माल्टा - अंग्रेज़ी - Medicines Authority

actavis h.f. reykjavikurvegur 78, 220 hafnarfjörður, iceland - ranitidine - film-coated tablet - ranitidine 300 mg - drugs for acid related disorders

माल्टा - अंग्रेज़ी - Medicines Authority

dolorgiet gmbh & co. kg otto-von-guericke-str. 1, 53757 sankt augustin / bonn, germany - paracetamol - suppository - paracetamol 250 mg - analgesics

माल्टा - अंग्रेज़ी - Medicines Authority

dolorgiet gmbh & co. kg otto-von-guericke-str. 1, 53757 sankt augustin / bonn, germany - paracetamol - suppository - paracetamol 125 mg - analgesics

माल्टा - अंग्रेज़ी - Medicines Authority

reckitt benckiser healthcare (uk) limited 103-105 bath road slough sl1 3uh, united kingdom - phenylephrine, paracetamol - powder for oral solution - phenylephrine 10 mg paracetamol 1000 mg - analgesics

माल्टा - अंग्रेज़ी - Medicines Authority

remedica limited limassol industrial estate, aharnon street, 3056 limassol, cyprus - paracetamol - suppository - paracetamol 125 mg - analgesics

माल्टा - अंग्रेज़ी - Medicines Authority

remedica limited limassol industrial estate, aharnon street, 3056 limassol, cyprus - paracetamol - suppository - paracetamol 250 mg - analgesics

माल्टा - अंग्रेज़ी - Medicines Authority

glaxo smithkline ireland limited 12, riverwalk, citywest business campus, dublin 24, ireland - ranitidine - solution for infusion or injection - ranitidine 25 mg/ml - drugs for acid related disorders

