États-Unis - anglais - NLM (National Library of Medicine)

wockhardt usa llc. - alfuzosin hydrochloride (unii: 75046a1xtn) (alfuzosin - unii:90347ytw5f) - alfuzosin hydrochloride 10 mg - alfuzosin hydrochloride extended-release tablets, usp are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. alfuzosin hydrochloride extended-release tablets, usp are not indicated for the treatment of hypertension. alfuzosin hydrochloride extended-release tablets, usp are not indicated for use in the pediatric population. alfuzosin hydrochloride extended-release tablets are contraindicated for use: - in patients with moderate or severe hepatic impairment (childs-pugh categories b and c), since alfuzosin blood levels are increased in these patients[seeuse in specific populations (8.7) andclinical pharmacology (12.3)]. - with potent cyp3a4 inhibitors such as ketoconazole, itraconazole, and ritonavir, since alfuzosin blood levels are increased [see drug interactions (7.1) and clinical pharmacology (12.3)]. - in patients with known hypersensitivity, such as urticaria and angioedema, to alfuzosin hydrochloride or any component of alfuzosin hydroch

États-Unis - anglais - NLM (National Library of Medicine)

wockhardt usa llc. - memantine hydrochloride (unii: jy0wd0ua60) (memantine - unii:w8o17sjf3t) - memantine hydrochloride 5 mg - memantine hydrochloride is indicated for the treatment of moderate to severe dementia of the alzheimer's type. memantine hydrochloride is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. pregnancy category b there are no adequate and well-controlled studies of memantine in pregnant women. memantine hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. memantine given orally to pregnant rats and pregnant rabbits during the period of organogenesis was not teratogenic up to the highest doses tested (18 mg/kg/day in rats and 30 mg/kg/day in rabbits, which are 9 and 30 times, respectively, the maximum recommended human dose [mrhd] on a mg/m2 basis). slight maternal toxicity, decreased pup weights and an increased incidence of non-ossified cervical vertebrae were seen at an oral dose of 18 mg/kg/day in a study in which rats were given oral memantine beginning pre-mating a

États-Unis - anglais - NLM (National Library of Medicine)

wockhardt usa llc. - amiodarone hydrochloride (unii: 976728sy6z) (amiodarone - unii:n3rq532iut) - amiodarone hydrochloride 50 mg in 1 ml - amiodarone injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (vf) and hemodynamically unstable ventricular tachycardia (vt) in patients refractory to other therapy. amiodarone also can be used to treat patients with vt/vf for whom oral amiodarone is indicated, but who are unable to take oral medication. during or after treatment with amiodarone, patients may be transferred to oral amiodarone therapy [see dosage and administration (2)] . use amiodarone for acute treatment until the patient's ventricular arrhythmias are stabilized. most patients will require this therapy for 48 to 96 hours, but amiodarone may be safely administered for longer periods if necessary. amiodarone is contraindicated in patients with: - known hypersensitivity to any of the components of amiodarone injection, including iodine. hypersensitivity reactions may involve rash, angioedema, cutaneous/mucosal hemorrhage (bleeding), fever, arthralgias (joint pains),

États-Unis - anglais - NLM (National Library of Medicine)

wockhardt limited - amiodarone hydrochloride (unii: 976728sy6z) (amiodarone - unii:n3rq532iut) - amiodarone hydrochloride 50 mg in 1 ml - amiodarone injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (vf) and hemodynamically unstable ventricular tachycardia (vt) in patients refractory to other therapy. amiodarone also can be used to treat patients with vt/vf for whom oral amiodarone is indicated, but who are unable to take oral medication. during or after treatment with amiodarone, patients may be transferred to oral amiodarone therapy [see dosage and administration (2)]. use amiodarone for acute treatment until the patient's ventricular arrhythmias are stabilized. most patients will require this therapy for 48 to 96 hours, but amiodarone may be safely administered for longer periods if necessary. amiodarone is contraindicated in patients with: - known hypersensitivity to any of the components of amiodarone, including iodine. hypersensitivity reactions may involve rash, angioedema, cutaneous/mucosal hemorrhage (bleeding), fever, arthralgias (joint pains), eosinophilia (abnormal bl

