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

taw pharma (ireland) limited - clopidogrel hydrochloride - peripheral vascular diseases; stroke; myocardial infarction; acute coronary syndrome - antithrombotic agents - , , , , secondary prevention of atherothrombotic events, , clopidogrel is indicated in: , - adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease., - adult patients suffering from acute coronary syndrome:,    - non-st segment elevation acute coronary syndrome (unstable angina or non-q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (asa).,     - st segment elevation acute myocardial infarction, in combination with asa in medically treated patients eligible for thrombolytic therapy., , in patients with moderate to high-risk transient ischaemic attack (tia) or minor ischaemic stroke (is), clopidogrel in combination with asa is indicated in:, - adult patients with moderate to high-risk tia (abcd2  score ≥4) or minor is (nihss  ≤3) within 24 hours of either the tia or is event. , , prevention of atherothrombotic and thromboembolic events in atrial fibrillation, in adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with vitamin k antagonists (vka) and who have a low bleeding risk, clopidogrel is indicated in combination with asa for the prevention of atherothrombotic and thromboembolic events, including stroke., , for further information please refer to section 5.1. , , ,

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

teva pharma b.v.  - clopidogrel (as hydrobromide) - peripheral vascular diseases; acute coronary syndrome; myocardial infarction; stroke - antithrombotic agents - prevention of atherothrombotic eventsclopidogrel is indicated in:adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease;adult patients suffering from acute coronary syndrome: non-st segment elevation acute coronary syndrome (unstable angina or non-q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (asa);st segment elevation acute myocardial infarction, in combination with asa in medically treated patients eligible for thrombolytic therapy.prevention of atherothrombotic and thromboembolic events in atrial fibrillationin adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with vitamin-k antagonists (vka) and who have a low bleeding risk, clopidogrel is indicated in combination with asa for the prevention of atherothrombotic and thromboembolic events, including stroke.

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

dr. friedrich eberth arzneimittel gmbh - lasofoxifene tartrate - osteoporosis, postmenopausal - sex hormones and modulators of the genital system, - fablyn is indicated for the treatment of osteoporosis in postmenopausal women at increased risk of fracture. a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated (see section 5.1).when determining the choice of fablyn or other therapies, including oestrogens, for a postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1).

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

cheplapharm arzneimittel gmbh - verteporfin - myopia, degenerative; macular degeneration - ophthalmologicals - visudyne is indicated for the treatment of:adults with exudative (wet) age-related macular degeneration (amd) with predominantly classic subfoveal choroidal neovascularisation (cnv) or;adults with subfoveal choroidal neovascularisation secondary to pathological myopia.

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

cheplapharm arzneimittel gmbh - orlistat - obesity - antiobesity preparations, excl. diet products - xenical is indicated in conjunction with a mildly hypocaloric diet for the treatment of obese patients with a body mass index (bmi) greater or equal to 30 kg/m2, or overweight patients (bmi > 28 kg/m2) with associated risk factors.treatment with orlistat should be discontinued after 12 weeks if patients have been unable to lose at least 5% of the body weight as measured at the start of therapy.

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

hope pharmaceuticals pty ltd - sodium thiosulfate pentahydrate, quantity: 12.5 g - solution - excipient ingredients: water for injections; potassium chloride; boric acid; sodium hydroxide - hope pharmaceuticals sodium thiosulfate injection is indicated as an antidote in the treatment of cyanide poisoning. it is frequently used in conjunction with sodium nitrite.,sodium thiosulfate is also indicated to prevent sodium nitroprusside induced cyanide poisoning.

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

noumed pharmaceuticals pty ltd - pseudoephedrine hydrochloride, quantity: 60 mg - tablet, uncoated - excipient ingredients: magnesium stearate; microcrystalline cellulose; calcium hydrogen phosphate dihydrate - fast, temporary relief from a runny nose and reduce the swollen membranes of the nose and sinuses and helping breathe easier.

