Drug information for APIDRA SOLOSTAR

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
INJECTABLE; SUBCUTANEOUS 300 UNITS/3ML Prescription   INSULIN GLULISINE RECOMBINANT insulin glulisine SANOFI AVENTIS US 21629
2009-03-17 Label
2009-02-27 Letter
2008-11-07 Label
2008-10-28 Letter
2007-04-20 Letter
2007-04-20 Label
2006-01-06 Label
2006-01-06 Label
2004-06-29 Review
2004-04-22 Label
2004-04-20 Letter

Drug Adverse Effects information for APIDRA SOLOSTAR

Role code Indications Reaction # Reports
PS DEVICE THERAPY ANAEMIA 1
PS DEVICE THERAPY HYPOGLYCAEMIA 1
PS DEVICE THERAPY RESPIRATORY TRACT INFECTION 1
PS DEVICE THERAPY THROMBOCYTOPENIA 1
PS DEVICE THERAPY WHITE BLOOD CELL COUNT INCREASED 1
PS DIABETES MELLITUS ASTHENIA 2
PS DIABETES MELLITUS DIABETES MELLITUS INADEQUATE CONTROL 2
PS DIABETES MELLITUS EXPIRED DRUG ADMINISTERED 2
PS DIABETES MELLITUS HYPOGLYCAEMIA 8
PS DIABETES MELLITUS WRONG DRUG ADMINISTERED 8
PS PRODUCT USED FOR UNKNOWN INDICATION DEVICE BREAKAGE 2
PS PRODUCT USED FOR UNKNOWN INDICATION DEVICE MALFUNCTION 14
PS PRODUCT USED FOR UNKNOWN INDICATION NO ADVERSE EVENT 2
PS PRODUCT USED FOR UNKNOWN INDICATION PRODUCT QUALITY ISSUE 6
PS PROPHYLAXIS ANAEMIA 1
PS PROPHYLAXIS HYPOGLYCAEMIA 1
PS PROPHYLAXIS RESPIRATORY TRACT INFECTION 1
PS PROPHYLAXIS THROMBOCYTOPENIA 1
PS PROPHYLAXIS WHITE BLOOD CELL COUNT INCREASED 1
SS ANTIDEPRESSANT THERAPY ISCHAEMIC STROKE 1
SS ANTIDEPRESSANT THERAPY MOBILITY DECREASED 1
SS ANTIDEPRESSANT THERAPY MUSCULOSKELETAL PAIN 1
SS ANTIDEPRESSANT THERAPY PAIN IN EXTREMITY 1
SS ANTIDEPRESSANT THERAPY SPEECH DISORDER 1
SS DEPRESSION CYANOSIS 1
SS DEPRESSION DRUG INEFFECTIVE 1
SS DEPRESSION HYPERGLYCAEMIA 1
SS DEPRESSION INCORRECT STORAGE OF DRUG 1
SS DEPRESSION MALAISE 1
SS DEPRESSION PRODUCT QUALITY ISSUE 1
SS DEPRESSION THIRST 1
SS DEVICE THERAPY ANAEMIA 5
SS DEVICE THERAPY HYPOGLYCAEMIA 5
SS DEVICE THERAPY ISCHAEMIC STROKE 1
SS DEVICE THERAPY MOBILITY DECREASED 1
SS DEVICE THERAPY MUSCULOSKELETAL PAIN 1
SS DEVICE THERAPY PAIN IN EXTREMITY 1
SS DEVICE THERAPY RESPIRATORY TRACT INFECTION 5
SS DEVICE THERAPY SPEECH DISORDER 1
SS DEVICE THERAPY THROMBOCYTOPENIA 5
SS DEVICE THERAPY WHITE BLOOD CELL COUNT INCREASED 5
SS DIABETIC NEUROPATHY CYANOSIS 4
SS DIABETIC NEUROPATHY DRUG INEFFECTIVE 4
SS DIABETIC NEUROPATHY HYPERGLYCAEMIA 4
SS DIABETIC NEUROPATHY INCORRECT STORAGE OF DRUG 4
SS DIABETIC NEUROPATHY MALAISE 4
SS DIABETIC NEUROPATHY PRODUCT QUALITY ISSUE 4
SS DIABETIC NEUROPATHY THIRST 4
SS HYPERTENSION CYANOSIS 1
SS HYPERTENSION DRUG INEFFECTIVE 1
SS HYPERTENSION HYPERGLYCAEMIA 1
SS HYPERTENSION INCORRECT STORAGE OF DRUG 1
SS HYPERTENSION MALAISE 1
SS HYPERTENSION PRODUCT QUALITY ISSUE 1
SS HYPERTENSION THIRST 1
SS INSOMNIA ISCHAEMIC STROKE 1
SS INSOMNIA MOBILITY DECREASED 1
SS INSOMNIA MUSCULOSKELETAL PAIN 1
SS INSOMNIA PAIN IN EXTREMITY 1
SS INSOMNIA SPEECH DISORDER 1
SS PROPHYLAXIS ANAEMIA 5
SS PROPHYLAXIS HYPOGLYCAEMIA 5
SS PROPHYLAXIS RESPIRATORY TRACT INFECTION 5
SS PROPHYLAXIS THROMBOCYTOPENIA 5
SS PROPHYLAXIS WHITE BLOOD CELL COUNT INCREASED 5
C DIABETES MELLITUS ADRENAL DISORDER 2
C DIABETES MELLITUS ASTHENIA 2
C DIABETES MELLITUS DECREASED IMMUNE RESPONSIVENESS 2
C DIABETES MELLITUS DIARRHOEA 4
C DIABETES MELLITUS DIVERTICULITIS 2
C DIABETES MELLITUS ENDOCRINE DISORDER 2
C DIABETES MELLITUS HEADACHE 2
C DIABETES MELLITUS NAUSEA 4
C DIABETES MELLITUS OPTIC NEURITIS 4
C MULTIPLE SCLEROSIS ADRENAL DISORDER 1
C MULTIPLE SCLEROSIS ASTHENIA 1
C MULTIPLE SCLEROSIS DECREASED IMMUNE RESPONSIVENESS 1
C MULTIPLE SCLEROSIS DIARRHOEA 2
C MULTIPLE SCLEROSIS DIVERTICULITIS 1
C MULTIPLE SCLEROSIS ENDOCRINE DISORDER 1
C MULTIPLE SCLEROSIS HEADACHE 1
C MULTIPLE SCLEROSIS NAUSEA 2
C MULTIPLE SCLEROSIS OPTIC NEURITIS 2
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