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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:NEUTROGIN for Injection 50 mcg |[pic] |

|Active ingredient:Lenograstim(genetical recombination) | |

|Dosage form:injection | |

|Imprint or print on wrapping: | |

|Effects of this medicine |

|This medicine helps neutrophils to increase by accelerating the proliferation of the cells (precursor cells) which will grow into neutrophils |

|(leukocytes) in bone marrow. |

|It is usually used to treat mobilization of hematopoietic stem cells into peripheral blood, acceleration of the increase in the neutrophil count in |

|hematopoietic stem cells transplantation, cancer chemotherapy-induced neutropenia, neutropenia in myelodysplastic syndrome, neutropenia in aplastic |

|anemia, congenital or idiopathic neutropenia, neutropenia that precludes treatment for human immunodeficiency virus (HIV) infection, neutropenia in |

|immunosuppressive therapy (in kidney transplantation), relapsed or refractory acute myeloid leukemia. |

|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 have: myeloid leukemia (in case that blast cells are present in blood, in case that blast cells in bone marrow do not decrease), allergic |

|predisposition, liver dysfunction, renal dysfunction, cardiac dysfunction, pulmonary dysfunction. |

|・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)) |

|・In general, inject intravenously or subcutaneously once or twice a day. It may be injected with intravenous infusion. |

|While being injected, dosage is adjusted by periodic blood test. |

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

|・Before using this medicine, you take a medical interview to predict the response of hypersensitivity, etc. |

|・In cases of aplastic anemia or congenital neutropenia, when physicians confirm that patients are able to reliably self-administer after advanced |

|instruction is provided regarding administration procedures at medical institution, self-administration may be conducted. You should be thoroughly |

|instructed regarding preparative procedures, administrative procedures, not to reuse needles or syringes, and their safe disposal methods. Strictly |

|follow the instructions. Do not stop administration or not adjust the dosage by self-judgment. |

|Precautions while taking this medicine |

|・When effects of this medicine appear and leukocytes are being produced in bone marrow, ostalgia (especially, breast and hip bones and so on) may |

|occur. If pain is persisting, consult with a doctor. |

|・If you have acute myeloid leukemia should have regular blood and bone marrow examinations. |

|Possible adverse reactions to this medicine |

|The most commonly reported adverse reactions include fever, back pain, headache, ostalgia, rash, chest pain and general malaise. 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. |

|・cold sweat, dizziness, pale face, cold limbs, loss of consciousness [shock] |

|・generalized itching, hives, itchy throat, lightheadedness, breathing difficulty, palpitation [anaphylaxis] |

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

|・breathing difficulty, cough, phlegm, rapid breathing, fast pulse, nails turning bluish purple, purple lips [acute respiratory distress syndrome] |

|・breathing difficulty, fever, general dullness, bleeding tendency, dizziness [increased blast cells (in cases of use for acute myeloid leukemia or |

|myelodysplastic syndrome)] |

|・general edema, sudden weight gain, shortness of breath, breathing difficulty, increased heart rates, lightheadedness, dizziness [capillary leak |

|syndrome] |

|・fever, general dullness, easy fatigability, weight loss, headache, pains in various parts such as the neck [large vessel vasculitis (Inflammation |

|of the aorta, common carotid artery, subclavian artery)] |

|・abdominal (left upper abdomen) discomfort, abdominal (left upper abdomen) pain [splenomegaly, splenic rupture] |

|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 |

|・If any symptoms suspected adverse reactions appear at the time of self-injection, consult with your doctor or pharmacist immediately. |

|If you feel you are not able to continue self-injections, consult with your doctor immediately. |

|・Discard the remainder. Do not store them. Seek advice of your pharmacy or medical institution about proper disposal of the unused medicines. Do |

|not give this medicine to others. |

|・Do not reuse syringe needles. |

|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:NEUTROGIN for Injection 100 mcg |[pic] |

|Active ingredient:Lenograstim(genetical recombination) | |

|Dosage form:injection | |

|Imprint or print on wrapping: | |

|Effects of this medicine |

|This medicine helps neutrophils to increase by accelerating the proliferation of the cells (precursor cells) which will grow into neutrophils |

|(leukocytes) in bone marrow. |

|It is usually used to treat mobilization of hematopoietic stem cells into peripheral blood, acceleration of the increase in the neutrophil count in |

|hematopoietic stem cells transplantation, cancer chemotherapy-induced neutropenia, neutropenia in myelodysplastic syndrome, neutropenia in aplastic |

|anemia, congenital or idiopathic neutropenia, neutropenia that precludes treatment for human immunodeficiency virus (HIV) infection, neutropenia in |

|immunosuppressive therapy (in kidney transplantation), relapsed or refractory acute myeloid leukemia. |

|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 have: myeloid leukemia (in case that blast cells are present in blood, in case that blast cells in bone marrow do not decrease), allergic |

|predisposition, liver dysfunction, renal dysfunction, cardiac dysfunction, pulmonary dysfunction. |

|・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)) |

|・In general, inject intravenously or subcutaneously once or twice a day. It may be injected with intravenous infusion. |

|While being injected, dosage is adjusted by periodic blood test. |

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

|・Before using this medicine, you take a medical interview to predict the response of hypersensitivity, etc. |

|・In cases of aplastic anemia or congenital neutropenia, when physicians confirm that patients are able to reliably self-administer after advanced |

|instruction is provided regarding administration procedures at medical institution, self-administration may be conducted. You should be thoroughly |

|instructed regarding preparative procedures, administrative procedures, not to reuse needles or syringes, and their safe disposal methods. Strictly |

|follow the instructions. Do not stop administration or not adjust the dosage by self-judgment. |

|Precautions while taking this medicine |

|・When effects of this medicine appear and leukocytes are being produced in bone marrow, ostalgia (especially, breast and hip bones and so on) may |

|occur. If pain is persisting, consult with a doctor. |

|・If you have acute myeloid leukemia should have regular blood and bone marrow examinations. |

|Possible adverse reactions to this medicine |

|The most commonly reported adverse reactions include fever, back pain, headache, ostalgia, rash, chest pain and general malaise. 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. |

|・cold sweat, dizziness, pale face, cold limbs, loss of consciousness [shock] |

|・generalized itching, hives, itchy throat, lightheadedness, breathing difficulty, palpitation [anaphylaxis] |

