Drug information for NOVOLIN N

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
INJECTABLE; INJECTION 100 UNITS/ML Discontinued   INSULIN SUSP ISOPHANE SEMISYNTHETIC PURIFIED HUMAN Insulin, Isophane NOVO NORDISK INC 19065
INJECTABLE; INJECTION 100 UNITS/ML Over The Counter  (Reference Drug) INSULIN SUSP ISOPHANE RECOMBINANT HUMAN Insulin, Isophane NOVO NORDISK INC 19959
2011-01-04 Letter

2010-06-29 Letter

2010-06-29 Letter

2009-07-24 Letter

2009-07-23 Label

2009-06-22 Label

2009-06-18 Letter

2003-04-17 Label

2002-04-15 Letter

2002-04-15 Label

2002-04-11 Letter

2002-04-11 Label

2002-03-11 Letter

2002-03-11 Label

1997-04-16 Review

Drug Adverse Effects information for NOVOLIN N

Role code Indications Reaction # Reports
PS DIABETES MELLITUS BLOOD GLUCOSE INCREASED 2
PS DIABETES MELLITUS CRANIOCEREBRAL INJURY 5
PS DIABETES MELLITUS DIABETIC KETOACIDOSIS 5
PS DIABETES MELLITUS DIABETIC NEPHROPATHY 2
PS DIABETES MELLITUS HYPERGLYCAEMIA 5
PS DIABETES MELLITUS HYPOGLYCAEMIA 5
PS DIABETES MELLITUS HYPOGLYCAEMIC UNCONSCIOUSNESS 5
PS PRODUCT USED FOR UNKNOWN INDICATION MYOCARDIAL INFARCTION 4
PS PRODUCT USED FOR UNKNOWN INDICATION VASCULAR GRAFT 4
PS TYPE 2 DIABETES MELLITUS ABDOMINAL DISCOMFORT 3
PS TYPE 2 DIABETES MELLITUS ANTI-INSULIN ANTIBODY POSITIVE 2
PS TYPE 2 DIABETES MELLITUS DYSPEPSIA 3
PS TYPE 2 DIABETES MELLITUS HEADACHE 1
PS TYPE 2 DIABETES MELLITUS HYPOGLYCAEMIC COMA 2
PS TYPE 2 DIABETES MELLITUS HYPOKALAEMIA 2
PS TYPE 2 DIABETES MELLITUS INFECTION 2
PS TYPE 2 DIABETES MELLITUS INTENTIONAL OVERDOSE 2
PS TYPE 2 DIABETES MELLITUS MYOCARDIAL INFARCTION 1
PS TYPE 2 DIABETES MELLITUS NAUSEA 1
PS TYPE 2 DIABETES MELLITUS PRURITUS 1
PS TYPE 2 DIABETES MELLITUS SKIN MASS 1
PS TYPE 2 DIABETES MELLITUS TREMOR 1
PS TYPE 2 DIABETES MELLITUS VASCULAR GRAFT 1
SS DIABETES MELLITUS CRANIOCEREBRAL INJURY 5
SS DIABETES MELLITUS DIABETIC KETOACIDOSIS 5
SS DIABETES MELLITUS HYPERGLYCAEMIA 5
SS DIABETES MELLITUS HYPOGLYCAEMIA 5
SS DIABETES MELLITUS HYPOGLYCAEMIC UNCONSCIOUSNESS 5
SS TYPE 1 DIABETES MELLITUS BLOOD GLUCOSE FLUCTUATION 2
SS TYPE 1 DIABETES MELLITUS HYPOGLYCAEMIC SEIZURE 2
SS TYPE 1 DIABETES MELLITUS HYPOGLYCAEMIC UNCONSCIOUSNESS 2
C ANTICOAGULANT THERAPY ANAEMIA 3
C ANTICOAGULANT THERAPY FLUID RETENTION 3
