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The Italian Medicines Agency ordered the removal of several batches of drugs based on the active substance Valsartan . Indeed, a quality defect was found which, as a precaution, was ordered by AIFA and the other European agencies, the immediate withdrawal of pharmacies and the distribution chain of all the packages concerned.
Valsartan is used for the treatment of high blood pressure and heart failure and in patients with cardiac infarction.
Patients treated with valsartan should check whether the drug they are taking is present in the list of medications involved in precautionary withdrawal
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Valsartan Retreat | Information for the citizen
- Several drugs containing valsartan are withdrawn
- If the medicine you are taking does not appear in the list, you can continue treatment regularly
- If you are treated with any of the products listed above, consult your doctor as soon as possible to switch to other drugs
- You must not discontinue the treatment without talking to your doctor, with whom you can agree on another treatment (with another valsartan-based medicine with another appropriate medication.)
- If you are participating in a clinical trial with valsartan and have doubts, contact the clinician responsible for the study.
- AIFA works with the European Medicines Agency (EMA) and other European agencies to badess the degree of contamination of the products concerned and to take corrective measures in the production process [19659013] Valsa Retreat rtan | Information for doctors
- The presence of an impurity was found in the active ingredient valsartan produced by Zhejiang Huahai Pharmaceuticals, at the site of Chuannan, Duqiao, Linai (China ) and it is currently clear that the impurity is present only in the products manufactured at the aforementioned site
- The impurity is N-nitrosodimetilamina (NDMA), clbadified as carcinogenic to humans , which would be present in batches of raw materials used to produce drugs containing valsartan subject to withdrawal
- Valsartan is an angiotensin II receptor antagonist used to treat hypertension and hypertension. Heart failure. It is available alone or in combination with other active substances
- For patients treated with the drugs listed above, the treatment may be substituted by another valsartan or other vasodide receptor antagonist. angiotensin II. 19659008] Patients treated with products badociated with valsartan and hydrochlorothiazide listed above may be treated with other combination products, valsartan hydrochlorothiazide or monocomponents, e.g. one tablet of valsartan (not listed) and one hydrochlorothiazide tablet or a combined product of hydrochlorothiazide + another angiotensin II receptor antagonist
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