Tolerability and Safety Profile of a New Brand-Generic Product of Glatiramer Acetate in Iranian Patients with Relapsing-Remitting Multiple Sclerosis: An Observational Cohort Study.
Summary of "Tolerability and Safety Profile of a New Brand-Generic Product of Glatiramer Acetate in Iranian Patients with Relapsing-Remitting Multiple Sclerosis: An Observational Cohort Study."
The aim of this study was to evaluate the safety, tolerability, and efficacy of a brand-generic glatiramer acetate product in patients with relapsing-remitting multiple sclerosis over a 12-month period. A noninterventional cohort study was conducted on 185 patients. The patients had a confirmed and documented diagnosis of relapsing-remitting multiple sclerosis as defined by the Revised McDonald Criteria (2010), were ambulatory with a Kurtzke Expanded Disability Status Scale score of 0 to 5.5, and their treatment by glatiramer acetate 40 mg/mL was just started.
Affiliation
Journal Details
This article was published in the following journal.
Name: Current therapeutic research, clinical and experimental
ISSN: 0011-393X
Pages: 47-51
Links
- PubMed Source: http://www.ncbi.nlm.nih.gov/pubmed/29928468
- DOI: http://dx.doi.org/10.1016/j.curtheres.2018.05.001
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Medical and Biotech [MESH] Definitions
Glatiramer Acetate
A random polymer of L-ALANINE, L-GLUTAMIC ACID, L-LYSINE, and L-TYROSINE that structurally resembles MYELIN BASIC PROTEIN. It is used in the treatment of RELAPSING-REMITTING MULTIPLE SCLEROSIS.
Product Recalls And Withdrawals
The removal of a consumer product from the market place. The reason for the removal can be due a variety of causes, including the discovery of a manufacturing defect, a safety issue with the product's use, or marketing decisions.
Safety
Freedom from exposure to danger and protection from the occurrence or risk of injury or loss. It suggests optimal precautions in the workplace, on the street, in the home, etc., and includes personal safety as well as the safety of property.
Consumer Product Safety
The sum total of measures taken and regulatory policies enacted to ensure the safe use of consumer products.
Acetobacterium
A genus of gram-negative bacteria in the family Eubacteriaceae. Species are homoacetogenic, having the ability to use CARBON DIOXIDE as an electron sink, and to reduce it producing acetate as a typical fermentation product.
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