Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

boehringer ingelheim pty ltd - telmisartan, quantity: 40 mg; amlodipine besilate, quantity: 13.87 mg (equivalent: amlodipine, qty 10 mg) - tablet, multilayer - excipient ingredients: colloidal anhydrous silica; sodium hydroxide; sorbitol; magnesium stearate; pregelatinised maize starch; povidone; microcrystalline cellulose; maize starch; meglumine; colour - treatment of hypertension. treatment should not be initiated with this fixed-dose combination. (see dosage and administration)

Eiropas Savienība - angļu - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - duloxetine - diabetic neuropathies - psychoanaleptics, - treatment of diabetic peripheral neuropathic pain in adults.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

generic health pty ltd - ziprasidone hydrochloride, quantity: 43.44 mg (equivalent: ziprasidone, qty 40 mg) - capsule, hard - excipient ingredients: titanium dioxide; pregelatinised maize starch; croscarmellose sodium; colloidal anhydrous silica; magnesium stearate; gelatin; indigo carmine - for the treatment of schizophrenia, related psychoses, prevention of relapse and for maintenance of clinical improvement during continuation therapy;,as monotherapy for the short term treatment of acute manic or mixed episodes associated with bipolar i disorder.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

generic health pty ltd - ziprasidone hydrochloride, quantity: 21.72 mg (equivalent: ziprasidone, qty 20 mg) - capsule, hard - excipient ingredients: gelatin; magnesium stearate; pregelatinised maize starch; croscarmellose sodium; indigo carmine; colloidal anhydrous silica; titanium dioxide - for the treatment of schizophrenia, related psychoses, prevention of relapse and for maintenance of clinical improvement during continuation therapy;,as monotherapy for the short term treatment of acute manic or mixed episodes associated with bipolar i disorder.

Singapūra - angļu - HSA (Health Sciences Authority)

boehringer ingelheim singapore pte. ltd. - afatinib dimaleate 44.3400mg eqv afatinib - tablet, film coated - 30.0000mg - afatinib dimaleate 44.3400mg eqv afatinib 30.0000mg