États-Unis - anglais - NLM (National Library of Medicine)

wockhardt limited - alfuzosin hydrochloride (unii: 75046a1xtn) (alfuzosin - unii:90347ytw5f) - alfuzosin hydrochloride 10 mg - alfuzosin hcl extended-release tablets are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. alfuzosin hcl extended-release tablets are not indicated for the treatment of hypertension. alfuzosin hcl extended-release tablets are not indicated for use in the pediatric population. alfuzosin hcl extended-release tablets are contraindicated for use: - in patients with moderate or severe hepatic impairment (childs-pugh categories b and c), since alfuzosin blood levels are increased in these patients [see use in specific populations (8.7) and clinical pharmacology (12.3)]. - with potent cyp3a4 inhibitors such as ketoconazole, itraconazole, and ritonavir, since alfuzosin blood levels are increased [see drug interactions (7.1) and clinical pharmacology (12.3)]. - in patients with known hypersensitivity, such as urticaria and angioedema, to alfuzosin hydrochloride or any component of  alfuzosin hcl extended-release tablets [see adverse reactions (6.2)] pregnancy category b. alfuzosin hc

États-Unis - anglais - NLM (National Library of Medicine)

wockhardt usa llc. - granisetron hydrochloride (unii: 318f6l70j8) (granisetron - unii:wzg3j2mcol) - granisetron 0.1 mg in 1 ml - granisetron hydrochloride injection is a serotonin-3 (5-ht3 ) receptor antagonist indicated for: - the prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. granisetron hydrochloride injection is contraindicated in patients with known hypersensitivity (eg. anaphylaxis, shortness of breath, hypotension, urticaria) to the drug or to any of its components. pregnancy  category  b reproduction studies have been performed in pregnant rats at intravenous doses up to 9 mg/kg/day (54 mg/m2 /day, 146 times the recommended human dose based on body surface area) and pregnant rabbits at intravenous doses up to 3 mg/kg/day (35.4 mg/m2 /day, 96 times the recommended human dose based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to granisetron. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predi

États-Unis - anglais - NLM (National Library of Medicine)

wockhardt usa llc. - granisetron hydrochloride (unii: 318f6l70j8) (granisetron - unii:wzg3j2mcol) - granisetron 1 mg in 1 ml - granisetron hydrochloride injection is a serotonin-3 (5-ht3 ) receptor antagonist indicated for: - the prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. granisetron hydrochloride injection is contraindicated in patients with known hypersensitivity (eg. anaphylaxis, shortness of breath, hypotension, urticaria) to the drug or to any of its components. pregnancy  category  b reproduction studies have been performed in pregnant rats at intravenous doses up to 9 mg/kg/day (54 mg/m2 /day, 146 times the recommended human dose based on body surface area) and pregnant rabbits at intravenous doses up to 3 mg/kg/day (35.4 mg/m2 /day, 96 times the recommended human dose based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to granisetron. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predi

États-Unis - anglais - NLM (National Library of Medicine)

american health packaging - dextroamphetamine sulfate (unii: jj768o327n) (dextroamphetamine - unii:tz47u051fi) - dextroamphetamine sulfate 15 mg - dextroamphetamine sulfate extended-release capsules are indicated in: narcolepsy attention deficit disorder with hyperactivity – as an integral part of a total treatment program that typically includes other measures (psychological, educational, social) for patients (ages 6 years to 16 years) with this syndrome. a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv) implies the presence of the hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. the symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in 2 or more settings, e.g., school (or work) and at home. the symptoms must not be better accounted for by another mental disorder. for the inattentive type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poo

États-Unis - anglais - NLM (National Library of Medicine)

specgx llc - dextroamphetamine sulfate (unii: jj768o327n) (dextroamphetamine - unii:tz47u051fi) - dextroamphetamine sulfate 5 mg - dextroamphetamine sulfate extended-release capsules are indicated in: narcolepsy attention deficit disorder with hyperactivity as an integral part of a total treatment program that typically includes other measures (psychological, educational, social) for patients (ages 6 years to 16 years) with this syndrome. a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv) implies the presence of the hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years.  the symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in 2 or more settings, e.g., school (or work) and at home.  the symptoms must not be better accounted for by another mental disorder.  for the inattentive type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks;

États-Unis - anglais - NLM (National Library of Medicine)

corepharma, llc - amphetamine sulfate (unii: 6dpv8nk46s) (amphetamine - unii:ck833kgx7e), dextroamphetamine saccharate (unii: g83415v073) (dextroamphetamine - unii:tz47u051fi), amphetamine aspartate monohydrate (unii: o1zpv620o4) (amphetamine - unii:ck833kgx7e), dextroamphetamine sulfate (unii: jj768o327n) (dextroamphetamine - unii:tz47u051fi) - amphetamine sulfate 1.875 mg - dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets are indicated for the treatment of attention deficit hyperactivity disorder (adhd) and narcolepsy. a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv® ) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. the symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. the symptoms must not be better accounted for by another mental disorder. for the inattentive type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful.