Patient package insert

Patient package insert and instructions are available with the product. The primary health care provider should be notified if any of the following occurs abnormal or excessive bleeding, severe cramping, abnormal or odorous vaginal discharge, fever or flu-like symptoms, pain, genital lesions, or missed periods. 

Before insertion, provide the patient with the patient package insert. 

A patient package insert is available widi die drug. Read the information carefully. If tiiere are any questions about this information, discuss diem widi the primary health care provider. 

Paytash, C.A., "Note, The Learned Intermediary Doctrine and Patient Package Inserts A Balanced Approach to Preventing Drug-Related Injury," Stanford L. Rev., 51, 1343-1371 (1999). 

Patents Citation Index, 18 227, 238 Patent searches, 18 207-210. See also Patentability searches Patent information searches Patent specifications, searching of, 18 234 Patents Preview, 18 226, 236 PATFULL files, 18 247-248 pat gene, 13 360, 361t Pathogenic yeasts, 26 475-476 Patient package inserts (PPIs), 18 718 PATOLIS database, 18 248-249 Patternation, 23 194 of sprays, 23 187-188 Patternators, 23 188, 194 Pattern dental waxes, 8 296 Patterned electrodeposition, 9 811-832 Patterned impressions, in blood, 12 102 Pattern recognition examinations, 12 100-101... 

Over-the-counter drugs (OTC) Patient package insert (PPI) Phase 4 study... 

Upjohn V Finch upholds enforcement of the 1962 drug effectiveness amendments by ruling that commercial success alone does not constitute substantial evidence of drug safety and efficacy. FDA requires the first patient package insert. 

Do not substitute Betapace for Betapace AF because of significant differences in labeling (eg, patient package insert, dosing administration, safety information). 

Transfer to Betapace AF from Betapace - Patients with a history of symptomatic atrial fibrillation/atrial flutter (AFIB/AFL) who are currently receiving Betapace for the maintenance of normal sinus rhythm should be transferred to Betapace AF because of the significant differences in labeling (ie, patient package insert for Sefapace AF, dosing, administration, and safety information). 

For the first time, the FDA requires a patient package insert (PPI) with a medicine. The PPI explains how to use the medication properly, iden-... 

Patient-directed labeling for prescription drugs (patient package inserts and Medication Guides) Summary of essential information needed for safe and effective use of the drug Patients... 

The patient package insert (PPI) provision (this provides that patient information on dosage, adverse effects, etc., would be included with prescription as well as over-the-counter drugs) of the DRRA appears to have gathered more attention on the cost impact side than is warranted. The PPI should save expensive physician time at a small cost per prescription. However, as long as no hard figures exist, the cost of PPIs will undoubtedly continue to be an issue. 

Calcium Disodium Versenate. 3M Pharmaceuticals, Patient package insert. 

FDA requires the first patient package insert with oral contraceptives that provides patients with risk/benefit information. 

In general, a medical information staff member can answer an off-label question if the request is of a spontaneous and unsolicited nature, if the response contains both scientific and fair balance, and if an appropriate disclaimer is included. Each company must interpret the FDA guidances and develop policies with respect to the details of how information is disseminated to healthcare professionals. The FDA does not provide any guidelines that delineate how to address consumer inquiries. Each company must again develop policies regarding the dissemination of information to consumers. The majority of companies in the United States limit discussions with consumers, if any occur, to data contained in the product s package insert (PI) or the patient package insert, if available. 

Institute of Medicine, Evaluating Patient Package Inserts. 1979, August (79-05), National Academy of Sciences, Washington, D.C. 

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