Spojené štáty - angličtina - NLM (National Library of Medicine)

bausch & lomb incorporated - timolol maleate (unii: p8y54f701r) (timolol anhydrous - unii:5jky92s7br) - timolol maleate sterile ophthalmic gel forming solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. timolol maleate ophthalmic gel forming solution is contraindicated in patients with (1) bronchial asthma; (2) a history of bronchial asthma; (3) severe chronic obstructive pulmonary disease [see warnings, obstructive pulmonary disease ]; (4) sinus bradycardia; (5) second or third degree atrioventricular block; (6) overt cardiac failure [see warnings, cardiac failure ]; (7) cardiogenic shock; or (8) hypersensitivity to any component of this product. timolol maleate ophthalmic gel forming solution 0.25% and 0.5% read this instructions for use that comes with timolol maleate ophthalmic gel forming solution before you start using it and each time you get a refill. there may be new information. this information does not take the place of talking with your doctor about your medical condition or treatment. important information about timol

Spojené štáty - angličtina - NLM (National Library of Medicine)

bausch & lomb incorporated - hyaluronidase (ovine) (unii: 64r4ohp8t0) (hyaluronidase, ovine - unii:64r4ohp8t0) - vitrase ® (hyaluronidase injection) is indicated as an adjuvant in subcutaneous fluid administration for achieving hydration. vitrase is indicated as an adjuvant to increase the dispersion and absorption of other injected drugs. vitrase is indicated as an adjuvant in subcutaneous urography for improving resorption of radiopaque agents. vitrase is contraindicated in patients with known hypersensitivity to hyaluronidase or any other ingredient in the formulation. discontinue vitrase if sensitization occurs. risk summary human studies of hyaluronidase as an aid to conception and as an aid to delivery have been conducted without reports of maternal or fetal harm. non-human animal reproduction studies have not been conducted with vitrase. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. however, the background risk in the u.s. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20%, of clinically recognized pregnancies. clinical considerations hyaluronidase has been used as a component to aid the in vitro fertilization of human eggs. administration of hyaluronidase during labor was reported to cause no complications; no increase in blood loss or differences in cervical trauma were observed. risk summary there is no information regarding the presence of vitrase in human milk, the effects on breastfed infants, or the effects on milk production to inform risk of vitrase to an infant during lactation. the developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for vitrase, and any potential adverse effects on the breastfed infant from vitrase. the safety and effectiveness of vitrase have been established in pediatric patients. use of vitrase in these patients is supported by evidence from adequate and well-controlled studies. clinical hydration requirements for children can be achieved through administration of subcutaneous fluids facilitated with vitrase. the dosage of subcutaneous fluids administered is dependent upon the age, weight, and clinical condition of the patient as well as laboratory determinations. the potential for chemical or physical incompatibilities should be kept in mind        [ see drug interactions (7)] . the rate and volume of subcutaneous fluid administration should not exceed those employed for intravenous infusion. for premature infants or during the neonatal period, the daily dosage should not exceed 25 ml/kg of body weight, and the rate of administration should not be greater than 2 ml per minute. during subcutaneous fluid administration, special care must be taken in pediatric patients to avoid overhydration by controlling the rate and total volume of the infusion [see dosage and administration (2.2)] . no overall differences in safety or effectiveness have been observed between elderly and younger adult patients.

Spojené štáty - angličtina - NLM (National Library of Medicine)

