Estados Unidos - inglês - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - pasireotide (unii: 98h1t17066) (pasireotide - unii:98h1t17066) - pasireotide 0.3 mg in 1 ml - signifor is indicated for the treatment of adult patients with cushing's disease for whom pituitary surgery is not an option or has not been curative. none. risk summary the limited data with signifor in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. in embryo-fetal development studies in rabbits, findings indicating developmental delay were observed with subcutaneous administration of pasireotide during organogenesis at doses less than the exposure in humans at the highest recommended dose; maternal toxicity was not observed at this dose (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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. data animal data in embryo-fetal development studies in rats given 1, 5, and 10 mg/kg/day subcutaneously throughout organog

Estados Unidos - inglês - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - panobinostat lactate (unii: hn0t99oo4v) (panobinostat - unii:9647fm7y3z) - panobinostat 10 mg - farydak, a histone deacetylase inhibitor, in combination with bortezomib and dexamethasone, is indicated for the treatment of patients with multiple myeloma who have received at least 2 prior regimens, including bortezomib and an immunomodulatory agent. this indication is approved under accelerated approval based on progression free survival [see clinical studies (14.1)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. none risk summary farydak can cause fetal harm when administered to a pregnant woman. panobinostat was teratogenic in rats and rabbits. if farydak is used during pregnancy or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus. data animal data in embryofetal development studies, panobinostat was administered orally 3 times per week during the period of organogenesis to pregnant rats (30, 100, and 300 mg/kg) and rabbits (10, 40, and 80 mg/kg). i

Estados Unidos - inglês - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - cyclosporine (unii: 83hn0gtj6d) (cyclosporine - unii:83hn0gtj6d) - cyclosporine 25 mg - neoral is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. neoral has been used in combination with azathioprine and corticosteroids. neoral is indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. neoral can be used in combination with methotrexate in rheumatoid arthritis patients who do not respond adequately to methotrexate alone. neoral is indicated for the treatment of adult, nonimmunocompromised patients with severe (i.e., extensive and/or disabling), recalcitrant, plaque psoriasis who have failed to respond to at least one systemic therapy (e.g., puva, retinoids, or methotrexate) or in patients for whom other systemic therapies are contraindicated or cannot be tolerated. while rebound rarely occurs, most patients will experience relapse with neoral as with other therapies upon cessation of treatment. neoral is contraindicated in patients with a hypersensitivity to cyclosporine or to any of the ingredients of the formulation. rheumatoid arthritis patients with abnormal renal function, uncontrolled hypertension, or malignancies should not receive neoral. psoriasis patients who are treated with neoral should not receive concomitant puva or uvb therapy, methotrexate or other immunosuppressive agents, coal tar or radiation therapy. psoriasis patients with abnormal renal function, uncontrolled hypertension, or malignancies should not receive neoral. although no adequate and well-controlled studies have been completed in children, transplant recipients as young as one year of age have received neoral with no unusual adverse effects. the safety and efficacy of neoral treatment in children with juvenile rheumatoid arthritis or psoriasis below the age of 18 have not been established. in rheumatoid arthritis clinical trials with cyclosporine, 17.5% of patients were age 65 or older. these patients were more likely to develop systolic hypertension on therapy, and more likely to show serum creatinine rises ≥ 50% above the baseline after 3 to 4 months of therapy. clinical studies of neoral in transplant and psoriasis patients did not include a sufficient number of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experiences have not identified differences in response 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.

Estados Unidos - inglês - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - carbamazepine (unii: 33cm23913m) (carbamazepine - unii:33cm23913m) - carbamazepine 100 mg in 5 ml - tegretol is indicated for use as an anticonvulsant drug. evidence supporting efficacy of tegretol as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: - partial seizures with complex symptomatology (psychomotor, temporal lobe). patients with these seizures appear to show greater improvement than those with other types. - generalized tonic-clonic seizures (grand mal). - mixed seizure patterns which include the above, or other partial or generalized seizures. absence seizures (petit mal) do not appear to be controlled by tegretol (see precautions, general). tegretol is indicated in the treatment of the pain associated with true trigeminal neuralgia. beneficial results have also been reported in glossopharyngeal neuralgia. this drug is not a simple analgesic and should not be used for the relief of trivial aches or pains. tegretol should not be used in patients with a history of previous bone marrow depression, hypersensitivity to the drug,

Estados Unidos - inglês - NLM (National Library of Medicine)

nephron pharmaceuticals corporation - ipratropium bromide (unii: j697uz2a9j) (ipratropium - unii:gr88g0i6ul) - ipratropium bromide anhydrous 0.5 mg in 2.5 ml - ipratropium bromide inhalation solution administered either alone or with other bronchodilators, especially beta adrenergics, is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema. ipratropium bromide is contraindicated in known or suspected cases of hypersensitivity to ipratropium bromide, or to atropine and its derivatives.

