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A MEDICAMENT WITH AN ACTIVE PHARMACEUTICAL INGREDIENT PUT UP IN MEASURED DOSES (10MG & 20MG TABLETS) FOR HUMAN CONSUMPTION. IT IS USED IN THE TREATMENT OF SEVERE ASTHMA AND ALLERGIC REACTIONS IN ADULTS & CHILDREN AND AS REPLACEMENT THERAPY FOR CHILDREN WITH CONGENITAL ADRENAL HYPERPLASIA.

SOLU-CORTEF STERILE POWDER IS A MEDICAMENT PACKAGED IN MEASURED DOSES. IT IS AN ANTI-INFLAMMATORY GLUCOCORTICOID, WHICH CONTAINS HYDROCORTISONE SODIUM SUCCINATE AS THE ACTIVE INGREDIENT. SOLU-CORTEF STERILE POWDER IS AVAILABLE IN SEVERAL PACKAGES FOR INTRAVENOUS OR INTRAMUSCULAR ADMINISTRATION. VIALS CONTAIN HYDROCORTISONE SODIUM SUCCINATE, MONOBASIC SODIUM PHOSPHATE ANHYDROUS AND DIBASIC SODIUM PHOSPHATE DRIED. AS A POWDER IT IS MIXED WITH SOLUTION IN ORDER TO FORM THE INJECTABLE SOLUTION.

BECLOMETHASONE DIPROPINATE HFA, WHICH IS CORTICOSTEROID IN NATURE, IS THE ACTIVE INGREDIENT IN INHALATION AEROSOL CANS, USED AS A PREVENTER ASTHMATIC THERAPY RESPIRATORY PHARMACEUTICAL PRODUCT. THE PRODUCT IS PUT UP IN MEASURED DOSES FOR RETAIL SALE. COLOUR: CLEAR SOLUTION UNDER PRESSURE GENERAL PHYSICAL FORM: GAS SPECIFIC PHYSICAL FORM: AEROSOL

