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but should consult their doctor, warns the National Institute of Patient Control . The State Institute for Drug Control, 4/7/2018, took all necessary measures to protect the patient. He ordered the removal of all the affected lots and informed the patients of the need to consult the attending physician within one month at the latest
The assessment was carried out after the appearance of impurity N-nitrozodimethylamine (NDMA) in the active substance produced by Zhejiang Huahai Pharmaceutical products based in China. The company delivers the active ingredient to manufacturers throughout the European Union. The withdrawal concerns only medicines that use the active ingredient of Zhejiang Huahai Pharmaceuticals. Other drugs containing valsartan will also be evaluated as part of the evaluation.
NDMA is classified as a probable carcinogen to humans (a substance that can cause cancer). The presence of NDMA was unexpected and would be related to changes in the method of manufacture of the active substance. This substance is usually present in the air or in certain foods, beverages and tobacco products. However, the requirements for safety and quality of drugs are also high, namely that the presence of the impurity is unacceptable in the long run. In the evaluation, the Committee for Medicinal Products for Human Use will examine the presence of NDMA in drugs containing valsartan, the potential impact on patients who took them and the measures to be taken to reduce or eliminate impurities future batches produced by the company. Taking into consideration the benefits and risks of the medications given for the patient's health, ŠKLC concluded that the patients' health is not seriously threatened. The National Institute for Drug Control and the European Medicines Agency do not recommend abrupt cessation of treatment [19609004] The abrupt cessation of antihypertensives and discontinuation of treatment in long-term hypertensive patients present a significant risk of safety and management of blood pressure. Immediate discontinuation of treatment may result in a sudden and sudden increase in blood pressure and, as a result, life-threatening complications, such as a sudden stroke. For all patients taking drugs containing valsartan, it is recommended to consult their attending physician at least within one month for the establishment and management of treatment. # 39; hypertension.
List of drugs containing valsartan from the manufacturer Zhejiang Huahai Pharmaceutical products which have been withdrawn from the market:
VAPRESS 160 mg, tbl flm 28 x 160 mg (blis.PVC / PE / PVDC / Al)
VAPRESS 80mg, 90mg tbl 90mg (blis.PVC / PE / PVDC / Al)
tbl fm 28x80mg (blis.PVC / PE / PVDC / Al)
Vasopentol HCT 80 / 12.5 mg, tbl / ml 30 x 80 mg / 12.5 mg (blis.PVC / PE / PVDC / Al)
Vasopentol HCT 160 / 12.5 mg, tbl / ml 30 x 160 mg / ml 12.5 mg (blis.PVC / PE / PVDC / Al)
Vasopentol HCT 160 / 98×160 mg / 12.5 mg (blis.PVC / PE / PVDC / Al)
Vasopentol HCT 160/25 mg, tblfm 30×160 mg / 25 mg (blis.PVC / PE / PVDC /
Vasopentol HCT 160/25 mg, tblfm 98×160 mg / 25 mg (blis.PVC / PE / PVDC / Al)
Vasopentol 80 mg tblfm 30 x 80 mg (bl.PVC / PVDC-Al)
Vasopentol 160 mg, tblfm 30 × 160 mg (blis.PVC / PE / PVDC-Al)
Vasopentol 160 mg, tb 1max 98x160mg (blis.PVC / PE / PVDC-A1)
bls.PVC / PE / PVDC / A1)
Valzap 160mg, tblfm 28x160mg (blis.PVC / PE / PVDC / Al)
PVC / PE / PVDC / Al)
Valzap HCT 160mg / 12.5mg, tblfm 28x160mg / 12.5mg
Valzap HCT 160mg / 12.5 mg, tblfm 84 x 160 mg / 12.5 mg (blis.PVC / PE / PVDC / Al)
Valzap HCT 160 mg / 25 mg Valsartan HCT Actavis 160/25 mg, tbl fm 28 x 160 mg / 25 mg (Blis.PVC / PE / PVDC / Al)
Valsartan HCT Actavis 160/12, Valsartan HCT Actavis 160 mg / 12.5 mg (blis.PVC / PE / PVDC / Al)
Valsartan HCT Actavis 160 mg / 12.5 mg tblfm 98 × 160 mg / 12.5 mg bls.PVC / PE / PVDC / Al)
Valsartan Actavis 80 mg, tbl fm 28 × 80 mg (blis.PVC / PE / PVDC / Al) blis.PVC / PE / PVDC / Al)
Valsartan A ctavis 160 mg, tblfm 98 x 160 mg (blis.PVC / PE / PVDC / Al)
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