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

douglas pharmaceuticals australia pty ltd - isotretinoin, quantity: 5 mg - capsule, soft - excipient ingredients: sorbitol solution (70 per cent) (non-crystallising); glycerol; purified water; butylated hydroxyanisole; hydrogenated vegetable oil; titanium dioxide; disodium edetate; soya oil; dl-alpha-tocopherol; gelatin; yellow beeswax; partially hydrogenated soya oil - treatment of patients with severe cystic acne and a single course of therapy has been shown to result in complete and prolonged remission of disease in many patients. if a second course of therapy is needed, it should not be initiated until at least eight weeks after completion of the first course, since experience has shown that patients may continue to improve while off the drug. because of significant adverse effects associated with its use, isotretinoin should be reserved for patients with severe cystic acne who are unresponsive to conventional therapy, including systemic antibiotics.

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

douglas pharmaceuticals australia pty ltd - isotretinoin, quantity: 40 mg - capsule, soft - excipient ingredients: titanium dioxide; glycerol; sorbitol solution (70 per cent) (non-crystallising); hydrogenated soya oil; dl-alpha-tocopherol; soya oil; disodium edetate; butylated hydroxyanisole; sunset yellow fcf; gelatin; partially hydrogenated soya oil; yellow beeswax; purified water - oratane is indicated for the treatment of severe cystic acne and a single course of therapy has been shown to result in complete and prolonged remission of disease in many patients. if a second course of therapy is needed, it should not be initiated until at least eight weeks after completion of the first course, since experience has shown that patients may continue to improve while off the drug. because of significant adverse effects associated with its use, isotretinoin should be reserved for patients with severe cyctic acne who are unresponsive to conventional therapy, including systemic antibiotics.

European Union - English - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - tezacaftor, ivacaftor - cystic fibrosis - other respiratory system products - symkevi is indicated in a combination regimen with ivacaftor tablets for the treatment of patients with cystic fibrosis (cf) aged 6 years and older who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: p67l, r117c, l206w, r352q, a455e, d579g, 711+3a→g, s945l, s977f, r1070w, d1152h, 2789+5g→a, 3272 26a→g, and 3849+10kbc→t.

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

douglas pharmaceuticals australia pty ltd - isotretinoin, quantity: 10 mg - capsule, soft - excipient ingredients: gelatin; soya oil; sorbitol solution (70 per cent) (non-crystallising); yellow beeswax; brilliant scarlet 4r; dl-alpha-tocopherol; disodium edetate; purified water; glycerol; butylated hydroxyanisole; iron oxide black; titanium dioxide; partially hydrogenated soya oil; hydrogenated vegetable oil - treatment of severe cystic acne. a single course of therapy has been shown to result in complete and prolonged remission of disease in many patients. if a second course of therapy is needed, it should not be initiated until at least eight weeks after completion of the first course, since experience has shown that patients may continue to improve while off the drug. because of significant adverse effects associated with its use, isotretinoin should be reserved for patients with severe cystic acne who are unresponsive to conventional therapy, including systemic antibiotics.

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

douglas pharmaceuticals australia pty ltd - isotretinoin, quantity: 20 mg - capsule, soft - excipient ingredients: purified water; indigo carmine; gelatin; disodium edetate; partially hydrogenated soya oil; butylated hydroxyanisole; dl-alpha-tocopherol; sorbitol solution (70 per cent) (non-crystallising); glycerol; yellow beeswax; brilliant scarlet 4r; soya oil; titanium dioxide; hydrogenated vegetable oil - oratane is indicated for the treatment of severe cystic acne and a single course of therapy has been shown to result in complete and prolonged remission of disease in many patients. if a second course of therapy is needed, it should not be initiated until at least eight weeks after completion of the first course, since experience has shown that patients may continue to improve while off the drug. because of significant adverse effects associated with its use. isotretinoin should be reversed for patients with severe cystic acne who are unresponsive to conventional therapy, including systemic antibiotics.

