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Post-marketing Safety Measures

MHLW Pharmaceuticals and Medical Devices Safety Information (FY2006)

FY 2006 (No.224-236)

Japanese
version
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No. Table of contents Posted
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March 22, 2007 234
  1. Standardization of color coding scheme for injection needles etc.
  2. Important Safety Information

    (1)Junchoto

    (2)Seihaito

    (3)Lansoprazole, Lansoprazole / Amoxicillin / Clarithromycin

  3. Revision of PRECAUTIONS (No. 185)
    Donepezil Hydrochloride (and 9 others)
  4. List of products subject to Early Post-marketing Phase Vigilance
<Reference>
  1. To all healthcare providers involved in the treatment of influenza (precautionary statement regarding measures to be taken after the initiation of influenza treatment)
  (Full text)
February 22, 2007 233
  1. Important Safety Information

    (1)Rituximab (Genetical recombination)

    (2)Cefcapene Pivoxil Hydrochloride

    (3)Nyoshinsan

  2. Revision of PRECAUTIONS (No. 184)
    Sodium Rabeprazole (and 2 others)
  3. List of products subject to Early Post-marketing Phase Vigilance
  (Full text)
January 25, 2007 232
  1. Important Safety Information

    (1)Tocilizumab (Genetical recombination)

  2. Revision of PRECAUTIONS (No. 183)
    Danaparoid Sodium (and 3 others)
  3. List of products subject to Early Post-marketing Phase Vigilance
  (Full text)
December 21, 2006 231
  1. Important Safety Information

    (1)Tacrolimus Hydrate (capsules 0.5 mg, 1 mg)

    (2)Gefitinib

  2. Revision of PRECAUTIONS (No. 182)
    Diclofenac Sodium (oral dosage form, suppository, rectal ointment) (and 9 others)
  3. List of products subject to Early Post-marketing Phase Vigilance
  (Full text)
November 21, 2006 230
  1. Manuals for Management of Individual Serious Adverse Drug Reactions
  2. Important Safety Information

    (1)Amantadine Hydrochloride

    (2)Ceftriaxone Sodium

  3. Revision of PRECAUTIONS (No. 181)
    Sulindac (and 11 others)
  4. List of products subject to Early Post-marketing Phase Vigilance
  (Full text)
October 26, 2006 229
  1. Guidance for bar code labeling on prescription drugs for the prevention of medical accident
  2. Project of Early Post-marketing Phase Safety Information collection (fixed-point observation project)
  3. Revision of PRECAUTIONS (No. 180)
    Automated external defibrillator (AED) without indication for children under age of 8
  4. List of products subject to Early Post-marketing Phase Vigilance
<Reference>
  1. Research on the occurrence status of influenza-associated symptoms
  (Full text)
September 28, 2006 228
  1. Reports etc. on adverse reactions associated with influenza vaccines in FY2005
  2. Revision of PRECAUTIONS (No. 179)
    Amiodarone Hydrochloride (and 5 others)
  3. List of products subject to Early Post-marketing Phase Vigilance
  (Full text)
August 24, 2006 227
  1. Important Safety Information

    (1)Gemcitabine Hydrochloride

    (2)Adsorbed Tetanus Toxoid

    (3)Sodium Picosulfate (product with the indication for bowel preparation before colon examination)

  2. Revision of PRECAUTIONS (No. 178)
    Pancuronium Bromide (and 13 others)
  3. List of products subject to Early Post-marketing Phase Vigilance
<Reference>
  1. Proper usage guideline for drug therapy of childhood asthma
  (Full text)
July 27, 2006 226
  1. Effects on implantable medical devices (cardiac pacemakers and cardioverter defibrillators) by new system mobile phone terminals
  2. Important Safety Information

    (1)Atorvastatin Calcium Hydrate

    (2)Goshajinkigan

  3. Revision of PRECAUTIONS (No. 177)
    Chlorpromazine Hydrochloride / Promethazine Hydrochloride / Phenobarbital (and 8 others)
  4. List of products subject to Early Post-marketing Phase Vigilance
  (Full text)
June 22, 2006 225
  1. Important Safety Information

    (1)Azithromycin Hydrate

  2. Revision of PRECAUTIONS (No. 176)
    Clenbuterol Hydrochloride (and 2 others)
  3. List of products subject to Early Post-marketing Phase Vigilance
  (Full text)
May 25, 2006 224
  1. Handling of lancing devices (component adjacent to a needle is not disposable) for obtaining blood samples
  2. Important Safety Information

    (1)Aspirin (excepting enteric coated tablet) (preparations with the indication for Kawasaki disease), Aspirin (excepting enteric coated tablet) (preparations without the indication for Kawasaki disease), Aspirin / Ascorbic Acid, Aspirin / Dialuminate (330 mg), Aspirin (enteric coated tablet), Aspirin / Dialuminate (81 mg)

    (2)Tiquizium Bromide

    (3)Dalteparin Sodium, Parnaparin Sodium, Reviparin Sodium, Heparin Calcium, Heparin Sodium (injectable dosage form) (preparations without the indication for prevention of blood coagulation into indwelling intravenous route), Heparin Sodium (injectable dosage form) (preparations with the indication for prevention of blood coagulation into indwelling intravenous route)

    (4)Triamcinolone Acetonide (injectable dosage form)

    (5)Norcholestenol Iodomethyl (131I)

    (6)Mecobalamin / Folic Acid / d-α-Tocopherol Acetate / Fursultiamine Hydrochloride / Pyridoxine Hydrochloride

  3. Revision of PRECAUTIONS (No. 175)

    (1)Piperidolate Hydrochloride (and 7 others)

    (2)Implantable cardiac pacemakers and implantable cardioverter defibrillators (interactions with the so-called smart key systems)

  4. List of products subject to Early Post-marketing Phase Vigilance
  (Full text)