Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

dechra regulatory b.v. - sulfadiazine 15 g; trimethoprim 3 g - oral paste - 333 mg/g - 67 mg/g - trimethoprim 66.7 mg/g; sulfadiazine 333.3 mg/g - sulfadiazine and trimethoprim - horse

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

aurobindo pharma limited - albuterol sulfate (unii: 021sef3731) (albuterol - unii:qf8svz843e) - albuterol tablets are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease. albuterol tablets are contraindicated in patients with a history of hypersensitivity to albuterol, or any of its components.

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

alcon laboratories, inc. - loteprednol etabonate (unii: yeh1ez96k6) (loteprednol - unii:z8cbu6kr16) - eysuvis is a corticosteroid indicated for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease. eysuvis, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. risk summary there are no adequate and well controlled studies with loteprednol etabonate in pregnant women. loteprednol etabonate produced teratogenicity at clinically relevant doses in the rabbit and rat when administered orally during pregnancy. loteprednol etabonate produced malformations when administered orally to pregnant rabbits at doses 1.4 times the recommended human ophthalmic dose (rhod) and to pregnant rats at doses 34 times the rhod. in pregnant rats receiving oral doses of loteprednol etabonate during the period equivalent to the last trimester of pregnancy through lactation in humans, survival of offspring was reduced at doses 3.4 times the rhod. maternal toxicity was observed in rats at doses 347 times the rhod, and a maternal no observed adverse effect level (noael) was established at 34 times the rhod. 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 loteprednol etabonate by oral gavage on gestation days 6 to 18, to target the period of organogenesis. loteprednol etabonate produced fetal malformations at 0.1 mg/kg (1.4 times the recommended human ophthalmic dose (rhod) based on body surface area, assuming 100% absorption). spina bifida (including meningocele) was observed at 0.1 mg/kg, and exencephaly and craniofacial malformations were observed at 0.4 mg/kg (5.6 times the rhod). at 3 mg/kg (41 times the rhod), loteprednol etabonate was associated with increased incidences of abnormal left common carotid artery, limb flexures, umbilical hernia, scoliosis, and delayed ossification. abortion and embryofetal lethality (resorption) occurred at 6 mg/kg (83 times the rhod). a noael for developmental toxicity was not established in this study. the noael for maternal toxicity in rabbits was 3 mg/kg/day. embryofetal studies were conducted in pregnant rats administered loteprednol etabonate by oral gavage on gestation days 6 to 15, to target the period of organogenesis. loteprednol etabonate produced fetal malformations, including absent innominate artery at 5 mg/kg (34 times the rhod); and cleft palate, agnathia, cardiovascular defects, umbilical hernia, decreased fetal body weight and decreased skeletal ossification at 50 mg/kg (347 times the rhod). embryofetal lethality (resorption) was observed at 100 mg/kg (695 times the rhod). the noael for developmental toxicity in rats was 0.5 mg/kg (3.4 times the rhod). loteprednol etabonate was maternally toxic (reduced body weight gain) at 50 mg/kg/day. the noael for maternal toxicity was 5 mg/kg. a peri-/postnatal study was conducted in rats administered loteprednol etabonate by oral gavage from gestation day 15 (start of fetal period) to postnatal day 21 (the end of lactation period). at 0.5 mg/kg (3.4 times the clinical dose), reduced survival was observed in live-born offspring. doses ≥ 5 mg/kg (34 times the rhod) caused umbilical hernia/incomplete gastrointestinal tract. doses ≥ 50 mg/kg (347 times the rhod) produced maternal toxicity (reduced body weight gain, death), decreased number of live-born offspring, decreased birth weight, and delays in postnatal development. a developmental noael was not established in this study. the noael for maternal toxicity was 5 mg/kg. there are no data on the presence of loteprednol etabonate 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 eysuvis and any potential adverse effects on the breastfed infant from eysuvis. safety and effectiveness in pediatric patients have not been established. no overall differences in safety and effectiveness have been observed between elderly and younger adult patients. instructions for use eysuvis [eye-su-vis] (loteprednol etabonate ophthalmic suspension) 0.25% for topical ophthalmic use this instructions for use contains information on how to properly administer eysuvis. important information you need to know before using eysuvis - eysuvis is for use in the eye. - wash your hands before using eysuvis. - do not use if the tamper-evident seal is not intact. - do not let the eysuvis dropper tip touch your eye, fingers, or any other surfaces to avoid contamination or injury to your eye. - use eysuvis exactly as your doctor tells you to. - if you are using eysuvis with other eye (ophthalmic) medicines, you should wait at least 5 minutes between using eysuvis and the other medicine. - if you wear contact lenses, remove them before using eysuvis. - put the pink cap back on eysuvis after each use. before you use eysuvis for the first time: there are two caps on your bottle of eysuvis. hold the bottle firmly by its neck. remove the white cap by twisting it clockwise (see figure a) . throw away the white cap. eysuvis is now ready to use. figure a follow steps 1 to 6 each time you use eysuvis. - wash your hands well. - shake the eysuvis bottle for 2 to 3 seconds before using (see figure b) . figure b figure b - remove the pink cap from the top of the eysuvis dropper by turning it counterclockwise (see figure c) . keep the pink cap. do not let the eysuvis dropper tip touch your eye, fingers, or any other surface. figure c figure c - turn the eysuvis bottle upside down (see figure d) . figure d figure d - tilt your head back. hold the bottle directly above your affected eye. squeeze the middle of the eysuvis bottle gently to put 1 to 2 drops (follow your doctor's instruction) into the affected eye (see figure e) . figure e figure e - place the pink cap back onto the eysuvis bottle and tighten by turning clockwise (see figure f) . figure f figure f if you use contact lenses, wait for 15 minutes before placing them back in. how should i store eysuvis? - store eysuvis upright between 59ºf to 77ºf (15ºc to 25ºc). - do not freeze. - after opening, eysuvis can be used until the expiration date (exp) on the bottle. the expiration date can be found on the lower right side of the label on the bottle. keep eysuvis and all medicines out of the reach of children. this instructions for use has been approved by the u.s. food and drug administration. manufactured for: kala pharmaceuticals, inc. watertown, ma 02472 approved: 10/2020