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - gabapentin is indicated for: • management of postherpetic neuralgia in adults • adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as gabapentin, during pregnancy. encourage women who are taking gabapentin during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling the toll free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. risk summary there are no adequate data on the developmental risks associated with the use of gabapentin in pregnant women. in nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic (increased fetal skeletal and visceral abnormalities, and increased embryofetal mortality) when administered to pregnant animals at doses similar to or lower than those used clinically [see data]. 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. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data   when pregnant mice received oral doses of gabapentin (500, 1000, or 3000 mg/kg/day) during the period of organogenesis, embryofetal toxicity (increased incidences of skeletal variations) was observed at the two highest doses. the no-effect dose for embryofetal developmental toxicity in mice (500 mg/kg/day) is less than the maximum recommended human dose (mrhd) of 3600 mg on a body surface area (mg/m 2 ) basis. in studies in which rats received oral doses of gabapentin (500 to 2000 mg/kg/day) during pregnancy, adverse effect on offspring development (increased incidences of hydroureter and/or hydronephrosis) were observed at all doses. the lowest dose tested is similar to the mrhd on a mg/m 2 basis. when pregnant rabbits were treated with gabapentin during the period of organogenesis, an increase in embryofetal mortality was observed at all doses tested (60, 300, or 1500 mg/kg). the lowest dose tested is less than the mrhd on a mg/m 2 basis. in a published study, gabapentin (400 mg/kg/day) was administered by intraperitoneal injection to neonatal mice during the first postnatal week, a period of synaptogenesis in rodents (corresponding to the last trimester of pregnancy in humans). gabapentin caused a marked decrease in neuronal synapse formation in brains of intact mice and abnormal neuronal synapse formation in a mouse model of synaptic repair. gabapentin has been shown in vitro to interfere with activity of the α2δ subunit of voltage-activated calcium channels, a receptor involved in neuronal synaptogenesis. the clinical significance of these findings is unknown. risk summary gabapentin is secreted in human milk following oral administration. the effects on the breastfed infant and on milk production are unknown. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for gabapentin and any potential adverse effects on the breastfed infant from gabapentin or from the underlying maternal condition. safety and effectiveness of gabapentin in the management of postherpetic neuralgia in pediatric patients have not been established. safety and effectiveness as adjunctive therapy in the treatment of partial seizures in pediatric patients below the age of 3 years has not been established  [see clinical studies (14.2)]. the total number of patients treated with gabapentin in controlled clinical trials in patients with postherpetic neuralgia was 336, of which 102 (30%) were 65 to 74 years of age, and 168 (50%) were 75 years of age and older. there was a larger treatment effect in patients 75 years of age and older compared to younger patients who received the same dosage.    since gabapentin is almost exclusively eliminated by renal excretion, the larger treatment effect observed in patients ≥ 75 years may be a consequence of increased gabapentin exposure for a given dose that results from an age-related decrease in renal function. however, other factors cannot be excluded. the types and incidence of adverse reactions were similar across age groups except for peripheral edema and ataxia, which tended to increase in incidence with age. clinical studies of gabapentin in epilepsy did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and dose should be adjusted based on creatinine clearance values in these patients [see dosage and administration (2.4), adverse reactions (6), and clinical pharmacology (12.3)] . dosage adjustment in adult patients with compromised renal function is necessary [see  dosage and administration (2.3) and clinical pharmacology (12.3)] . pediatric patients with renal insufficiency have not been studied. dosage adjustment in patients undergoing hemodialysis is necessary [see dosage and administration (2.3) and clinical pharmacology (12.3)] . gabapentin is not a scheduled drug. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. gabapentin does not exhibit affinity for benzodiazepine, opioid (mu, delta or kappa), or cannabinoid 1 receptor sites. gabapentin misuse and abuse have been reported in the postmarketing setting and published literature. most of the individuals described in these reports had a history of polysubstance abuse. some of these individuals were taking higher than recommended doses of gabapentin for unapproved uses. when prescribing gabapentin, carefully evaluate patients for a history of drug abuse and observe them for signs and symptoms of gabapentin misuse or abuse (e.g., self-dose escalation and drug-seeking behavior). the abuse potential of gabapentin has not been evaluated in human studies. 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. there are rare postmarketing reports of individuals experiencing withdrawal symptoms shortly after discontinuing higher than recommended doses of gabapentin used to treat illnesses for which the drug is not approved. such symptoms included agitation, disorientation and confusion after suddenly discontinuing gabapentin that resolved after restarting gabapentin. the dependence potential of gabapentin has not been evaluated in human studies.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - emtricitabine, quantity: 200 mg; tenofovir disoproxil fumarate, quantity: 300 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; pregelatinised starch; croscarmellose sodium; magnesium stearate; lactose monohydrate; titanium dioxide; hypromellose; triacetin; indigo carmine aluminium lake - treatment of hiv-1 infection: tenvir emtri 300/200 is indicated for the treatment of hiv infected adults over the age of 18 years, in combination with other antiretroviral agents. pre-exposure prophylaxis: tenvir emtri 300/200 is indicated in combination with safer sex practices for pre-exposure prophylaxis (prep) to reduce the risk of sexually acquired hiv-1 in adults at high risk. this indication is based on clinical trials in men who have sex with men (msm) at high risk for hiv-1 infection and in heterosexual serodiscordant couples.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - esomeprazole magnesium dihydrate, quantity: 21.69 mg - capsule, enteric - excipient ingredients: methacrylic acid - ethyl acrylate copolymer (1:1); triethyl citrate; titanium dioxide; mannitol; hypromellose; gelatin; stearoyl macrogolglycerides; maize starch; polysorbate 80; purified talc; iron oxide yellow; sucrose; diacetylated monoglycerides; purified water; dimeticone 350; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - gastro-oesophageal reflux disease (gord),? treatment of erosive reflux oesophagitis,? long-term management of patients with healed oesophagitis to prevent relapse,? symptomatic treatment of gastro-oesophageal reflux disease (gord),patients requiring nsaid therapy,? short-term treatment of upper gastrointestinal symptoms associated with non-steroidal anti-inflammatory drug nsaid (non-selective and cox-2 selective) therapy.,? healing of gastric ulcers associated with non-steroidal anti-inflammatory,drug nsaid (non-selective and cox-2 selective) therapy,? prevention of gastric and duodenal ulcers associated with non-steroidal anti inflammatory drug nsaid (non-selective and cox-2 selective) therapy in patients at risk.,prevention of rebleeding of gastric or duodenal ulcers following treatment with iv esomeprazole solution by intravenous infusion.,pathological hypersecretory conditions including zollinger-ellison syndrome and idiopathic hypersecretion,in combination with appropriate antibiotics for:,? healing of duodenal ulcer associated with helicobacter pylori,? eradication of helicobacter pylori in patients with active or healed peptic ulcer

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - esomeprazole magnesium dihydrate, quantity: 43.37 mg - capsule, enteric - excipient ingredients: maize starch; dimeticone 350; gelatin; purified water; hypromellose; sucrose; methacrylic acid - ethyl acrylate copolymer (1:1); titanium dioxide; polysorbate 80; triethyl citrate; purified talc; iron oxide yellow; diacetylated monoglycerides; mannitol; stearoyl macrogolglycerides; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - gastro-oesophageal reflux disease (gord),? treatment of erosive reflux oesophagitis,? long-term management of patients with healed oesophagitis to prevent relapse,? symptomatic treatment of gastro-oesophageal reflux disease (gord),patients requiring nsaid therapy,? short-term treatment of upper gastrointestinal symptoms associated with non-steroidal anti-inflammatory drug nsaid (non-selective and cox-2 selective) therapy.,? healing of gastric ulcers associated with non-steroidal anti-inflammatory,drug nsaid (non-selective and cox-2 selective) therapy,? prevention of gastric and duodenal ulcers associated with non-steroidal anti inflammatory drug nsaid (non-selective and cox-2 selective) therapy in patients at risk.,prevention of rebleeding of gastric or duodenal ulcers following treatment with iv esomeprazole solution by intravenous infusion.,pathological hypersecretory conditions including zollinger-ellison syndrome and idiopathic hypersecretion,in combination with appropriate antibiotics for:,? healing of duodenal ulcer associated with helicobacter pylori,? eradication of helicobacter pylori in patients with active or healed peptic ulcer

Īrija - angļu - HPRA (Health Products Regulatory Authority)

sanofi-aventis ireland limited t/a sanofi - aluminium oxide, hydrated ph. eur; magnesium hydroxide ph. eur.; dimeticone ph. eur. (as simeticone ph. eur.) - chewable tablet - 200mg/200mg/25 milligram(s) - antacids with antiflatulents; ordinary salt combinations and antiflatulents