Singapore - English - HSA (Health Sciences Authority)

pfizer private limited - moroctocog alfa (af-cc) - injection, powder, for solution - 2000iu/vial - moroctocog alfa (af-cc) 2000iu/vial

Singapore - English - HSA (Health Sciences Authority)

pfizer private limited - moroctocog alfa (af-cc) - injection, powder, for solution - 250iu/vial - moroctocog alfa (af-cc) 250iu/vial

Singapore - English - HSA (Health Sciences Authority)

pfizer private limited - moroctocog alfa (af-cc) - injection, powder, for solution - 500iu/vial - moroctocog alfa (af-cc) 500iu/vial

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

physicians total care, inc. - dorzolamide hydrochloride (unii: qzo5366ew7) (dorzolamide - unii:9jdx055tw1) - dorzolamide 22.3 mg in 1 ml - dorzolamide hcl ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. dorzolamide hcl ophthalmic solution is contraindicated in patients who are hypersensitive to any component of this product. dorzolamide hcl ophthalmic solution 2% instructions for use please follow these instructions carefully when using dorzolamide hcl ophthalmic solution 2%. use dorzolamide hcl ophthalmic solution 2% as prescribed by your doctor. 1. if you use other topically applied ophthalmic medications, they should be administered at least 10 minutes before or after dorzolamide hcl ophthalmic solution 2%. 2. wash hands before each use. 3. to open the bottle, remove the shrink neck band and unscrew the cap by turning counter clockwise. 4. tilt your head back and pull your lower eyelid down slightly to form a pocket between your eyelid and your eye. 5. instill drops as directed by your doctor. ophthalmic medications, if handled improperly, can beco

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

a-s medication solutions - moxifloxacin hydrochloride monohydrate (unii: b8956s8609) (moxifloxacin - unii:u188xyd42p) - moxifloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: corynebacterium species* micrococcus luteus* staphylococcus aureus staphylococcus epidermidis staphylococcus haemolyticus staphylococcus hominis staphylococcus warneri* streptococcus pneumoniae streptococcus viridans group acinetobacter lwoffii* haemophilus influenza haemophilus parainfluenzae* chlamydia trachomatis *efficacy for this organism was studied in fewer than 10 infections. moxifloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication. pregnancy category c. teratogenic effects: moxifloxacin was not teratogenic when administered to pregnant rats during organogenesis at oral doses as high as 500 mg/kg/day (approximately 21,700 times the highest recommended total daily human ophthalmic dose); ho

Canada - English - Health Canada

sandoz canada incorporated - latanoprost - solution - 50mcg - latanoprost 50mcg - prostaglandin analogs

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

florida rum company llc - alcohol (unii: 3k9958v90m) (alcohol - unii:3k9958v90m) - antiseptic, hand sanitizer hand sanitizer to help reduce bacteria that potentially can cause disease. for use when soap and water are not available. - in children less than 2 months of age - on open skin wounds stop use and ask a doctor if irritation or rash occurs. these may be signs of a serious condition.

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

florida rum company llc - alcohol (unii: 3k9958v90m) (alcohol - unii:3k9958v90m) - antiseptic, hand sanitizer hand sanitizer to help reduce bacteria that potentially can cause disease. for use when soap and water are not available. - in children less than 2 months of age - on open skin wounds stop use and ask a doctor if irritation or rash occurs. these may be signs of a serious condition.

