Safety Communication

As a form of responsibility of the pharmaceutical industry in monitoring the safety aspects of the drugs produced and marketed, PT Boehringer Ingelheim Indonesia  diseminate safety communication for healthcare professionals regarding post-marketing cases of drug-induced liver injury (DILI) in patients with idiopathic pulmonary fibrosis (IPF) treated with Ofev®. Majority of the hepatic events occurred within the first three months of Ofev® initiation. Therefore, transaminases and bilirubin levels should be investigated upon initiation of treatment, at regular intervals during the first three months of treatment and periodically thereafter or as clinically indicated. Please refer to the letter for details.

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Badan POM mengidentifikasi adanya isu aspek keamanan obat mengenai Risiko retensi gadolinium di jaringan otak pada penggunaan media kontras gadolinium untuk pemindaian Magnetic Resonance Imaging (MRI).

Informasi ini diperoleh dari beberapa sumber informasi seperti European Medicines Agency (EMA) dan sumber lainnya.

Demikian informasi ini kami sampaikan sebagai komunikasi risiko dalam rangka meningkatkan kehati-hatian  / awareness Bpk/Ibu sekalian dalam penggunaan media kontras ini.

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Dear Healthcare Professional,

As part of Risk Management Plan (RMP) conducted by pharmaceutical industry, PT Roche Indonesia communicate safety information for doctor related to Esbriet (Pirfenidone).

Esbriet (Pirfenidone) is medicine for mild to moderate Idiopathic Pulmonary Fibrosis (IPF) in adult. This safety information contains important elements for Esbriet (Pirfenidone) use especially related to photosensitivity and hepatic function.

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Dear Healthcare Professionals,

Related to safety issue of drug containing Policresulen concentrate liquid for external use, please find the link for NADFC regulatory action on 15 February 2018 as follow:

 https://www.pom.go.id/new/view/more/klarifikasi/80/PENJELASAN-BPOM-RI--TERKAIT-ISU-KEAMANAN-OBAT-MENGANDUNG-POLICRESULEN-CAIRAN-OBAT-LUAR-KONSENTRAT.html

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