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Drug Information Sheet("Kusuri-no-Shiori")

Injection

Revised: 12/2022

|The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines |

|have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a |

|better therapeutic response, patients should understand their medication and cooperate with the treatment. |

|Brand name:PICIBANIL for Injection 1KE |[pic] |

|Active ingredient:Lyophilized powder of Streptococcus pyogenes (A group, type 3) Su strain treated with penicillin | |

|Dosage form:injection | |

|Imprint or print on wrapping: | |

|Effects of this medicine |

|This medicine shows anti-tumor effects with enhancement of immuno function of the body and decreases cancerous pleural effusion or ascites. |

|It is usually used to treat gastric or lung cancer in combination with chemotherapy, cancerous pleural effusion or ascites in patients with |

|gastrointestinal cancer or lung cancer, head and neck cancer and lymphangioma. |

|The following patients may need to be careful when using this medicine.Be sure to tell your doctor and pharmacist. |

|・If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines or foods. |

|If you or your family members have predisposition of allergic symptoms such as bronchial asthma, rash and hives. |

|If you have heart or renal diseases. |

|・If you are pregnant or breastfeeding. |

|・If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter |

|medicines and dietary supplements as well as other prescription medicines.) |

|Dosing schedule (How to take this medicine) |

|・Your dosing schedule prescribed by your doctor is(( to be written by a healthcare professional)) |

|・For patients with gastric cancer (postoperative cases) or primary lung cancer in combination with chemotherapy: In general, inject |

|intramuscularly, subcutaneously or intradermally once a day or once every other day. Two or three weeks later, inject once or twice a week. |

|Reduction of cancerous pleural effusion or ascites in patients with gastrointestinal cancer or lung cancer: In general, inject into the serous |

|cavity once or twice a week. |

|Head and neck cancer and thyroid cancer: In general, inject on the affected site once a day or once every several days. |

|Lymphangioma: In general, inject locally. |

|・The treatment period with this medicine depends on your response to this treatment. |

|Precautions while taking this medicine |

|Possible adverse reactions to this medicine |

|The most commonly reported adverse reactions include fever, swelling at injection site and redness at injection site. If any of these symptoms |

|occur, consult with your doctor or pharmacist. |

|The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, |

|stop taking this medicine and see your doctor immediately. |

|・chill, cold sweat, numbness of hands and feet, dizziness on standing up, respiratory distress, chest distress, rash, hives, itch, edema, falling |

|in blood pressure [shock, anaphylaxis] |

|・shortness of breath, breathing difficulty, fever, dry cough [interstitial pneumonia] |

|・bloody urine, decreased urinary volume, edema on body or feet, puffy eyes, general dullness [acute kidney injury] |

|The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of |

|concern other than those listed above. |

|Storage conditions and other information |

|For healthcare professional use only / / |

| |

For further information, talk to your doctor or pharmacist.

Drug Information Sheet("Kusuri-no-Shiori")

Injection

Revised: 12/2022

|The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines |

|have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a |

|better therapeutic response, patients should understand their medication and cooperate with the treatment. |

|Brand name:PICIBANIL for Injection 5KE |[pic] |

|Active ingredient:Lyophilized powder of Streptococcus pyogenes (A group, type 3) Su strain treated with penicillin | |

|Dosage form:injection | |

|Imprint or print on wrapping: | |

|Effects of this medicine |

|This medicine shows anti-tumor effects with enhancement of immuno function of the body and decreases cancerous pleural effusion or ascites. |

|It is usually used to treat gastric or lung cancer in combination with chemotherapy, cancerous pleural effusion or ascites in patients with |

|gastrointestinal cancer or lung cancer, head and neck cancer and lymphangioma. |

|The following patients may need to be careful when using this medicine.Be sure to tell your doctor and pharmacist. |

|・If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines or foods. |

|If you or your family members have predisposition of allergic symptoms such as bronchial asthma, rash and hives. |

|If you have heart or renal diseases. |

|・If you are pregnant or breastfeeding. |

|・If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter |

|medicines and dietary supplements as well as other prescription medicines.) |

|Dosing schedule (How to take this medicine) |

|・Your dosing schedule prescribed by your doctor is(( to be written by a healthcare professional)) |

|・For patients with gastric cancer (postoperative cases) or primary lung cancer in combination with chemotherapy: In general, inject |

|intramuscularly, subcutaneously or intradermally once a day or once every other day. Two or three weeks later, inject once or twice a week. |

|Reduction of cancerous pleural effusion or ascites in patients with gastrointestinal cancer or lung cancer: In general, inject into the serous |

|cavity once or twice a week. |

|Head and neck cancer and thyroid cancer: In general, inject on the affected site once a day or once every several days. |

|Lymphangioma: In general, inject locally. |

|・The treatment period with this medicine depends on your response to this treatment. |

|Precautions while taking this medicine |

|Possible adverse reactions to this medicine |

|The most commonly reported adverse reactions include fever, swelling at injection site and redness at injection site. If any of these symptoms |

|occur, consult with your doctor or pharmacist. |

|The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, |

|stop taking this medicine and see your doctor immediately. |

|・chill, cold sweat, numbness of hands and feet, dizziness on standing up, respiratory distress, chest distress, rash, hives, itch, edema, falling |

|in blood pressure [shock, anaphylaxis] |

|・shortness of breath, breathing difficulty, fever, dry cough [interstitial pneumonia] |

|・bloody urine, decreased urinary volume, edema on body or feet, puffy eyes, general dullness [acute kidney injury] |

|The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of |

|concern other than those listed above. |

|Storage conditions and other information |

|For healthcare professional use only / / |

| |

For further information, talk to your doctor or pharmacist.

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