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

professional complementary health formulas - sinus 12x - for the temporary relief of mild headache, nasal congestion, facial tenderness, minor pressure or pain in sinuses or ear(s), cough, or minor sore throat.* *claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated.

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

ironwood pharmaceuticals, inc. - lesinurad (unii: 09erp08i3w) (lesinurad - unii:09erp08i3w), allopurinol (unii: 63cz7gjn5i) (allopurinol - unii:63cz7gjn5i) - lesinurad 200 mg - duzallo®, a combination of lesinurad, a uric acid transporter 1 (urat1) inhibitor, and allopurinol, a xanthine oxidase inhibitor, is indicated for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a medically appropriate daily dose of allopurinol alone [see clinical studies (14) ]. duzallo is not recommended for the treatment of asymptomatic hyperuricemia. the use of duzallo is contraindicated in the following conditions: - severe renal impairment (eclcr less than 30 ml/min), end-stage renal disease, kidney transplant recipients, or patients on dialysis [see use in specific populations (8.6) ]. - tumor lysis syndrome or lesch-nyhan syndrome [see use in specific populations (8.8) ]. - known hypersensitivity to allopurinol, including previous occurrence of skin rash [see warnings and precautions (5.2) ]. risk summary there are no available human data on use of duzallo or lesinurad in pregnant women to inform a drug-associated risk of adverse

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

ironwood pharmaceuticals, inc. - lesinurad (unii: 09erp08i3w) (lesinurad - unii:09erp08i3w) - lesinurad 200 mg - zurampic is indicated in combination with a xanthine oxidase inhibitor for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a xanthine oxidase inhibitor alone [see clinical studies (14) ]. zurampic is not recommended for the treatment of asymptomatic hyperuricemia. zurampic should not be used as monotherapy [see warnings and precautions (5.1) ]. the use of zurampic is contraindicated in the following conditions: - severe renal impairment (eclcr less than 30 ml/min), end stage renal disease, kidney transplant recipients, or patients on dialysis [see use in specific populations (8.6) ] - tumor lysis syndrome or lesch-nyhan syndrome [see use in specific populations (8.8) ]. risk summary there are no available human data on use of zurampic in pregnant women to inform a drug-associated risk. no teratogenicity or effects on fetal development were observed in embryo-fetal development studies with oral administration of lesinurad to pregnant rats

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

biogen - nusinersen (unii: 5z9sp3x666) (nusinersen - unii:5z9sp3x666) - nusinersen 2.4 mg in 1 ml - spinraza is indicated for the treatment of spinal muscular atrophy (sma) in pediatric and adult patients. none. risk summary there are no adequate data on the developmental risk associated with the use of spinraza in pregnant women. when nusinersen was administered by subcutaneous injection to mice throughout pregnancy and lactation, developmental toxicity (long-term neurobehavioral impairment) was observed at all doses tested (see data). in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data when nusinersen (0, 3, 10, or 25 mg/kg) was administered subcutaneously to male and female mice every other day prior to and during mating and continuing in females throughout organogenesis, no adverse effects on embryofetal development were observed. subcutaneous administration of nusinersen (0, 6, 12.6, or 25 mg/kg) to pregnant rabbits every other day throughout organogenesis produced no evidence of embryofetal developmental toxicity. when nusinersen (1.4, 5.8, or 17.2 mg/kg) was administered to pregnant female mice by subcutaneous injection every other day throughout organogenesis and continuing once every six days throughout the lactation period, adverse neurobehavioral effects (alterations in locomotor activity, learning and memory deficits) were observed when offspring were tested after weaning or as adults. a no-effect level for neurobehavioral impairment was not established. risk summary there are no data on the presence of nusinersen in human milk, the effects on the breastfed infant, or the effects of the drug on milk production.nusinersen was detected in the milk of lactating mice when administered by subcutaneous injection. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for spinraza and any potential adverse effects on the breastfed infant from spinraza or from the underlying maternal condition. the safety and effectiveness of spinraza in pediatric patients from newborn to 17 years have been established [see clinical studies (14.1)]. juvenile animal toxicity data in intrathecal toxicity studies in juvenile monkeys, administration of nusinersen (0, 0.3, 1, or 3 mg/dose for 14 weeks and 0, 0.3, 1, or 4 mg/dose for 53 weeks) resulted in brain histopathology (neuronal vacuolation and necrosis/cellular debris in the hippocampus) at the mid and high doses and acute, transient deficits in lower spinal reflexes at the high dose in each study. in addition, possible neurobehavioral deficits were observed on a learning and memory test at the high dose in the 53-week monkey study. the no-effect dose for neurohistopathology in monkeys (0.3 mg/dose) is approximately equivalent to the human dose when calculated on a yearly basis and corrected for the species difference in csf volume. clinical studies of spinraza did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

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

link medical products pty ltd t/a link pharmaceuticals - argipressin, quantity: 1 mg - injection, solution - excipient ingredients: water for injections; acetic acid - pitressin is used in the prevention and treatment of postoperative abdominal distension; in abdominal radiography to dispel interfering gas shadows and in diabetes insipidus.

Malta - English - Medicines Authority

mercury pharmaceuticals limited capital house, 85 king william street, london ec4n 7bl, united kingdom - argipressin - solution for injection - argipressin 20 iu/ml - pituitary and hypothalamic hormones and analogues

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

pharmgate animal health llc - tylvalosin tartrate (unii: al5667fy0w) (tylvalosin - unii:9t02s42wqo) - tylvalosin 62.5 g in 100 g - control of porcine proliferative enteropathy (ppe) associated with lawsonia intracellularis infection in groups of swine in buildings experiencing an outbreak of ppe. control of swine respiratory disease (srd) associated with bordetella bronchiseptica, haemophilus parasuis, pasteurella multocida, streptococcus suis, and mycoplasma hyopneumoniae in groups of swine intended for slaughter in buildings experiencing an outbreak of srd. not for use in humans. keep out of reach of children. may cause skin irritation. tylvalosin tartrate has been shown to cause hypersensitivity reactions in laboratory animals. people with known hypersensitivity to tylvalosin tartrate should avoid contact with this product. in case of accidental ingestion, seek medical advice. when handling aivlosin® water soluble granules and preparing medicated drinking water, avoid direct contact with the eyes and skin. wear a dust mask, coveralls and impervious gloves when mixing and handling this product. eye protection is recommended. in

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

advanz pharma - argipressin - solution for injection - 20unit/1ml

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

astrazeneca pharmaceuticals lp - lesinurad (unii: 09erp08i3w) (lesinurad - unii:09erp08i3w) - lesinurad 200 mg

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

pharmgate animal health - tylvalosin (unii: 9t02s42wqo) (tylvalosin - unii:9t02s42wqo) - tylvalosin 170 g in 1 kg - indication: swine: control of porcine proliferative enteropathy (ppe) associated with lawsonia intracellularis infection in groups of swine in buildings experiencing an outbreak of ppe.