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

apotex corp. - balsalazide disodium (unii: 1xl6bji034) (balsalazide - unii:p80al8j7zp) - balsalazide disodium 750 mg - balsalazide disodium capsules are indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. limitations of use safety and effectiveness of balsalazide beyond 8 weeks in pediatric patients 5 years to 17 years of age and 12 weeks in adults have not been established. balsalazide disodium capsules is contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, or to any of the components of balsalazide disodium capsules or balsalazide metabolites [see warnings and precautions (5.3), adverse reactions (6.2), description (11)]. risk summary published data from meta-analyses, cohort studies and case series on the use of mesalamine, the active moiety of balsalazide, during pregnancy have not reliably informed an association with mesalamine and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data). there are adverse effects on maternal and fetal outcomes associated with ulcerative colitis in pregnancy (see clinical considerations). in animal reproduction studies, there were no adverse developmental effects observed after oral administration of balsalazide disodium in pregnant rats and rabbits during organogenesis at doses up to 2.4 and 4.7 times, respectively, the maximum recommended human dose (mrhd) (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 birth defect, loss, or other adverse outcomes. in the u.s. 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.   clinical considerations disease-associated maternal and embryo/fetal risk   published data suggest that increased disease activity is associated with the risk of developing adverse pregnancy outcomes in women with ulcerative colitis. adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2,500 g) infants, and small for gestational age at birth.   data human data published data from meta-analyses, cohort studies and case series on the use of mesalamine, the active moiety of balsalazide, during early pregnancy (first trimester) and throughout pregnancy have not reliably informed an association of mesalamine and major birth defects, miscarriage, or adverse maternal or fetal outcomes. there is no clear evidence that mesalamine exposure in early pregnancy is associated with an increased risk in major congenital malformations, including cardiac malformations. published epidemiologic studies have important methodological limitations which hinder interpretation of the data, including inability to control for confounders, such as underlying maternal disease, and maternal use of concomitant medications, and missing information on the dose and duration of use for mesalamine products.   animal data   reproduction studies were performed in rats and rabbits following administration of balsalazide during organogenesis at oral doses up to 2 g/kg/day, 2.4 and 4.7 times the mrhd based on body surface area for the rat and rabbit, respectively, and revealed no adverse embryofetal developmental effects due to balsalazide disodium. risk summary data from published literature report the presence of mesalamine and its metabolite, n acetyl-5 aminosalicylic acid, in human milk in small amounts with relative infant doses (rid) of 0.1% or less for mesalamine (see data). there are case reports of diarrhea in breastfed infants exposed to mesalamine (see clinical considerations). there is no information on the effects of the drug on milk production. the lack of clinical data during lactation precludes a clear determination of the risk of balsalazide to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for balsalazide and any potential adverse effects on the breastfed child from balsalazide or from the underlying maternal condition.   clinical considerations advise the caregiver to monitor breastfed infants for diarrhea.   data in published lactation studies, maternal mesalamine doses from various oral and rectal mesalamine formulations and products ranged from 500 mg to 4.8 g daily. the average concentration of mesalamine in milk ranged from non-detectable to 0.5 mg/l. the average concentration of n-acetyl-5-aminosalicylic acid in milk ranged from 0.2 to 9.3 mg/l. based on these concentrations, estimated infant daily dosages for an exclusively breastfed infant are 0 to 0.075 mg/kg/day (rid 0 to 0.1%) of mesalamine and 0.03 to 1.4 mg/kg/day of n-acetyl-5-aminosalicylic acid. the safety and effectiveness of balsalazide disodium has been established for the treatment of mildly to moderately active ulcerative colitis in pediatric and adolescent patients 5 years to 17 years of age. use of balsalazide disodium for this indication is supported by evidence from adequate and well-controlled clinical studies in adults with additional pharmacokinetic and safety data in pediatric patients aged 5 years to 17 years [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14.2)]. based on the limited data available, dosing can be initiated at either 6.75 or 2.25 g/day [see dosage and administration (2.2)].   the safety and effectiveness of balsalazide disodium capsules in pediatric patients below the age of 5 years have not been established.  clinical trials of balsalazide disodium did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently than younger subjects. reports from uncontrolled clinical studies and postmarketing reporting systems suggested a higher incidence of blood dyscrasias, i.e., neutropenia and pancytopenia, in patients who were 65 years or older compared to younger patients taking mesalamine-containing products. balsalazide disodium is converted into mesalamine in the colon. monitor complete blood cell counts and platelet counts in elderly patients during treatment with balsalazide disodium. in general, consider the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in elderly patients when prescribing balsalazide disodium capsules [see use in specific populations (8.6)]. mesalamine is known to be substantially excreted by the kidney, and the risk of adverse reactions to balsalazide disodium, which is converted to mesalamine, may be greater in patients with impaired renal function. evaluate renal function in all patients prior to initiation and periodically while on balsalazide disodium capsules therapy. monitor patients with known renal impairment or history of renal disease or taking nephrotoxic drugs for decreased renal function and mesalamine-related adverse reactions. discontinue balsalazide disodium capsules if renal function deteriorates while on therapy [see warnings and precautions (5.1), adverse reactions (6.2), drug interactions (7.1)].

