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    The document summarizes two adverse event reports for the drug Samsca from Japan received by PT Otsuka Indonesia in January 2016. The first report described a case of aggravated cardiac failure and hepatic function disorder. The second report described a case with increased hemoglobin A1c, blood sugar levels, and symptoms of diabetes mellitus. Both reports were forwarded to the Indonesian drug regulatory agency BPOM within the required deadline.

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    The document summarizes two adverse event reports for the drug Samsca from Japan received by PT Otsuka Indonesia in January 2016. The first report described a case of aggravated cardiac failure and hepatic function disorder. The second report described a case with increased hemoglobin A1c, blood sugar levels, and symptoms of diabetes mellitus. Both reports were forwarded to the Indonesian drug regulatory agency BPOM within the required deadline.

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    11 tayangan2 halaman

    Jsdjshdajk

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    Mata suci
    The document summarizes two adverse event reports for the drug Samsca from Japan received by PT Otsuka Indonesia in January 2016. The first report described a case of aggravated cardiac failure and hepatic function disorder. The second report described a case with increased hemoglobin A1c, blood sugar levels, and symptoms of diabetes mellitus. Both reports were forwarded to the Indonesian drug regulatory agency BPOM within the required deadline.

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    dari 2

    SAE Report from Foreign Country in 2016 - Samsca

    Name of Company: PT Otsuka Indonesia


    Date of Update: 28-Jan-16

    No

    File Code

    MFR Control No.

    Product

    Country

    2015_015280-2-YNY-27-Jan-2016-161110.324

    2015_015280

    Samsca

    Japan

    2016_001628-0-YNY-27-Jan-2016-195404.503

    2016_001628

    Samsca

    Japan

    Report Source
    Health Professional,
    Other

    Health Professional,
    Other

    Report Type

    Event Term/Describe Reaction(s)

    FU2

    Cardiac failure aggravated (Pleural effusion);


    [Cardiac failure aggravated]; Hepatic function
    disorder [Hepatic function disorder]

    Initial

    Other Serious Criteria: Medically Significant;


    Increased levels of sugar blood and haemoglobin
    A1c [Haemoglobin A1C increased]; Increased levels
    of sugar blood and haemoglobin A1c [Sugar blood
    level increased]; Symptoms like diabetes mellitus
    [Diabetes mellitus]

    Version

    3.0.196

    Date Received Date Forwarded to Date Forwarded


    to BPOM (by
    by PTOI
    RA
    RA)
    27-Jan-16

    Submission
    Deadline
    30-Jan-16

    28-Jan-16
    2.0.151

    28-Jan-16

    30-Jan-16

    SAE Report from Foreign Country in 2016

    No

    MFR Control No.

    Product

    Date Received
    by Email

    2015_015280

    Samsca

    27-Jan-16

    2016_001628

    Samsca

    28-Jan-16

    Date Submission
    by Email

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