Spojené státy - angličtina - 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

Spojené státy - angličtina - 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

Spojené státy - angličtina - 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

Spojené státy - angličtina - 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

Tanzanie - angličtina - Tanzania Medicinces & Medical Devices Authority

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

Malajsie - angličtina - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

healol pharmaceuticals sdn. bhd. - aripiprazole -

Nový Zéland - angličtina - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - bleomycin sulfate 15000 [iu];   - powder for injection - 15000 iu - active: bleomycin sulfate 15000 [iu]   excipient: water for injection - dbl™ bleomycin sulfate for injection should be considered a palliative treatment. it has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents; squamous cell carcinoma: head and neck including mouth, tongue, tonsil, nasopharynx, oropharynx, sinus, palate, lip, buccal mucosa, gingiva, epiglottis, skin, larynx, penis, cervix, and vulva. the response to bleomycin sulfate is poorer in patients with head and neck cancer previously irradiated.

Singapur - angličtina - HSA (Health Sciences Authority)

leo pharma asia pte ltd - tinzaparin sodium - injection - 10,000 axa iu/ml - tinzaparin sodium 10,000 axa iu/ml

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - bleomycin sulfate, quantity: 15000 iu - injection, powder for - excipient ingredients: sodium hydroxide; hydrochloric acid - palliation and treatment adjuvant to surgery and radiation therapy of the following neoplasms: squamous cell carcinoma of the skin, head and neck, and oesophagus (primary indication). squamous cell carcinoma of the larynx, penis and uterine cervix. squamous cell carcinoma of the bronchus (response infrequent). choriocarcinoma and embryonal cell carcinoma of the testis. advanced hodgkin's disease and other lymphomas. mycosis fungoides note. use of bleomycin after radiation therapy is less successful than use before radiation therapy. bleomycin is bone marrow sparing and may be used when other cytotoxic agents are contraindicated.

Jihoafrická republika - angličtina - South African Health Products Regulatory Authority (SAHPRA)

macleods pharmaceuticals sa (pty) ltd - injection - see ingredients - each vial contains hydrocortisone sodium succinate equivalent to hydrocortisone 100,0 mg