Drug Information Sheet("Kusuri-no-Shiori")
Injection
Revised: 10/2012
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:ROCEPHIN I.V. 0.5 g
Active ingredient:Ceftriaxone sodium hydrate
Dosage form:injection
Print on wrapping:
Effects of this medicine
This medicine kills bacteria which cause infectious disease or inflammation.
It is usually used for the treatment of sepsis, pharyngitis/laryngitis, tonsillitis, acute bronchitis, pneumonia, lung
abscess, pyothorax, secondary infection of chronic respiratory lesion, cystitis, pyelonephritis, epididymo-orchitis
(epididymitis), urethritis, cervicitis, pelvic inflammatory disease, proctitis, peritonitis, intraperitoneal abscess,
cholecystitis, cholangitis, bartholinitis, intrauterine infection, adnexitis, parametritis, purulent meningitis, keratitis
(including corneal ulcer), otitis media, sinusitis, perimaxillary cellulitis and jaw inflammation.
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 or any of your parents or siblings predisposed to allergic reactions, such as bronchial asthma, rash, and
urticaria.
If you have renal disorder, poor food intake or physical debility.
・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, this medicine is given once daily or twice daily for adults and children, once daily for premature infants
and neonates aged 0-3 days, twice daily for premature infants and neonates aged 4 days or older, by intravenous
injection. It can be used by intravenous drip infusion.
・The treatment period with this medicine is decided, depending on the symptoms.
Precautions while taking this medicine
・The medicine may cause deficiency of vitamin B, K, etc., which may result in symptoms such as nose bleeding
tendency or stomatitis. Ingest enough foods to prevent vitamin deficiency. Contact your doctor when you cannot
ingest enough foods because of loss of appetite, etc.
Possible adverse effects of this medicine
The most commonly reported adverse reactions include rash, diarrhea, hives, fever, redness, itch and erythema. 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.
・chill, cold sweat, numbness in the limbs, dizziness on standing up, breathing difficulty, chest pressured feeling, rash,
urticaria, itch, swelling, decreased blood pressure [shock, anaphylactoid symptoms]
・easy fatigability, anemia, sudden high fever, chill, sore throat, petechial hemorrhage in the limbs, easy bruising,
easy to bleed (gum/nose bleeding, prolonged menstruation) [pancytopenia, agranulocytosis, white blood cell
decreased, platelets decreased, haemolytic anaemia]
・yellowness in the skin and/or the white of the eye, lassitude, disturbance of consciousness, loss of appetite
[hepatitis fulminant, hepatic function disorder, jaundice]
・joint pain, fever, decreased urinary volume, difficult urination, temporary increased urinary volume, urine with
blood, rash, swelling, lassitude [renal failure acute, nephritis interstitial]
・bloody stool, abdominal pain, frequent diarrhea [pseudomembranous colitis]
・high fever (38℃ or higher), bloodshot eyes, eye mucus (discharge from eyes), swollen eyelid, difficulty opening
eyes, sore in the lips/genitalia, pain on urinating/defecating, sore throat, widespread redness in the skin [toxic
1/6
epidermal necrolysis (TEN), oculomucocutaneous syndrome (stevens-Johnson syndrome)]
・shortness of breath/breathlessness when going up stairs or exercising a little harder, cough, fever [interstitial
pneumonia, pulmonary eosinophilia (PIE syndrome)]
・upper abdominal pain, fever, itch, yellowness in the skin and/or the white of the eye, nausea, vomiting [gallstones,
gallbladder precipitation]
・abdominal/back pain, urine with blood [calculus urinary/renal]
・decreased consciousness, impaired mind, impaired judgment [consciousness disturbed]
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.
2/6
Drug Information Sheet("Kusuri-no-Shiori")
Injection
Revised: 10/2012
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:ROCEPHIN I.V. 1 g
Active ingredient:Ceftriaxone sodium hydrate
Dosage form:injection
Print on wrapping:
Effects of this medicine
This medicine kills bacteria which cause infectious disease or inflammation.
It is usually used for the treatment of sepsis, pharyngitis/laryngitis, tonsillitis, acute bronchitis, pneumonia, lung
abscess, pyothorax, secondary infection of chronic respiratory lesion, cystitis, pyelonephritis, epididymo-orchitis
(epididymitis), urethritis, cervicitis, pelvic inflammatory disease, proctitis, peritonitis, intraperitoneal abscess,
cholecystitis, cholangitis, bartholinitis, intrauterine infection, adnexitis, parametritis, purulent meningitis, keratitis
(including corneal ulcer), otitis media, sinusitis, perimaxillary cellulitis and jaw inflammation.
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 or any of your parents or siblings predisposed to allergic reactions, such as bronchial asthma, rash, and
urticaria.
If you have renal disorder, poor food intake or physical debility.
・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, this medicine is given once daily or twice daily for adults and children, once daily for premature infants
and neonates aged 0-3 days, twice daily for premature infants and neonates aged 4 days or older, by intravenous
injection. It can be used by intravenous drip infusion.
・The treatment period with this medicine is decided, depending on the symptoms.
Precautions while taking this medicine
・The medicine may cause deficiency of vitamin B, K, etc., which may result in symptoms such as nose bleeding
tendency or stomatitis. Ingest enough foods to prevent vitamin deficiency. Contact your doctor when you cannot
ingest enough foods because of loss of appetite, etc.
Possible adverse effects of this medicine
The most commonly reported adverse reactions include rash, diarrhea, hives, fever, redness, itch and erythema. 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.