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

douglas pharmaceuticals australia pty ltd - isotretinoin, quantity: 30 mg - capsule, soft - excipient ingredients: soya oil; disodium edetate; partially hydrogenated soya oil; hydrogenated soya oil; yellow beeswax; gelatin; glycerol; sorbitol solution (70 per cent) (non-crystallising); purified water; titanium dioxide; iron oxide red; butylated hydroxyanisole; dl-alpha-tocopherol - treatment of severe cystic acne. a single course of therapy has been shown to result in complete and prolonged remission of disease in many patients. if a second course of therapy is needed, it should not be initiated until at least eight weeks after completion of the first course, since experience has shown that patients may continue to improve while off the drug. because of significant adverse effects associated with its use, isotretinoin should be reserved for patients with severe cystic acne who are unresponsive to conventional therapy, including systemic antibiotics.

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

novomedx inc, united states - syrup - 800 mg - butterbur herb dried extract

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

glenmark pharmaceuticals (malaysia) sdn. bhd. - olopatadine hydrochloride; mometasone furoate -

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

hikma pharmaceuticals usa inc. - ipratropium bromide (unii: j697uz2a9j) (ipratropium - unii:gr88g0i6ul) - ipratropium bromide anhydrous 21 ug - ipratropium bromide nasal solution 0.03% is indicated for the symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis in adults and children age 6 years and older. ipratropium bromide 0.03% does not relieve nasal congestion, sneezing, or postnasal drip associated with allergic or nonallergic perennial rhinitis. ipratropium bromide nasal solution 0.03% is contraindicated in patients with a history of hypersensitivity to atropine or its derivatives, or to any of the other ingredients. ipratropium bromide nasal solution, 0.03% nasal spray, 21mcg/spray read complete instructions carefully before using. in order to ensure proper dosing, do not attempt to change the size of the spray opening.   ipratropium bromide nasal solution, 0.03% is indicated for the symptomatic relief of rhinorrhea (runny nose) associated with allergic and nonallergic perennial rhinitis in adults and children age 6 years and older. ipratropium bromide nasal solution, 0.03% does not relieve nasal congestion, sneezing, or postnasal drip associated with allergic or nonallergic perennial rhinitis. read complete instructions carefully and use only as directed. to use: figure 1 figure 1 figure 2 figure 2 figure 3 figure 3 to clean: if the nasal tip becomes clogged, remove the clear plastic dust cap and safety clip. hold the nasal tip under running, warm tap water (figure 4) for about a minute. dry the nasal tip, reprime the nasal spray pump (step 2 above), and replace the plastic dust cap and safety clip. figure 4 figure 4 caution: ipratropium bromide nasal solution, 0.03% is intended to relieve your rhinorrhea (runny nose) with regular use. it is therefore important that you use ipratropium bromide nasal solution, 0.03% as prescribed by your physician. for most patients, some improvement in runny nose is usually apparent during the first full day of treatment with ipratropium bromide nasal solution, 0.03% some patients may require up to two weeks of treatment to obtain maximum benefit. do not spray ipratropium bromide nasal solution, 0.03% in your eyes. should this occur, immediately flush your eye with cool tap water for several minutes. if you accidentally spray ipratropium bromide nasal solution, 0.03% in your eyes, you may experience a temporary blurring of vision, visual halos or colored images in association with red eyes from conjunctival and corneal congestion, development or worsening of narrow-angle glaucoma, pupil dilation, or acute eye pain/discomfort, and increased sensitivity to light, which may last a few hours. should acute eye pain or blurred vision occur, contact your doctor. should you experience excessive nasal dryness or episodes of nasal bleeding contact your doctor. if you have glaucoma or difficulty urinating due to an enlargement of the prostate, be sure to tell your physician prior to using ipratropium bromide nasal solution, 0.03% if you are pregnant or you are breast feeding your baby, be sure to tell your physician prior to using ipratropium bromide nasal solution, 0.03% storage store at 20° to 25°c (68° to 77°f). [see usp controlled room temperature.] avoid freezing. keep out of reach of children. address medical inquiries to hikma pharmaceuticals usa inc. at 1-800-962-8364. distributed by: hikma pharmaceuticals usa inc. berkeley heights, nj 07922 c50000619/01 revised july 2022

