संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

btg international inc. - crotalus atrox immune fab antivenin (ovine) (unii: rbr61yaj4v) (crotalus atrox immune fab antivenin (ovine) - unii:rbr61yaj4v), agkistrodon piscivorus immune fab antivenin (ovine) (unii: ia6o0k772m) (agkistrodon piscivorus immune fab antivenin (ovine) - unii:ia6o0k772m), crotalus scutulatus immune fab antivenin (ovine) (unii: 7wz1744g86) (crotalus scutulatus immune fab antivenin (ovine) - unii:7wz1744g86), crotalus adamanteus immune fab antivenin (ovine) (unii: a4229a7019) (crotalus adamanteus immune fa - crotalus atrox immune fab antivenin (ovine) 1 g - crofab is indicated for the management of adult and pediatric patients with north american crotalid envenomation. the term crotalid is used to describe the crotalinae subfamily (formerly known as crotalidae) of venomous snakes which includes rattlesnakes, copperheads and cottonmouths/water moccasins. do not administer crofab to patients with a known history of hypersensitivity to papaya or papain unless the benefits outweigh the risks and appropriate management for anaphylactic reactions is readily available. risk summary animal reproduction studies have not been conducted with crofab. it is also not known whether crofab can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. crofab should be given to a pregnant woman only if clearly needed. 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. risk summary it is not known whether crofab is excret

ऑस्ट्रेलिया - अंग्रेज़ी - APVMA (Australian Pesticides and Veterinary Medicines Authority)

ranvet pty. limited - citric acid; sodium citrate dihydrate - oral solution/suspension - citric acid acid-general active 2.8 g/30ml; sodium citrate dihydrate mineral-sodium-salt active 8.38 g/30ml - nutrition & metabolism - horse | colt | donkey | endurance horse | filly | foal | gelding | high performance horses | horses at stud | mare | pacer | pol - acidosis | dehydration | myopathy

आयरलैंड - अंग्रेज़ी - HPRA (Health Products Regulatory Authority)

egis pharmaceuticals plc - rosuvastatin zinc; ezetimibe - capsule, hard - 20 mg/10 milligram(s) - rosuvastatin and ezetimibe

आयरलैंड - अंग्रेज़ी - HPRA (Health Products Regulatory Authority)

egis pharmaceuticals plc - rosuvastatin zinc; ezetimibe - capsule, hard - 10 mg /10 milligram(s) - rosuvastatin and ezetimibe

आयरलैंड - अंग्रेज़ी - HPRA (Health Products Regulatory Authority)

egis pharmaceuticals plc - rosuvastatin zinc; ezetimibe - capsule, hard - 40 /10 milligram(s) - rosuvastatin and ezetimibe

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

remedyrepack inc. - insulin glargine (unii: 2zm8cx04rz) (insulin glargine - unii:2zm8cx04rz) - lantus is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. limitations of use lantus is not recommended for the treatment of diabetic ketoacidosis. lantus is contraindicated - during episodes of hypoglycemia [see warnings and precautions (5.3)]. - in patients with hypersensitivity to lantus or one of its excipients [see warnings and precautions (5.5)]. there are no well-controlled clinical studies of the use of lantus in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. all pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. this background risk is increased in pregnancies complicated by hyperglycemia and may be decreased with good metabolic control. it is essential for patients with diabetes or

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

remedyrepack inc. - tacrolimus (unii: wm0haq4wnm) (tacrolimus anhydrous - unii:y5l2157c4j) - tacrolimus capsules is indicated for the prophylaxis of organ rejection in patients receiving allogeneic kidney transplants. it is recommended that tacrolimus be used concomitantly with azathioprine or mycophenolate mofetil (mmf) and adrenal corticosteroids [ see clinical studies ( 14.1)] . therapeutic drug monitoring is recommended for all patients receiving tacrolimus [ see dosage and administration ( 2.6)]. tacrolimus capsules is indicated for the prophylaxis of organ rejection in patients receiving allogeneic liver transplants. it is recommended that tacrolimus be used concomitantly with adrenal corticosteroids [ see clinical studies ( 14.2)]. therapeutic drug monitoring is recommended for all patients receiving tacrolimus[ see dosage and administration ( 2.6)]. tacrolimus capsules is indicated for the prophylaxis of organ rejection in patients receiving allogeneic heart transplants. it is recommended that tacrolimus capsules be used concomitantly with azathioprine or mycophenolate mofetil (mmf) and adrenal corticosteroids [ see clinical studies ( 14.3)]. therapeutic drug monitoring is recommended for all patients receiving tacrolimus capsules [ see dosage and administration ( 2.6)]. tacrolimus capsules should not be used simultaneously with cyclosporine [ see dosage and administration ( 2.5)]. use with sirolimus is not recommended in liver and heart transplant. the safety and efficacy of tacrolimus with sirolimus has not been established in kidney transplant [ see warnings and precautions ( 5.12)]. intravenous use reserved for patients who cannot tolerate capsules orally. tacrolimus capsules are contraindicated in patients with a hypersensitivity to tacrolimus. tacrolimus injection is contraindicated in patients with a hypersensitivity to hco-60 (polyoxyl 60 hydrogenated castor oil). hypersensitivity symptoms reported include dyspnea, rash, pruritus, and acute respiratory distress syndrome [see adverse reactions (6)]. pregnancy category c - there are no adequate and well-controlled studies in pregnant women. tacrolimus is transferred across the placenta. the use of tacrolimus during pregnancy in humans has been associated with neonatal hyperkalemia and renal dysfunction. tacrolimus given orally to pregnant rabbits at 0.5 to 4.3 times the clinical dose and pregnant rats at 0.8 to 6.9 times the clinical dose was associated with an increased incidence of fetal death in utero, fetal malformations (cardiovascular, skeletal, omphalocele, and gallbladder agenesis) and maternal toxicity. tacrolimus should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. in pregnant rabbits, tacrolimus at oral doses of 0.32 and 1.0 mg/kg, 0.5 to 4.3 times the clinical dose range (0.075 – 0.2 mg/kg) based on body surface area, was associated with maternal toxicity as well as an increased incidence of abortions. at the 1 mg/kg dose, fetal rabbits showed an increased incidence of malformations (ventricular hypoplasia, interventricular septal defect, bulbous aortic arch, stenosis of ductus arteriosus, interrupted ossification of vertebral arch, vertebral and rib malformations, omphalocele, and gallbladder agenesis) and developmental variations. in pregnant rats, tacrolimus at oral doses of 3.2 mg/kg, 2.6 to 6.9 times the clinical dose range was associated with maternal toxicity, an increase in late resorptions, decreased numbers of live births, and decreased pup weight and viability. tacrolimus, given orally to pregnant rats after organogenesis and during lactation at 1.0 and 3.2 mg/kg, 0.8 to 6.9 times the recommended clinical dose range was associated with reduced pup weights and pup viability (3.2 mg/kg only); among the high dose pups that died early, an increased incidence of kidney hydronephrosis was observed. tacrolimus is excreted in human milk. as the effect of chronic exposure to tacrolimus in healthy infants is not established, patients maintained on tacrolimus should discontinue nursing taking into consideration importance of drug to the mother. the safety and efficacy of tacrolimus in pediatric kidney and heart transplant patients have not been established. successful liver transplants have been performed in pediatric patients (ages up to 16 years) using tacrolimus. two randomized active-controlled trials of tacrolimus in primary liver transplantation included 56 pediatric patients. thirty-one patients were randomized to tacrolimus-based and 25 to cyclosporine-based therapies. additionally, a minimum of 122 pediatric patients were studied in an uncontrolled trial of tacrolimus in living related donor liver transplantation. pediatric patients generally required higher doses of tacrolimus to maintain blood trough concentrations of tacrolimus similar to adult patients [ see dosage and administration ( 2.2)]. clinical trials of tacrolimus 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 or other drug therapy. the pharmacokinetics of tacrolimus in patients with renal impairment was similar to that in healthy volunteers with normal renal function. however, consideration should be given to dosing tacrolimus at the lower end of the therapeutic dosing range in patients who have received a liver or heart transplant and have pre-existing renal impairment. further reductions in dose below the targeted range may be required [see dosage and administration ( 2.3) and clinical pharmacology ( 12.3)]. the mean clearance of tacrolimus was substantially lower in patients with severe hepatic impairment (mean child-pugh score: >10) compared to healthy volunteers with normal hepatic function. close monitoring of tacrolimus trough concentrations is warranted in patients with hepatic impairment [ see clinical pharmacology ( 12.3)]. the use of tacrolimus in liver transplant recipients experiencing post-transplant hepatic impairment may be associated with increased risk of developing renal insufficiency related to high whole-blood trough concentrations of tacrolimus. these patients should be monitored closely and dosage adjustments should be considered. some evidence suggests that lower doses should be used in these patients [ see dosage and administration ( 2.3) and clinical pharmacology ( 12.3)].

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

par pharmaceutical inc. - posaconazole (unii: 6tk1g07bhz) (posaconazole - unii:6tk1g07bhz) - posaconazole delayed-release tablets are indicated for the treatment of invasive aspergillosis in adults and pediatric patients 13 years of age and older. posaconazole is indicated for the prophylaxis of invasive aspergillus and candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (hsct) recipients with graft-versus-host disease (gvhd) or those with hematologic malignancies with prolonged neutropenia from chemotherapy [see clinical studies (14.1)] as follows: - posaconazole delayed-release tablets : adults and pediatric patients 2 years of age and older who weigh greater than 40 kg - posaconazole oral suspension: adults and pediatric patients 13 years of age and older posaconazole oral suspension is indicated for the treatment of oropharyngeal candidiasis, including oropharyngeal candidiasis refractory to itraconazole and/or fluconazole in adults and pediatric patients 13 years of age and o

ऑस्ट्रेलिया - अंग्रेज़ी - APVMA (Australian Pesticides and Veterinary Medicines Authority)

kenso corporation (m) sdn. bhd. - ethephon - emulsifiable concentrate - ethephon organophosphorus active 720.0 g/l - growth regulator - apple | apple - legana | apple - stark crimson | cherry - see label for variety | cotton | delicious apple | golden delicious ap - accelerate ripening | acceleration of boll opening | advance or delay maturity (inc. rind) | advance/concentrate fruit maturity | aid complete removal of fruit from trees | aid mechanical harvesting | cane ripening | defoliation of cotton plants | early colour development | even out production cycle | fruit thinning | increase crop yield | increase fruit maturity or colour | initiate flowering in ratoon | pre-conditioning treatment | promote eveness of maturity | promote uniform nutfall | reduce size of heavy crop | stimulate flowering in following season | defoliation aid | delay ageing | delay harvest | delay maturity | fruit thinning | increased red colour

ऑस्ट्रेलिया - अंग्रेज़ी - APVMA (Australian Pesticides and Veterinary Medicines Authority)

ranvet pty. limited - sodium citrate anhydrous; citric acid; tris = trometamol = tromethamine - oral solution/suspension - sodium citrate anhydrous ungrouped active 279.26 g/l; citric acid acid-general active 93.23 g/l; tris = trometamol = tromethamine ungrouped active 11.08 g/l - nutrition & metabolism - horse | colt | donkey | endurance horse | filly | foal | gelding | high performance horses | horses at stud | mare | pacer | pol - acidosis | dehydration | myopathy