Singapore - engelsk - HSA (Health Sciences Authority)

kci medical asia pte. ltd. - general hospital - tielle® plus sacrum dressing is indicated for the management of moderate to heavily exuding sacral wounds and other difficult to dress areas. tielle® plus sacrum dressing should be used under health care professional direction for the following indications: • sacral pressure ulcers. • difficult to dress areas

Singapore - engelsk - HSA (Health Sciences Authority)

kci medical asia pte. ltd. - general hospital - tielle® xtra dressing is indicated for the management of low to heavily exuding wounds. tielle® xtra dressing should be used under health care professional direction for the following indications: • lower extremity ulcers o venous o arterial o mixed aetiology • diabetic ulcers • donor sites • pressure ulcers • post-surgical or traumatic wounds tielle® xtra dressing is also suitable for use under compression bandaging.

Singapore - engelsk - HSA (Health Sciences Authority)

medtronic international, ltd. - orthopaedics - progenix dbm putty is single use product intended for filling bony voids or gaps of the skeletal system and oralmaxillofacial region not intrinsic to the stability of the bony structure.

USA - engelsk - NLM (National Library of Medicine)

zogenix, inc. - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7) - hydrocodone bitartrate 10 mg - zohydro® er (hydrocodone bitartrate) is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. limitations of use - because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve zohydro er for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. - zohydro er is not indicated as an as-needed (prn) analgesic. zohydro er is contraindicated in patients with: - significant respiratory depression - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment - known or suspected paralytic ileus - hypersensitivity (e.g., anaphylaxis) to hydrocodone bitartr

USA - engelsk - NLM (National Library of Medicine)

zogenix, inc. - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7) - zohydro® er (hydrocodone bitartrate) is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. limitations of use - because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve zohydro er for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. - zohydro er is not indicated as an as-needed (prn) analgesic. zohydro er is contraindicated in patients with: - significant respiratory depression - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment - known or suspected paralytic ileus - hypersensitivity (e.g., anaphylaxis) to hydrocodone bitartr

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - etranacogene dezaparvovec, quantity: 1 u - injection, intravenous infusion - excipient ingredients: monobasic potassium phosphate; water for injections; potassium chloride; dibasic sodium phosphate; sodium chloride; polysorbate 20; hydrochloric acid; sucrose - this medicine has provisional approval in australia.,hemgenix? is an adeno-associated virus vector-based gene therapy indicated for treatment of adults with haemophilia b (congenital factor ix deficiency), without a history of factor ix inhibitors, who:,- currently use factor ix prophylaxis therapy, or,- have current or historical life-threatening haemorrhage, or repeated, serious spontaneous bleeding episodes.,the decision to approve this indication has been made on the basis of short-term efficacy and safety data from the clinical trial program. continued approval of this indication depends on confirmation of longer-term benefit from ongoing clinical trials.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

genesis pharma pty ltd - meloxicam, quantity: 7.5 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; calcium hydrogen phosphate dihydrate; croscarmellose sodium; povidone; colloidal anhydrous silica; magnesium stearate; hypromellose; macrogol 400; carnauba wax - relief of the signs & symptoms of osteoarthritis.

Den Europæiske Union - engelsk - EMA (European Medicines Agency)

tigenix n.v. - characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins - cartilage diseases - other drugs for disorders of the musculo-skeletal system - repair of single symptomatic cartilage defects of the femoral condyle of the knee (international cartilage repair society [icrs] grade iii or iv) in adults.concomitant asymptomatic cartilage lesions (icrs grade i or ii) might be present. demonstration of efficacy is based on a randomised controlled trial evaluating the efficacy of chondrocelect in patients with lesions between 1 and 5 cm².

USA - engelsk - NLM (National Library of Medicine)

innogenix, inc. - labetalol hydrochloride (unii: 1gev3baw9j) (labetalol - unii:r5h8897n95) - labetalol hydrochloride tablets, usp are indicated in the management of hypertension. labetalol hydrochloride tablets, usp may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics. labetalol hydrochloride is contraindicated in bronchial asthma, overt cardiac failure, greater-than-first-degree heart block, cardiogenic shock, severe bradycardia, other conditions associated with severe and prolonged hypotension, and in patients with a history of hypersensitivity to any component of the product ( see   warnings ). beta-blockers, even those with apparent cardioselectivity, should not be used in patients with a history of obstructive airway disease, including asthma.

Malta - engelsk - Medicines Authority

novelgenix therapeutics limited 20, oliver business park, oliver road, park royal, london, nw10 7jb, united kingdom - flucloxacillin sodium - powder for oral solution - flucloxacillin sodium 250/5 milligram(s) - antibacterials for systemic use