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

sun pharmaceutical industries limited - azithromycin monohydrate (unii: jte4mnn1md) (azithromycin anhydrous - unii:j2klz20u1m) - azithromycin for injection is a macrolide antibacterial drug indicated for the treatment of patients with infections caused by susceptible strains of the designated microorganisms in the conditions listed below. due to chlamydophila pneumoniae , haemophilus influenzae , legionella pneumophila , moraxella catarrhalis , mycoplasma pneumoniae , staphylococcus aureus , or streptococcus pneumoniae in patients who require initial intravenous therapy. due to chlamydia trachomatis , neisseria gonorrhoeae , or mycoplasma hominis in patients who require initial intravenous therapy. if anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with azithromycin for injection. azithromycin for injection should be followed by azithromycin by the oral route as required [see dosage and administration (2)]. to reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacter

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

zydus pharmaceuticals usa inc. - decitabine (unii: 776b62cq27) (decitabine - unii:776b62cq27) - decitabine for injection is indicated for treatment of adult patients with myelodysplastic syndromes (mds) including previously treated and untreated, de novo and secondary mds of all french-american-british subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk international prognostic scoring system groups. none. risk summary based on findings from human data, animal studies, and the mechanism of action, decitabine can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)  and nonclinical toxicology (13.1)] . limited published data on decitabine use throughout the first trimester during pregnancy describe adverse developmental outcomes including major birth defects (structural abnormalities). in animal reproduction studies, administration of decitabine to pregnant mice and rats

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

armas pharmaceuticals inc - mycophenolate mofetil (unii: 9242ecw6r0) (mycophenolic acid - unii:hu9dx48n0t) - mycophenolate mofetil is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see clinical studies (14.1)], heart [see clinical studies (14.2)] or liver transplants [see clinical studies (14.3)] , in combination with other immunosuppressants. allergic reactions to mycophenolate mofetil have been observed; therefore, mycophenolate mofetil for injection is contraindicated in patients with a hypersensitivity to mycophenolate mofetil (mmf), mycophenolic acid (mpa) or any component of the drug product. mycophenolate mofetil is contraindicated in patients who are allergic to polysorbate 80 (tween). pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to mycophenolate during pregnancy and those becoming pregnant within 6 weeks of discontinuing mycophenolate mofetil treatment. to report a pregnancy or obtain information about the re

Malta - English - Malta Medicines Authority

aurobindo pharma (malta) limited vault 14, level 2, valletta waterfront, floriana frn 1913, malta - tablet - olanzapine 5 mg - psycholeptics

Malta - English - Malta Medicines Authority

aurobindo pharma (malta) limited vault 14, level 2, valletta waterfront, floriana frn 1913, malta - tablet - olanzapine 10 mg - psycholeptics

Malta - English - Malta Medicines Authority

aurobindo pharma (malta) limited vault 14, level 2, valletta waterfront, floriana frn 1913, malta - orodispersible tablet - olanzapine 5 mg - psycholeptics

Malta - English - Malta Medicines Authority

aurobindo pharma (malta) limited vault 14, level 2, valletta waterfront, floriana frn 1913, malta - orodispersible tablet - olanzapine 10 mg - psycholeptics

Malta - English - Malta Medicines Authority

aurobindo pharma (malta) limited vault 14, level 2, valletta waterfront, floriana frn 1913, malta - orodispersible tablet - olanzapine 15 mg - psycholeptics

Malta - English - Malta Medicines Authority

aurobindo pharma (malta) limited vault 14, level 2, valletta waterfront, floriana frn 1913, malta - orodispersible tablet - olanzapine 20 mg - psycholeptics

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

generic health pty ltd - ibuprofen, quantity: 200 mg; paracetamol, quantity: 500 mg - tablet, film coated - excipient ingredients: hypromellose; crospovidone; pregelatinised maize starch; titanium dioxide; microcrystalline cellulose; colloidal anhydrous silica; purified talc; magnesium stearate; povidone; purified water; polysorbate 80; polyvinyl alcohol; macrogol 3350; mica - temporary relief of acute (short term) pain and / or inflammation associated with headache, migraine headache, tension headache, sinus pain, toothache, dental procedures, backache, muscular aches and pains, period pain, sore throat, tennis elbow, rheumatic pain and arthritis, and the aches and pains associated with colds and flu. reduces fever.