C ANTICOAGULANT THERAPY HAEMATOCHEZIA 3
C ANTICOAGULANT THERAPY HAEMORRHAGE 3
C ANTICOAGULANT THERAPY HAEMORRHOIDAL HAEMORRHAGE 3
C ANTICOAGULANT THERAPY LOSS OF CONSCIOUSNESS 3
C ANTICOAGULANT THERAPY MOUTH HAEMORRHAGE 3
C ANTICOAGULANT THERAPY OEDEMA 3
C ANTICOAGULANT THERAPY OEDEMA PERIPHERAL 3
C ANTICOAGULANT THERAPY PAIN IN EXTREMITY 1
C ANTICOAGULANT THERAPY VOMITING 3
C ATRIAL FIBRILLATION ANAEMIA 6
C ATRIAL FIBRILLATION FLUID RETENTION 6
C ATRIAL FIBRILLATION GASTROINTESTINAL HAEMORRHAGE 1
C ATRIAL FIBRILLATION HAEMATOCHEZIA 6
C ATRIAL FIBRILLATION HAEMORRHAGE 6
C ATRIAL FIBRILLATION HAEMORRHOIDAL HAEMORRHAGE 6
C ATRIAL FIBRILLATION INTERNATIONAL NORMALISED RATIO INCREASED 1
C ATRIAL FIBRILLATION LOSS OF CONSCIOUSNESS 6
C ATRIAL FIBRILLATION MOUTH HAEMORRHAGE 6
C ATRIAL FIBRILLATION OEDEMA 6
C ATRIAL FIBRILLATION OEDEMA PERIPHERAL 6
C ATRIAL FIBRILLATION PAIN IN EXTREMITY 2
C ATRIAL FIBRILLATION RESPIRATORY FAILURE 1
C ATRIAL FIBRILLATION VOMITING 6
C BLOOD CHOLESTEROL INCREASED ANAEMIA 6
C BLOOD CHOLESTEROL INCREASED FLUID RETENTION 6
C BLOOD CHOLESTEROL INCREASED HAEMATOCHEZIA 6
C BLOOD CHOLESTEROL INCREASED HAEMORRHAGE 6
C BLOOD CHOLESTEROL INCREASED HAEMORRHAGIC STROKE 1
C BLOOD CHOLESTEROL INCREASED HAEMORRHOIDAL HAEMORRHAGE 6
C BLOOD CHOLESTEROL INCREASED INTRACRANIAL ANEURYSM 1
C BLOOD CHOLESTEROL INCREASED LOSS OF CONSCIOUSNESS 6
C BLOOD CHOLESTEROL INCREASED MOUTH HAEMORRHAGE 6
C BLOOD CHOLESTEROL INCREASED OEDEMA 6
C BLOOD CHOLESTEROL INCREASED OEDEMA PERIPHERAL 6
C BLOOD CHOLESTEROL INCREASED PAIN IN EXTREMITY 2
C BLOOD CHOLESTEROL INCREASED VOMITING 6
C BLOOD PRESSURE CORONARY ARTERY BYPASS 2
C BLOOD PRESSURE FLUSHING 2
C BLOOD TRIGLYCERIDES INCREASED ANAEMIA 3
C BLOOD TRIGLYCERIDES INCREASED FLUID RETENTION 3
C BLOOD TRIGLYCERIDES INCREASED HAEMATOCHEZIA 3
C BLOOD TRIGLYCERIDES INCREASED HAEMORRHAGE 3
C BLOOD TRIGLYCERIDES INCREASED HAEMORRHOIDAL HAEMORRHAGE 3
C BLOOD TRIGLYCERIDES INCREASED LOSS OF CONSCIOUSNESS 3
C BLOOD TRIGLYCERIDES INCREASED MOUTH HAEMORRHAGE 3
C BLOOD TRIGLYCERIDES INCREASED OEDEMA 3
C BLOOD TRIGLYCERIDES INCREASED OEDEMA PERIPHERAL 3
C BLOOD TRIGLYCERIDES INCREASED PAIN IN EXTREMITY 1
C BLOOD TRIGLYCERIDES INCREASED VOMITING 3
C CARDIAC FAILURE CARDIAC FAILURE ACUTE 20
C CARDIAC FAILURE FLUID OVERLOAD 20
