United States - English - NLM (National Library of Medicine)

ferring pharmaceuticals inc. - donor human stool (unii: 3tvp4e28jr) (donor human stool - unii:3tvp4e28jr) - rebyota is indicated for the prevention of recurrence of clostridioides difficile infection (cdi) in individuals 18 years of age and older following antibiotic treatment for recurrent cdi. limitation of use: rebyota is not indicated for treatment of cdi. do not administer rebyota to individuals with a history of a severe allergic reaction (e.g. anaphylaxis) to any of the known product components [see description 11] . risk summary rebyota is not absorbed systemically following rectal administration, and maternal use is not expected to result in fetal exposure to the drug. rebyota is not absorbed systemically by the mother following rectal administration, and breastfeeding is not expected to result in exposure of the child to rebyota. safety and effectiveness of rebyota in individuals younger than 18 years of age have not been established. of the 978 adults who received rebyota, 48.8% were 65 years of age and over (n=477), and 25.7% were 75 years of age and over (n=251). data from clinical studies of rebyota

United States - English - NLM (National Library of Medicine)

ferring pharmaceuticals inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - ortikos is indicated for the treatment of mild to moderate active crohn's disease involving the ileum and/or the ascending colon in patients 8 years of age and older. ortikos is indicated for the maintenance of clinical remission of mild to moderate crohn's disease involving the ileum and/or the ascending colon for up to 3 months in adults. ortikos is contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of the capsules. serious hypersensitivity reactions, including anaphylaxis have occurred [see adverse reactions (6.2)]. risk summary limited published studies report on the use of budesonide in pregnant women; however, the data are insufficient to inform a drug-associated risk for major birth defects and miscarriage. there are clinical considerations (see clinical considerations). in animal reproduction studies with pregnant rats and rabbits, administration of subcutaneous budesonide during organogenesis at doses approximately 0.5 times or 0.05 times, respectively, the max

European Union - English - EMA (European Medicines Agency)

ferring pharmaceuticals a/s - atosiban (as acetate) - premature birth - other gynecologicals - tractotile is indicated to delay imminent pre-term birth in pregnant adult women with:regular uterine contractions of at least 30 seconds duration at a rate of ≥ 4 per 30 minutes;a cervical dilation of 1 to 3 cm (0-3 for nulliparas) and effacement of ≥ 50%;a gestational age from 24 until 33 completed weeks;a normal foetal heart rate.

Australia - English - Department of Health (Therapeutic Goods Administration)

ferring pharmaceuticals pty ltd - desmopressin acetate -

Australia - English - Department of Health (Therapeutic Goods Administration)

ferring pharmaceuticals pty ltd - triptorelin acetate, quantity: 100 microgram (equivalent: triptorelin, qty 95.6 microgram/ml) - injection, solution - excipient ingredients: glacial acetic acid; water for injections; sodium chloride - decapeptyl 100 micrograms/1 ml is indicated for down-regulation and prevention of premature luteinising hormone (lh) surges in women undergoing controlled ovarian hyperstimulation for assisted reproductive technologies (art).,in clinical trials decapeptyl 100 micrograms/1 ml has been used in cycles where urinary and recombinant human follicle stimulating hormone (fsh) as well as human menopausal gonadotrophin (hmg) were used for stimulation.

Australia - English - Department of Health (Therapeutic Goods Administration)

ferring pharmaceuticals pty ltd - mesalazine, quantity: 4 g - granules, modified release - excipient ingredients: povidone; ethylcellulose - treatment of mild to moderate ulcerative colitis and crohn's disease and maintenance of remission.

Australia - English - Department of Health (Therapeutic Goods Administration)

ferring pharmaceuticals pty ltd - mesalazine, quantity: 1 g - tablet, modified release - excipient ingredients: magnesium stearate; purified talc; ethylcellulose; povidone; microcrystalline cellulose - treatment of mild to moderate ulcerative colitis and crohn's disease and maintenance of remission.

Australia - English - Department of Health (Therapeutic Goods Administration)

ferring pharmaceuticals pty ltd - human menopausal gonadotrophin, quantity: 1200 iu - injection, solvent for - excipient ingredients: water for injections; metacresol - menopur is indicated for the treatment of infertility in the following clinical situations:,anovulatory infertility, including polycystic ovarian disease (pcod), in women who have been unresponsive to treatment with clomiphene citrate.,controlled ovarian hyperstimulation to induce the development of multiple follicles for assisted reproductive technologies (art) (e.g. in vitro fertilisation/embryo transfer (ivf/et), gamete intra-fallopian transfer (gift) and intracytoplasmic sperm injection (icsi)).

Australia - English - Department of Health (Therapeutic Goods Administration)

ferring pharmaceuticals pty ltd - human menopausal gonadotrophin, quantity: 600 iu - injection, solvent for - excipient ingredients: water for injections; metacresol - menopur is indicated for the treatment of infertility in the following clinical situations:,anovulatory infertility, including polycystic ovarian disease (pcod), in women who have been unresponsive to treatment with clomiphene citrate.,controlled ovarian hyperstimulation to induce the development of multiple follicles for assisted reproductive technologies (art) (e.g. in vitro fertilisation/embryo transfer (ivf/et), gamete intra-fallopian transfer (gift) and intracytoplasmic sperm injection (icsi)).

Australia - English - Department of Health (Therapeutic Goods Administration)

ferring pharmaceuticals pty ltd - mesalazine, quantity: 2 g - granules, modified release - excipient ingredients: povidone; ethylcellulose - treatment of mild to moderate ulcerative colitis and crohn's disease and maintenance of remission.