220-Dictionary of Pharmaceutical Medicine, 2nd Edition-Gerhard Nahler Annette Mollet-3211898352-S

104lablabelling FDA: “all labels and other written, printed or graphic matterupon any article or any of its containers or wrappers – or accompanyingsuch article”; → see also misbranded drug; labelling ofinvestigational drug samples for clinical trials requires, accordingto EC guidelines of good clinical practice (III), the followingminimal amount of information: “For clinical trial”, name of theresponsible physician (investigator), identification-code of thetrial, substance or patient code, expiry/retest date, producer (importerif manufacturer is outside the EU); for clinical trials of medicinalproducts for use before and during pregnancy: within theEC the following categories for labelling are used: A – product hasbeen assessed, no harmful effects are known; B1 – safety not established,animal studies do not indicate harmful effects; B2 – safetynot established, animal studies are insufficient to assess safety; B3– safety not established, animal studies have shown reproductivetoxicity; C – product does not increase spontaneous incidence ofbirth defects, but has potential hazardous pharmacological effectswith respect to the course of pregnancy; D – product is known orsuspect to cause birth defects and/or irreversible adverse effectson pregnancy outcome; it may also have potential hazardous pharmacologicaleffects with respect to the course of pregnancy; → seealso adverse drug experience, investigational drug labelling,label text.labelling phenomenon Means that the patient experiences an increasednumber of subjective symptoms (depression of mood,tiredness, anxiety etc.) after being informed of his/her diagnosis ofe.g. hypertension or carcinoma; in general, the number of days ofabsence from work will also increase after being “labelled”; l.p. maybe a considerable confounder in clinical trials; → see also hawthorneeffect, placebo effect, white-coat hypertension.label text Requirements for label texts of medicinal products differsomewhat between countries; the following information has to begiven routinely or may be requested in addition: name of drug orcode, dosage, dosage form, route of administration, directions foruse, quantity/volume, special storage conditions, special statementsas: “keep out of reach of children”, “for clinical trial only”,caution statements etc., lot no., expiry date, bottle no., study no.,patient no., name of investigator, name of manufacturer, address ofmanufacturer; texts must be in the local language if the medicationis handed out to the patient; → see also labelling.label use American term for use of a drug for its approved indications.laboratory normal range syn. reference range (preferred term), eachlaboratory has its own ranges within which values or results of a