The instructions for use of a drug, also known as the package leaflet or package insert, is an official document that accompanies each drug and contains complete and detailed information about the drug that is necessary in order for it to be used correctly and safely. This document is intended to inform both healthcare professionals and patients about the properties of a drug, its use, dosage, side effects, contraindications, storage conditions and other important aspects. In addition, specialist information containing more detailed information on pharmacokinetics, among other things, is available for healthcare professionals.

The sections of the instructions for use (German: translation: Gebrauchsinformation) of a drug include:

• name of the drug, including its international nonproprietary name and brand name
• strength and dosage form
• indications: Conditions or diseases the drug is intended to treat or prevent.
• contraindications: Conditions or factors whereby the use of the drug is inadmissible or requires particular caution.
• interactions with other drugs: Description of possible effects on efficacy and safety when co-administered with other drugs.
• special notes: Warnings and recommendations for the use of the drug under certain conditions such as pregnancy (German: Schwangerschaft), breastfeeding and in children.
• application and dosage: Instructions on the dosage, frequency and route of administration of a drug
• side effects: Information on possible adverse effects (German translation: unerwünschte Wirkungen) in connection with the use of a drug
• storage conditions: Temperature and other conditions required to maintain drug quality
• shelf life: Period during which a drug can be used
• ingredients: List of active pharmaceutical ingredients and excipients

The instructions for use play an important role in ensuring the effective and safe use of drugs and allow patients and healthcare professionals to make informed decisions about the use of medicines.

Our experienced GMP translators and pharmaceutical interpreters will provide you with reliable and competent support if you need to have pharmaceutical documents such as SOPs translated or require language support during a GMP inspection by foreign authorities.