United Arab Emirates - English - MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

delta medical establishment japan - 80 ml - spray - combination - musculoskeletal ,joint diseases-soft-tissue inflammation

United Arab Emirates - English - MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

delta medical establishment abu dhabi-tourist club street - capsaicin, glycol salicylate - patch - combination - musculoskeletal ,joint diseases-rheumatic diseases , gout

United Arab Emirates - English - MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

delta medical establishment japan - 20's (6.5 x 4.2cm patch x 20) - patch - combination - musculoskeletal ,joint diseases-natural source - see indication field for description

United Arab Emirates - English - MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

delta medical establishment japan - 5 patches (7cm x 10cm) - patch - combination - musculoskeletal ,joint diseases-rheumatic diseases , gout

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

noven therapeutics, llc - asenapine (unii: jkz19v908o) (asenapine - unii:jkz19v908o) - secuado is indicated for the treatment of adults with schizophrenia [see clinical studies (14) ]. secuado is contraindicated in patients with: - severe hepatic impairment (child-pugh c) [see specific populations (8.7), clinical pharmacology (12.3)] . - a history of hypersensitivity reactions to asenapine or any components of the transdermal system. reactions with asenapine have included anaphylaxis, angioedema, hypotension, tachycardia, swollen tongue, dyspnea, wheezing and rash [see warnings and precautions (5.6), adverse reactions (6)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including secuado, during pregnancy. for more information contact the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/ . risk summary neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms. studies have not been conducted with secuado in pregnant women. there are no available human data informing the drug-associated risk. the background risk of major birth defects and miscarriage for the indicated populations are unknown. however, the background risk in the u.s. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. no teratogenicity was observed in animal reproduction studies with intravenous administration of asenapine to rats and rabbits during organogenesis at doses 0.7 and 0.4 times, respectively, the maximum recommended human dose (mrhd) of 10 mg of sublingual asenapine twice daily and 1.1 and 0.66 times, respectively, the mrhd of 12.8 mg of transdermal asenapine daily. in a pre-and post-natal study in rats, intravenous administration of asenapine at doses up to 0.7 times the mrhd of 10 mg of sublingual asenapine twice daily produced increases in post-implantation loss and early pup deaths, and decreases in subsequent pup survival and weight gain [see data ]. these doses are up to 1.1 times the mrhd of 12.8 mg transdermal asenapine daily. advise pregnant women of the potential risk to a fetus. clinical considerations fetal/neonatal adverse reactions extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs during the third trimester of pregnancy. these symptoms have varied in severity. some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately. data animal data in animal studies, asenapine increased post-implantation loss and decreased pup weight and survival at doses similar to or less than recommended clinical doses. in these studies, there was no increase in the incidence of structural abnormalities caused by asenapine. asenapine was not teratogenic in reproduction studies in rats and rabbits at intravenous doses up to 1.5 mg/kg in rats and 0.44 mg/kg in rabbits administered during organogenesis. these doses are 0.7 and 0.4 times, respectively, mrhd of 10 mg of sublingual asenapine twice daily and 1.1 and 0.66 times, respectively, the mrhd of 12.8 mg transdermal asenapine daily. plasma levels of asenapine were measured in the rabbit study, and the area under the curve (auc) at the highest dose tested was 2 times that in humans receiving the mrhd of 10 mg of sublingual asenapine twice daily. in a study in which rats were treated from day 6 of gestation through day 21 postpartum with intravenous doses of asenapine of 0.3, 0.9, and 1.5 mg/kg/day (0.15, 0.44, and 0.7 times the mrhd of 10 mg of sublingual asenapine twice daily and 0.22, 0.68 and 1.13 times the mrhd of 12.8 mg transdermal asenapine daily), increases in post-implantation loss and early pup deaths were seen at all doses, and decreases in subsequent pup survival and weight gain were seen at the two higher doses. a cross-fostering study indicated that the decreases in pup survival were largely due to prenatal drug effects. increases in post-implantation loss and decreases in pup weight and survival were also seen when pregnant rats were dosed orally with asenapine. risk summary lactation studies have not been conducted to assess the presence of asenapine in human milk, the effects of asenapine on the breastfed infant, or the effects of asenapine on milk production. asenapine