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

macleods pharmaceuticals sa (pty) ltd - tablet - 100,0 mg - each tablet contains clofazimine 100,0 mg

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

macleods pharmaceuticals limited - montelukast (unii: mhm278sd3e) (montelukast - unii:mhm278sd3e) - montelukast 4 mg - montelukast sodium chewable tablet is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older. montelukast sodium chewable tablet is indicated for prevention of exercise-induced bronchoconstriction (eib) in patients 6 years of age and older. montelukast sodium chewable tablet is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 2 years of age and older. because the benefits of montelukast sodium chewable tablets may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis [see warnings and precautions (5.1)], reserve use for patients who have an inadequate response or intolerance to alternative therapies. montelukast sodium chewable tablet is not indicated for the treatment of an acute asthma attack. montelukast sodium chewable tablets is contraindicated in patients with hypersensitivity to any of its components. risk su

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

macleods pharmaceuticals limited - risedronate sodium (unii: ofg5exg60l) (risedronic acid - unii:km2z91756z) - risedronate sodium 5 mg - risedronate sodium tablets, usp are indicated for the treatment and prevention of osteoporosis in postmenopausal women. in postmenopausal women with osteoporosis, risedronate sodium tablets, usp reduces the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures [see clinical studies (14.1, 14.2) ]. risedronate sodium tablets, usp are indicated for treatment to increase bone mass in men with osteoporosis. risedronate sodium tablets, usp are indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoid treatment (daily dosage of greater than or equal to 7.5 mg of prednisone or equivalent) for chronic diseases. patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin d. risedronate sodium tablets, usp are indicated for treatment of paget's disease of bone in men and women. the optimal duration of use has not been determined. t

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

macleods pharmaceuticals limited - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 37.5 mg - venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of: • major depressive disorder (mdd) [see clinical studies (14.1)] • generalized anxiety disorder (gad) [see clinical studies (14.2)] • social anxiety disorder (sad) [see clinical studies (14.3)] • panic disorder (pd) [see clinical studies (14.4)] venlafaxine hydrochloride extended-release capsules are contraindicated in patients: • with known hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate or to any excipients in the formulation [see adverse reactions (6.2)]. • taking, or within 14 days of stopping, maois (including the maois linezolid and intravenous methylene blue) because of the risk of serotonin syndrome [see dosage and administration (2.11), warnings and precautions (5.2), and drug interactions (7.1)]. pregnancy exposure registry   there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including venlafaxine hydr

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

macleods pharmaceuticals limited, india - isoniazid - tablets - 100 mg

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

macleods pharmaceuticals limited, india - triamcinolone acetonide - ointment - 0.1/1 %w/w

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

macleods pharmaceuticals limited, india - eszopiclone - oral tablet - 3

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

macleods pharmaceuticals limited - levofloxacin (unii: 6gnt3y5lmf) (levofloxacin anhydrous - unii:rix4e89y14) - levofloxacin tablets are indicated in adult patients for the treatment of nosocomial pneumonia due to methicillin-susceptible staphylococcus aureus, pseudomonas aeruginosa, serratia marcescens, escherichia coli, klebsiella pneumoniae, haemophilus influenzae, or streptococcus pneumoniae. adjunctive therapy should be used as clinically indicated. where pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended [see clinical studies (14.1) ]. levofloxacin tablets are indicated in adult patients for the treatment of community-acquired pneumonia due to methicillin-susceptible staphylococcus aureus , streptococcus pneumoniae (including multi-drug-resistant streptococcus pneumoniae [mdrsp]), haemophilus influenzae, haemophilus parainfluenzae, klebsiella pneumoniae, moraxella catarrhalis, chlamydophila pneumoniae, legionella pneumophila , or mycoplasma pneumoniae [see dosage and administration ( 2.1 ) and clinical studies (14.2 )]. mdrsp i

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

macleods pharmaceuticals limited - lurasidone hydrochloride (unii: o0p4i5851i) (lurasidone - unii:22ic88528t) - lurasidone hydrochloride is indicated for: • treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see clinical studies (14.1)]. • monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar i disorder (other indication) [see clinical studies (14.2)]. • adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar i disorder (other indication) [see clinical studies (14.2)]. • known hypersensitivity to lurasidone hcl or any components in the formulation. angioedema has been observed with lurasidone [see adverse reactions (6.1)]. • strong cyp3a4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.) [see drug interactions (7.1)]. • strong cyp3a4 inducers (e.g., rifampin, avasimibe, st. john’s wort, phenytoin, carbamazepine, etc.) [see drug interactions (7.1)]. pregnancy exposure registry there is a pregna

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

macleods pharmaceuticals limited - pantoprazole sodium (unii: 6871619q5x) (pantoprazole - unii:d8tst4o562) - pantoprazole 20 mg - pantoprazole sodium delayed-release tablets are indicated for: pantoprazole sodium delayed-release tablets are  indicated in adults for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (ee). for those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium may be considered. safety of treatment beyond 8 weeks in pediatric patients has not been established. pantoprazole sodium delayed-release tablets are  indicated for maintenance of healing of ee and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with gerd. controlled studies did not extend beyond 12 months. pantoprazole sodium delayed-release tablets are  indicated for the long-term treatment of pathological hypersecretory conditions, including zollinger-ellison (ze) syndrome. • pantoprazole sodium delayed-release tablets are contraindicated in patients with known hypersensitivity to any component of the for