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

|・breathing difficulty, cough, phlegm, rapid breathing, fast pulse, nails turning bluish purple, purple lips [acute respiratory distress syndrome] |

|・breathing difficulty, fever, general dullness, bleeding tendency, dizziness [increased blast cells (in cases of use for acute myeloid leukemia or |

|myelodysplastic syndrome)] |

|・general edema, sudden weight gain, shortness of breath, breathing difficulty, increased heart rates, lightheadedness, dizziness [capillary leak |

|syndrome] |

|・fever, general dullness, easy fatigability, weight loss, headache, pains in various parts such as the neck [large vessel vasculitis (Inflammation |

|of the aorta, common carotid artery, subclavian artery)] |

|・abdominal (left upper abdomen) discomfort, abdominal (left upper abdomen) pain [splenomegaly, splenic rupture] |

|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 |

|・If any symptoms suspected adverse reactions appear at the time of self-injection, consult with your doctor or pharmacist immediately. |

|If you feel you are not able to continue self-injections, consult with your doctor immediately. |

|・Discard the remainder. Do not store them. Seek advice of your pharmacy or medical institution about proper disposal of the unused medicines. Do |

|not give this medicine to others. |

|・Do not reuse syringe needles. |

|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:NEUTROGIN for Injection 250 mcg |[pic] |

|Active ingredient:Lenograstim(genetical recombination) | |

|Dosage form:injection | |

|Imprint or print on wrapping: | |

|Effects of this medicine |

|This medicine helps neutrophils to increase by accelerating the proliferation of the cells (precursor cells) which will grow into neutrophils |

|(leukocytes) in bone marrow. |

|It is usually used to treat mobilization of hematopoietic stem cells into peripheral blood, acceleration of the increase in the neutrophil count in |

|hematopoietic stem cells transplantation, cancer chemotherapy-induced neutropenia, neutropenia in myelodysplastic syndrome, neutropenia in aplastic |

|anemia, congenital or idiopathic neutropenia, neutropenia that precludes treatment for human immunodeficiency virus (HIV) infection, neutropenia in |

|immunosuppressive therapy (in kidney transplantation), relapsed or refractory acute myeloid leukemia. |

|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 have: myeloid leukemia (in case that blast cells are present in blood, in case that blast cells in bone marrow do not decrease), allergic |

|predisposition, liver dysfunction, renal dysfunction, cardiac dysfunction, pulmonary dysfunction. |

|・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)) |

|・In general, inject intravenously or subcutaneously once or twice a day. It may be injected with intravenous infusion. |

|While being injected, dosage is adjusted by periodic blood test. |

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

|・Before using this medicine, you take a medical interview to predict the response of hypersensitivity, etc. |

|・In cases of aplastic anemia or congenital neutropenia, when physicians confirm that patients are able to reliably self-administer after advanced |

|instruction is provided regarding administration procedures at medical institution, self-administration may be conducted. You should be thoroughly |

|instructed regarding preparative procedures, administrative procedures, not to reuse needles or syringes, and their safe disposal methods. Strictly |

|follow the instructions. Do not stop administration or not adjust the dosage by self-judgment. |

|Precautions while taking this medicine |

|・When effects of this medicine appear and leukocytes are being produced in bone marrow, ostalgia (especially, breast and hip bones and so on) may |

|occur. If pain is persisting, consult with a doctor. |

|・If you have acute myeloid leukemia should have regular blood and bone marrow examinations. |

|Possible adverse reactions to this medicine |

|The most commonly reported adverse reactions include fever, back pain, headache, ostalgia, rash, chest pain and general malaise. 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. |

|・cold sweat, dizziness, pale face, cold limbs, loss of consciousness [shock] |

|・generalized itching, hives, itchy throat, lightheadedness, breathing difficulty, palpitation [anaphylaxis] |

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

|・breathing difficulty, cough, phlegm, rapid breathing, fast pulse, nails turning bluish purple, purple lips [acute respiratory distress syndrome] |

|・breathing difficulty, fever, general dullness, bleeding tendency, dizziness [increased blast cells (in cases of use for acute myeloid leukemia or |

|myelodysplastic syndrome)] |

|・general edema, sudden weight gain, shortness of breath, breathing difficulty, increased heart rates, lightheadedness, dizziness [capillary leak |

|syndrome] |

|・fever, general dullness, easy fatigability, weight loss, headache, pains in various parts such as the neck [large vessel vasculitis (Inflammation |

|of the aorta, common carotid artery, subclavian artery)] |

|・abdominal (left upper abdomen) discomfort, abdominal (left upper abdomen) pain [splenomegaly, splenic rupture] |

|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 |

|・If any symptoms suspected adverse reactions appear at the time of self-injection, consult with your doctor or pharmacist immediately. |

|If you feel you are not able to continue self-injections, consult with your doctor immediately. |

|・Discard the remainder. Do not store them. Seek advice of your pharmacy or medical institution about proper disposal of the unused medicines. Do |

|not give this medicine to others. |

|・Do not reuse syringe needles. |

|For healthcare professional use only / / |

| |

For further information, talk to your doctor or pharmacist.

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