Drug Information Sheet("Kusuri-no-Shiori")
Injection
Revised: 08/2012
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:MIRCERA Injection Syringe 25 mcg
Active ingredient:Epoetin beta pegol (genetical recombination)
Dosage form:injection
Print on wrapping:
Effects of this medicine
This medicine helps erythrocytes to produce.
It is usually used to treat renal anemia. (This medicine does not treat kidney disease.)
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 or have previously experienced thrombosis (myocardial infarction, pulmonary infarction, cerebral
infarction, etc).
If you have: hypertenstion or allergic predisposition.
・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 on dialysis: In general, inject intravenously once every two weeks or every four weeks after the
completion of dialysis. For patients on peritoneal dialysis, it may be injected subcutaneously. When anemia
improves, inject at an interval of once every four weeks.
For patients not on dialysis: In general, inject intravenously or subcutaneously once every two weeks or every four
weeks. When anemia improves, inject at an interval of once every four weeks.
・Depending on your response to the treatment, you may be administered this medicine over a long time.
・Before using this medicine, you may take a test to confirm presence or absence of allergy.
Precautions while taking this medicine
・Even if the symptoms of anemia improved, do not stop consulting with the doctor on your own. Even when the
symptoms of anemia disappear, it does not always mean that kidney disease has been cured.
・Iron and vitamins are necessary to help erythrocytes produce. If you are prescribed iron, etc., you should take it as
instructed by your doctor.
・While you may feel better and appetite may increase due to the treatment, follow the instruction by your doctor or
pharmacist as before as to how to intake dietary, water, iron and potassium.
Possible adverse effects of this medicine
The most commonly reported adverse reactions include increased blood pressure and shunt obstruction/stenosis. 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.
・headache, grogginess, convulsion [cerebral hemorrhage, hypertensive encephalopathy]
・chest pain, feeling of tight chest [myocardial infarction]
・chill, cold sweat, numbness of hands and feet, lightheadedness, dyspnea, feeling of tight chest, rash, urticaria, itch,
edema, falling in blood pressure [shock, anaphylactoid symptoms]
・lassitude, dull headache, headache, dizziness, ear ringing, palpitation or shortness of breath in climbing up stairs or
walking up a slope [pure red-cell aplasia.]
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
/
/
1 / 14
For further information, talk to your doctor or pharmacist.
2 / 14
Drug Information Sheet("Kusuri-no-Shiori")
Injection
Revised: 08/2012
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:MIRCERA Injection Syringe 50 mcg
Active ingredient:Epoetin beta pegol (genetical recombination)
Dosage form:injection
Print on wrapping:
Effects of this medicine
This medicine helps erythrocytes to produce.
It is usually used to treat renal anemia. (This medicine does not treat kidney disease.)
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 or have previously experienced thrombosis (myocardial infarction, pulmonary infarction, cerebral
infarction, etc).
If you have: hypertenstion or allergic predisposition.
・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 on dialysis: In general, inject intravenously once every two weeks or every four weeks after the
completion of dialysis. For patients on peritoneal dialysis, it may be injected subcutaneously. When anemia
improves, inject at an interval of once every four weeks.
For patients not on dialysis: In general, inject intravenously or subcutaneously once every two weeks or every four
weeks. When anemia improves, inject at an interval of once every four weeks.
・Depending on your response to the treatment, you may be administered this medicine over a long time.
・Before using this medicine, you may take a test to confirm presence or absence of allergy.
Precautions while taking this medicine
・Even if the symptoms of anemia improved, do not stop consulting with the doctor on your own. Even when the
symptoms of anemia disappear, it does not always mean that kidney disease has been cured.
・Iron and vitamins are necessary to help erythrocytes produce. If you are prescribed iron, etc., you should take it as
instructed by your doctor.
・While you may feel better and appetite may increase due to the treatment, follow the instruction by your doctor or
pharmacist as before as to how to intake dietary, water, iron and potassium.
Possible adverse effects of this medicine
The most commonly reported adverse reactions include increased blood pressure and shunt obstruction/stenosis. 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.
