Europäische Union - Englisch - EMA (European Medicines Agency)

takeda pharma a/s - alogliptin - diabetes mellitus, type 2 - drugs used in diabetes, dipeptidyl peptidase 4 (dpp-4) inhibitors - vipidia is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).

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

chiesi australia pty ltd - stiripentol, quantity: 500 mg - capsule - excipient ingredients: sodium starch glycollate type a; magnesium stearate; povidone; gelatin; titanium dioxide; iron oxide black; shellac - diacomit is indicated for adjunctive treatment of generalised tonic-clonic and clonic seizures associated with severe myoclonic epilepsy in infancy (smei, also known as dravet syndrome) in patients whose seizures are not adequately controlled with a benzodiazepine (usually clobazam) and valproate.

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

chiesi australia pty ltd - stiripentol, quantity: 250 mg - capsule - excipient ingredients: sodium starch glycollate type a; magnesium stearate; povidone; gelatin; titanium dioxide; erythrosine; indigo carmine; shellac; iron oxide black - diacomit is indicated for adjunctive treatment of generalised tonic-clonic and clonic seizures associated with severe myoclonic epilepsy in infancy (smei, also known as dravet syndrome) in patients whose seizures are not adequately controlled with a benzodiazepine (usually clobazam) and valproate.

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

zoetis inc. - toceranib phosphate (unii: 24f9pf7j3r) (toceranib - unii:59l7y0530c) - toceranib 10 mg - palladia tablets are indicated for the treatment of patnaik grade ii or iii, recurrent, cutaneous mast cell tumors with or without regional lymph node involvement in dogs. do not use in dogs used for breeding, or for pregnant or lactating bitches (see clinical pharmacology ).

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

lake erie medical dba quality care products llc - morphine sulfate (unii: x3p646a2j0) (morphine - unii:76i7g6d29c) - kadian is indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. limitations of use kadian is not for use: ¯ as an as-needed (prn) analgesic ¯ for pain that is mild or not expected to persist for an extended period of time ¯ for acute pain ¯ for postoperative pain unless the patient is already receiving chronic opioid therapy prior to surgery or if the kadian 100 mg and 200 mg capsules are only for patients in whom tolerance to an opioid of comparable potency is established. patients considered opioid-tolerant are those taking at least 60 mg of morphine daily, at least 30 mg of oral oxycodone daily, at least 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid for a week or longer. kadian 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 susp

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

biocodex, inc. - stiripentol (unii: r02xot8v8i) (stiripentol - unii:r02xot8v8i) - diacomit is indicated for the treatment of seizures associated with dravet syndrome (ds) in patients taking clobazam who are 6 months of age and older and weighing 7 kg or more. there are no clinical data to support the use of diacomit as monotherapy in dravet syndrome. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, such as diacomit, during pregnancy. physicians are advised to recommend that pregnant patients taking diacomit enroll in the north american antiepileptic drug (naaed) pregnancy registry. this can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves or their caregiver. information on the registry can also be found at the website http://www.aedpregnancyregistry.org/. risk summary there are no adequate data on the developmental risks associated with the use of diacomit in pregnant women. administration of stiripentol to pregnant animals produced evidence of development

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

cardiac rhythm diagnostics pty ltd - 47699 - cardiac electrophysiology application software - bittium cardiac navigator is intended for the analysis of data pre-recorded on bittium faros series ambulatory ecg devices. in addition, cardiac navigator software can display and analyse rest and stress ecg data. the cardiac navigator is intended for analysing, editing, reviewing, reporting, and storing of pre-recorded ambulatory egg and accelerometer data on bittium faros series ambulatory ecg devices. the results of the automated analysis are intended to assist the physician in the interpretation of the recorded data. this information is not intended to serve as a substitute for the physician overread of the recorded ecg data. cardiac navigator is intended to be used by trained operators and licensed healthcare practitioner in a hospital or clinic environment. cardiac navigator is intended for use under the supervision of a physician or those knowledgeable in all aspects of ecg morphology, rhythm, and arrhythmia. this procedure is known as a holter procedure and captures infrequent or activity provoked ecg rhythm abnormalities inside or outside hospital or clinical environment. bittium cardiac navigator analyses are not intended for infants weighing less than 10 kg (22 lbs). bittium cardiac navigator comprises bittium faros ambulatory ecg sensors and bittium cardiac navigator software. as the patient wears the ambulatory ecg sensor, it records ecg data. the cardiac navigator application analyses the recorded data. bittium faros series sensors provide signal acquisition patient ecg waveforms through skin surface electrodes adhered to the body. in addition to patient ecg waveforms, bittium faros devices allow measuring physical activity with devices? in-built 3-axis accelerometer.

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

boehringer ingelheim pty ltd - empagliflozin, quantity: 12.5 mg; metformin hydrochloride, quantity: 1000 mg - tablet, film coated - excipient ingredients: maize starch; copovidone; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; purified talc; iron oxide red; iron oxide black; macrogol 400 - jardiamet is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and metformin is appropriate (see sections 4.2 dose and method of administration and 5.1 pharmacodynamic properties - clinical trials).,empagliflozin is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease to reduce the risk of cardiovascular death (see section 5.1 pharmacodynamic properties - clinical trials).,to prevent cardiovascular deaths, empagliflozin should be used in conjunction with other measures to reduce cardiovascular risk in line with the current standard of care.

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

boehringer ingelheim pty ltd - empagliflozin, quantity: 12.5 mg; metformin hydrochloride, quantity: 850 mg - tablet, film coated - excipient ingredients: maize starch; copovidone; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; purified talc; iron oxide red; iron oxide black; macrogol 400 - jardiamet is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and metformin is appropriate (see sections 4.2 dose and method of administration and 5.1 pharmacodynamic properties - clinical trials).,empagliflozin is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease to reduce the risk of cardiovascular death (see section 5.1 pharmacodynamic properties - clinical trials).,to prevent cardiovascular deaths, empagliflozin should be used in conjunction with other measures to reduce cardiovascular risk in line with the current standard of care.

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

boehringer ingelheim pty ltd - empagliflozin, quantity: 12.5 mg; metformin hydrochloride, quantity: 500 mg - tablet, film coated - excipient ingredients: maize starch; copovidone; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; purified talc; iron oxide red; iron oxide black; macrogol 400 - jardiamet is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and metformin is appropriate (see sections 4.2 dose and method of administration and 5.1 pharmacodynamic properties - clinical trials).,empagliflozin is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease to reduce the risk of cardiovascular death (see section 5.1 pharmacodynamic properties - clinical trials).,to prevent cardiovascular deaths, empagliflozin should be used in conjunction with other measures to reduce cardiovascular risk in line with the current standard of care.