Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

glaxosmithkline llc - salmeterol xinafoate (unii: 6ew8q962a5) (salmeterol - unii:2i4bc502bt) - salmeterol 50 ug - serevent diskus is indicated for the treatment of asthma and in the prevention of bronchospasm only as concomitant therapy with an ics in patients aged 4 years and older with reversible obstructive airway disease, including patients with symptoms of nocturnal asthma. laba, such as salmeterol, the active ingredient in serevent diskus, as monotherapy (without ics) increase the risk of asthma-related death [see warnings and precautions (5.1)] . use of serevent diskus for the treatment of asthma without concomitant use of an ics is contraindicated [see contraindications (4)] . use serevent diskus only as additional therapy for patients with asthma who are currently taking but are inadequately controlled on an ics. do not use serevent diskus for patients whose asthma is adequately controlled on low- or medium-dose ics. pediatric and adolescent patients available data from controlled clinical trials suggest that laba as monotherapy increase the risk of asthma-related hospitalization in pediatric and adolescent pati

Սինգապուր - անգլերեն - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - bupropion hcl - tablet, film coated - 150 mg - bupropion hcl 150 mg

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

glaxosmithkline llc - ezogabine (unii: 12g01i6bbu) (ezogabine - unii:12g01i6bbu) - ezogabine 50 mg - potiga® is indicated as adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments and for whom the benefits outweigh the risk of retinal abnormalities and potential decline in visual acuity [see warnings and precautions (5.1)] . none. pregnancy category c. there are no adequate and well-controlled studies in pregnant women. potiga should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. in animal studies, doses associated with maternal plasma exposures (auc) to ezogabine and its major circulating metabolite, n-acetyl metabolite of ezogabine (namr), similar to or below those expected in humans at the maximum recommended human dose (mrhd) of 1,200 mg per day produced developmental toxicity when administered to pregnant rats and rabbits. the maximum doses evaluated were limited by maternal toxicity (acute neurotoxicity). treatment of pregnant rats with ezogabine (oral doses

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

glaxosmithkline llc - rosiglitazone maleate (unii: kx2339dp44) (rosiglitazone - unii:05v02f2kdg) - rosiglitazone 2 mg - avandia is a thiazolidinedione antidiabetic agent indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. important limitations of use: risk summary limited data with avandia in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations) . in animal reproduction studies, no adverse developmental effects were observed when rosiglitazone was administered to pregnant rats and rabbits during organogenesis at exposures up to 4 times the maximum recommended human dose (mrhd) of 8 mg daily (see data). the estimated background risk of major birth defects is 6% to 10% in women with pre-gestational diabetes with a hba1c >7 and has been reported to be as high as 20% to 25% in women with a hba1c >10. the estimated background risk of miscarriage for the indicated population is unknown. in the

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

glaxosmithkline llc - lamotrigine (unii: u3h27498ks) (lamotrigine - unii:u3h27498ks) - lamotrigine 25 mg - lamictal xr is indicated as adjunctive therapy for primary generalized tonic-clonic (pgtc) seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. lamictal xr is indicated for conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (aed). safety and effectiveness of lamictal xr have not been established (1) as initial monotherapy or (2) for simultaneous conversion to monotherapy from 2 or more concomitant aeds. safety and effectiveness of lamictal xr for use in patients younger than 13 years have not been established. lamictal xr is contraindicated in patients who have demonstrated hypersensitivity (e.g., rash, angioedema, acute urticaria, extensive pruritus, mucosal ulceration) to the drug or its ingredients [see boxed warning, warnings and precautions (5.1, 5.3)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy ou

Սինգապուր - անգլերեն - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - fluticasone propionate; salmeterol xinafoate eqv salmeterol - powder, metered - 100 mcg/inhalation - fluticasone propionate 100 mcg/inhalation; salmeterol xinafoate eqv salmeterol 50 mcg/inhalation

Սինգապուր - անգլերեն - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - fluticasone propionate; salmeterol xinafoate eqv salmeterol - powder, metered - 250 mcg/inhalation - fluticasone propionate 250 mcg/inhalation; salmeterol xinafoate eqv salmeterol 50 mcg/inhalation

Սինգապուր - անգլերեն - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - fluticasone propionate; salmeterol xinafoate eqv salmeterol - powder, metered - 500 mcg/inhalation - fluticasone propionate 500 mcg/inhalation; salmeterol xinafoate eqv salmeterol 50 mcg/inhalation

Սինգապուր - անգլերեն - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - lamotrigine - tablet, film coated - 2 mg - lamotrigine 2 mg

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

glaxosmithkline llc - beclomethasone dipropionate monohydrate (unii: 4h7l9ai22i) (beclomethasone - unii:kgz1slc28z) - beclomethasone dipropionate 42 ug - beconase aq nasal spray is indicated for the relief of the symptoms of seasonal or perennial allergic and nonallergic (vasomotor) rhinitis. results from 2 clinical trials have shown that significant symptomatic relief was obtained within 3 days. however, symptomatic relief may not occur in some patients for as long as 2 weeks. beconase aq nasal spray should not be continued beyond 3 weeks in the absence of significant symptomatic improvement. beconase aq nasal spray should not be used in the presence of untreated localized infection involving the nasal mucosa. beconase aq nasal spray is also indicated for the prevention of recurrence of nasal polyps following surgical removal. clinical studies have shown that treatment of the symptoms associated with nasal polyps may have to be continued for several weeks or more before a therapeutic result can be fully assessed. recurrence of symptoms due to polyps can occur after stopping treatment, depending on the severity of the disease. hypersensitivity to any of the in