Drug Warning Ordinance
| Basic data | |
|---|---|
| Title: | Drug Warning Ordinance |
| Abbreviation: | AMWarnV |
| Type: | Federal Ordinance |
| Scope: | Federal Republic of Germany |
| Issued on the basis of: | Section 12 AMG |
| Legal matter: | Administrative law |
| References : | 2121-51-17 |
| Issued on: | December 21, 1984 ( BGBl. 1985 I p. 22 ) |
| Entry into force on: | April 1, 1985 |
| Last change by: | Appendix 1 chap. X subject D Section II No. 26 Unification Agreement ( BGBl. 1990 II p. 885, 1085 ) |
| Effective date of the last change: |
September 29, 1990 |
| Please note the note on the applicable legal version. | |
The drug warning ordinance is a German statutory ordinance authorized by the Drugs Act (AMG) and, in addition to the labeling requirements specified therein, prescribes special warnings for drugs that contain ethanol ("alcohol") above a certain amount or tartrazine as ingredients.
Warning for ethanol
Ethanol is an organic solvent with multiple uses in pharmaceutical technology . For example, ethanol is used as an extraction agent, a penetration aid or a disinfectant.
According to AMWarnV, a warning is required for drugs containing ethanol from a maximum single dose of 0.05 g of ethanol. With an ethanol content of up to 0.5 g per maximum single dose, appropriate labeling on the container and, if present, on the outer cover is sufficient. If the ethanol content is higher, additional information is required in the package insert and in the information for healthcare professionals. There it must be stated that the amount of ethanol supplied poses a health risk for certain patient groups such as alcoholics, pregnant women and children and that there may be drug interactions with other drugs administered at the same time. From an ethanol content of more than 3 g per maximum single dose, a reduced ability to react - including restricted ability to drive in road traffic - must be pointed out.
Warning for tartrazine
Tartrazine is a yellow azo dye . Dyes are used in drug production to reduce the risk of mix-ups, but also to achieve certain psychological effects.
Azo dyes, and in particular tartrazine, are suspected of causing pseudo- allergies. Regardless of the quantity, medicinal products containing tartrazine must therefore be indicated that they contain tartrazine. It must be stated in the instructions for use and in the specialist information that sensitive persons may experience allergic reactions.
Individual evidence
- ^ Voigt R: Pharmaceutical Technology. Edited by Alfred Fahr . 10th edition. Deutscher Apotheker-Verlag, Stuttgart 2006, ISBN 3-7692-3511-8 , p. 137 .
- ↑ a b Voigt R: Pharmaceutical Technology. Edited by Alfred Fahr . 10th edition. Deutscher Apotheker-Verlag, Stuttgart 2006, ISBN 3-7692-3511-8 , p. 178 f .