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

salix pharmaceuticals, inc. - mesalamine (unii: 4q81i59gxc) (mesalamine - unii:4q81i59gxc) - mesalamine 375 mg - apriso ® is indicated for the maintenance of remission of ulcerative colitis in adults. apriso is contraindicated in patients with hypersensitivity to salicylates or aminosalicylates or to any of the components of apriso capsules [see warnings and precautions ( 5.3), adverse reactions ( 6.2), description ( 11)] . risk summary published data from meta-analyses, cohort studies and case series on the use of mesalamine during pregnancy have not reliably informed an association with mesalamine and major birth defects, miscarriage, or adverse maternal or fetal outcomes ( see data) . in animal reproduction studies, there were no adverse developmental outcomes with administration of oral mesalamine during organogenesis to pregnant rats and rabbits at doses 1.7 and 5.4 times, respectively, the maximum recommended human dose ( see data) . the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. in the u.s. 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. clinical considerations disease-associated maternal and embryo/fetal risk published data suggest that increased disease activity is associated with the risk of developing adverse pregnancy outcomes in women with ulcerative colitis. adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth. data human data published data from meta-analyses, cohort studies and case series on the use of mesalamine during early pregnancy (first trimester) and throughout pregnancy have not reliably informed an association of mesalamine and major birth defects, miscarriage, or adverse maternal or fetal outcomes. there is no clear evidence that mesalamine exposure in early pregnancy is associated with an increased risk in major congenital malformations, including cardiac malformations. published epidemiologic studies have important methodological limitations which hinder interpretation of the data, including inability to control for confounders, such as underlying maternal disease, and maternal use of concomitant medications, and missing information on the dose and duration of use for mesalamine products. animal data reproduction studies with mesalamine during organogenesis have been performed in rats at oral doses up to 320 mg/kg/day (about 1.7 times the recommended human dose based on a body surface area comparison) and rabbits at doses up to 495 mg/kg/day (about 5.4 times the recommended human dose based on a body surface area comparison) and have revealed no evidence of harm to the fetus due to mesalamine. risk summary data from published literature report the presence of mesalamine and its metabolite, n-acetyl 5-aminosalicylic acid in human milk in small amounts with relative infant doses (rid) of 2% or less ( see data) . there are case reports of diarrhea in breastfed infants exposed to mesalamine (see clinical considerations) . there is no information on the effects of the drug on milk production. the lack of clinical data during lactation precludes a clear determination of the risk of apriso to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for apriso and any potential adverse effects on the breastfed child from apriso or from the underlying maternal condition. clinical considerations advise the caregiver to monitor the breastfed infant for diarrhea. data in published lactation studies, maternal mesalamine doses from various oral and rectal formulations and products ranged from 500 mg to 4.8 g daily. the average concentration of mesalamine in milk ranged from non-detectable to 0.5 mg/l. the average concentration of the n-acetyl-5-aminosalicylic acid in milk ranged from 0.2 to 9.3 mg/l. based on these concentrations, estimated infant daily dosages for an exclusively breastfed infant are 0 to 0.075 mg/kg/day (rid 0 to 0.1%) of mesalamine and 0.03 to 1.4 mg/kg/day of n-acetyl-5-aminosalicylic acid. safety and effectiveness of apriso in pediatric patients have not been established. clinical studies of apriso did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. reports from uncontrolled clinical studies and postmarketing reporting systems suggested a higher incidence of blood dyscrasias (i.e., agranulocytosis, neutropenia and pancytopenia) in patients who were 65 years or older compared to younger patients taking mesalamine-containing products such as apriso. monitor complete blood cell counts and platelet counts in elderly patients during treatment with apriso. in general, consider the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in elderly patients when prescribing apriso [see use in specific populations ( 8.6)]. mesalamine is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. evaluate renal function in all patients prior to initiation and periodically while on apriso therapy. monitor patients with known renal impairment or history of renal disease or taking nephrotoxic drugs for decreased renal function and mesalamine-related adverse reactions. discontinue apriso if renal function deteriorates while on therapy [see warnings and precautions (5.1), adverse reactions (6.2), drug interactions (7.2)].

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

physicians total care, inc. - acetylcysteine (unii: wyq7n0bpyc) (acetylcysteine - unii:wyq7n0bpyc) - acetylcysteine 200 mg in 1 ml - acetylcysteine is the nonproprietary name for the n-acetyl derivative of the naturally occurring amino acid, l-cysteine. chemically, it is n-acetyl-l-cysteine. the compound is a white crystalline powder which melts in the range of 104° to 110°c and has a very slight odor. the structural formula of acetylcysteine is: c5 h9 no3 s                                                                                                      m.w.=163.19 acetylcysteine solution, usp is supplied as a sterile unpreserved solution (not for injection) in vials containing a 10% (100 mg/ml) or 20% (200 mg/ml) solution of acetylcysteine as the sodium salt. the inactive ingredients are edetate disodium, sodium hydroxide and sterile water for injection, usp. the ph of the solution ranges from 6.0 to 7.5. it is administered by inhalation or direct instillation for mucolysis, or orally for acetaminophen overdosage.