is excreted in rat milk. the development and health benefits of breastfeeding should be considered along with the mother's clinical need for secuado and any potential adverse effects on the breastfed infant from secuado or from the underlying maternal condition. safety and effectiveness of secuado in pediatric patients have not been established. efficacy of sublingual asenapine was not demonstrated in an 8-week, placebo-controlled, double-blind trial, in 306 adolescent patients aged 12 to 17 years with schizophrenia at doses of 2.5 and 5 mg twice daily. the most common adverse reactions (proportion of patients equal or greater than 5% and at least twice placebo) reported were somnolence, akathisia, dizziness, and oral hypoesthesia or paresthesia. the proportion of patients with an equal or greater than 7% increase in body weight at endpoint compared to baseline for placebo, sublingual asenapine 2.5 mg twice daily, and sublingual asenapine 5 mg twice daily was 3%, 10%, and 10%, respectively. no new major safety findings were reported from a 26-week, open-label, uncontrolled safety trial in pediatric patients with schizophrenia treated with sublingual asenapine. juvenile animal data subcutaneous administration of asenapine to juvenile rats for 56 days from day 14 of age to day 69 of age at 0.4, 1.2, and 3.2 mg/kg/day (0.2, 0.6 and 1.5 times the maximum recommended human dose of 10 mg twice daily given sublingually on a mg/m2 basis) resulted in significant reduction in body weight gain in animals of both sexes at all dose levels from the start of dosing until weaning. body weight gain remained reduced in males to the end of treatment, however, recovery was observed once treatment ended. neurobehavioral assessment indicated increased motor activity in animals at all dose levels following the completion of treatment, with the evidence of recovery in males. there was no recovery after the end of treatment in female activity pattern as late as day 30 following the completion of treatment (last retesting). therefore, a no observed adverse effect level (noael) for the juvenile animal toxicity of asenapine could not be determined. there were no treatment-related effects on the startle response, learning/memory, organ weights, microscopic evaluations of the brain and, reproductive performance (except for minimally reduced conception rate and fertility index in males and females administered 1.2 and 3.2 mg/kg/day). the secuado placebo-controlled trial for the treatment of schizophrenia did not include sufficient numbers of patients aged 65 and over to determine whether or not they respond differently than younger patients. of the approximately 614 patients in placebo-controlled study of secuado, 1.6% (10) were 65 years of age or over. multiple factors that might increase the pharmacodynamic response to secuado, causing poorer tolerance or orthostasis, could be present in elderly patients, and these patients should be monitored carefully. based on a pharmacokinetic study in elderly patients with sublingual asenapine, dosage adjustments are not recommended based on age alone [see clinical pharmacology (12.3) ]. elderly patients with dementia-related psychosis treated with secuado are at an increased risk of death compared to placebo. secuado is not approved for the treatment of patients with dementia-related psychosis [see warning and precautions (5.1, 5.2) ]. no dosage adjustment for secuado is required on the basis of a patient’s renal function (mild to severe renal impairment, glomerular filtration rate between 15 and 90 ml/minute). the exposure of asenapine was similar among subjects with varying degrees of renal impairment and subjects with normal renal function [see clinical pharmacology (12.3) ]. the effect of renal function on the excretion of other metabolites and the effect of dialysis on the pharmacokinetics of asenapine has not been studied. secuado is contraindicated in patients with severe hepatic impairment (child-pugh c) because asenapine exposure is 7-fold higher in subjects with severe hepatic impairment than the exposure observed in subjects with normal hepatic function. no dosage adjustment for secuado is required in patients with mild to moderate hepatic impairment (child-pugh a and b) because asenapine exposure is similar to that in subjects with normal hepatic function [see contraindications (4) and clinical pharmacology (12.3) ]. secuado is not a controlled substance. secuado has not been systematically studied in animals or humans for its abuse potential or its ability to induce tolerance or physical dependence. thus, it is not possible to predict the extent to which a cns-active drug will be misused, diverted and/or abused once it is marketed. patients should be evaluated carefully for a history of drug abuse, and such patients should be observed carefully for signs that they are misusing or abusing secuado (e.g., drug-seeking behavior, increases in dose). instructions for use secuado® (seh kue a’ doe) (asenapine) transdermal system read this instructions for use before you start using the secuado transdermal system (patch) and each time you get a refill. