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An intramuscular vaccine, including , to infants born prematurely should be based on consideration of the individual infant s medical status, and the potential benefits and possible risks of vaccination. (5.4) HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . (Pneumococcal 13-valent Conjugate Vaccine Diphtheria CRM197 Protein ).
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18c FAQ
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What is the Prescribing Information? FDA-approved Prescribing Information (PI), also known as United States Prescribing Information (USPI), reflects FDA's finding regarding the safety and effectiveness of the human prescription drug under the labeled conditions of use.
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The Selected Requirement of Prescribing Information (SRPI) is a 41-item, drop-down checklist of important format elements of the Prescribing Information (PI) based on labeling regulations (21 CFR 201.56 and 201.57) and guidances. There is one drop-down menu and one comment field for each item.
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How Do I Use Prescription Drug Labeling Highlights of Prescribing Information. Section 1: Indications and Usage. Section 2: Dosage and Administration. Section 3: Dosage Forms and Strengths. Section 4: Contraindications. Section 5: Warnings and Precautions. Section 6: Adverse Reactions. Section 7: Drug Interactions.
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Prescriptive authority is the ability of healthcare providers to prescribe specific medications, including controlled substances. Physicians of either Doctor of Medicine (MD) or Doctor of Osteopathic Medicine (DO) designations have the highest degree of prescriptive authority.
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How Do I Use Prescription Drug Labeling Highlights of Prescribing Information. Section 1: Indications and Usage. Section 2: Dosage and Administration. Section 3: Dosage Forms and Strengths. Section 4: Contraindications. Section 5: Warnings and Precautions. Section 6: Adverse Reactions. Section 7: Drug Interactions.
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Prescriber information: The doctor's name, address and phone number should be clearly written (or preprinted) on the top of the prescription form.
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What is the Prescribing Information? FDA-approved Prescribing Information (PI), also known as United States Prescribing Information (USPI), reflects FDA's finding regarding the safety and effectiveness of the human prescription drug under the labeled conditions of use.
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Definition/Introduction Date of issue. Patient's name and address. Patient's date of birth. Clinician name, address, DEA number. Drug name. Drug strength. Dosage form. Quantity prescribed.
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