Recent，News about the banned by Panlone tablets abroad by multiple parties，The highest regulatory department in China finally issued a modification limited order。One month ago，Southern Weekend published the title "Ha nabin，True Spirit? Breeding in the United States，EU warning，China Congress Pharmaceuticals "deep report，Call for relevant departments to pay attention to the safety information of the drug，Treatment of extensive discussion of the society。

 

   & ldquo; National response is fast。& rdquo; A doctor who has been paying attention to drug safety for a long time。September 14, 2016，A announcement on the website of the State Food and Drug Administration: The General Administration's Announcement on the Revister on the Revised Panlizone Preparation Manual (No. 152, 2016)，[Bad Reactions]、[Contraindications]、[Note]、[Usage Dosage] and other items to revise，also required enterprises Stake Sports Bettingto My stake betting appmake a record of changing the instructions by November 15。6 months after the filing，All the drug manuals that have been exported to the factory need to be replaced with new instructions and labels。

 

  Southern weekend reporters discovered，New modifications and reminders mainly refer to Canada、EU warning content。In North America and the European Union，The regulatory authorities have repeatedly emphasized its serious adverse reactions，Including arrhythmia、​​Cardiac arrest、Sudden death。In the United States，This medicine is banned from listing。2014，After taking the sudden death of the dharopoline drugs，The European Drug Administration (EMA) also re -evaluated Doradone，Confirm that it may cause arrhythmia or even myocardial infarction，Risks that can cause life to the heart。

 

   & ldquo; Duo Panliraidone preparation manufacturers should carry out in -depth research on the new adverse reaction mechanism，Take effective measures to take the use of Panlone's preparation and publicity problems and training，Guide the doctor for reasonable medication。& rdquo; Announcement of the State Administration of Food and Drug wrote。

 

  Southern weekend reporters see，The most important modification is about dosage and treatment。New explanation changed to: adult 3 times a day，10mg each time，Daily must not exceed 40 mg。Three days of medication，Symptoms have not been relieved，You need to consult a physician or pharmacist。The regular use time of the drug must not exceed one week。Before，The recommendation course on the instructions of the urtin is & ldquo; when there is no consulting physician，It must not exceed 14 days & rdquo;。

 

  The manual also deleted & ldquo; 2. It is recommended that children use Doraone mixed liquid。& rdquo; This means，Dorpone mixed My stake betting appStake Sports Bettingsuspension will no longer apply to children。

 

  In terms of adverse reactions，Modifying instructions have increased risk prompts related to heart disease，Indications，& ldquo; There are reports of more than 30 mg of daily doses and/or patients with heart disease、Tumor patients receiving chemotherapy、Patients with severe organic diseases such as electrolyte disorders、Among patients who are older than 60，The risk of severe ventricular arrhythmia or even sudden cardiac death may increase。& rdquo;

 

  The revised version also added & ldquo;。& rdquo; warning。

 

  But the scope of indications that are generally concerned about experts and Europe and the United States，and prescription drugs non -prescription attribute，Announcement shows that it has not been changed。

 

  The State Administration of Food and Drugs on the Revision Revision Revision Revision of Doramone Preparation Non -prescription Drug Manual

 

  a、[Adverse reactions]: & ldquo; 3. There are research on patients with a daily dose of more than 30 mg and older than 60 years old，The risk of severe ventricular heart rate or sudden cardiac death may increase。& rdquo; Modified to: & ldquo; 3. There are reports of more than 30 mg of daily dosage and/or patients with heart disease、Tumor patients receiving chemotherapy、Patients with severe organic diseases such as electrolyte disorders、Among patients who are older than 60，The risk of severe ventricular arrhythmia or even sudden cardiac death may increase。& rdquo;

 

  2. [Contraindications]:

 

  (1) & ldquo; 1. Mechanical obstruction、Gastrointestinal bleeding、Patients with gastrointestinal tract perforation for disable。& rdquo; Modified to & ldquo; 1. mechanical digestive tract obstruction，Gastrointestinal bleeding、Patients with perforations forbidden。& rdquo;

 

  (2) & ldquo; 3. It is forbidden to combine with the ketonazole oral preparation。My stake betting appstake online sports betting& rdquo; Modify to & ldquo; 3. Forbidden to be、erythromycin or other CYP3A4 enzyme strong inhibitors that may extend the QTC interval (e.g.、Voldemidazole、Craimin、Amine iodone、Telicillin) Combined。& rdquo;

 

  (3) Increase & ldquo; 4. Patients with medium -weight liver dysfunction disable。& rdquo;

 

  3, [Precautions]:

 

  (1) Increase & ldquo; 1. 3 days of medication for this product，Symptoms have not been relieved，Please consult a physician or pharmacist。Drugs must not exceed 1 week。& rdquo;

 

  (2) Delete & ldquo; 2. It is recommended that children use Doraone mixed suspension。& rdquo;

 

  (3) & ldquo; 3. Since Dorazone is mainly metabolized in the liver，So patients with liver dysfunction use with caution。& rdquo; Modified to & ldquo; 5. Since Dorazone is mainly metabolized in the liver，So patients with abnormal liver biochemical indicators use with caution。& rdquo;

 

  (4) & ldquo; 5. Patients with heart disease (such as arrhythmia、congestive heart failure, etc.) and patients with tumor receiving chemotherapy、Patients with obvious electrolytes need to be carefully used，It may add gravity disorders。& rdquo; Modified to & ldquo; 2. patients with heart disease、Tumor patients receiving chemotherapy、Patients with electrolyte disorders need to be cautious when applying it，It may add gravity disorders。& rdquo;

 

  (5) Increase & ldquo; 3. Strong vomiting、Patients with acute abdominal pain should go to the hospital for treatment。& rdquo;

 

  (6) & ldquo; 6. Elderly patients should use it under the guidance of the doctor。& rdquo; Modified to & ldquo; elderly patients over 6.60 years old should be used under the guidance of a doctor。& rdquo;

 

  (7) Other project numbers are postponed.

 

  4. [Drug Interaction]:

 

  (1) & ldquo; 3. Drugs that anti -acid drugs and inhibitory gastric acid secretion can reduce the biological utilization of this product，Not suitable to take with this product。& rdquo; Modified to & ldquo; 3. Drugs that anti -acid drugs and gastric My stake betting appstake sports betting appacid secretion are used at the same time to reduce the biological utilization of this product，Sugged interval。& rdquo;

 

  (2) Increase & ldquo; 5. Combining with calcium antagonists (such as: El dealzor and Verapmi) and Arimtan will lead to increased blood concentrations of Doradone。& rdquo;

 

  (3) Other project numbers are postponed.