C CARDIAC FAILURE PULMONARY CONGESTION 20
C CARDIAC FAILURE CHRONIC CARDIAC FAILURE ACUTE 3
C CARDIAC FAILURE CHRONIC FLUID OVERLOAD 3
C CARDIAC FAILURE CHRONIC PULMONARY CONGESTION 3
C CARDIOVASCULAR DISORDER VITREOUS HAEMORRHAGE 2
C CARDIOVASCULAR EVENT PROPHYLAXIS CORONARY ARTERY BYPASS 1
C CARDIOVASCULAR EVENT PROPHYLAXIS FLUSHING 1
C CAROTID ARTERY STENOSIS VITREOUS HAEMORRHAGE 2
C CHEST PAIN BACK PAIN 2
C CHEST PAIN BLOOD PRESSURE DECREASED 2
C CHEST PAIN CARDIAC ARREST 2
C CHEST PAIN CARDIAC DISORDER 2
C CHEST PAIN DYSPNOEA 2
C CHEST PAIN LOSS OF CONSCIOUSNESS 2
C CHEST PAIN MYOCARDIAL INFARCTION 2
C CHEST PAIN ORGAN FAILURE 2
C CHEST PAIN RESPIRATORY FAILURE 2
C CHEST PAIN SYNCOPE 2
C CONSTIPATION CARDIAC FAILURE ACUTE 4
C CONSTIPATION FLUID OVERLOAD 4
C CONSTIPATION PULMONARY CONGESTION 4
C CONTRACEPTION DEEP VEIN THROMBOSIS 3
C CONTRACEPTION PAIN 3
C CORONARY ARTERY BYPASS ANXIETY 1
C CORONARY ARTERY BYPASS EMOTIONAL DISTRESS 1
C CORONARY ARTERY BYPASS FEAR 1
C CORONARY ARTERY BYPASS PAIN 1
C CORONARY ARTERY BYPASS RENAL FAILURE 1
C CORONARY ARTERY BYPASS RENAL IMPAIRMENT 1
C CORONARY ARTERY BYPASS RENAL INJURY 1
C CORONARY ARTERY BYPASS STRESS 1
C CORONARY ARTERY BYPASS UNEVALUABLE EVENT 1
C COUGH HAEMORRHAGIC STROKE 1
C COUGH INTRACRANIAL ANEURYSM 1
C DIABETES MELLITUS ABDOMINAL PAIN UPPER 3
C DIABETES MELLITUS ANAEMIA 6
C DIABETES MELLITUS ANGER 3
C DIABETES MELLITUS CARDIAC DISORDER 6
C DIABETES MELLITUS CARDIAC FAILURE ACUTE 8
C DIABETES MELLITUS CORONARY ARTERY BYPASS 2
C DIABETES MELLITUS DIARRHOEA 3
C DIABETES MELLITUS DRUG INEFFECTIVE 2
C DIABETES MELLITUS DYSPNOEA 3
C DIABETES MELLITUS FLUID OVERLOAD 8
C DIABETES MELLITUS FLUID RETENTION 6
C DIABETES MELLITUS FLUSHING 2
C DIABETES MELLITUS HAEMATOCHEZIA 6
C DIABETES MELLITUS HAEMORRHAGE 6
C DIABETES MELLITUS HAEMORRHAGIC STROKE 3
C DIABETES MELLITUS HAEMORRHOIDAL HAEMORRHAGE 6
C DIABETES MELLITUS INSOMNIA 3
C DIABETES MELLITUS INTRACRANIAL ANEURYSM 3
C DIABETES MELLITUS LOSS OF CONSCIOUSNESS 6
C DIABETES MELLITUS MOUTH HAEMORRHAGE 6
C DIABETES MELLITUS MYOCARDIAL INFARCTION 6
C DIABETES MELLITUS OEDEMA 6
C DIABETES MELLITUS OEDEMA PERIPHERAL 12
C DIABETES MELLITUS ORGANISING PNEUMONIA 1
C DIABETES MELLITUS PAIN IN EXTREMITY 2