bausch & lomb incorporated - latanoprostene bunod (unii: i6393o0922) (latanoprost acid - unii:ej85341990) - vyzulta ® (latanoprostene bunod ophthalmic solution) 0.024% is indicated for the reduction of intraocular pressure (iop) in patients with open-angle glaucoma or ocular hypertension. none. risk summary there are no available human data for the use of vyzulta during pregnancy to inform any drug associated risks. latanoprostene bunod has caused miscarriages, abortion, and fetal harm in rabbits. latanoprostene bunod was shown to be abortifacient and teratogenic when administered intravenously (iv) to pregnant rabbits at exposures ≥ 0.28 times the clinical dose. doses ≥ 20 mcg/kg/day (23 times the clinical dose) produced 100% embryofetal lethality. structural abnormalities observed in rabbit fetuses included anomalies of the great vessels and aortic arch vessels, domed head, sternebral and vertebral skeletal anomalies, limb hyperextension and malrotation, abdominal distension and edema. latanoprostene bunod was not teratogenic in the rat when administered iv at 150 mcg/kg/day (87 times the clinical dose) [see data] . the background risk of major birth defects and miscarriage for the indicated population is unknown. however, the background risk in the u.s. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20%, of clinically recognized pregnancies. data animal data embryofetal studies were conducted in pregnant rabbits administered latanoprostene bunod daily by intravenous injection on gestation days 7 through 19, to target the period of organogenesis. the doses administered ranged from 0.24 to 80 mcg/kg/day. abortion occurred at doses ≥ 0.24 mcg/kg/day latanoprostene bunod (0.28 times the clinical dose, on a body surface area basis, assuming 100% absorption). embryofetal lethality (resorption) was increased in latanoprostene bunod treatment groups, as evidenced by increases in early resorptions at doses ≥ 0.24 mcg/kg/day and late resorptions at doses ≥ 6 mcg/kg/day (approximately 7 times the clinical dose). no fetuses survived in any rabbit pregnancy at doses of 20 mcg/kg/day (23 times the clinical dose) or greater. latanoprostene bunod produced structural abnormalities at doses ≥ 0.24 mcg/kg/day (0.28 times the clinical dose). malformations included anomalies of sternum, coarctation of the aorta with pulmonary trunk dilation, retroesophageal subclavian artery with absent brachiocephalic artery, domed head, forepaw hyperextension and hindlimb malrotation, abdominal distention/edema, and missing/fused caudal vertebrae. an embryofetal study was conducted in pregnant rats administered latanoprostene bunod daily by intravenous injection on gestation days 7 through 17, to target the period of organogenesis. the doses administered ranged from 150 to 1500 mcg/kg/day. maternal toxicity was produced at 1500 mcg/kg/day (870 times the clinical dose, on a body surface area basis, assuming 100% absorption), as evidenced by reduced maternal weight gain. embryofetal lethality (resorption and fetal death) and structural anomalies were produced at doses ≥ 300 mcg/kg/day (174 times the clinical dose). malformations included anomalies of the sternum, domed head, forepaw hyperextension and hindlimb malrotation, vertebral anomalies and delayed ossification of distal limb bones. a no observed adverse effect level (noael) was established at 150 mcg/kg/day (87 times the clinical dose) in this study. risk summary there are no data on the presence of vyzulta in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for vyzulta, and any potential adverse effects on the breastfed infant from vyzulta. use in pediatric patients aged 16 years and younger is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use. no overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients.

Spojené štáty - angličtina - NLM (National Library of Medicine)

insmed incorporated - amikacin (unii: 84319sgc3c) (amikacin - unii:84319sgc3c) - limited population: arikayce® is indicated in adults, who have limited or no alternative treatment options, for the treatment of mycobacterium avium complex (mac) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. as only limited clinical safety and effectiveness data for arikayce are currently available, reserve arikayce for use in adults who have limited or no alternative treatment options. this drug is indicated for use in a limited and specific population of patients. this indication is approved under accelerated approval based on achieving sputum culture conversion (defined as 3 consecutive negative monthly sputum cultures) by month 6. clinical benefit has not yet been established [see clinical studies (14)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. limitati

