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

organon llc - follitropin (unii: 076whw89tw) (follitropin - unii:076whw89tw) - follistim® aq cartridge (follitropin beta) injection, is indicated: in women for: prior to initiation of treatment with follistim aq cartridge: - women should have a complete gynecologic and endocrinologic evaluation. - primary ovarian failure should be excluded. - the possibility of pregnancy should be excluded. - tubal patency should be demonstrated. - the fertility status of the male partner should be evaluated. prior to initiation of treatment with follistim aq cartridge: - women should have a complete gynecologic and endocrinologic evaluation and diagnosis of cause of infertility. - the possibility of pregnancy should be excluded. - the fertility status of the male partner should be evaluated. in men for: prior to initiation of treatment with follistim aq cartridge: - men should have a complete medical and endocrinologic evaluation. - hypogonadotropic hypogonadism should be confirmed and primary testicular failure should be excluded. - serum testosterone levels should be normalized with human chorionic gonadotropin (hcg) treatment. - the fertility status of the female partner should be evaluated. follistim aq cartridge is contraindicated in women and men who exhibit: - prior hypersensitivity to recombinant hfsh products - high levels of fsh indicating primary gonadal failure - presence of uncontrolled non-gonadal endocrinopathies (e.g., thyroid, adrenal, or pituitary disorders) [see indications and usage (1.1, 1.2, 1.3)] - hypersensitivity reactions to streptomycin or neomycin. follistim aq may contain traces of these antibiotics - tumors of the ovary, breast, uterus, testis, hypothalamus or pituitary gland follistim aq cartridge is also contraindicated in women who exhibit: - pregnancy [see use in specific populations (8.1)] - heavy or irregular vaginal bleeding of undetermined origin - ovarian cysts or enlargement not due to polycystic ovary syndrome (pcos) risk summary follistim aq cartridge is contraindicated for use in pregnant women and offers no benefit during pregnancy. risk summary it is not known whether this drug is excreted in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for follistim aq cartridge and any potential adverse effects on the breastfed child from follistim aq cartridge or from the underlying maternal condition. follistim aq cartridge is not indicated for use in pediatric patients. clinical studies have not been conducted in the pediatric population. clinical studies of follistim aq cartridge have not been conducted in patients 65 years of age and older.

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

rebel distributors corp - mycophenolate mofetil (unii: 9242ecw6r0) (mycophenolic acid - unii:hu9dx48n0t) - mycophenolate mofetil 250 mg - cellcept is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. cellcept should be used concomitantly with cyclosporine and corticosteroids. cellcept intravenous is an alternative dosage form to cellcept capsules, tablets and oral suspension. cellcept intravenous should be administered within 24 hours following transplantation. cellcept intravenous can be administered for up to 14 days; patients should be switched to oral cellcept as soon as they can tolerate oral medication. allergic reactions to cellcept have been observed; therefore, cellcept is contraindicated in patients with a hypersensitivity to mycophenolate mofetil, mycophenolic acid or any component of the drug product. cellcept intravenous is contraindicated in patients who are allergic to polysorbate 80 (tween).

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

grifols usa, llc - .alpha.1-proteinase inhibitor human (unii: f43i396ois) (.alpha.1-proteinase inhibitor human - unii:f43i396ois) - .alpha.1-proteinase inhibitor human 1000 mg in 20 ml - prolastin® -c liquid is an alpha1 -proteinase inhibitor (human) (alpha1 -pi) indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe hereditary deficiency of alpha1 -pi (alpha1 -antitrypsin deficiency). limitations of use - the effect of augmentation therapy with any alpha1 -pi, including prolastin-c liquid, on pulmonary exacerbations and on the progression of emphysema in alpha1 -pi deficiency has not been conclusively demonstrated in randomized, controlled clinical trials.    - clinical data demonstrating the long-term effects of chronic augmentation or maintenance therapy with prolastin-c liquid are not available. - prolastin-c liquid is not indicated as therapy for lung disease in patients in whom severe alpha1 -pi deficiency has not been established. prolastin-c liquid is contraindicated in: - iga deficient patients with antibodies against iga, due to the risk of severe hypersensitivity. - patients with a history of anaphylaxis or other sever

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - mycophenolate mofetil 200 mg/ml;   - powder for oral suspension - 200 mg/ml - active: mycophenolate mofetil 200 mg/ml   excipient: aspartame citric acid colloidal silicon dioxide fruit mix flavour 274869 lecithin methyl hydroxybenzoate sodium citrate dihydrate sorbitol xanthan gum - cellcept is indicated for the prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants. cellcept is indicated for the prophylaxis of organ rejection in paediatric patients (2 to 18 years) receiving allogeneic renal transplants.

