Europska Unija - engleski - EMA (European Medicines Agency)

pharmaswiss ceska republika s.r.o - pegaptanib - wet macular degeneration - ophthalmologicals - macugen is indicated for the treatment of neovascular (wet) age-related macular degeneration (amd).

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

bausch health us, llc - pegaptanib sodium (unii: 3hp012q0fh) (pegaptanib - unii:2h1pa8h1en) - pegaptanib sodium 3.47 mg in 1 ml - macugen® (pegaptanib sodium injection) is indicated for the treatment of neovascular (wet) age-related macular degeneration. macugen is contraindicated in patients with ocular or periocular infections. macugen is contraindicated in patients with known hypersensitivity to pegaptanib sodium or any other excipient in this product. teratogenic effects: pregnancy category b. pegaptanib produced no maternal toxicity and no evidence of teratogenicity or fetal mortality in mice at intravenous doses of up to 40 mg/kg/day (about 7,000 times the recommended human monocular ophthalmic dose of 0.3 mg/eye). pegaptanib crosses the placenta in mice. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. it is not known whether pegaptanib is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when macugen is adm

Velika Britanija - engleski - MHRA (Medicines & Healthcare Products Regulatory Agency)

ferring pharmaceuticals ltd - somatropin (rbe) - powder and solvent for solution for injection - 10mg

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

ferring pharmaceuticals inc. - somatropin (unii: nqx9kb6pcl) (somatropin - unii:nqx9kb6pcl) - somatropin 5 mg - zomacton is indicated for the treatment of pediatric patients with: - growth failure due to inadequate secretion of endogenous growth hormone (gh), - short stature associated with turner syndrome, - idiopathic short stature (iss), height standard deviation score (hsds) ≤-2.25 and associated with growth rates unlikely to permit attainment of adult height in the normal range, - short stature or growth failure in short stature homeobox-containing gene (shox) deficiency, - short stature born small for gestational age (sga) with no catch-up growth by 2 years to 4 years of age. zomacton is indicated for the replacement of endogenous gh in adults with gh deficiency. zomacton is contraindicated in patients with: - acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure due to the risk of increased mortality with use of pharmacologic doses of somatropin [see warnings and precautions (5.1)] . - pediatric patients with prader-willi s

Australija - engleski - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - sodium chloride, quantity: 175.35 mg; macrogol 3350, quantity: 6562.5 mg; sodium bicarbonate, quantity: 89.25 mg; potassium chloride, quantity: 23.3 mg - powder, oral - excipient ingredients: acesulfame potassium - for effective relief from constipation and treatment of chronic constipation in adults and children aged 2 years and older. for resolving faecal impaction, defined as refractory constipation with faecal loading of the rectum, or the rectum and colon, confirmed by physical examination of abdomen and rectum, in adults and children 2 years and older. for prevention of recurrence of faecal impaction in children aged 2 years and older. use in children 2 years and older should be limited to 12 weeks except under medical supervision.

Australija - engleski - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - sodium chloride, quantity: 350.7 mg; sodium bicarbonate, quantity: 178.5 mg; potassium chloride, quantity: 46.6 mg; macrogol 3350, quantity: 13125 mg - powder, oral - excipient ingredients: acesulfame potassium; flavour - for effective relief from constipation, treatment of constipation, and treatment of faecal impaction defined as refractory constipation with faecal loading of the rectum and/or colon confirmed by the physical examination of the abdomen and rectum, in adults and children 12 years and over.

Australija - engleski - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - sodium chloride, quantity: 175.35 mg; sodium bicarbonate, quantity: 89.25 mg; potassium chloride, quantity: 23.3 mg; macrogol 3350, quantity: 6562.5 mg - powder, oral - excipient ingredients: acesulfame potassium; flavour - for effective relief from constipation and treatment of chronic constipation in adults and children aged 2 years and older. for resolving faecal impaction, defined as refractory constipation with faecal loading of the rectum, or the rectum and colon, confirmed by physical examination of abdomen and rectum, in adults and children 2 years and older. for prevention of recurrence of faecal impaction in children aged 2 years and older. use in children 2 years and older should be limited to 12 weeks except under medical supervision.

Irska - engleski - HPRA (Health Products Regulatory Authority)

helsinn birex pharmaceuticals limited - macrogol 3350 - powder for oral solution - 5.9 gram(s) - osmotically acting laxatives; macrogol, combinations

Malta - engleski - Malta Medicines Authority

stirling anglian pharmaceuticals ltd hillington park innovation centre, 1 ainslie road, hillington park, glasgow g52 4ru, united - macrogol, sodium chloride, sodium hydrogen, carbonate, potassium chloride - powder for oral solution - macrogol 3350 6.563 gram(s) ; sodium chloride 0.1754 gram(s) ; sodium hydrogen carbonate 0.0893 gram(s) ; potassium chloride 0.0233 gram(s) - drugs for constipation

Malta - engleski - Malta Medicines Authority

stirling anglian pharmaceuticals ltd hillington park innovation centre, 1 ainslie road, hillington park, glasgow g52 4ru, united - macrogol, sodium chloride, sodium hydrogen, carbonate, potassium chloride - powder for oral solution - macrogol 3350 6.563 gram(s) ; sodium chloride 0.1754 gram(s) ; sodium hydrogen carbonate 0.0893 gram(s) ; potassium chloride 0.0233 gram(s) - drugs for constipation