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2018-08-30 - Female - 60 Years old

717553

Adverse reaction report number 717553
Latest AER version number 0
Market authorization holder AER number 618107
Initial received date 2018-08-30
Latest received date 2018-08-30
Age 60 Years
Gender Female
Weight 82 Kilograms
Type of report Study
Reporter type Other Health Professional
Source of report MAH
Report outcome Unknown
Serious report? Yes

Reason for seriousness

Death
Disability
Cogenital anomaly
Life threateting
Hospitalization
Other medically important Yes

Product information

Product description Dosage form Health product role Route of administration Dose Frequency Therapy duration Indication(s)
DIAMICRONTABLETSuspectOral120 Milligram1 every 1 Day(s) Type 2 diabetes mellitus
OZEMPICSOLUTION SUBCUTANEOUSSuspectSubcutaneous0.25 Milligram1 every 1 Week(s) Type 2 diabetes mellitus
OZEMPICSOLUTION SUBCUTANEOUSSuspectSubcutaneous0.5 Milligram1 every 1 Week(s) Type 2 diabetes mellitus
OZEMPICSOLUTION SUBCUTANEOUSSuspectSubcutaneous Type 2 diabetes mellitus

Adverse reaction term information

MedDRA version: v.21.1
Adverse reaction terms Reaction duration
Blood glucose increased
Dizziness
Drug titration error
Fall
Foot fracture
Ligament sprain
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