・headache, grogginess, convulsion [cerebral hemorrhage, hypertensive encephalopathy]
・chest pain, feeling of tight chest [myocardial infarction]
・chill, cold sweat, numbness of hands and feet, lightheadedness, dyapnea, feeling of tight chest, rash, urticaria, itch,
edema, falling in blood pressure [shock, anaphylactoid symptoms]
・lassitude, dull headache, headache, dizziness, ear ringing, palpitation or shortness of breath in climbing up stairs or
walking up a slope [pure red-cell aplasia]
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
/
/
3 / 14
For further information, talk to your doctor or pharmacist.
4 / 14
Drug Information Sheet("Kusuri-no-Shiori")
Injection
Revised: 08/2012
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:MIRCERA Injection Syringe 75 mcg
Active ingredient:Epoetin beta pegol (genetical recombination)
Dosage form:injection
Print on wrapping:
Effects of this medicine
This medicine helps erythrocytes to produce.
It is usually used to treat renal anemia. (This medicine does not treat kidney disease.)
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 or have previously experienced thrombosis (myocardial infarction, pulmonary infarction, cerebral
infarction, etc).
If you have: hypertenstion or allergic predisposition.
・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 on dialysis: In general, inject intravenously once every two weeks or every four weeks after the
completion of dialysis. For patients on peritoneal dialysis, it may be injected subcutaneously. When anemia
improves, inject at an interval of once every four weeks.
For patients not on dialysis: In general, inject intravenously or subcutaneously once every two weeks or every four
weeks. When anemia improves, inject at an interval of once every four weeks.
・Depending on your response to the treatment, you may be administered this medicine over a long time.
・Before using this medicine, you may take a test to confirm presence or absence of allergy.
Precautions while taking this medicine
・Even if the symptoms of anemia improved, do not stop consulting with the doctor on your own. Even when the
symptoms of anemia disappear, it does not always mean that kidney disease has been cured.
・Iron and vitamins are necessary to help erythrocytes produce. If you are prescribed iron, etc., you should take it as
instructed by your doctor.
・While you may feel better and appetite may increase due to the treatment, follow the instruction by your doctor or
pharmacist as before as to how to intake dietary, water, iron and potassium.
Possible adverse effects of this medicine
The most commonly reported adverse reactions include increased blood pressure and shunt obstruction/stenosis. 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.
・headache, grogginess, convultion [cerebral hemorrhage, hypertensive encephalopathy]
・chest pain, feeling of tight chest [myocardial infarction]
・chill, cold sweat, numbness of hands and feet, lightheadedness, dyspnea, feeling of tight chest, rash, urticaria, itch,
edema, falling in blood pressure [shock, anaphylactoid symptoms]
・lassitude, dull headache, headache, dizziness, ear ringing, palpitation or shortness of breath in climbing up stairs or
walking up a slope [pure red-cell aplasia]
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
/
/
5 / 14
For further information, talk to your doctor or pharmacist.
6 / 14
Drug Information Sheet("Kusuri-no-Shiori")
Injection
Revised: 08/2012
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:MIRCERA Injection Syringe 100 mcg
Active ingredient:Epoetin beta pegol (genetical recombination)
Dosage form:injection
Print on wrapping:
Effects of this medicine
This medicine helps erythrocytes to produce.
It is usually used to treat renal anemia. (This medicine does not treat kidney disease.)
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 or have previously experienced thrombosis (myocardial infarction, pulmonary infarction, cerebral
infarction, etc).
If you have: hypertenstion or allergic predisposition.
・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 on dialysis: In general, inject intravenously once every two weeks or every four weeks after the
completion of dialysis. For patients on peritoneal dialysis, it may be injected subcutaneously. When anemia
improves, inject at an interval of once every four weeks.
For patients not on dialysis: In general, inject intravenously or subcutaneously once every two weeks or every four
weeks. When anemia improves, inject at an interval of once every four weeks.
・Depending on your response to the treatment, you may be administered this medicine over a long time.
・Before using this medicine, you may take a test to confirm presence or absence of allergy.
