Drug Information Sheet("Kusuri-no-Shiori") Injection Revised: 06

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Drug Information Sheet("Kusuri-no-Shiori")
Injection
Revised: 06/2014
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval
details may vary by country. Medicines have adverse effects (risks) as well as efficacies (benefits). It is
important to minimize adverse effects and maximize efficacy. To obtain a better therapeutic response, patients
should understand their medication and cooperate with the treatment.
Brand name:NEUTROGIN Injection 50 mcg
Active ingredient:Lenograstim (genetical recombination)
Dosage form:injection
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 anaemia, congenital or idiopathic neutropenia,
neutropenia that precludes treatment for human immunodeficiency virus (HIV) infection, neutropenia in
immunosuppressive therapy (in kidney transplantation).
Before 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.
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 may take a test to confirm presence or absence of allergy.
・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
・If anaphylaxis (lassitude, lightheadedness, decreased consciousness, impaired mind/judgment, glow, swelling around
the eye/lip, hoarseness, breathlessness, shortness of breath, palpitation, urticaria and so on ) or infectious
symptoms (fever, chill) occur, contact with a doctor immediately.
・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.
Possible adverse effects of 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 effects indicated in
brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
・cold sweat, dizziness, faint consciousness, impaired mind/judgment, pale face, shortness of breath [shock]
・shortness of breath, breathlessness, fever, dry cough [interstitial pneumonia]
・blue lips, rapid breathing with difficulty, blue nails on limb [acute respiratory distress syndrome]
・abdominal (left upper abdomen) pain [splenic rupture]
1/6
・general edema, sudden weight gain, shortness of breath, breathing difficulty, increased pulse rate, lightheadedness,
dizziness, nausea, vomiting [capillary leak syndrome]
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.
For healthcare professional use only
/
/
For further information, talk to your doctor or pharmacist.
2/6
Drug Information Sheet("Kusuri-no-Shiori")
Injection
Revised: 06/2014
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval
details may vary by country. Medicines have adverse effects (risks) as well as efficacies (benefits). It is
important to minimize adverse effects and maximize efficacy. To obtain a better therapeutic response, patients
should understand their medication and cooperate with the treatment.
Brand name:NEUTROGIN injection 100 mcg
Active ingredient:Lenograstim (genetical recombination)
Dosage form:injection
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 anaemia, congenital or idiopathic neutropenia,
neutropenia that precludes treatment for human immunodeficiency virus (HIV) infection, neutropenia in
immunosuppressive therapy (in kidney transplantation).
Before 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.
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 may take a test to confirm presence or absence of allergy.
・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
・If anaphylaxis (lassitude, lightheadedness, decreased consciousness, impaired mind/judgment, glow, swelling around
the eye/lip, hoarseness, breathlessness, shortness of breath, palpitation, urticaria and so on ) or infectious
symptoms (fever, chill) occur, contact with a doctor immediately.
・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.
Possible adverse effects of 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 effects indicated in
brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
・cold sweat, dizziness, faint consciousness, impaired mind/judgment, pale face, shortness of breath [shock]
・shortness of breath, breathlessness, fever, dry cough [interstitial pneumonia]
・blue lips, rapid breathing with difficulty, blue nails on limb [acute respiratory distress syndrome]
・abdominal (left upper abdomen) pain [splenic rupture]
3/6
・general edema, sudden weight gain, shortness of breath, breathing difficulty, increased pulse rate, lightheadedness,
dizziness, nausea, vomiting [capillary leak syndrome]
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.
・capillary leak syndrome
For healthcare professional use only
/
/
For further information, talk to your doctor or pharmacist.
4/6
Drug Information Sheet("Kusuri-no-Shiori")
Injection
Revised: 06/2014
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval
details may vary by country. Medicines have adverse effects (risks) as well as efficacies (benefits). It is
important to minimize adverse effects and maximize efficacy. To obtain a better therapeutic response, patients
should understand their medication and cooperate with the treatment.
Brand name:NEUTROGIN Injection 250 mcg
Active ingredient:Lenograstim (genetical recombination)
Dosage form:injection
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 anaemia, congenital or idiopathic neutropenia,
neutropenia that precludes treatment for human immunodeficiency virus (HIV) infection, neutropenia in
immunosuppressive therapy (in kidney transplantation).
Before 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.
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 may take a test to confirm presence or absence of allergy.
・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
・If anaphylaxis (lassitude, lightheadedness, decreased consciousness, impaired mind/judgment, glow, swelling around
the eye/lip, hoarseness, breathlessness, shortness of breath, palpitation, urticaria and so on ) or infectious
symptoms (fever, chill) occur, contact with a doctor immediately.
・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.
Possible adverse effects of 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 effects indicated in
brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
・cold sweat, dizziness, faint consciousness, impaired mind/judgment, pale face, shortness of breath [shock]
・shortness of breath, breathlessness, fever, dry cough [interstitial pneumonia]
・blue lips, rapid breathing with difficulty, blue nails on limb [acute respiratory distress syndrome]
・abdominal (left upper abdomen) pain [splenic rupture]
5/6
・general edema, sudden weight gain, shortness of breath, breathing difficulty, increased pulse rate, lightheadedness,
dizziness, nausea, vomiting [capillary leak syndrome]
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.
For healthcare professional use only
/
/
For further information, talk to your doctor or pharmacist.
6/6
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