Spojené štáty - angličtina - NLM (National Library of Medicine)

versapharm incorporated - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - fluocinolone acetonide topical oil, 0.01% is indicated for the topical treatment of atopic dermatitis in adult patients. fluocinolone acetonide topical oil, 0.01% is indicated for the topical treatment of moderate to severe atopic dermatitis in pediatric patients, 3 months and older for up to 4 weeks. safety and effectiveness in pediatric patients younger than 3 months of age have not been established. apply the least amount of fluocinolone acetonide topical oil, 0.01% needed to cover the affected areas. as with other corticosteroids, fluocinolone acetonide topical oil, 0.01% should be discontinued when control of disease is achieved. contact the physician if no improvement is seen within 2 weeks. fluocinolone acetonide topical oil, 0.01% should not be applied to the diaper area; diapers or plastic pants may constitute occlusive use. fluocinolone acetonide topical oil, 0.01% should not be used on the face, axillae, or groin unless directed by the physician.  application to intertriginous areas should be avoid

Spojené štáty - angličtina - NLM (National Library of Medicine)

calvin, scott and company, incorporated - diethylpropion hydrochloride (unii: 19v2pl39ng) (diethylpropion - unii:q94yyu22b8) - diethylpropion hydrochloride extended release tablets, 75 mg are indicated in the management of exogenous obesity as a short-term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (bmi) of 30 kg/m2 or higher and who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. below is a chart of bmi based on various heights and weights. bmi is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. metric conversions are as follows: pounds divided by 2.2 = kg; inches x 0.0254 = meters. body mass index (bmi), kg/m2 weight (pounds) height (feet, inches) 5’0” 5’3” 5’6” 5’9” 6’0” 6’3” 140 27 25 23 21 19 18 150 29 27 24 22 20 19 160 31 28 26 24 22 20 170 33 30 28 25 23 21 180 35 32 29 27 25 23 190 37 34 31 28 26 24 200 39 36 32 30 27 25 210 41 37 34 31 29 26 220 43 39 36 33 30 28 230 45 41 37 34 31 29 240 47 43 39 36 33 30 250 49 44 40 37 34 31 th

Austrália - angličtina - APVMA (Australian Pesticides and Veterinary Medicines Authority)

titan ag pty ltd - 2,4-d present as isopropylamine and dimethylamine salts; polyethanoxy (15) tallow amine - soluble concentrate - 2,4-d present as isopropylamine and dimethylamine salts phenoxy acids-2,4d active 720.0 g/l; polyethanoxy (15) tallow amine emulsifiers & surfactants other 20.0 g/l - herbicide

Austrália - angličtina - APVMA (Australian Pesticides and Veterinary Medicines Authority)

titan ag pty ltd - 2,4-d present as the dimethylamine and diethanolamine sa - soluble concentrate - 2,4-d present as the dimethylamine and diethanolamine sa phenoxy acids-2,4-d active 700.0 g/l - herbicide

Spojené štáty - angličtina - NLM (National Library of Medicine)

bausch & lomb incorporated - timolol maleate (unii: p8y54f701r) (timolol anhydrous - unii:5jky92s7br) - preservative-free timolol maleate ophthalmic solution in ocudose is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. preservative-free timolol maleate ophthalmic solution in ocudose may be used when a patient is sensitive to the preservative in timolol maleate ophthalmic solution, benzalkonium chloride, or when use of a preservative-free topical medication is advisable. preservative-free timolol maleate ophthalmic solution in ocudose is contraindicated in patients with (1) bronchial asthma; (2) a history of bronchial asthma; (3) severe chronic obstructive pulmonary disease (see warnings); (4) sinus bradycardia; (5) second or third degree atrioventricular block; (6) overt cardiac failure (see warnings); (7) cardiogenic shock; or (8) hypersensitivity to any component of this product.

Kanada - angličtina - Health Canada

vertex pharmaceuticals (canada) incorporated - tezacaftor; ivacaftor; ivacaftor; elexacaftor - tablet - 50mg; 75mg; 150mg; 100mg - tezacaftor 50mg; ivacaftor 75mg; ivacaftor 150mg; elexacaftor 100mg - cystic fibrosis transmembrane conductance regulator correctors