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

par pharmaceutical, inc. - dexmethylphenidate hydrochloride (unii: 1678ok0e08) (dexmethylphenidate - unii:m32rh9mfgp) - dexmethylphenidate hydrochloride 40 mg - dexmethylphenidate hydrochloride extended-release is indicated for the treatment of attention deficit hyperactivity disorder (adhd) [see clinical studies (14)].   - hypersensitivity to methylphenidate or other components of dexmethylphenidate hydrochloride extended-release. hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [see adverse reactions (6.1)]. hypersensitivity to methylphenidate or other components of dexmethylphenidate hydrochloride extended-release. hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [see adverse reactions (6.1)]. - concomitant treatment with monoamine oxidase inhibitors (maois) or within 14 days following discontinuation of treatment with an maoi, because of the risk of hypertensive crises [see drug interactions (7.1)]. concomitant treatment with monoamine oxidase inhibitors (maois) or within 14 days following disc

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

lupin pharmaceuticals, inc. - ziprasidone hydrochloride (unii: 216x081oru) (ziprasidone - unii:6uka5vej6x) - ziprasidone 20 mg - ziprasidone capsules usp are indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. when deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone's greater capacity to prolong the qt/qtc interval compared to several other antipsychotic drugs [see warnings and precautions (5.3)]. prolongation of the qtc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. in many cases this would lead to the conclusion that other drugs should be tried first. whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see warnings and precautions (5.3)]. schizophrenia •ziprasidone capsules usp are indicated for th

Jordan - English - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

الشركة الأردنية السويدية - jordan sweden medical & sterilization co. - valproic acid 145 milligram/1 tablet, sodium valproate 333 milligram/1 tablet - 145 milligram/1 tablet, 333 milligram/1 tablet

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

proficient rx lp - cimetidine (unii: 80061l1wgd) (cimetidine - unii:80061l1wgd) - cimetidine 400 mg - cimetidine tablets are indicated in: cimetidine is contraindicated for patients known to have hypersensitivity to the product.

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

readymeds - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole tablets usp are indicated for the treatment of t. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). metronidazole tablets usp are indicated in the treatment of asymptomatic t. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion.  since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. t. vaginalis infection is a venereal disease. therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. the decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. in ma

New Zealand - English - Ministry for Primary Industries

adria new zealand ltd - flufenacet - flufenacet 400 g/litre - herbicide

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

lannett company, inc. - baclofen (unii: h789n3fke8) (baclofen - unii:h789n3fke8) - baclofen 10 mg - baclofen tablets usp are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. baclofen tablets usp may also be of some value in patients with spinal cord injuries and other spinal cord diseases. baclofen tablets usp are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. the efficacy of baclofen in stroke, cerebral palsy, and parkinson's disease has not been established and, therefore, it is not recommended for these conditions. hypersensitivity to baclofen.