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

hikma pharmaceuticals usa inc. - ipratropium bromide (unii: j697uz2a9j) (ipratropium - unii:gr88g0i6ul) - ipratropium bromide nasal solution 0.06% is indicated for the symptomatic relief of rhinorrhea associated with the common cold or seasonal allergic rhinitis for adults and children age 5 years and older. ipratropium bromide 0.06% does not relieve nasal congestion or sneezing associated with the common cold or seasonal allergic rhinitis. the safety and effectiveness of the use of ipratropium bromide 0.06% beyond four days in patients with the common cold or beyond three weeks in patients with seasonal allergic rhinitis has not been established. ipratropium bromide nasal solution 0.06% is contraindicated in patients with a history of hypersensitivity to atropine or its derivatives, or to any of the other ingredients. ipratropium bromide nasal solution 0.06% nasal spray, 42 mcg/spray rx only read complete instructions carefully before using. in order to ensure proper dosing, do not attempt to change the size of the spray opening. ipratropium bromide nasal solution 0.06% is indicated for the symptomatic relief of rhinorrhea (runny nose) associated with the common cold or seasonal allergic rhinitis for adults and children age 5 years and older. ipratropium bromide nasal solution 0.06% does not relieve nasal congestion or sneezing, associated with the common cold or seasonal allergic rhinitis. do not use ipratropium bromide nasal solution 0.06 % for longer than four days for a common cold or three weeks for seasonal allergic rhinitis unless instructed by your physician. read complete instructions carefully and use only as directed. to use: figure 1 figure 1 figure 2 figure 2 figure 3 figure 3 to clean: if the nasal tip becomes clogged, remove the clear plastic dust cap and safety clip. hold the nasal tip under running, warm tap water (figure 4) for about a minute. dry the nasal tip, reprime the nasal spray pump (step 2 above), and replace the plastic dust cap and safety clip. figure 4 figure 4 caution: ipratropium bromide nasal solution 0.06% is intended to relieve your rhinorrhea (runny nose) with regular use. it is therefore important that you use ipratropium bromide nasal solution 0.06% as prescribed by your physician. for most patients, some improvement in runny nose is usually apparent following the first dose of treatment with ipratropium bromide nasal solution 0.06%. do not use ipratropium bromide nasal solution 0.06% for longer than four days for your cold or three weeks for seasonal allergic rhinitis unless instructed by your physician. do not spray ipratropium bromide nasal solution 0.06% in your eyes. should this occur, immediately flush your eye with cool tap water for several minutes. if you accidentally spray ipratropium bromide nasal solution 0.06% in your eyes, you may experience a temporary blurring of vision, visual halos or colored images in association with red eyes from conjunctival and corneal congestion, development or worsening of narrow-angle glaucoma, pupil dilation, or acute eye pain/discomfort, and increased sensitivity to light, which may last a few hours. should eye pain or blurred vision occur, contact your doctor. should you experience excessive nasal dryness or episodes of nasal bleeding, contact your doctor. if you have glaucoma or difficulty urinating due to an enlargement of the prostate, be sure to tell your physician prior to using ipratropium bromide nasal solution 0.06%. if you are pregnant or breast feeding your baby, be sure to tell your physician prior to using ipratropium bromide nasal solution 0.06%. storage store at 20° to 25°c (68° to 77°f). [see usp controlled room temperature.] avoid freezing. keep out of reach of children. address medical inquiries to hikma pharmaceuticals usa inc. at 1-800-962-8364. distributed by: hikma pharmaceuticals usa inc. berkeley heights, nj 07922 c50000618/01 revised july 2022