Concetti Chiave
- Prescription inserts provide detailed information about a drug, including its generic and brand names, dosage, administration method, and pharmacological class.
- The clinical pharmacology section explains how the drug works, using the LADME framework.
- Indications and usage detail the conditions and symptoms the drug treats, including any off-label uses.
- Contraindications and warnings highlight when the drug should not be used and possible hazards.
- Adverse reactions cover side effects from administration errors, interactions, and allergies.
Prescription inserts
Prescription inserts known as package insert in USA and patient information leaflet in Europe contains specific information on a particular prescription drug
DA imparare:
• Description: generic name (scientific or chemical), brand name, type of dosage, administration method, pharmacological or therapeutic class, chemical information;
• Clinical pharmacology: how the drug works (LADME)
• indications and usage: conditions, symptoms and diagnosis, as well as approval; includes off-label use
• Contraindications: circumstances in which the drug should not be used
• Warnings: possible hazards and what to do in cases of emergency
• Precautions: indications for special categories and situations to pay attention to; laboratory tests and possible adverse reactions
• Adverse reactions (or “side effects”) due to administration errors, interaction with drugs or food, allergic reactions, combination with other drugs in the same class or other causes
• Drug abuse and dependence: potential for abuse, dependence or withdrawal symptoms
• Overdosage: signs, symptoms and laboratory findings associated with excessive dosage
• Dosage and administration: recommended, usual an limit dosage, intervals, duration
• Supply information: available dosage forms, strength, units, description and appearance, special handling and storage
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