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

viatris pty ltd - tretinoin, quantity: 0.25 mg; clindamycin phosphate, quantity: 12 mg (equivalent: clindamycin, qty 10 mg) - gel - excipient ingredients: purified water; disodium edetate; methyl hydroxybenzoate; carbomer 981; butylated hydroxytoluene; polysorbate 80; citric acid; glycerol; propyl hydroxybenzoate; trometamol - acnatac is indicated for the topical treatment of acne vulgaris when comedones, papules and pustules are present in patients 12 years or older. consideration should be given to official guidance on the appropriate use of antibacterial agents and acne treatment.

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

sun pharma anz pty ltd - sonidegib phosphate, quantity: 280.8 mg (equivalent: sonidegib, qty 200 mg) - capsule, hard - excipient ingredients: colloidal anhydrous silica; magnesium stearate; purified water; gelatin; lactose monohydrate; titanium dioxide; iron oxide red; sodium lauryl sulfate; poloxamer; crospovidone; butylated hydroxytoluene; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; ethanol absolute; iron oxide black; ethanol; shellac; sulfuric acid - odomzo is indicated for the treatment of adult patients with:,- locally advanced basal cell carcinoma (bcc) who are not amenable to curative surgery or radiation therapy.,- metastatic bcc

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

novartis pharmaceuticals australia pty ltd - ruxolitinib phosphate, quantity: 19.8 mg (equivalent: ruxolitinib, qty 15 mg) - tablet - excipient ingredients: povidone; microcrystalline cellulose; magnesium stearate; lactose monohydrate; sodium starch glycollate type a; colloidal anhydrous silica - jakavi is indicated for the treatment of disease-related splenomegaly or symptoms in patients with primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythaemia myelofibrosis.,jakavi is indicated for the treatment of adult patients with polycythemia vera who are resistant to or intolerant of hydroxyurea.,jakavi is indicated for the treatment of patients aged 12 years and older with acute graft-versus-host disease who have inadequate response to corticosteroids.,jakavi is indicated for the treatment of patients aged 12 years and older with chronic graft-versus-host disease who have inadequate response to corticosteroids.

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

novartis pharmaceuticals australia pty ltd - ruxolitinib phosphate, quantity: 6.6 mg (equivalent: ruxolitinib, qty 5 mg) - tablet - excipient ingredients: hyprolose; povidone; lactose monohydrate; microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; sodium starch glycollate type a - jakavi is indicated for the treatment of disease-related splenomegaly or symptoms in patients with primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythaemia myelofibrosis.,jakavi is indicated for the treatment of adult patients with polycythemia vera who are resistant to or intolerant of hydroxyurea.,jakavi is indicated for the treatment of patients aged 12 years and older with acute graft-versus-host disease who have inadequate response to corticosteroids.,jakavi is indicated for the treatment of patients aged 12 years and older with chronic graft-versus-host disease who have inadequate response to corticosteroids.

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

novartis pharmaceuticals australia pty ltd - ruxolitinib phosphate, quantity: 26.4 mg (equivalent: ruxolitinib, qty 20 mg) - tablet - excipient ingredients: colloidal anhydrous silica; microcrystalline cellulose; hyprolose; magnesium stearate; lactose monohydrate; sodium starch glycollate type a; povidone - jakavi is indicated for the treatment of disease-related splenomegaly or symptoms in patients with primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythaemia myelofibrosis.,jakavi is indicated for the treatment of adult patients with polycythemia vera who are resistant to or intolerant of hydroxyurea.,jakavi is indicated for the treatment of patients aged 12 years and older with acute graft-versus-host disease who have inadequate response to corticosteroids.,jakavi is indicated for the treatment of patients aged 12 years and older with chronic graft-versus-host disease who have inadequate response to corticosteroids.

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

nucare pharmaceuticals, inc. - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - acetaminophen 300 mg - acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain,where treatment with an opioid is appropriate and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings ], reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] - have not provided adequate analgesia, or are not expected to provide adequate analgesia - have not been tolerated, or are not expected to be tolerated acetaminophen and codeine phosphate tablets are contraindicated in patients with: - patients with significant respiratory depression [see warnings].  - patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings].  - postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy [see warnings]

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

preferred pharmaceuticals inc. - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - acetaminophen 300 mg - acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings ], reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] acetaminophen and codeine phosphate tablets are contraindicated for: acetaminophen and codeine phosphate tablets are contraindicated in patients with: acetaminophen and codeine phosphate tablets contain codeine. codeine in combination with acetaminophen, a schedule iii controlled substance. acetaminophen and codeine phosphate tablets contain codeine, a substance with a high potential for abuse similar to other opioids, including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol. acetaminophen and c

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

physician therapeutics llc - codeine phosphate (unii: gsl05y1mn6) (codeine - unii:q830pw7520), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - codeine phosphate 30 mg - indications and usage acetaminophen and codeine phosphate tablets are indicated for the relief of mild to moderately severe pain. contraindications this product should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen. drug abuse and dependence controlled substance: acetaminophen and codeine phosphate tablets are classified as a schedule iii controlled substance. abuse and dependence: codeine can produce drug dependence of the morphine type and, therefore, has the potential for being abused. psychological dependence, physical dependence, and tolerance may develop upon repeated administration, and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral narcotic medications. indications for use theramine is intended for the clinical dietary management of the metabolic processes of pain disorders and inflammatory conditions. precautions and contraindications theramine is contraindicated in an extre

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

fresenius kabi usa, llc - fludarabine phosphate (unii: 1x9vk9o1sc) (fludarabine - unii:p2k93u8740) - fludarabine phosphate 25 mg in 1 ml - fludarabine phosphate injection, usp is indicated for the treatment of patients with b-cell chronic lymphocytic leukemia (cll) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen.  the safety and effectiveness of fludarabine phosphate injection, usp in previously untreated or non-refractory patients with cll have not been established. fludarabine phosphate injection, usp is contraindicated in those patients who are hypersensitive to this drug or its components.

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

par pharmaceutical, inc. - butalbital (unii: khs0az4jvk) (butalbital - unii:khs0az4jvk), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), caffeine (unii: 3g6a5w338e) (caffeine - unii:3g6a5w338e), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - butalbital 50 mg - butalbital, acetaminophen, caffeine, and codeine phosphate capsules are indicated for the management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse with opioids and butalbital, even at recommended doses [see warnings and precautions (5.1)], reserve butalbital, acetaminophen, caffeine, and codeine phosphate capsules for use in patients for whom alternative treatment options [e.g., non-opioid, non-barbiturate analgesics]: - have not been tolerated, or are not expected to be tolerated, - have not provided adequate analgesia, or are not expected to provide adequate analgesia. butalbital, acetaminophen, caffeine, and codeine phosphate capsules are contraindicated for: - all children younger than 12 years of age [see warnings and precautions (5.5)]. - post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoide