Information about counterfeited Kaletra (lopinavir, ritonavir) in Germany
17.06.2014
The Agency for Medicinal Products and Medical devices (HALMED) has received an information about a suspected counterfeit of Kaletra (lopinavir, ritonavir) in Germany. This medicine is used in treatment of human immunodeficiency (HIV-1) infection.
The suspected counterfeited medicine has been reported by a parallel trade company from Germany, who discovered during the check up of purchased quantities a non-conformity in labelling of the outer package and the package leaflet with the information figuring on the original product packaging.
The following batches are affected by the suspected counterfeit: 276268D, 345118D, 336398D. The manufacturer’s investigation is in the course and further distribution of these batches from the stock has been suspended.
These batches have never been on the Croatian market.
Even though these batches have never been distributed in the Republic of Croatia, all healthcare professionals are warned to pay special attention at handling and administration of Kaletra. In case of any suspected counterfeited medicinal product, it should be reported to HALMED by e-mail: krivotvorine@halmed.hr.
HALMED has never received any suspected counterfeit of this medicine, or quality defect or suspected adverse reaction which would indicate about a counterfeited medicine.
HALMED will continue to closely monitor the safe use of Kaletra and will inform promptly the public about any new information.
More about the medicine
Kaletra is in combination with other antiretroviral medicines indicated for treatment of adults, adolescents and children above 2 infected with the human immunodeficiency (HIV-1 virus). The choice of treatment with this medicine in HIV-1 infected individuals previously using protease inhibitor, should be based on individual viral resistance and patient treatment history.
Kaletra may be prescribed by doctors experienced in treating HIV infections.