Precautions while taking this medicine
・Even if the symptoms of anemia improved, do not stop consulting with the doctor on your own. Even when the
symptoms of anemia disappear, it does not always mean that kidney disease has been cured.
・Iron and vitamins are necessary to help erythrocytes produce. If you are prescribed iron, etc., you should take it as
instructed by your doctor.
・While you may feel better and appetite may increase due to the treatment, follow the instruction by your doctor or
pharmacist as before as to how to intake dietary, water, iron and potassium.
Possible adverse effects of this medicine
The most commonly reported adverse reactions include increased blood pressure and shunt obstruction/stenosis. 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.
・headache, grogginess, convulsion [cerebral hemorrhage, hypertensive encephalopathy]
・chest pain, feeling of tight chest [myocardical infarction]
・chill, cold sweat, numbness of hands and feet, lightheadedness, dyspnea, feeling of tight chest, rash, urticaria, itch,
edema, falling in blood pressure [shock, anaphylactoid symptoms]
・lassitude, dull headache, headache, dizziness, ear ringing, palpitation or shortness of breath in climbing up stairs or
walking up a slope [pure red-cell aplasia]
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
/
/
7 / 14
For further information, talk to your doctor or pharmacist.
8 / 14
Drug Information Sheet("Kusuri-no-Shiori")
Injection
Revised: 08/2012
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:MIRCERA Injection Syringe 150 mcg
Active ingredient:Epoetin beta pegol (genetical recombination)
Dosage form:injection
Print on wrapping:
Effects of this medicine
This medicine helps erythrocytes to produce.
It is usually used to treat renal anemia. (This medicine does not treat kidney disease.)
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 or have previously experienced thrombosis (myocardial infarction, pulmonary infarction, cerebral
infarction, etc).
If you have: hypertenstion or allergic predisposition.
・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 on dialysis: In general, inject intravenously once every two weeks or every four weeks after the
completion of dialysis. For patients on peritoneal dialysis, it may be injected subcutaneously. When anemia
improves, inject at an interval of once every four weeks.
For patients not on dialysis: In general, inject intravenously or subcutaneously once every two weeks or every four
weeks. When anemia improves, inject at an interval of once every four weeks.
・Depending on your response to the treatment, you may be administered this medicine over a long time.
・Before using this medicine, you may take a test to confirm presence or absence of allergy.
Precautions while taking this medicine
・Even if the symptoms of anemia improved, do not stop consulting with the doctor on your own. Even when the
symptoms of anemia disappear, it does not always mean that kidney disease has been cured.
・Iron and vitamins are necessary to help erythrocytes produce. If you are prescribed iron, etc., you should take it as
instructed by your doctor.
・While you may feel better and appetite may increase due to the treatment, follow the instruction by your doctor or
pharmacist as before as to how to intake dietary, water, iron and potassium.
Possible adverse effects of this medicine
The most commonly reported adverse reactions include increased blood pressure and shunt obstruction/stenosis. 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.
・headache, grogginess, convulsion [cerebral hemorrhage, hypertensive encephalopathy]
・chest pain, feeling of tight chest [myocardial infarction]
・chill, cold sweat, numbness of hands and feet, lightheadedness, dyspnea, feeling of tight chest, rash, urticaria, itch,
edema, falling in blood pressure [shock, anaphylactoid symptoms]
・lassitude, dull headache, headache, dizziness, ear ringing, palpitation or shortness of breath in climbing up stairs or
walking up a slope [pure red-cell aplasia]
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
/
/
9 / 14
For further information, talk to your doctor or pharmacist.
10 / 14
Drug Information Sheet("Kusuri-no-Shiori")
Injection
Revised: 08/2012
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:MIRCERA Injection Syringe 200 mcg
Active ingredient:Epoetin beta pegol (genetical recombination)
Dosage form:injection
Print on wrapping:
Effects of this medicine
This medicine helps erythrocytes to produce.
It is usually used to treat renal anemia. (This medicine does not treat kidney disease.)
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 or have previously experienced thrombosis (myocardial infarction, pulmonary infarction, cerebral
infarction, etc).
If you have: hypertenstion or allergic predisposition.