SUMMARY ILUVIEN R A PHARMACEUTICAL, IS INDICATED FOR THE TREATMENT OF VISUAL IMPAIRMENT DUE TO DIABETIC MACULAR EDEMA (DME) INSUFFICIENTLY RESPONSIVE TO AVAILABLE THERAPY. THE ACTIVE INGREDIENT, FLUOCINOLONE ACETONIDE (FAC), IN ILUVIEN R IS A HALOGENATED CORTICOSTEROID. ILIVIEN R IS AVAILABLE BY PRESCRIPTION ONLY AND IS PACKAGED AS A SINGLE DOSE. THE VALUE OF A UNIT OF ILUVIEN R IS $350. THE ACTIVE INGREDIENT FLUOCINOLONE ACETONIDE IS INCLUDED UNDER THE CUSTOMS NOMENCLATURE CODE 2937220 (HALOGENATED DERIVATIVES OF CORTICOSTEROIDAL HORMONES). HOWEVER THE ILUVIEN R PRODUCT FALLS UNDER THE CUSTOMS NOMENCLATURE CODE 30043900 (MEDICAMENTS, CONTAINING PRODUCTS OF HEADING 2937 NESOI, IN DOSAGE FORM OR PACKED FOR RETAIL). PRODUCT DETAILS: ILUVIEN R CARTON CONTAINS: A SINGLE SUSTAINED RELEASE STERILE INJECTABLE INTRAVITREAL INSERT MADE FROM A TINY HOLLOW POLYIMIDE TUBE CONTAINING 190 UG OF FLUOCINOLONE ACETONIDE (FAC) THAT IS PRELOADED INTO A STERILE DISPOSABLE APPLICATOR. THE APPLICATOR CONSISTS OF A PLASTIC HANDPIECE WITH A STAINLESS STEEL NEEDLE ATTACHED TO A GUIDESHAFT WHERE THE INSERT IS HELD IN PLACE PRIOR TO USE. THE STAINLESS STEEL PUSH ROD IN THE GUIDESHAFT IS ACTIVATED BY SLIDING FORWARD THE BUTTON LOCATED ON TOP OF THE APPLICATOR. THIS ACTION PUSHES THE INSERT INTO THE NEEDLE JUST PRIOR TO INSERTION INTO THE EYE. ONCE THE NEEDLE IS INSIDE THE EYE, THE BUTTON IS AGAIN SLID FORWARD TO DELIVER THE INSERT. THE NEEDLE IS PROTECTED BY A SAFETY CAP. ILUVIEN R IS PACKAGED IN A STERILE PLASTIC TRAY WITH A TYVEK LID. ILUVIEN R IS FOR SINGLE USE ONLY AND IS DESIGNED FOR THE TREATMENT OF A SINGLE EYE. THE TECHNOLOGY INVOLVES THE USE OF A TINY HOLLOW POLYIMIDE CYLINDER (3.5 MM X 0.37MM) CONTAINING FAC WHICH CAN BE INSERTED THROUGH THE PARS PLANA INTO THE OCULAR VITREOUS CHAMBER BY INJECTION THROUGH A 25-GAUGE NEEDLE. THE 25- GAUGE NEEDLE IS MODIFIED TO CONTROL THE INJECTION DEPTH. ILUVIEN R IS DESIGNED TO HAVE AN INITIAL RELEASE RATE OF 0.25 UG/DAY OF FAC AND RELEASES FAC UP TO 30-36 MONTHS. THE PACKAGED PRODUCT IS TERMINALLY STERILIZED BY GAMMA IRRADIATION FOR USE IN AN OUTPATIENT SETTING. THE STORAGE TEMPERATURE RANGE IS 15 – 30C AND THE PROPOSED SHELF LIFE IS 24 MONTHS.FAC IS A MEMBER OF A CLASS OF FLUORINATED (HALOGENATED) SYNTHETIC CORTICOSTEROIDS THAT INCLUDE DEXAMETHASONE, TRIAMCINOLONE ACETONIDE AND FLUOCINONIDE. FAC IS QUANTITATIVELY DETERMINED BY HIGH PRESSURE LIQUID CHROMATOGRAPHY (HPLC) AS A QUALITY REQUIREMENT BEFORE BEING APPROVED AS A FINISHED PRODUCT. THE CHEMICAL NAME FOR FLUOCINOLONE ACETONIDE IS: PREGNA-1,4-DIENE-3,20-DIONE, 6,9-DIFLUORO-11,21-DIHYDROXY-16,17-(1-METHYL-ETHYLIDENE)BIS(OXY)1-, (6A, 1 1B, 16A)-. THE INSERT IS MADE FROM THE FOLLOWING MATERIALS: POLYIMIDE-INACTIVE INGREDIENT. POLYVINYL ALCOHOL (PVA) – INACTIVE INGREDIENT. SILICONE ADHESIVE – INACTIVE INGREDIENT. WATER FOR INJECTION – INACTIVE INGREDIENT. FLUOCINOLONE ACETONIDE – ACTIVE INGREDIENT. THE APPLICATOR IS MADE FROM THE FOLLOWING MATERIALS: 304 STAINLESS STEEL. ZYLAR 220 (ACRYLIC). LUSTRAN 348-012002 (ABS). SANTOPRENE TPV 8271-55B100. METHOD OF PRODUCTION: INJECTION MOULDING. MACHINING. MANUAL ASSEMBLY. MANUAL AND AUTOMATED PACKAGING. MANUAL FORMULATION OF THE FAC COMPOUND

KENACORT-A IS GIVEN AS AN INJECTION INTO JOINTS, TENDONS, SKIN OR MUSCLE. INJECTION INTO JOINTS AND TENDONS MAY BE GIVEN AS SHORT-TERM TREATMENT OF OSTEOARTHRITIS, RHEUMATOID ARTHRITIS, BURSITIS, GOUT, EPICONDYLITIS AND TENOSYNOVITIS. INJECTIONS MAY BE GIVEN INTO THE SKIN TO TREAT CONDITIONS SUCH AS KELOIDS, GANGLIA, DISCOID LUPUS AND PSORIASIS.INJECTIONS INTO THE MUSCLE CAN BE USED TO PROVIDE SYSTEMIC CORTICOSTEROID THERAPY. PUT UP IN MEASURED DOSES OF 5 X 1 ML. THE ACTIVE INGREDIENT IS TRIAMCINOLONE ACETONIDE