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

i-care pharma distributors pty ltd - ocriplasmin -

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

i-care pharma distributors pty ltd - ocriplasmin, quantity: 1.25 mg/ml - injection, solution - excipient ingredients: mannitol; citric acid monohydrate; sodium chloride; sodium hydroxide; hydrochloric acid; water for injections - jetrea rtu is indicated in adults for the treatment of vitreomacular traction (vmt), including when associated with macular hole of diameter less than or equal to 400 microns.

Ireland - Inggeris - HPRA (Health Products Regulatory Authority)

norbrook laboratories limited - cyanocobalamin - solution for injection - 0.05 %w/v - antianemic preparations - bovine, canine, caprine, equine - food, feline, ovine, porcine - vitamins & minerals

Ireland - Inggeris - HPRA (Health Products Regulatory Authority)

norbrook laboratories limited - cyanocobalamin - solution for injection - 0.05 percent weight/volume - antianemic preparations - cats, cattle, dogs, goats, horses, pigs, sheep - vitamins and minerals

United Kingdom - Inggeris - VMD (Veterinary Medicines Directorate)

norbrook laboratories limited - cyanocobalamin - solution for injection - vitamin - cattle, horses, pigs, sheep

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

roche products pty ltd - faricimab, quantity: 120 mg/ml - injection, solution - excipient ingredients: histidine; acetic acid; methionine; sodium chloride; sucrose; polysorbate 20; water for injections - vabysmo is indicated for the treatment of:,- neovascular (wet) age-related macular degeneration (namd),- diabetic macular oedema (dmo).

Kanada - Inggeris - Health Canada

bausch & lomb inc - ganciclovir - implant - 4.5mg - ganciclovir 4.5mg - nucleosides and nucleotides

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

allergan, inc. - dexamethasone (unii: 7s5i7g3jql) (dexamethasone - unii:7s5i7g3jql) - dexamethasone 0.7 mg - ozurdex ®   (dexamethasone intravitreal implant) is indicated for the treatment of macular edema following branch retinal vein occlusion (brvo) or central retinal vein occlusion (crvo). ozurdex ®   is indicated for the treatment of non-infectious uveitis affecting the posterior segment of the eye. ozurdex ®   is indicated for the treatment of diabetic macular edema.   ozurdex ®   (dexamethasone intravitreal implant) is contraindicated in patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.  ozurdex ® is contraindicated in patients with glaucoma, who have cup to disc ratios of greater than 0.8. ozurdex ® is contraindicated in patients whose posterior lens capsule is torn or ruptured because of the risk of migration into the anterior chamber. laser posterior capsulotomy in pseudophakic patients is not a contraindication for ozurdex ® use. ozurdex ® is contraindicated in patients with known hypersensitivity to any components of this product [see adverse reactions ( 6 )] . risk summary there are no adequate and well-controlled studies with ozurdex ® in pregnant women. topical ocular administration of dexamethasone in mice and rabbits during the period of organogenesis produced cleft palate and embryofetal death in mice, and malformations of the abdominal wall/intestines and kidneys in rabbits at doses 5 and 4 times higher than the recommended human ophthalmic dose (rhod) of ozurdex ® (0.7 milligrams dexamethasone), respectively. in the us 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. data animal data topical ocular administration of 0.15% dexamethasone (0.75 mg/kg/day) on gestational days 10 to 13 produced embryofetal lethality and a high incidence of cleft palate in mice. a dose of 0.75 mg/kg/day in the mouse is approximately 5 times an ozurdex ® injection in humans (0.7 mg dexamethasone) on a mg/m2 basis. in rabbits, topical ocular administration of 0.1% dexamethasone throughout organogenesis (0.20 mg/kg/day, on gestational day 6 followed by 0.13 mg/kg/day on gestational days 7-18) produced intestinal anomalies, intestinal aplasia, gastroschisis and hypoplastic kidneys. a dose of 0.13 mg/kg/day in the rabbit is approximately 4 times an ozurdex ® injection in humans (0.7 mg dexamethasone) on a mg/m2 basis. a no-observed-adverse-effect-level (noael) was not identified in the mouse or rabbits studies. risk summary systemically administered corticosteroids are present in human milk and can suppress growth and interfere with endogenous corticosteroid production or cause other unwanted effects. there is no information regarding the presence of dexamethasone in human milk, the effects on the breastfed infants, or the effects on milk production to inform risk of ozurdex ® to an infant during lactation. the developmental and health benefits of breastfeeding should be considered, along with  the mother’s clinical need for ozurdex ® and any potential adverse effects on the breastfed child from ozurdex ® . safety and effectiveness of ozurdex ® in pediatric patients have not been established. no overall differences in safety or effectiveness have been observed between elderly and younger patients.

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

alimera sciences, inc. - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - fluocinolone acetonide 0.19 mg - iluvien® (fluocinolone acetonide intravitreal implant) 0.19 mg is indicated for the treatment of diabetic macular edema (dme) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. iluvien is contraindicated in patients with active or suspected ocular or periocular infections including most viral disease of the cornea and conjunctiva including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections and fungal diseases. iluvien is contraindicated in patients with glaucoma, who have cup to disc ratios of greater than 0.8. iluvien is contraindicated in patients with known hypersensitivity to any components of this product. pregnancy category c there are no adequate and well-controlled studies of iluvien in pregnant women. animal reproduction studies have not been conducted with fluocinolone acetonide. corticosteroids have been shown to be teratogenic in labor