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

mayne pharma international pty ltd - oxycodone hydrochloride, quantity: 5 mg - tablet - excipient ingredients: microcrystalline cellulose; sodium starch glycollate type a; silicon dioxide; lactose monohydrate; maize starch; stearic acid - mayne pharma oxycodone ir is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

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

noumed pharmaceuticals pty ltd - ibuprofen, quantity: 20 mg/ml - oral liquid, suspension - excipient ingredients: saccharin sodium; purified water; sodium benzoate; sodium citrate dihydrate; sodium propyl hydroxybenzoate; maltitol solution; polysorbate 80; xanthan gum; sodium methyl hydroxybenzoate; citric acid monohydrate; flavour; microcrystalline cellulose; carmellose sodium - pharmacy choice ibuprofen children's suspension may be used for the temporary relief of pain and discomfort resulting from headaches, teething, earache and muscle sprains. pharmacy choice ibuprofen children's suspension reduces fever and relieves the discomfort of cold and flu symptoms. pharmacy choice ibuprofen children's suspension may be used to reduce fever after childhood vaccinations.

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

mayne pharma international pty ltd - erythromycin, quantity: 250 mg - capsule, enteric - excipient ingredients: povidone; monobasic potassium phosphate; lactose monohydrate; gelatin; carbon black; sunset yellow fcf; shellac; indigo carmine; purified water; cellacefate; erythrosine; diethyl phthalate - mayne pharma erythromycin is indicated in children and adults for the treatment of the following conditions: upper respiratory tract infections of mild to moderate degree caused by streptococcus pyogenes (group a beta haemolytic streptococci), streptococcus pneumoniae (diplococcus pneumoniae). lower respiratory tract infections of mild to moderate severity caused by streptococcus pyogenes (group a beta hemolytic streptococci), streptococcus pneumoniae (diplococcus pneumoniae), acute and chronic bronchitis, pneumonia. sinusitis caused by streptococcus pneumoniae, streptococcus pyogenes. otitis media due to streptococcus pneumoniae, streptococcus pyogenes. respiratory tract infections due to mycoplasma pneumonia (eaton's agent). skin, and skin structure infections of mild to moderate severity caused by streptococcus pyogenes and staphylococcus aureus (resistant staphylococci may emerge during treatment). bordetella pertussis: erythromycin produces early elimination of the causative organism from the nasopharynx although the clinical course of the disease is not altered; therapeutic doses should be continued for at least 10 days. diphtheria: as an adjunct to antitoxin infections due to corynebacterium diphtheriae, to prevent establishment of carriers and to eradicate the organism in carriers. erythrasma: in the treatment of infections due to corynebacterium minutissimum. infections due to listera monocytogenes. non-gonococcal urethritis: chlamydia trachomatis and ureaplasma urealyticum have been shown to be sensitive to erythromycin and clinical studies have demonstrated its efficacy in urethritis due to these organisms. a minimum of 10 days therapy appears to be required. chlamydia trachomatis infection (excluding non-gonococcal urethritis): erythromycin has been shown to be effective in the treatment of trachoma or inclusion-body conjunctivitis and pneumonia in infants caused by chlamydia trachomatis. campylobacter fetus (subspecies) jejuni: infections due to this organism when antibiotic therapy is indicated. primary syphilis caused by treponema pallidum: erythromycin (oral forms only) is an alternative choice of treatment for primary syphilis in patients allergic to the penicillins. in the treatment of primary syphilis, spinal fluid should be examined before treatment and as part of the followup after therapy. legionnaires' disease caused by legionella pneumophila: although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating legionnaires' disease. prevention of initial attacks of rheumatic fever: penicillin is considered by the american heart association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of group a beta - haemolytic streptococcal infections of the upper respiratory tract e.g. tonsillitis or pharyngitis). erythromycin is indicated for the treatment of penicillin allergic patients. a therapeutic dose should be administered for 10 days. prevention of recurrent attacks of rheumatic fever: penicillin or sulphonamides are considered by the american heart association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. in patients who are allergic to penicillin and sulphonamides, oral erythromycin is recommended by the american heart association in the long term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever). prevention of bacterial endocarditis: although no controlled clinical efficacy trials have been conducted, oral erythromycin has been suggested by the american heart association and the american dental association in a regimen for prophylaxis against bacterial endocarditis in patients sensitive to penicillin who have congenital heart disease, or rheumatic or other acquired valvular heart disease when they undergo dental or surgical procedures of the upper respiratory tract. erythromycin is not suitable prior to genitourinary or gastrointestinal tract surgery.