Australia - English - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - mycophenolate mofetil, quantity: 200 mg/ml - suspension - excipient ingredients: citric acid; xanthan gum; aspartame; methyl hydroxybenzoate; purified water; silicon dioxide; sorbitol; lecithin; sodium citrate dihydrate; flavour - cellcept is indicated for the prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants. cellcept is indicated for the prophylaxis of organ rejection in paediatric patients (2 to 18 years) receiving allogeneic renal transplants.

Australia - English - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - mycophenolate mofetil, quantity: 500 mg - injection, powder for - excipient ingredients: polysorbate 80; sodium hydroxide; citric acid; hydrochloric acid - cellcept is indicated for the prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants. cellcept is indicated for the prophylaxis of organ rejection in paediatric patients (2 to 18 years) receiving allogeneic renal transplants.

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

sti pharma llc - arsenic trioxide (unii: s7v92p67ho) (arsenic cation (3+) - unii:c96613f5av) - arsenic trioxide injection is indicated for induction of remission and consolidation in patients with apl who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose apl is characterized by the presence of the t(15;17) translocation or pml/rar-alpha gene expression. arsenic trioxide for injection is contraindicated in patients who are hypersensitive to arsenic. risk summary based on the mechanism of action [see clinical pharmacology ( 12.1) ] and findings in animal studies, arsenic trioxide injection can cause fetal harm when administered to a pregnant woman. arsenic trioxide was embryolethal and teratogenic in rats when administered on gestation day 9 at a dose approximately 10 times the recommended human daily dose on a mg/m 2 basis ( see data ). a related trivalent arsenic, sodium arsenite, produced teratogenicity when

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

sti pharma llc - thiotepa (unii: 905z5w3gkh) (thiotepa - unii:905z5w3gkh) - thiotepa for injection, usp has been tried with varying results in the palliation of a wide variety of neoplastic diseases. however, the most consistent results have been seen in the following tumors: 1. adenocarcinoma of the breast. 2. adenocarcinoma of the ovary. 3. for controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities. 4. for the treatment of superficial papillary carcinoma of the urinary bladder. while now largely superseded by other treatments, thiotepa has been effective against other lymphomas, such as lymphosarcoma and hodgkin's disease. thiotepa is contraindicated in patients with a known hypersensitivity (allergy) to this preparation. therapy is probably contraindicated in cases of existing hepatic, renal, or bone-marrow damage. however, if the need outweighs the risk in such patients, thiotepa may be used in low dosage, and a

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

sti pharma - ethambutol hydrochloride (unii: qe4vw5fo07) (ethambutol - unii:8g167061qz) - ethambutol hydrochloride 400 mg - ethambutol hci is indicated for the treatment of pulmonary tuberculosis. it should not be used as the sole antituberculous drug, but should be used in conjunction with at least one other antituberculous drug. selection of the companion drug should be based on clinical experience, considerations of comparative safety, and appropriate in vitro susceptibility studies. in patients who have not received previous antituberculous therapy, ie, initial treatment, the most frequently used regimens have been the following: in patients who have received previous antituberculous therapy, mycobacterial resistance to other drugs used in initial therapy is frequent. consequently, in such retreatment patients, ethambutol hci should be combined with at least one of the second line drugs not previously administered to the patient and to which bacterial susceptibility has been indicated by appropriate in vitro studies. antituberculous drugs used with ethambutol hci have included cycloserine, ethionamide, pyrazinamide, viomycin a

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

sti pharma llc - carmustine (unii: u68wg3173y) (carmustine - unii:u68wg3173y) - carmustine for injection is indicated as palliative therapy as a single agent or in established combination therapy in the following: - brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors. - multiple myeloma in combination with prednisone. - relapsed or refractory hodgkin's lymphoma in combination with other approved drugs. - relapsed or refractory non-hodgkin's lymphomas in combination with other approved drugs. carmustine for injection is contraindicated in patients with previous hypersensitivity to carmustine or its components. risk summary carmustine for injection can cause fetal harm when administered to a pregnant woman based on the mechanism of action [ see clinical pharmacology (12.1) ] and findings in animals [see data] . limited available data with carmustine for injection use in pregnant women ar