C DIABETES MELLITUS PULMONARY CONGESTION 8
C DIABETES MELLITUS RASH 1
C DIABETES MELLITUS SUFFOCATION FEELING 6
C DIABETES MELLITUS SUICIDAL IDEATION 3
C DIABETES MELLITUS VOMITING 6
C EAR INFECTION HAEMORRHAGIC STROKE 1
C EAR INFECTION INTRACRANIAL ANEURYSM 1
C EAR PAIN HAEMORRHAGIC STROKE 1
C EAR PAIN INTRACRANIAL ANEURYSM 1
C GASTRITIS PROPHYLAXIS CARDIAC FAILURE ACUTE 4
C GASTRITIS PROPHYLAXIS FLUID OVERLOAD 4
C GASTRITIS PROPHYLAXIS PULMONARY CONGESTION 4
C GLAUCOMA VITREOUS HAEMORRHAGE 6
C GOUT ABDOMINAL PAIN UPPER 1
C GOUT ANGER 1
C GOUT DIARRHOEA 1
C GOUT DYSPNOEA 1
C GOUT INSOMNIA 1
C GOUT SUICIDAL IDEATION 1
C HAEMORRHOIDS CARDIAC FAILURE ACUTE 4
C HAEMORRHOIDS FLUID OVERLOAD 4
C HAEMORRHOIDS PULMONARY CONGESTION 4
C HIGH DENSITY LIPOPROTEIN DECREASED CORONARY ARTERY BYPASS 1
C HIGH DENSITY LIPOPROTEIN DECREASED FLUSHING 1
C HYPERLIPIDAEMIA CARDIAC FAILURE ACUTE 4
C HYPERLIPIDAEMIA FLUID OVERLOAD 4
C HYPERLIPIDAEMIA PULMONARY CONGESTION 4
C HYPERLIPIDAEMIA TENDON RUPTURE 1
C HYPERTENSION ANAEMIA 18
C HYPERTENSION ANGIOGRAM PERIPHERAL 3
C HYPERTENSION APATHY 3
C HYPERTENSION ARTHRITIS 3
C HYPERTENSION BACK PAIN 3
C HYPERTENSION BLOOD GLUCOSE FLUCTUATION 3
C HYPERTENSION BLOOD GLUCOSE INCREASED 3
C HYPERTENSION CLOSTRIDIAL INFECTION 3
C HYPERTENSION CYSTITIS 3
C HYPERTENSION FLUID RETENTION 18
C HYPERTENSION HAEMATOCHEZIA 18
C HYPERTENSION HAEMORRHAGE 18
C HYPERTENSION HAEMORRHAGIC STROKE 1
C HYPERTENSION HAEMORRHOIDAL HAEMORRHAGE 18
C HYPERTENSION HEART RATE DECREASED 3
C HYPERTENSION HYPERHIDROSIS 3
C HYPERTENSION IMPAIRED HEALING 3
C HYPERTENSION INTRACRANIAL ANEURYSM 1
C HYPERTENSION KNEE OPERATION 3
C HYPERTENSION LIMB OPERATION 3
C HYPERTENSION LOSS OF CONSCIOUSNESS 18
C HYPERTENSION MEMORY IMPAIRMENT 3
C HYPERTENSION MOBILITY DECREASED 3
C HYPERTENSION MOUTH HAEMORRHAGE 18
C HYPERTENSION OEDEMA 18
C HYPERTENSION OEDEMA PERIPHERAL 18
C HYPERTENSION PAIN IN EXTREMITY 6
C HYPERTENSION PNEUMONIA 3
C HYPERTENSION PYREXIA 3
C HYPERTENSION RHEUMATOID ARTHRITIS 3
C HYPERTENSION SPINAL FUSION SURGERY 3
C HYPERTENSION THERAPEUTIC REACTION TIME DECREASED 3
C HYPERTENSION VITREOUS HAEMORRHAGE 4
C HYPERTENSION VOMITING 18
C HYPERTENSION WOUND 3
C HYPERURICAEMIA CARDIAC FAILURE ACUTE 4
C HYPERURICAEMIA FLUID OVERLOAD 4
C HYPERURICAEMIA PULMONARY CONGESTION 4
