South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

novagen pharma (pty) ltd - #n/a - not indicated - none

Philippines - English - FDA (Food And Drug Administration)

castlerock biotech industries, inc. - ascorbic acid - capsule - 500mg ( eq. to 562.50 mg sodium ascorbate)

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

novagenit australia pty ltd - 61057 - implantable-device infection control barrier - 100% cross linked hyaluronic acid with poly dl-lactide powder hydrated before use with an antibiotic solution. other elements provided are sterile empty syringe, sterile accessories for hydration & uniform application onto the surfaces of the implant. antibiotic loading of hydrogel destroys bacteria kept in planktonic state by temporary coating and complements systemic antibiotic dose by generating high local concentration at the implant site. biodegradable and absorbed in less than 7 days. kit dac is a product designed for the preparation and application of a bio-resorbable hydrogel coating mixed with antibiotics to be used in orthopaedics and traumatology for prevention of surgical site infections. the product in combination with an antibiotic is specifically indicated in orthopaedics and traumatology as a preventive measure against bacterial adhesion, colonization (which is cause of bacterial infections) on the implant surface in the very early time window after implantation. dac is an antibacterial coating indicated to be applied on uncemented prostheses and on trauma devices. - when considering whether to use dac, patient selection must be balanced between patient risk factors / co-morbidities and responsible antimicrobial stewardship. - dac is indicated to deliver antibiotics for primary or secondary prevention of deep periprosthetic infection in patients of both sexes 18+ years of age who have an elevated risk of such infection in the following surgeries: o patients undergoing second stage (aseptic) uncemented or hybrid hip and knee arthroplasty for periprosthetic infection o patients undergoing primary uncemented or hybrid hip and knee arthroplasty in groups known to be risk for infection including: * class 2 or class 3 obesity (bmi > 35) * asa 2+ o patients undergoing orthopaedic long bone fracture fixation <7 days from injury o patients undergoing all-cause revision surgery, with the same risk factors as the primary arthroplasty population

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

novagen pharma (pty) ltd - tramadol hydrochloride & paracetamol - tablet - see ingredients - each film- coated tablet contains: tramadol hydrochloride37,5 mg; paracetamol 325,0 mg

Philippines - English - FDA (Food And Drug Administration)

under license from: nirpromp - vitex negundo l. (lagundi leaf) - syrup - 300mg/ 5ml

Philippines - English - FDA (Food And Drug Administration)

ascorbic acid - capsule - 500 mg (equivalent to 608.5 mg calcium ascorbate)

Philippines - English - FDA (Food And Drug Administration)

n/a; distributor: n/a - ascorbic acid - syrup (orange flavor) - 100mg/5ml

Philippines - English - FDA (Food And Drug Administration)

fervormed opc - cetirizine dihydrochloride - syrup (oral drops) (orange flavor) - 2.5mg/ml

Philippines - English - FDA (Food And Drug Administration)

fervormed opc - cetirizine dihydrochloride - syrup - 5mg/5ml

Philippines - English - FDA (Food And Drug Administration)

fervormed opc - cetirizine hydrochloride - syrup (oral drops) (orange flavor) - 2.5mg/ml