Israel - English - Ministry of Health

eldan electronic instruments co ltd, israel - sodium iodide (131 i) - hard capsule - sodium iodide (131 i) 37 - 5550 mbq - sodium iodide (131i) - sodium iodide (131i) - theracap 131 is a radioiodine thyroid therapy indicated for:1.treatment of grave's disease, toxic multinodular goitre or autonomous nodules.2.treatmernt of papilary and follicular thyroid carcinoma including metastastic desease.

United States - English - NLM (National Library of Medicine)

jubilant draximage inc., dba jubilant radiopharma - sodium iodide i-131 (unii: 29vco8achh) (iodide ion i-131 - unii:4gc1foq22u) - iodide ion i-131 100 mci - sodium iodide i 131 capsules diagnostic is indicated for use in adults for: - assessment of thyroid function using radioactive iodine (rai) uptake test - imaging the thyroid (scintigraphy) sodium iodide i 131 capsules diagnostic is contraindicated in pregnancy [see warnings and precautions (5.1) , use in specific populations (8.1) ]. risk summary sodium iodide i 131 capsules diagnostic is contraindicated in pregnancy because fetal exposure can lead to neonatal hypothyroidism, which in some cases is severe and irreversible. data from the published literature describe reports of neonatal thyroid abnormalities after fetal exposure, including agenesis of the thyroid and hypothyroidism (see clinical considerations, data ). no animal reproductive studies have been conducted. 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 pregnanc

United States - English - NLM (National Library of Medicine)

international isotopes inc - sodium iodide i-131 (unii: 29vco8achh) (iodide ion i-131 - unii:4gc1foq22u) - iodide ion i-131 3500 mci in 1 ml - sodium iodide i-131 is indicated for the treatment of hyperthyroidism and selected cases of thyroid carcinoma. sodium iodide i-131 is contraindicated in: - patients with vomiting and diarrhea [see warning and precautions (5.7)] . - pregnancy [see warnings and precautions (5.4), see use in specific populations (8.1)] . - lactation [see warnings and precautions (5.5)] . - patients receiving concurrent anti-thyroid therapy [see warning and precautions (5.1) and drug interactions (7)] . risk summary sodium iodide i-131 is contraindicated in pregnancy because fetal exposure can lead to neonatal hypothyroidism, which in some cases is severe and irreversible. data from the published literature describe thyroid abnormalities after fetal exposure; including agene

United States - English - NLM (National Library of Medicine)

sandoz inc - betaxolol hydrochloride (unii: 6x97d2xt0o) (betaxolol - unii:o0zr1r6rz2) - betaxolol hydrochloride 5.6 mg in 1 ml - betaxolol hydrochloride ophthalmic solution has been shown to be effective in lowering intraocular pressure and is indicated in the treatment of ocular hypertension and chronic open-angle glaucoma. it may be used alone or in combination with other anti-glaucoma drugs. in clinical studies, betaxolol hydrochloride ophthalmic solution was safely used to lower intraocular pressure in 47 patients with both glaucoma and reactive airway disease who were followed for a mean period of 15 months. however, caution should be used in treating patients with severe reactive airway disease or a history of asthma. hypersensitivity to any component of this product. betaxolol hydrochloride ophthalmic solution is contraindicated in patients with sinus bradycardia, greater than a first degree atrioventricular block, cardiogenic shock, or patients with overt cardiac failure. safety and effectiveness in pediatric patients have not been established. no overall differences in safety or effectiveness have been observed between elderly

United States - English - NLM (National Library of Medicine)

sandoz inc - olopatadine hydrochloride (unii: 2xg66w44kf) (olopatadine - unii:d27v6190pm) - olopatadine hydrochloride ophthalmic solution 0.1% is indicated for the treatment of the signs and symptoms of allergic conjunctivitis. olopatadine hydrochloride ophthalmic solution 0.1% is contraindicated in persons with a known hypersensitivity to olopatadine hydrochloride or any components of olopatadine hydrochloride ophthalmic solution 0.1%.

United States - English - NLM (National Library of Medicine)

sandoz inc - olopatadine hydrochloride (unii: 2xg66w44kf) (olopatadine - unii:d27v6190pm) - olopatadine hydrochloride ophthalmic solution, 0.2% is indicated for the treatment of ocular itching associated with allergic conjunctivitis. none. teratogenic effects: pregnancy category c olopatadine was found not to be teratogenic in rats and rabbits. however, rats treated at 600 mg/kg/day, or 150,000 times the mrohd and rabbits treated at 400 mg/kg/day, or approximately 100,000 times the mrohd, during organogenesis showed a decrease in live fetuses. in addition, rats treated with 600 mg/kg/day of olopatadine during organogenesis showed a decrease in fetal weight. further, rats treated with 600 mg/kg/day of olopatadine during late gestation through the lactation period showed a decrease in neonatal survival and body weight. there are, however, no adequate and well- controlled studies in pregnant women. because animal studies are not always predictive of human responses, this drug should be used in pregnant women only if the potential benefit to the mother justifies the potential risk to the embryo or fetus

United States - English - NLM (National Library of Medicine)

iso-tex diagnostics, inc. - human serum albumin i-131 (unii: ach35131l1) (human serum albumin i-131 - unii:ach35131l1) - iodinated i-131 serum albumin 0.025 mci in 1 ml - volumex (iodinated i 131 allbumin injection) is indicated for use in determinations of total blood and plasma volumes and in protein turnover studies none known.

United States - English - NLM (National Library of Medicine)

anazaohealth corporation - sodium iodide i-131 (unii: 29vco8achh) (iodide i-131 - unii:i5x6l61hut) - sodium iodide i-131 500 mci - radioiodine is excreted in human milk during lactation; breast feeding must be substituted during and following dose administration. sodium iodide 131 is not usually used for treatment of hyperthyroidism in patients under 30 years of age.  reactions to administration are rare; however potential side effects such as radiation sickness and bone marrow depression, acute leukemia, anemia, chromosomal abnormalities, acute thyroid crisis, blood dyscrasia, leukopenia, thrombocytopenia, and death represent potential side effects.

United States - English - NLM (National Library of Medicine)

sandoz inc. - filgrastim (unii: pvi5m0m1gw) (filgrastim - unii:pvi5m0m1gw) - filgrastim, license holder unspecified 300 ug in 0.5 ml - zarxio is indicated to decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever [see clinical studies ( 14.1 )] . zarxio is indicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (aml) [see clinical studies ( 14.2)] . zarxio is indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation [see clinical studies (14.3)]. zarxio is indicated for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis [see clinical studies (14.4)] . zarxio is indicated for chronic administration t

United States - English - NLM (National Library of Medicine)

sandoz inc - azelastine hydrochloride (unii: 0l591qr10i) (azelastine - unii:zqi909440x) - azelastine hydrochloride ophthalmic solution, 0.05% is indicated for the treatment of itching of the eye associated with allergic conjunctivitis. azelastine hydrochloride ophthalmic solution, 0.05% is contraindicated in persons with known or suspected hypersensitivity to any of its components.