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The documents published use the HL7 version 3 Structured Product Labeling (SPL) standard, [1] which is an XML format that combines the human readable text of the product label with structured data elements that describe the composition, form, packaging, and other properties of the drug products in detail according to the HL7 Reference ...
A package insert from 1970, with Ovrette brand contraception pills A package insert is a document included in the package of a medication that provides information about that drug and its use. For prescription medications , the insert is technical , providing information for medical professionals about how to prescribe the drug.
In the United States, a boxed warning (sometimes "black box warning", colloquially) is a type of warning that appears near the beginning of the package insert for certain prescription drugs, so called because the U.S. Food and Drug Administration specifies that it is formatted with a 'box' or border around the text [1] to emphasize it is of ...
In general, the expiry date of the drug is required and shall appear on the mediate container and the outer package. [5] Additional, label statements should be displayed with prominence and conspicuousness. The lot number, also called batch number, on the label should generate the full manufacturing history of the package. [5]
Zafirlukast is FDA-approved for the prevention and treatment of asthma in adults and children older than 5 years old. [1] Like other leukotriene receptor antagonists, zafirlukast is thought to be useful for the long-term treatment of asthma, but it is generally less effective than inhaled glucocorticoids as monotherapy (which are the standard of care) or long-acting beta-2 agonists in ...
The EMA proposed to avoid any allusion to a possible use as an abortifacient in the package insert to avert off-label use. [ 32 ] : 41 It is unlikely that ulipristal acetate could effectively be used as an abortifacient, since it is used in much lower doses (30 mg) than the roughly equipotent mifepristone (600 mg), and since mifepristone has to ...
Common side effects of dolutegravir in clinical trials included insomnia and headache. Serious side effects included allergic reactions and abnormal liver function in patients who were also infected with hepatitis B or C. [15] The package insert warns against a mean rise in serum creatinine of 0.11 mg/dL due to inhibition of tubular secretion of creatinine and does not affect GFR.
Idarubicin / ˌ aɪ d ə ˈ r uː b ɪ s ɪ n / or 4-demethoxydaunorubicin is an anthracycline antileukemic drug.It inserts [1] itself into DNA and prevents DNA unwinding by interfering with the enzyme topoisomerase II.