Canada - English - Health Canada

bausch health, canada inc. - tretinoin - lotion - 0.05% - tretinoin 0.05% - cell stimulants and proliferants

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

baxter healthcare pty ltd - thrombin; factor xiii; calcium chloride; fibrinogen; aprotinin -

Canada - English - Health Canada

bausch health, canada inc. - clindamycin phosphate; tretinoin - gel - 1.2%; 0.025% - clindamycin phosphate 1.2%; tretinoin 0.025% - keratolytic agents

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

baxter healthcare pty ltd - human thrombin, quantity: 3.2 iu/ml; calcium chloride dihydrate, quantity: 36 micromole/ml - solution - excipient ingredients: sodium chloride; albumin; water for injections - artiss is indicated to adhere autologous skin grafts in burn patients. artiss is indicated to adhere tissue flaps during rhytidectomy (face-lift). artiss is not indicated for haemostasis

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

haleon uk ltd - diclofenac diethylammonium - cutaneous gel - 23.2mg/1gram

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

colorama pharmaceuticals ltd - diclofenac diethylammonium - cutaneous gel - 23.2mg/1gram

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

de pharmaceuticals - diclofenac diethylammonium - cutaneous gel - 23.2mg/1gram

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

bausch health us, llc - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c), tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - clindamycin 12 mg in 1 g - ziana gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older. ziana gel is contraindicated in patients with regional enteritis, ulcerative colitis, or history of antibiotic-associated colitis. pregnancy category c. there are no well-controlled trials in pregnant women treated with ziana gel. ziana gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. ziana gel was tested for maternal and developmental toxicity in new zealand white rabbits with topical doses of 60, 180 and 600 mg/kg/day. ziana gel at 600 mg/kg/day (approximately 12 times the recommended clinical dose assuming 100% absorption and based on body surface area comparison) was considered to be the no-observed-adverse-effect level (noael) for maternal and developmental toxicity following dermal administration of ziana gel for 2 weeks prior to artificial insemination and continuing until gestation day 18, inclusive. for purposes of comparisons of the animal expos

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

oceanside pharmaceuticals - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c), tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - clindamycin phosphate 1.2% and tretinoin 0.025% gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older. clindamycin phosphate 1.2% and tretinoin 0.025% gel is contraindicated in patients with regional enteritis, ulcerative colitis, or history of antibiotic-associated colitis. pregnancy category c. there are no well-controlled trials in pregnant women treated with clindamycin phosphate 1.2% and tretinoin 0.025% gel. clindamycin phosphate 1.2% and tretinoin 0.025% gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. clindamycin phosphate 1.2% and tretinoin 0.025% gel was tested for maternal and developmental toxicity in new zealand white rabbits with topical doses of 60, 180 and 600 mg/kg/day. clindamycin phosphate 1.2% and tretinoin 0.025% gel at 600 mg/kg/day (approximately 12 times the recommended clinical dose assuming 100% absorption and based on body surface area comparison) was considered to be the no-observed-adve

New Zealand - English - Medsafe (Medicines Safety Authority)

baxter healthcare ltd - aprotinin 2250 kiu/ml - 3750 kiu/ml; factor xiii 1.2 iu/ml - 10 iu/ml; fibrinogen 72 mg/ml - 110 mg/ml; calcium chloride dihydrate 0.036 mmol/ml - 0.044 mmol/ml; thrombin 3.2 iu/ml - 5 iu/ml - topical solution - 4 iu - active: aprotinin 2250 kiu/ml - 3750 kiu/ml factor xiii 1.2 iu/ml - 10 iu/ml fibrinogen 72 mg/ml - 110 mg/ml excipient: albumin histidine nicotinamide polysorbate 80 sodium citrate dihydrate water for injection active: calcium chloride dihydrate 0.036 mmol/ml - 0.044 mmol/ml thrombin 3.2 iu/ml - 5 iu/ml excipient: albumin sodium chloride water for injection - artiss is indicated for use in adhering autologous skin grafts in burn patients. artiss is not indicated for haemostasis.