・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 on dialysis: In general, inject intravenously once every two weeks or every four weeks after the
completion of dialysis. For patients on peritoneal dialysis, it may be injected subcutaneously. When anemia
improves, inject at an interval of once every four weeks.
For patients not on dialysis: In general, inject intravenously or subcutaneously once every two weeks or every four
weeks. When anemia improves, inject at an interval of once every four weeks.
・Depending on your response to the treatment, you may be administered this medicine over a long time.
・Before using this medicine, you may take a test to confirm presence or absence of allergy.
Precautions while taking this medicine
・Even if the symptoms of anemia improved, do not stop consulting with the doctor on your own. Even when the
symptoms of anemia disappear, it does not always mean that kidney disease has been cured.
・Iron and vitamins are necessary to help erythrocytes produce. If you are prescribed iron, etc., you should take it as
instructed by your doctor.
・While you may feel better and appetite may increase due to the treatment, follow the instruction by your doctor or
pharmacist as before as to how to intake dietary, water, iron and potassium.
Possible adverse effects of this medicine
The most commonly reported adverse reactions include increased blood pressure and shunt obstruction/stenosis. 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.
・headache, grogginess, convulsion [cerebral hemorrhage, hypertensive encephalopathy]
・chest pain, feeling of tight chest [myocardial infarction]
・chill, cold sweat, numbness of hands and feet, lightheadedness, dyspnea, feeling of tight chest, rash, urticaria, itch,
edema, falling in blood pressure [shock, anaphylactoid symptoms]
・lassitude, dull headache, headache, dizziness, ear ringing, palpitation or shortness of breath in climbing up stairs or
walking up a slope [pure red-cell aplasia]
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
/
/
11 / 14
For further information, talk to your doctor or pharmacist.
12 / 14
Drug Information Sheet("Kusuri-no-Shiori")
Injection
Revised: 08/2012
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:MIRCERA Injection Syringe 250 mcg
Active ingredient:Epoetin beta pegol (genetical recombination)
Dosage form:injection
Print on wrapping:
Effects of this medicine
This medicine helps erythrocytes to produce.
It is usually used to treat renal anemia. (This medicine does not treat kidney disease.)
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 or have previously experienced thrombosis (myocardial infarction, pulmonary infarction, cerebral
infarction, etc).
If you have: hypertenstion or allergic predisposition.
・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 on dialysis: In general, inject intravenously once every two weeks or every four weeks after the
completion of dialysis. For patients on peritoneal dialysis, it may be injected subcutaneously. When anemia
improves, inject at an interval of once every four weeks.
For patients not on dialysis: In general, inject intravenously or subcutaneously once every two weeks or every four
weeks. When anemia improves, inject at an interval of once every four weeks.
・Depending on your response to the treatment, you may be administered this medicine over a long time.
・Before using this medicine, you may take a test to confirm presence or absence of allergy.
Precautions while taking this medicine
・Even if the symptoms of anemia improved, do not stop consulting with the doctor on your own. Even when the
symptoms of anemia disappear, it does not always mean that kidney disease has been cured.
・Iron and vitamins are necessary to help erythrocytes produce. If you are prescribed iron, etc., you should take it as
instructed by your doctor.
・While you may feel better and appetite may increase due to the treatment, follow the instruction by your doctor or
pharmacist as before as to how to intake dietary, water, iron and potassium.
Possible adverse effects of this medicine
The most commonly reported adverse reactions include increases blood pressure and shunt obstruction/stenosis. 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.
・headache, grogginess, convulsion [cerebral hemorrhage, hypertensive encephalopathy]
・chest pain, feeling of tight chest [myocardial infarction]
・chill, cold sweat, numbness of hands and feet, lightheadedness, dyspnea, feeling of tight chest, rash, urticaria, itch,
edema, falling in blood pressure [shock, anaphylactoid symptoms]
・lassitude, dull headache, headache, dizziness, ear ringing, palpitation or shortness of breath in climbing up stairs or
walking up a slope [pure red-cell aplasia]
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
/
/
13 / 14
For further information, talk to your doctor or pharmacist.
14 / 14