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or treatment. important information: - the secuado transdermal system (patch) is for use on the skin only (transdermal). - do not cut the pouch open until you are ready to apply the patch. - you should apply only 1 secuado patch to 1 application site every 24 hours. the patch should only be worn for 24 hours. do not wear the patch longer than 24 hours. - avoid bathing or swimming while wearing the patch. swimming or bathing may cause the patch to fall off. you may shower. - avoid exposing the patch application site to direct heat sources such as hair dryers, heating pads, electric blankets, or heated water beds. - if your skin feels irritated or feels like it is burning after you apply the patch, remove the patch and apply a new patch to a new application site. applying your secuado patch: - change (rotate) your patch application site every time you apply a new patch. changing your application site every time you apply a patch will help to lessen your chances of developing skin irritation at the application site. do not use the same application site 2 times in a row . - the application site you choose should be clean, dry, and intact. do not apply the patch on skin that has cuts, scrapes, burns, rashes, redness, or other skin problems. - the application site you choose should be hairless or nearly hairless . if there is a lot of hair, use scissors to clip the hair as close to the skin as possible. do not shave the application site. - do not apply the patch on skin that has oils, lotions, or powders on it. - do not apply the patch to areas of your skin where you wear tight clothing, such as waistbands, bras, or tank top straps. - always remove the used patch before applying a new one. you should only wear 1 patch at a time. - choose 1 application site to apply 1 patch. - the application site you may choose should be one of the approved sites listed. apply the patch to the left or right: upper arm upper back stomach area (abdomen) hip - upper arm - upper back - stomach area (abdomen) - hip - do not use the patch if it is cut or damaged or if the seal on the pouch is broken. throw it away and get a new one. - apply the patch right away after removing it from the pouch. - do not touch the sticky side of the patch. - check the patch regularly during the day to make sure the patch is still firmly attached to your skin, especially after showering, using the bathroom, undressing, changing clothes, sleeping, or sweating. - if the patch edges lift off your skin, you should smooth down edges with your fingers, press and hold the patch firmly with the palm of your hand. - if your patch falls off, do not reapply the same patch. choose a new application site, and repeat steps 1 through 7 to apply a new secuado patch. then, follow your normal schedule for changing the patch. removing and disposing of your used secuado patch: - your used patch still has some medicine and should be folded . - if the patch is hard to remove from the skin, gently apply an oil-based product (petroleum jelly, olive oil, or mineral oil) to the patch edges. - if any adhesive (glue) remains on the skin after you remove the patch, apply an oil-based product or lotion to help with the removal. how should i store secuado patch? - store secuado patches at room temperature between 68°f to 77°f (20°c to 25°c). - keep secuado patches and all medicines out of the reach of children. manufactured by: hisamitsu pharmaceutical co., inc., 408, tashirodaikan-machi, tosu, saga, japan ©2019-2023, hisamitsu pharmaceutical co., inc. all rights reserved. distributed by: noven therapeutics, llc, miami, florida usa secuado is a registered trademark of hisamitsu pharmaceutical co., inc. this instructions for use has been approved by the u.s. food and drug administration 4o134a-0                                                                                                                                                                                 revised: 12/2023

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

prasco laboratories - lidocaine (unii: 98pi200987) (lidocaine - unii:98pi200987) - the lidocaine patch is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type, or to any other component of the product.

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

hisamitsu america, inc. - benzyl alcohol  10%, lidocaine hcl  4% - topical anesthetic for temporary relief of pain

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

hisamitsu america, inc. - camphor 3.1%, menthol 10.0%, methyl salicylate 15.0% - topical analgesic for temporary relief of minor aches and pains of muscles and joints associated with: - simple backache - sprains - strains - arthritis - bruises

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

hisamitsu uk ltd - levomenthol; methyl salicylate - medicated plaster - 31.5mg ; 105mg

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

hisamitsu america, inc. - benzyl alcohol  10%, lidocaine hcl  4% - topical anesthetic for temporary relief of pain