美国 - 英文 - NLM (National Library of Medicine)

methapharm inc. - methacholine chloride (unii: 0w5etf9m2k) (methacholine - unii:03v657zd3v) - methacholine 100 mg in 100 mg - provocholine, used in a methacholine challenge test, is indicated for the diagnosis of bronchial airway hyperreactivity in adults and pediatric patients five years of age and older who do not have clinically apparent asthma. provocholine is contraindicated in the following: - hypersensitivity to methacholine or other parasympathomimetic agents. reactions have included rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. - baseline fev1 < 60% predicted (adults or pediatric patients) or <1.5 l (adults) risk summary the available data from published literature on provocholine use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. animal reproduction studies evaluating effects of methacholine chloride on embryofetal development have not been conducted. diagnosis of bronchial airway hyperreactivity with bronchoprovocation challenge is not recommended for pregnant wo

欧盟 - 英文 - EMA (European Medicines Agency)

bioprojet pharma - pitolisant - sleep apnea, obstructive - other nervous system drugs - ozawade is indicated to improve wakefulness and reduce excessive daytime sleepiness (eds) in adult patients with obstructive sleep apnoea (osa)

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

sanofi-aventis healthcare pty ltd t/a sanofi consumer healthcare - chromium picolinate, quantity: 403 microgram (equivalent: chromium, qty 49.6 microgram) - tablet, uncoated - excipient ingredients: crospovidone; povidone; calcium hydrogen phosphate dihydrate; magnesium stearate; microcrystalline cellulose - aid/assist/helps glucose/sugar/carbohydrate metabolism ; maintain/support (state vitamin/mineral) within normal range

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

aspen pharmacare australia pty ltd - amoxicillin sodium, quantity: 1.06 g (equivalent: amoxicillin, qty 1 g) - injection, powder for - excipient ingredients: - amoxil parenteral is intended for use where the patient's condition precludes the administration of the oral form. it is indicated for the treatment of the following infections due to susceptible strains of sensitive organisms: note: therapy should be guided by bacteriological studies, including sensitivity tests, and clinical response. however, in emergency cases where the causative organism has not been identified, therapy with amoxycillin may be useful. clinical judgement will decide whether combination with another antibiotic would provide a sufficiently broad spectrum of activity pending sensitivity test results. septicaemia: (bacterial) h. influenzae; e. coli (see microbiology); p.mirabilis; streptococcus; s. pneumoniae; s. faecalis and salmonella typhi. skin and skin structure: staphylococcus, non-penicillinase-producing; streptococcus; e. coli (see microbiology). respiratory, acute and chronic: haemophilus influenzae; streptococcus; s. pneumoniae; staphylococcus, non-penicillinase producing; e. co

欧盟 - 英文 - EMA (European Medicines Agency)

abbott laboratories ltd. - adalimumab - spondylitis, ankylosing; arthritis, rheumatoid; arthritis, psoriatic; crohn disease - immunosuppressants - rheumatoid arthritistrudexa in combination with methotrexate, is indicated for:the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.trudexa can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.trudexa has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function, when given in combination with methotrexate.psoriatic arthritistrudexa is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate.ankylosing spondylitistrudexa is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.crohn's diseasetrudexa is indicated for treatment of severe, active crohn's disease, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. for induction treatment, trudexa should be given in combination with cortiocosteroids. trudexa can be given as monotherapy in case of intolerance to corticosteroids or when continued treatment with corticosteroids is inappropriate (see section 4.2).

欧盟 - 英文 - EMA (European Medicines Agency)

schering-plough europe - interferon alfa-2b - hepatitis c, chronic; hepatitis b, chronic - immunostimulants, - chronic hepatitis b: treatment of adult patients with chronic hepatitis b associated with evidence of hepatitis b viral replication (presence of hbv-dna and hbeag), elevated alanine aminotransferase (alt) and histologically proven active liver inflammation and/or fibrosis.chronic hepatitis c:adult patients:introna is indicated for the treatment of adult patients with chronic hepatitis c who have elevated transaminases without liver decompensation and who are positive for serum hcv-rna or anti-hcv (see section 4.4).the best way to use introna in this indication is in combination with ribavirin.chidren and adolescents:introna is intended for use, in a combination regimen with ribavirin, for the treatment of children and adolescents 3 years of age and older, who have chronic hepatitis c, not previously treated, without liver decompensation, and who are positive for serum hcv-rna. the decision to treat should be made on a case by case basis, taking into account any evidence of disease progression such as hepatic inflammation and fibrosis, as well as prognostic factors for response, hcv genotype and viral load. the expected benefit of treatment should be weighed against the safety findings observed for paediatric subjects in the clinical trials (see sections 4.4, 4.8 and 5.1).

欧盟 - 英文 - EMA (European Medicines Agency)

grünenthal gmbh - lesinurad - hyperuricemia - antigout preparations - zurampic, in combination with a xanthine oxidase inhibitor, is indicated in adults for the adjunctive treatment of hyperuricaemia in gout patients (with or without tophi) who have not achieved target serum uric acid levels with an adequate dose of a xanthine oxidase inhibitor alone.,

英国 - 英文 - MHRA (Medicines & Healthcare Products Regulatory Agency)

lipomed gmbh - cladribine - solution for injection - 2mg/1ml

新加坡 - 英文 - HSA (Health Sciences Authority)

astrazeneca singapore pte ltd - eculizumab - infusion, solution concentrate - 300 mg / vial - eculizumab 300 mg / vial

爱尔兰 - 英文 - HPRA (Health Products Regulatory Authority)

bracco imaging spa - barium sulfate - powder for rectal suspension - 96.5 percent weight/weight - barium sulfate containing x-ray contrast media; barium sulfate with suspending agents