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Phase 3 clinical studies comparing Hexaxim to licensed combination vaccines demonstrated that Hexaxim is safe and induces a robust immune response against the six targeted diseases.
As of 2012 there is currently no licensed combination of long-acting β-agonist/long-acting muscarinic antagonist, either as two separate drugs in the same device or as a single molecule.
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Currently, there are four licensed drugs and one licensed drug combination for the treatment of HAT, all of which suffer from problems such as high toxicity, inappropriate administration in a rural African setting, or the emergence of drug resistance.
Rituximab is therefore only licensed in combination with methotrexate (www.accessdata.fda.gov/scripts/cder/drugsatfda, www.ema.eu.int/humans/Humans/EPAR/mabthera/mabthera).
Abiraterone is licensed in combination with prednisone 5 mg twice daily to prevent a syndrome of secondary mineralocorticoid excess.
However, it is licensed in combination with corticosteroids for mHRPC in the USA and is widely given for metastatic prostate cancer in the UK.
Rituximab 2×1000 mg is currently licensed in combination with MTX for patients with RA who have had an IR or intolerance to other disease-modifying antirheumatic drugs, including one or more TNF inhibitor treatments.
Bevacizumab is licensed in combination with chemotherapy in metastatic colorectal cancer (Hurwitz et al, 2004), renal cell cancer (Escudier et al, 2010) and unresectable advanced non-squamous non-small cell lung cancer (Sandler et al, 2006) (licensed doses 5 10 mg kg−1 q2w or 7.5 15 mg kg−1 q3w).
State authorities too have licensed myriad combinations of individually approved drugs without proof that the new products are safe and effective.
Results of this study confirm the suitability of GSK Biologicals' new DTPw-HBV/Hib vaccine containing DTPw antigens from a new source and a reduced quantity of PRP as an alternative to currently licensed DTPw-based combination vaccines for use as a primary or booster dose in routine pediatric vaccination programs.
Although anti-PRP geometric mean antibody concentrations and the percent of subjects achieving the 1 μg/mL seroprotective level were lower after the mixed administration, they were in the range seen with monovalent Hib vaccines or with other DTaP-based/Hib combinations licensed in some European countries.
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CEO of Professional Science Editing for Scientists @ prosciediting.com