・chill, cold sweat, numbness in the limbs, dizziness on standing up, breathing difficulty, chest pressured feeling, rash,
urticaria, itch, swelling, decreased blood pressure [shock, anaphylactoid symptoms]
・easy fatigability, anemia, sudden high fever, chill, sore throat, petechial hemorrhage in the limbs, easy bruising,
easy to bleed (gum/nose bleeding, prolonged menstruation) [pancytopenia, agranulocytosis, white blood cell
decreased, platelets decreased, haemolytic anaemia]
・yellowness in the skin and/or the white of the eye, lassitude, disturbance of consciousness, loss of appetite
[hepatitis fulminant, hepatic function disorder, jaundice]
・joint pain, fever, decreased urinary volume, difficult urination, temporary increased urinary volume, urine with
blood, rash, swelling, lassitude [renal failure acute, nephritis interstitial]
・bloody stool, abdominal pain, frequent diarrhea [pseudomembranous colitis]
・high fever (38℃ or higher), bloodshot eyes, eye mucus (discharge from eyes), swollen eyelid, difficulty opening
eyes, sore in the lips/genitalia, pain on urinating/defecating, sore throat, widespread redness in the skin [toxic
3/6
epidermal necrolysis (TEN), oculomucocutaneous syndrome (stevens-Johnson syndrome)]
・shortness of breath/breathlessness when going up stairs or exercising a little harder, cough, fever [interstitial
pneumonia, pulmonary eosinophilia (PIE syndrome)]
・upper abdominal pain, fever, itch, yellowness in the skin and/or the white of the eye, nausea, vomiting [gallstones,
gallbladder precipitation]
・abdominal/back pain, urine with blood [calculus urinary/renal]
・decreased consciousness, impaired mind, impaired judgment [consciousness disturbed]
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.
4/6
Drug Information Sheet("Kusuri-no-Shiori")
Injection
Revised: 10/2012
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:ROCEPHIN 1 g Plastic Bag for I.V. Drip Infusion
Active ingredient:Ceftriaxone sodium hydrate
Dosage form:injection
Print on wrapping:
Effects of this medicine
This medicine kills bacteria which cause infectious disease or inflammation.
It is usually used for the treatment of sepsis, pharyngitis/laryngitis, tonsillitis, acute bronchitis, pneumonia, lung
abscess, pyothorax, secondary infection of chronic respiratory lesion, cystitis, pyelonephritis, epididymo-orchitis
(epididymitis), urethritis, cervicitis, pelvic inflammatory disease, proctitis, peritonitis, intraperitoneal abscess,
cholecystitis, cholangitis, bartholinitis, intrauterine infection, adnexitis, parametritis, purulent meningitis, keratitis
(including corneal ulcer), otitis media, sinusitis, perimaxillary cellulitis and jaw inflammation.
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 or any of your parents or siblings predisposed to allergic reactions, such as bronchial asthma, rash, and
urticaria.
If you have renal disorder, circulatory functional disorder such as cardiac dysfunction, poor food intake or physical
debility.
・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, this medicine is given once daily or twice daily for adults and children, once daily for premature infants
and neonates aged 0-3 days, twice daily for premature infants and neonates aged 4 days or older, by intravenous
drip infusion.
・The treatment period with this medicine is decided, depending on the symptoms.
Precautions while taking this medicine
・The medicine may cause deficiency of vitamin B, K, etc., which may result in symptoms such as nose bleeding
tendency or stomatitis. Ingest enough foods to prevent vitamin deficiency. Contact your doctor when you cannot
ingest enough foods because of loss of appetite, etc.
Possible adverse effects of this medicine
The most commonly reported adverse reactions include rash, diarrhea, hives, fever, redness, itch and erythema. 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.
・chill, cold sweat, numbness in the limbs, dizziness on standing up, breathing difficulty, chest pressured feeling, rash,
urticaria, itch, swelling, decreased blood pressure [shock, anaphylactoid symptoms]
・easy fatigability, anemia, sudden high fever, chill, sore throat, petechial hemorrhage in the limbs, easy bruising,
easy to bleed (gum/nose bleeding, prolonged menstruation) [pancytopenia, agranulocytosis, white blood cell
decreased, platelets decreased, haemolytic anaemia]
・yellowness in the skin and/or the white of the eye, lassitude, disturbance of consciousness, loss of appetite
[hepatitis fulminant, hepatic function disorder, jaundice]
・joint pain, fever, decreased urinary volume, difficult urination, temporary increased urinary volume, urine with
blood, rash, swelling, lassitude [renal failure acute, nephritis interstitial]
・bloody stool, abdominal pain, frequent diarrhea [pseudomembranous colitis]
・high fever (38℃ or higher), bloodshot eyes, eye mucus (discharge from eyes), swollen eyelid, difficulty opening
5/6
eyes, sore in the lips/genitalia, pain on urinating/defecating, sore throat, widespread redness in the skin [toxic
epidermal necrolysis (TEN), oculomucocutaneous syndrome (stevens-Johnson syndrome)]
・shortness of breath/breathlessness when going up stairs or exercising a little harder, cough, fever [interstitial
pneumonia, pulmonary eosinophilia (PIE syndrome)]
・upper abdominal pain, fever, itch, yellowness in the skin and/or the white of the eye, nausea, vomiting [gallstones,
gallbladder precipitation]
・abdominal/back pain, urine with blood [calculus urinary/renal]
・decreased consciousness, impaired mind, impaired judgment [consciousness disturbed]
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.
6/6