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

apotex corp. - lacosamide (unii: 563ks2pqy5) (lacosamide - unii:563ks2pqy5) - lacosamide oral solution is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. additional pediatric use information is approved for ucb, inc.’s vimpat® (lacosamide) oral solution. however, due to ucb, inc.’s marketing exclusivity rights, this drug product is not labeled with that information. lacosamide oral solution is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older. none. there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as lacosamide oral solution, during pregnancy. encourage women who are taking lacosamide oral solution  during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. available data from the north american antiepileptic drug (naaed) pregnancy registry, a prospective cohort study, case reports, and a case series with lacosamide oral solution use in pregnant women are insufficient to identify a drug associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. lacosamide produced developmental toxicity (increased embryofetal and perinatal mortality, growth deficit) in rats following administration during pregnancy. developmental neurotoxicity was observed in rats following administration during a period of postnatal development corresponding to the third trimester of human pregnancy. these effects were observed at doses associated with clinically relevant plasma exposures (see data) .   the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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. animal data oral administration of lacosamide to pregnant rats (20, 75, or 200 mg/kg/day) and rabbits (6.25, 12.5, or 25 mg/kg/day) during the period of organogenesis did not produce any effects on the incidences of fetal structural abnormalities. however, the maximum doses evaluated were limited by maternal toxicity in both species and embryofetal death in rats. these doses were associated with maternal plasma lacosamide exposures (auc) approximately 2 and 1 times (rat and rabbit, respectively) that in humans at the maximum recommended human dose (mrhd) of 400 mg/day.   in two studies in which lacosamide (25, 70, or 200 mg/kg/day and 50, 100, or 200 mg/kg/day) was orally administered to rats throughout pregnancy and lactation, increased perinatal mortality and decreased body weights in the offspring were observed at the highest dose tested. the no-effect dose for pre-and postnatal developmental toxicity in rats (70 mg/kg/day) was associated with a maternal plasma lacosamide auc similar to that in humans at the mrhd.   oral administration of lacosamide (30, 90, or 180 mg/kg/day) to rats during the neonatal and juvenile periods of development resulted in decreased brain weights and long-term neurobehavioral changes (altered open field performance, deficits in learning and memory). the early postnatal period in rats is generally thought to correspond to late pregnancy in humans in terms of brain development. the no-effect dose for developmental neurotoxicity in rats was associated with a plasma lacosamide auc less than that in humans at the mrhd.  in vitro data lacosamide has been shown in vitro to interfere with the activity of collapsin response mediator protein-2 (crmp-2), a protein involved in neuronal differentiation and control of axonal outgrowth. potential adverse effects on cns development related to this activity cannot be ruled out. risk summary data from published literature indicate that lacosamide is present in human milk. there are reports of increased sleepiness in breastfed infants exposed to lacosamide (see clinical considerations). there is no information on the effects of lacosamide on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for lacosamide and any potential adverse effects on the breastfed infant from lacosamide or from the underlying maternal condition.  clinical considerations monitor infants exposed to lacosamide through breastmilk for excess sedation. partial-onset seizures safety and effectiveness of lacosamide oral solution for the treatment of partial-onset seizures have been established in pediatric patients 4 years to less than 17 years of age. use of lacosamide oral solution in this age group is supported by evidence from adequate and well-controlled studies of lacosamide oral solution in adults with partial-onset seizures, pharmacokinetic data from adult and pediatric patients, and safety data in 328 pediatric patients 4 years to less than 17 years of age [see adverse reactions (6.1),  clinical pharmacology (12.3), and clinical studies (14.1, 14.2)] . safety and effectiveness in pediatric patients below 1 month of age have not been established. primary generalized tonic-clonic seizures safety and effectiveness of lacosamide oral solution as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in pediatric patients with idiopathic generalized epilepsy 4 years of age and older was established in a 24-week double-blind, randomized, placebo-controlled, parallel-group, multi-center study (study 5), which included 37 pediatric patients 4 years to less than 17 years of age [see adverse reactions (6.1) and clinical studies (14.3)] . safety and effectiveness in pediatric patients below the age of 4 years have not been established. animal data lacosamide has been shown in vitro to interfere with the activity of collapsin response mediator protein-2 (crmp-2), a protein involved in neuronal differentiation and control of axonal outgrowth. potential related adverse effects on cns development cannot be ruled out. administration of lacosamide to rats during the neonatal and juvenile periods of postnatal development (approximately equivalent to neonatal through adolescent development in humans) resulted in decreased brain weights and long-term neurobehavioral changes (altered open field performance, deficits in learning and memory). the no-effect dose for developmental neurotoxicity in rats was associated with a plasma lacosamide exposure (auc) less than that in humans at the maximum recommended human dose of 400 mg/day. additional pediatric use information is approved for ucb, inc.’s vimpat® (lacosamide) oral solution. however, due to ucb, inc.’s marketing exclusivity rights, this drug product is not labeled with that information . there were insufficient numbers of elderly patients enrolled in partial-onset seizure trials (n=18) to adequately determine whether they respond differently from younger patients. no lacosamide oral solution dose adjustment based on age is necessary. in elderly patients, dose titration should be performed with caution, usually starting at the lower end of the dosing range, reflecting the greater frequency of decreased hepatic function, decreased renal function, increased cardiac conduction abnormalities, and polypharmacy [see dosage and administration ( 2.1, 2.4, 2.5) and clinical pharmacology ( 12.3)]. no dose adjustment is necessary in patients with mild to moderate renal impairment (clcr ≥30 ml/min). in patients with severe renal impairment (clcr <30 ml/min as estimated by the cockcroft-gault equation for adults; clcr less than 30 ml/min/ 1.73m2 as estimated by the schwartz equation for pediatric patients) and in those with end-stage renal disease, a reduction of 25% of the maximum dosage is recommended [see dosage and administration (2.4) and clinical pharmacology (12.3)]. in all patients with renal impairment, dose initiation and titration should be based on clinical response and tolerability. lacosamide is effectively removed from plasma by hemodialysis. dosage supplementation of up to 50% following hemodialysis should be considered. for adult and pediatric patients with mild to moderate hepatic impairment, a reduction of 25% of the maximum dosage is recommended. patients with mild to moderate hepatic impairment should be observed closely for adverse reactions, and dose initiation and titration should be based on clinical response and tolerability [see dosage and administration (2.5), clinical pharmacology (12.3)]. the pharmacokinetics of lacosamide has not been evaluated in severe hepatic impairment. lacosamide oral solution  use is not recommended in patients with severe hepatic impairment. lacosamide oral solution contains lacosamide, a schedule v controlled substance. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. in a human abuse potential study, single doses of 200 mg (equal to the maximum single dosage) and 800 mg lacosamide (equal to twice the recommended daily maintenance dosage)  produced euphoria-type subjective responses that differentiated statistically from placebo; at 800 mg, these euphoria-type responses were statistically indistinguishable from those produced by alprazolam, a schedule iv drug. the duration of the euphoria-type responses following lacosamide was less than that following alprazolam. a high rate of euphoria was also reported as an adverse event in the human abuse potential study following single doses of 800 mg lacosamide (15% [5/34]) compared to placebo (0%) and in two pharmacokinetic studies following single and multiple doses of 300 to 800 mg lacosamide (ranging from 6% [2/33] to 25% [3/12]) compared to placebo (0%). however, the rate of euphoria reported as an adverse event in the lacosamide development program at therapeutic doses was less than 1%. physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. abrupt termination of lacosamide in clinical trials with diabetic neuropathic pain patients produced no signs or symptoms that are associated with a withdrawal syndrome indicative of physical dependence. however, psychological dependence cannot be excluded due to the ability of lacosamide to produce euphoria-type adverse events in humans.

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

apotex corp. - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - diclofenac sodium 16.05 mg in 1 ml - diclofenac sodium topical solution is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1). diclofenac sodium topical solution is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac sodium or any components of the drug product [see warnings and precautions (5.7, 5.9)] . - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions (5.7, 5.8)] . - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions (5.1)] . risk summary use of nsaids, including diclofenac sodium topical solution, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. because of these risks, limit dose and duratio