Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - ezetimibe, quantity: 10 mg; simvastatin, quantity: 10 mg - tablet - excipient ingredients: ascorbic acid; iron oxide red; microcrystalline cellulose; lactose monohydrate; magnesium stearate; croscarmellose sodium; butylated hydroxyanisole; iron oxide black; propyl gallate; hypromellose; iron oxide yellow; citric acid - adults (?18 years),prevention of cardiovascular disease ezetimibe/simvastatin-sandoz is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of simvastatin and in need of additional lowering of ldl-c in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy (see clinical trials).,primary hypercholesterolaemia ezetimibe/simvastatin-sandoz is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate: ? patients not appropriately controlled with a statin or ezetimibe alone. ? patients already treated with a statin and ezetimibe.,homozygous familial hypercholesterolaemia (hofh) ezetimibe/simvastatin-sandoz is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis). children and adolescents 10-17 years (pubertal status: boys tanner stage ii and above and girls who are at least one year post- menarche),heterozygous familial hypercholesterolaemia (hefh) ezetimibe/simvastatin-sandoz is indicated as adjunctive therapy to diet in adolescent patients (10-17 years old) with heterozygous familial hypercholesterolaemia where use of a combination product is appropriate: ? patients not appropriately controlled with a statin or ezetimibe alone. ? patients already treated with a statin and ezetimibe.,homozygous familial hypercholesterolaemia (hofh) ezetimibe/simvastatin-sandoz is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

Spojené státy - angličtina - NLM (National Library of Medicine)

amerigen pharmaceuticals inc. - dextroamphetamine sulfate (unii: jj768o327n) (dextroamphetamine - unii:tz47u051fi), dextroamphetamine saccharate (unii: g83415v073) (dextroamphetamine - unii:tz47u051fi), amphetamine aspartate monohydrate (unii: o1zpv620o4) (amphetamine - unii:ck833kgx7e), amphetamine sulfate (unii: 6dpv8nk46s) (amphetamine - unii:ck833kgx7e) - mas-er capsules are indicated for the treatment of attention deficit hyperactivity disorder (adhd). the efficacy of mas-er capsules in the treatment of adhd was established on the basis of two controlled trials in children aged 6 to 12, one controlled trial in adolescents aged 13 to 17, and one controlled trial in adults who met dsm-iv® criteria for adhd [see clinical studies (14)]. a diagnosis of 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

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

torrent australasia pty ltd - simvastatin, quantity: 10 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: butylated hydroxyanisole; microcrystalline cellulose; lactose monohydrate; croscarmellose sodium; hypromellose; magnesium stearate; ferric oxide; propyl gallate; ascorbic acid; citric acid monohydrate - adults (greater than or equal to 18 years),prevention of cardiovascular disease,simtorsi is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of simvastatin and in need of additional lowering of ldl-c in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy (see section 5.1 pharmacodynamic properties - clinical trials),primary hypercholesterolaemia,simtorsi is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate:,? patients not appropriately controlled with a statin or ezetimibe alone. ? patients already treated with a statin and ezetimibe.,homozygous familial hypercholesterolaemia (hofh),simtorsi is indicated in patients with hofh. patients may also receive adjunctive treatments (eg. ldl apheresis).,children and adolescents 10-17 years (pubertal status: boys tanner stage ii and above and girls who are at least one year post-menarche),heterozygous familial hypercholesterolaemia (hefh),simtorsi is indicated as adjunctive therapy to diet in adolescent patients (10-17 years old) with hefh where use of a combination product is appropriate:,? patients not appropriately controlled with a statin or ezetimibe alone. ? patients already treated with a statin and ezetimibe.,homozygous familial hypercholesterolaemia (hofh),simtorsi is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (eg. ldl apheresis).

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

torrent australasia pty ltd - simvastatin, quantity: 10 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: magnesium stearate; lactose monohydrate; croscarmellose sodium; ferric oxide; ascorbic acid; propyl gallate; microcrystalline cellulose; citric acid monohydrate; butylated hydroxyanisole; hypromellose - adults (greater than or equal to 18 years),prevention of cardiovascular disease,ezetorin is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of simvastatin and in need of additional lowering of ldl-c in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy (see section 5.1 pharmacodynamic properties - clinical trials),primary hypercholesterolaemia,ezetorin is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate:,? patients not appropriately controlled with a statin or ezetimibe alone. ? patients already treated with a statin and ezetimibe.,homozygous familial hypercholesterolaemia (hofh),ezetorin is indicated in patients with hofh. patients may also receive adjunctive treatments (eg. ldl apheresis).,children and adolescents 10-17 years (pubertal status: boys tanner stage ii and above and girls who are at least one year post-menarche),heterozygous familial hypercholesterolaemia (hefh),ezetorin is indicated as adjunctive therapy to diet in adolescent patients (10-17 years old) with hefh where use of a combination product is appropriate:,? patients not appropriately controlled with a statin or ezetimibe alone. ? patients already treated with a statin and ezetimibe.,homozygous familial hypercholesterolaemia (hofh),ezetorin is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (eg. ldl apheresis).

Spojené státy - angličtina - NLM (National Library of Medicine)

asclemed usa, inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol tablets are indicated in the: - treatment of moderate to severe vasomotor symptoms associated with the menopause. - treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. when prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. - treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. - treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease. - treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). - prevention of osteoporosis. when prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate (see clinical pharmacology, clinical studies). the mainstays for decreasi

Spojené státy - angličtina - NLM (National Library of Medicine)

novitium pharma llc - fluphenazine hydrochloride (unii: zou145w1xl) (fluphenazine - unii:s79426a41z) - fluphenazine hydrochloride tablets are indicated in the management of manifestations of psychotic disorders. fluphenazine hydrochloride has not been shown effective in the management of behavioral complications in patients with mental retardation. phenothiazines are contraindicated in patients with suspected or established subcortical brain damage, in patients receiving large doses of hypnotics, and in comatose or severely depressed states.  the presence of blood dyscrasia or liver damage precludes the use of fluphenazine hydrochloride. fluphenazine hydrochloride is contraindicated in patients who have shown hypersensitivity to fluphenazine; cross-sensitivity to phenothiazine derivatives may occur.

Spojené státy - angličtina - NLM (National Library of Medicine)

par pharmaceutical, inc. - norepinephrine bitartrate (unii: ify5pe3zrw) (norepinephrine - unii:x4w3enh1cv) - norepinephrine in sodium chloride injection is indicated to raise blood pressure in adult patients with severe, acute hypotension. none. risk summary limited published data consisting of a small number of case reports and multiple small trials involving the use of norepinephrine in pregnant women at the time of delivery have not identified an increased risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. there are risks to the mother and fetus from hypotension associated with septic shock, myocardial infarction and stroke which are medical emergencies in pregnancy and can be fatal if left untreated (see clinical considerations) . in animal reproduction studies, using high doses of intravenous norepinephrine resulted in lowered maternal placental blood flow. clinical relevance to changes in the human fetus is unknown since the average maintenance dose is ten times lower (see data) . increased fetal reabsorptions were observed in pregnant hamsters after receiving daily injections at a

Spojené státy - angličtina - NLM (National Library of Medicine)

ajenat pharmaceuticals llc - 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 concomitantl

Spojené státy - angličtina - NLM (National Library of Medicine)

quallent pharmaceuticals health llc - escitalopram oxalate (unii: 5u85dbw7lo) (escitalopram - unii:4o4s742any) - escitalopram tablets are indicated for the treatment of: • major depressive disorder (mdd) in adults and pediatric patients 12 years of age and older. • generalized anxiety disorder (gad) in adults. additional pediatric use information is approved for abbvie inc.'s lexapro (escitalopram) tablets. however, due to abbvie inc.'s marketing exclusivity rights, this drug product is not labeled with that information. escitalopram tablets are contraindicated in patients: • taking maois with escitalopram tablets or within 14 days of stopping treatment with escitalopram tablets because of an increased risk of serotonin syndrome. the use of escitalopram tablets within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration (2.7), and warnings and precautions (5.2)] . starting escitalopram tablets in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin

Spojené státy - angličtina - NLM (National Library of Medicine)

steriscience specialties private limited - ampicillin sodium (unii: jfn36l5s8k) (ampicillin - unii:7c782967rd) - ampicillin for injection, usp is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions: respiratory tract infections caused by s. pneumoniae . staphylococcus aureus (penicillinase and nonpenicillinase-producing), h. influenzae , and group a beta-hemolytic streptococci. bacterial meningitis caused by e. coli , group b streptococci, and other gram-negative bacteria ( listeria monocytogenes, n. meningitidis ). the addition of an aminoglycoside with ampicillin may increase its effectiveness against gram-negative bacteria. septicemia and endocarditis caused by susceptible gram-positive organisms including streptococcus spp ., penicillin g-susceptible staphylococci, and enterococci. gram-negative sepsis caused by e. coli, proteus mirabilis and salmonella spp. responds to ampicillin. endocarditis due to enterococcal strains usually respond to intraven