Estados Unidos - inglês - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - pindolol (unii: bj4hf6iu1d) (pindolol - unii:bj4hf6iu1d) - tablet - 5 mg - visken® (pindolol) is indicated in the management of hypertension. it may be used alone or concomitantly with other antihypertensive agents, particularly with a thiazide-type diuretic. visken® (pindolol) is contraindicated in: 1) bronchial asthma; 2) overt cardiac failure; 3) cardiogenic shock; 4) second and third degree heart block; 5) severe bradycardia. (see warnings)

Estados Unidos - inglês - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - baclofen (unii: h789n3fke8) (baclofen - unii:h789n3fke8) - tablet - lioresal is useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. patients should have reversible spasticity so that lioresal treatment will aid in restoring residual function. lioresal may also be of some value in patients with spinal cord injuries and other spinal cord diseases. lioresal is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. the efficacy of lioresal in stroke, cerebral palsy, and parkinson’s disease has not been established and, therefore, it is not recommended for these conditions. hypersensitivity to baclofen. safety and effectiveness in pediatric patients below the age of 12 years have not been established.

Estados Unidos - inglês - NLM (National Library of Medicine)

nephron pharmaceuticals corporation - ipratropium bromide (unii: j697uz2a9j) (ipratropium - unii:gr88g0i6ul), albuterol sulfate (unii: 021sef3731) (albuterol - unii:qf8svz843e) - ipratropium bromide anhydrous 0.5 mg in 3 ml - ipratropium bromide and albuterol sulfate inhalation solution is indicated for the treatment of bronchospasm associated with copd in patients requiring more than one bronchodilator. ipratropium bromide and albuterol sulfate inhalation solution is contraindicated in patients with a history of hypersensitivity to any of its components, or to atropine and its derivatives.

Estados Unidos - inglês - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - cyclosporine (unii: 83hn0gtj6d) (cyclosporine - unii:83hn0gtj6d) - cyclosporine 25 mg - sandimmune (cyclosporine) is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. it is always to be used with adrenal corticosteroids. the drug may also be used in the treatment of chronic rejection in patients previously treated with other immunosuppressive agents. because of the risk of anaphylaxis, sandimmune injection (cyclosporine injection, usp) should be reserved for patients who are unable to take the soft gelatin capsules or oral solution. sandimmune injection (cyclosporine injection, usp) is contraindicated in patients with a hypersensitivity to sandimmune (cyclosporine) and/or cremophor® el (polyoxyethylated castor oil). although no adequate and well-controlled studies have been conducted in children, patients as young as 6 months of age have received the drug with no unusual adverse effects. clinical studies of sandimmune (cyclosporine) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger patients. 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.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - yellow fever virus, quantity: 1000 pfu e.1000 mouse ld50 - injection, powder for - excipient ingredients: calcium chloride dihydrate; magnesium sulfate heptahydrate; histidine hydrochloride; sodium chloride; dibasic sodium phosphate dihydrate; alanine; sorbitol; potassium chloride; lactose monohydrate; monobasic potassium phosphate; sodium hydroxide - prevention of yellow fever. vaccination is recommended for:,? every individual aged 9 months and over living or travelling through an endemic area with a current or periodic risk of yellow fever transmission. ? non-vaccinated individual moving from an endemic area with a current or periodic risk of yellow fever transmission to a potentially receptive non-endemic area with a current or periodic risk of yellow fever transmission. ? laboratory workers handling potentially infectious materials. in order to be officially recognised, the yellow fever vaccination must be administered in an approved vaccination centre and registered on an international certificate. the validity period of the certificate is established according to international health regulations recommendations and starts 10 days after primary vaccination and immediately after re-vaccination.