Yhdysvallat - englanti - NLM (National Library of Medicine)

golden state medical supply, inc. - dicyclomine hydrochloride (unii: cq903kqa31) (dicyclomine - unii:4kv4x8if6v) - dicyclomine hydrochloride capsules, usp are indicated for the treatment of patients with functional bowel/irritable bowel syndrome. dicyclomine hydrochloride is contraindicated in infants less than 6 months of age [see use in specificp opu l a ti on s (8.4) ] , nursing mothers [see use in specific populations (8.3)] and in patients with: •     unstable cardiovascular status in acute hemorrhage •     myasthenia gravis [see warnings and precautions (5.4)] •     glaucoma [see adverse reactions (6.3) and drug interactions (7.1)] •     obstructive uropathy [see warnings and precautions (5.8)] •     obstructive disease of the gastrointestinal tract [see warnings and precautions (5.5)] •     severe ulcerative colitis [see warnings and precautions (5.7)] •     reflux esophagitis p r e g n a n c y category b adequate and well-controlled studies have not been conducted with dicyclomine hydrochloride in pregnant women at the recommended doses of 80 to 160 mg/day. however, epidemiologic studies did not show an increased risk of structural malformations among babies born to women who took products containing dicyclomine hydrochloride at doses up to 40 mg/day during the first trimester of pregnancy. reproduction studies have been performed in rats and rabbits at doses up to 33 times the maximum recommended human dose based on 160 mg/day (3 mg/kg) and have revealed no evidence of harm to the fetus due to dicyclomine.  because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. dicyclomine hydrochloride is contraindicated in women who are breastfeeding. dicyclomine hydrochloride is excreted in human milk. because of the potential for serious adverse reactions in breast-fed infants from dicyclomine hydrochloride, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother [see use in specific populations (8.4)] . safety and effectiveness in pediatric patients have not been established. dicyclomine hydrochloride is contraindicated in infants less than 6 months of age [see contraindications (4)] . there are published cases reporting that the administration of dicyclomine hydrochloride to infants has been followed by serious respiratory symptoms (dyspnea, shortness of breath, breathlessness, respiratory collapse, apnea and asphyxia), seizures, syncope, pulse rate fluctuations, muscular hypotonia, and coma, and death, however; no causal relationship has been established. clinical studies of dicyclomine hydrochloride 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 in adults, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy . because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. effects of renal impairment on pk, safety and efficacy of dicyclomine hydrochloride have not been studied.  dicyclomine hydrochloride drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. dicyclomine hydrochloride should be administered with caution in patients with renal impairment. effects of renal impairment on pk, safety and efficacy of dicyclomine hydrochloride have not been studied.  dicyclomine hydrochloride should be administered with caution in patients with hepatic impairment.

Yhdysvallat - englanti - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - dicyclomine hydrochloride (unii: cq903kqa31) (dicyclomine - unii:4kv4x8if6v) - dicyclomine hydrochloride capsules, usp are indicated for the treatment of patients with functional bowel/irritable bowel syndrome. dicyclomine hydrochloride is contraindicated in infants less than 6 months of age [see use in specific populations (8.4)], nursing mothers [see use in specific populations (8.3)] and in patients with: pregnancy category b adequate and well-controlled studies have not been conducted with dicyclomine hydrochloride in pregnant women at the recommended doses of 80 to 160 mg/day. however, epidemiologic studies did not show an increased risk of structural malformations among babies born to women who took products containing dicyclomine hydrochloride at doses up to 40 mg/day during the first trimester of pregnancy. reproduction studies have been performed in rats and rabbits at doses up to 33 times the maximum recommended human dose based on 160 mg/day (3 mg/kg) and have revealed no evidence of harm to the fetus due to dicyclomine.  because animal reproduction studies are not always p

Uusi-Seelanti - englanti - Medsafe (Medicines Safety Authority)

viatris limited - tobramycin 28mg - powder filled inhalation capsule - 28 mg - active: tobramycin 28mg excipient: butyl alcohol calcium chloride dihydrate carnauba wax carrageenan distearoyl-dl-phosphatidylcholine hypromellose indigo carmine aluminium lake isopropyl alcohol potassium chloride propylene glycol shellac sulfuric acid titanium dioxide water for injection - management of cystic fibrosis patients with pseudomonas aeruginosa infections.

Yhdysvallat - englanti - NLM (National Library of Medicine)

teva pharmaceuticals inc - verapamil hydrochloride (unii: v3888oey5r) (verapamil - unii:cj0o37ku29) - verapamil hydrochloride 120 mg - verapamil hydrochloride sustained-release capsules are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variety of pharmacolo

Yhdysvallat - englanti - NLM (National Library of Medicine)

physicians total care, inc. - verapamil hydrochloride (unii: v3888oey5r) (verapamil - unii:cj0o37ku29) - verapamil hydrochloride 360 mg - verapamil hydrochloride sustained-release capsules are indicated for the management of essential hypertension. verapamil hcl is contraindicated in: - severe left ventricular dysfunction. (see warnings. ) - hypotension (less than 90 mm hg systolic pressure) or cardiogenic shock. - sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker). - second- or third-degree av block (except in patients with a functioning artificial ventricular pacemaker). - patients with atrial flutter or atrial fibrillation and an accessory bypass tract (e.g., wolff-parkinson-white, lown-ganong-levine syndromes). (see warnings. ) - patients with known hypersensitivity to erapamil hydrochloride.

Yhdysvallat - englanti - NLM (National Library of Medicine)

bryant ranch prepack - verapamil hydrochloride (unii: v3888oey5r) (verapamil - unii:cj0o37ku29) - verapamil hydrochloride sustained-release capsules are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program's joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variety of pharmaco

Yhdysvallat - englanti - NLM (National Library of Medicine)

laboratoires dermo cosmetik inc - salicylic acid (unii: o414pz4lpz) (salicylic acid - unii:o414pz4lpz) - salicylic acid 2000 mg in 1 g

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

basf australia ltd - flocoumafen - vertebrate poison - agricultural/farm buildings | building | commercial premises - general | industrial and/or domestic premises | animal housing | - mouse - mus spp. | rat

Israel - englanti - Ministry of Health

abic marketing ltd, israel - fluorouracil - solution for injection - fluorouracil 50 mg/ml - fluorouracil - fluorouracil - palliative management of carcinoma of the colon, rectum, breast, stomach and pancreas, in selected patients considered incurable by surgery or other means.as leucovorin-fluorouracil chemotherapy combination for cancer treatment.

Israel - englanti - Ministry of Health

novartis israel ltd - fluorouracil - concentrate for solution for injection / infusion - fluorouracil 50 mg/ml - fluorouracil - fluorouracil - palliative management of carcinoma of the colon, rectum, breast, stomach and pancreas, in selected patients considered incurable by surgery or other means.as leucovorin-fluorouracil chemotherapy combination for cancer treatment.