus pneumoniae, neisseria meningitidis, or haemophilus influenzae type b. risk summary available data from clinical trials with fabhalta use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. there are risks to the mother and fetus associated with untreated pnh in pregnancy (see clinical considerations) . the use of fabhalta in pregnant women or women planning to become pregnant may be considered following an assessment of the risks and benefits. in animal reproduction studies, oral administration of iptacopan to pregnant rats and rabbits during organogenesis at exposures 4 to 6-times the human exposure (based on auc) at the maximum recommended human dose (mrhd) of 200 mg twice daily did not induce embryo or fetal toxicity (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of major birth defects, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk pnh in pregnancy is associated with adverse maternal outcomes, including worsening cytopenias, thrombosis, infections, bleeding, miscarriages, increased maternal mortality, and adverse fetal outcomes, including fetal death and premature delivery. data animal data in an embryo-fetal development study in rats, oral administration of iptacopan during organogenesis did not cause embryo-fetal toxicity when given up to the highest dose of 1,000 mg/kg/day, which corresponds to 4-times the mrhd based on auc. in an embryo-fetal development study in rabbits, oral administration of iptacopan during organogenesis did not cause embryo-fetal toxicity when given up to the highest dose of 450 mg/kg/day, which corresponds to 6-times the mrhd based on auc. in a pre- and postnatal development study in rats, oral administration of iptacopan during gestation, parturition, and lactation did not cause adverse effects in offspring when given up to the highest dose of 1,000 mg/kg/day, which corresponds to 4-times the mrhd based on auc. risk summary there are no data on the presence of iptacopan or its metabolite in either human or animal milk, the effects on the breastfed child or on milk production. since many medicinal products are secreted into human milk, and because of the potential for serious adverse reactions in a breastfed child, breastfeeding should be discontinued during treatment and for 5 days after the final dose. safety and effectiveness in pediatric patients with pnh have not been established. there were 29 pnh patients 65 years of age and older in apply-pnh and appoint-pnh [see clinical studies (14)] . of the total number of fabhalta-treated patients during the 24-week treatment period in these studies, 21 (20.6%) were 65 years of age and older, while 7 (6.9%) were 75 years of age and older. clinical studies of fabhalta did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. the use of fabhalta is not recommended in patients with severe renal impairment (estimated glomerular filtration rate (egfr) < 30 ml/min/1.73 m2 ) with or without hemodialysis. no dose adjustment is required in patients with mild (egfr 60 to < 90 ml/min/1.73 m2 ) or moderate (egfr 30 to < 60 ml/min/1.73 m2 ) renal impairment [see clinical pharmacology (12.3)] . the use of fabhalta is not recommended in patients with severe hepatic impairment (child-pugh class c). no dose adjustment is required for patients with mild (child-pugh class a) or moderate (child-pugh class b) hepatic impairment [see clinical pharmacology (12.3)] .

Philippines - English - FDA (Food And Drug Administration)

smodic 10 mg/5 ml syrup

iae pharmaceuticals corp. - dicycloverine hydrochloride - syrup - 10 mg/5 ml

Philippines - English - FDA (Food And Drug Administration)

fergesol 66 mg (equivalent to 200 mg ferrous fumarate) / 250 mcg capsule

iae pharmaceuticals corp. - ferrous fumarate , folic acid - capsule - 66 mg (equivalent to 200 mg ferrous fumarate) / 250 mcg

Philippines - English - FDA (Food And Drug Administration)

clovomet 5mg/ 5ml syrup

iae pharmaceuticals corporation - metoclopramide hydrochloride - syrup - 5mg/ 5ml

Philippines - English - FDA (Food And Drug Administration)

ventomex 1mg/50mg per 5ml syrup

iae pharmaceuticals corporation - salbutamol , guaifenesin - syrup - 1mg/50mg per 5ml

Philippines - English - FDA (Food And Drug Administration)

broxytone 250mg/5ml syrup

iae pharmaceuticals corporation - carbocisteine - syrup - 250mg/5ml

Philippines - English - FDA (Food And Drug Administration)

ralgec 50mg / 5ml suspension

iae pharmaceuticals corporation - mefenamic acid - suspension - 50mg / 5ml