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calendary December 12, 2024

Preparations with ivy extract will be contraindicated for children under two years of age.

At the end of October 2024, information appeared on the GRLS website about amendments to consumer documentation for drugs containing ivy leaf extract as an active ingredient.

The changes are associated with the introduction of contraindications for the use of drugs in children under two years of age. Enough knowledge has been accumulated in the expert community to conclude that ivy leaf extract increases the risk of stagnation in the respiratory tract and exacerbation of bronchiolitis in children under two years of age due to the functional features of their respiratory tract and thoracic cavity (small bronchi, immature bronchial surfaces that limit the ability of the lungs to remove mucus) Therefore, in the documentation for consumers, it is necessary to update the sections "Contraindications", "Dosage regimen and method of use", "Children".

Ivy preparations are registered in several dosage forms on the Russian market:

  1. Syrup;
  2. Solution for oral administration;
  3. Drops for oral administration.

There are 20 trade names of drugs in the GRLS, which include ivy extract. These drugs are indicated as expectorants in the complex therapy of acute and chronic respiratory tract diseases accompanied by cough and sputum formation.

Contraindications for the use of mucolytic drugs in children under two years of age were also adopted in France (in April 2010) based on data from a pharmacovigilance survey and subsequently in Italy.

 

References:
  1. https://grls.minzdrav.gov.ru/GRLS.aspx
  2. https://www.ema.europa.eu/en/documents/herbal-report/superseded-assessment-report-hedera-helix-l-folium-revision-1_en.pdf

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