Yhdysvallat - englanti - NLM (National Library of Medicine)

par pharmaceutical, inc. - methimazole (unii: 554z48xn5e) (methimazole - unii:554z48xn5e) - methimazole 5 mg - methimazole is indicated: - in patients with graves’ disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option - to ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy methimazole is contraindicated in the presence of hypersensitivity to the drug or any of the other product components.

Yhdysvallat - englanti - NLM (National Library of Medicine)

par pharmaceutical, inc. - tramadol hydrochloride (unii: 9n7r477wck) (tramadol - unii:39j1lgj30j), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - tramadol hydrochloride 37.5 mg - tramadol hydrochloride and acetaminophen tablets are indicated for the management of acute pain severe enough to require an opiod analgesic and for which alternative treatments are inadequate. l imitations of use tramadol hydrochloride and acetaminophen tablets are indicated for short-tern use of five days or less. because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see warnings and precautions (5.1)] , reserve tramadol hydrochloride and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: - have not been tolerated, or are not expected to be tolerated, - have not provided adequate analgesia, or are not expected to provide adequate analgesia. tramadol hydrochloride and acetaminophen tablets are contraindicated for: - all children younger than 12 years of age [see warnings and precautions (5.3)] - post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see

Yhdysvallat - englanti - NLM (National Library of Medicine)

servier pharmaceuticals llc - pegaspargase (unii: 7d96ir0ppm) (pegaspargase - unii:7d96ir0ppm) - oncaspar® is indicated as a component of a multi-agent chemotherapeutic regimen for the first-line treatment of pediatric and adult patients with all. oncaspar is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of pediatric and adult patients with all and hypersensitivity to native forms of l-asparaginase. oncaspar is contraindicated in patients with a: - history of serious hypersensitivity reactions, including anaphylaxis, to oncaspar or to any of the excipients [see warnings and precautions (5.1)] . - history of serious thrombosis with prior l-asparaginase therapy [see warnings and precautions (5.2)] . - history of pancreatitis, including pancreatitis related to prior l-asparaginase therapy [see warnings and precautions (5.3)] . - history of serious hemorrhagic events with prior l-asparaginase therapy [see warnings and precautions (5.5)] . - severe hepatic impairment [see warnings and precautions (5.6)] . risk summary based on published literature studies with l-asparaginase in pregnant animals, oncaspar can cause fetal harm when administered to a pregnant woman. there are no available data on oncaspar use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. published literature studies in pregnant animals suggest asparagine depletion may cause harm to the animal offspring (see data) . advise pregnant women of the potential risk to a fetus. in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively. data animal data animal reproduction studies have not been conducted with oncaspar to evaluate its effect on reproduction and fetal development. published literature studies in which pregnant rabbits were administered l-asparaginase or pregnant rats were deprived of dietary asparagine suggested harm to the animal offspring. risk summary there are no data on the presence of pegaspargase in human milk, the effects on the breastfed child, or the effects on milk production. because of the potential for adverse reactions in the breastfed child, advise women not to breastfeed during treatment with oncaspar and for 1 month after the last dose. oncaspar can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy pregnancy testing is recommended in females of reproductive potential prior to initiating oncaspar. contraception advise females of reproductive potential to use effective non-hormonal contraceptive methods during treatment with oncaspar and for 3 months after the last dose. the safety and effectiveness of oncaspar in the treatment of all have been established in pediatric patients. use of oncaspar in these age groups is supported by evidence of efficacy as first-line treatment from one adequate and well-controlled trial, and evidence of efficacy for treatment of patients with hypersensitivity to asparaginase from four adequate and well-controlled trials [see clinical studies (14.1)] , and safety data from 7 total trials. the pediatric patients treated with oncaspar 2,500 international units/m2 on these trials included 26 infants (1 month to <2 years old), 165 children (2 years to <12 years old), and 39 adolescents (12 to 17 years old). clinical studies of oncaspar did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects.

Yhdysvallat - englanti - NLM (National Library of Medicine)

par pharmaceutical inc. - nystatin (unii: bdf1o1c72e) (nystatin - unii:bdf1o1c72e) - powder - 100000 in 1 g - nystatin topical powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by candida albicans and other susceptible candida species. this topical powder is not indicated for systemic, oral, intravaginal or ophthalmic use. nystatin topical powder is contraindicated in patients with a history of hypersensitivity to any of its components.

Yhdysvallat - englanti - NLM (National Library of Medicine)

navidea biopharmaceuticals, inc. - technetium tc-99m tilmanocept (unii: 8ihi69pqtc) (technetium tc-99m tilmanocept - unii:8ihi69pqtc) - tilmanocept 250 ug - lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for: - lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management. - guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma. none. pregnancy category c there are no adequate or well-controlled studies of lymphoseek in pregnant women. additionally, animal reproduction studies have not been conducted with technetium tc 99m tilmanocept. however, all radiopharmaceuticals, including lymphoseek, have a potential to cause fetal harm. lymphoseek should be given to a pregnant woman only if the potential benefit justifies the potential risk to the fetus. it is not known whether technetium tc 99m tilmanocept is present in human milk.  based on the half-life of technetiu

Yhdysvallat - englanti - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - bacitracin zinc (unii: 89y4m234es) (bacitracin - unii:58h6rwo52i), polymyxin b sulfate (unii: 19371312d4) (polymyxin b - unii:j2vz07j96k) - this product is contraindicated in those individuals who have shown hypersensitivity to any of its components.

Yhdysvallat - englanti - NLM (National Library of Medicine)

ferring pharmaceuticals inc. - progesterone (unii: 4g7ds2q64y) (progesterone - unii:4g7ds2q64y) - milprosa™ is indicated to support embryo implantation and early pregnancy (up to 10 weeks post-embryo transfer) by supplementation of corpus luteal function as part of an assisted reproductive technology (art) treatment program for infertile women up to and including 34 years of age. limitation of use efficacy in women 35 years of age and older has not been established. milprosa is contraindicated in women with: - known sensitivity to progesterone or any of the ingredients of milprosa [see description (11)] - undiagnosed vaginal bleeding - severe hepatic impairment or disease - known or suspected malignancy of the breast - active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events risk summary milprosa is indicated to support embryo implantation and early pregnancy as part of an assisted reproductive technology treatment program in vitro fertilization (ivf) with or without intracytoplasmic sperm injection (icsi) and embryo transfer for infertile women. maternal risks a

Kanada - englanti - Health Canada

fresenius kabi canada ltd - zinc (zinc sulfate) - solution - 1mg - zinc (zinc sulfate) 1mg

Kanada - englanti - Health Canada

fresenius kabi canada ltd - zinc (zinc sulfate) - solution - 5mg - zinc (zinc sulfate) 5mg

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

servier laboratories (aust) pty ltd - pegaspargase, quantity: 750 u/ml - solution, powder for - excipient ingredients: sucrose; dibasic sodium phosphate; monobasic sodium phosphate; sodium chloride; sodium hydroxide; hydrochloric acid - oncaspar is indicated as a component of antineoplastic combination therapy in patients with acute lymphoblastic leukaemia (all).