C HYPOTHYROIDISM CARDIAC DISORDER 3
C HYPOTHYROIDISM DRUG INEFFECTIVE 1
C HYPOTHYROIDISM MYOCARDIAL INFARCTION 3
C HYPOTHYROIDISM OEDEMA PERIPHERAL 3
C HYPOTHYROIDISM SUFFOCATION FEELING 3
C INSOMNIA CARDIAC FAILURE ACUTE 4
C INSOMNIA FLUID OVERLOAD 4
C INSOMNIA PULMONARY CONGESTION 4
C LOW DENSITY LIPOPROTEIN INCREASED CORONARY ARTERY BYPASS 1
C LOW DENSITY LIPOPROTEIN INCREASED FLUSHING 1
C MYOCARDIAL INFARCTION CARDIAC FAILURE ACUTE 8
C MYOCARDIAL INFARCTION FLUID OVERLOAD 8
C MYOCARDIAL INFARCTION PULMONARY CONGESTION 8
C PANCREATIC CARCINOMA CARDIOVASCULAR DISORDER 1
C PANCREATIC CARCINOMA DIARRHOEA 1
C PANCREATIC CARCINOMA INCORRECT DOSE ADMINISTERED 1
C PRODUCT USED FOR UNKNOWN INDICATION BACK PAIN 20
C PRODUCT USED FOR UNKNOWN INDICATION BLOOD PRESSURE DECREASED 20
C PRODUCT USED FOR UNKNOWN INDICATION CARDIAC ARREST 20
C PRODUCT USED FOR UNKNOWN INDICATION CARDIAC DISORDER 41
C PRODUCT USED FOR UNKNOWN INDICATION CORONARY ARTERY BYPASS 9
C PRODUCT USED FOR UNKNOWN INDICATION DRUG INEFFECTIVE 7
C PRODUCT USED FOR UNKNOWN INDICATION DYSPNOEA 20
C PRODUCT USED FOR UNKNOWN INDICATION FLUSHING 9
C PRODUCT USED FOR UNKNOWN INDICATION HAEMORRHAGIC STROKE 1
C PRODUCT USED FOR UNKNOWN INDICATION HYPOGLYCAEMIA 1
C PRODUCT USED FOR UNKNOWN INDICATION INTRACRANIAL ANEURYSM 1
C PRODUCT USED FOR UNKNOWN INDICATION LOSS OF CONSCIOUSNESS 20
C PRODUCT USED FOR UNKNOWN INDICATION MYOCARDIAL INFARCTION 41
C PRODUCT USED FOR UNKNOWN INDICATION OEDEMA PERIPHERAL 21
C PRODUCT USED FOR UNKNOWN INDICATION ORGAN FAILURE 20
C PRODUCT USED FOR UNKNOWN INDICATION RESPIRATORY FAILURE 20
C PRODUCT USED FOR UNKNOWN INDICATION SUFFOCATION FEELING 21
C PRODUCT USED FOR UNKNOWN INDICATION SYNCOPE 20
C PROPHYLAXIS ANAEMIA 3
C PROPHYLAXIS FLUID RETENTION 3
C PROPHYLAXIS HAEMATOCHEZIA 3
C PROPHYLAXIS HAEMORRHAGE 3
C PROPHYLAXIS HAEMORRHOIDAL HAEMORRHAGE 3
C PROPHYLAXIS LOSS OF CONSCIOUSNESS 3
C PROPHYLAXIS MOUTH HAEMORRHAGE 3
C PROPHYLAXIS OEDEMA 3
C PROPHYLAXIS OEDEMA PERIPHERAL 3
C PROPHYLAXIS PAIN IN EXTREMITY 1
C PROPHYLAXIS VOMITING 3
C PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER VITREOUS HAEMORRHAGE 2
C PULMONARY ARTERIAL HYPERTENSION ATRIAL FIBRILLATION 2
C PULMONARY ARTERIAL HYPERTENSION CHEST PAIN 2
C PULMONARY ARTERIAL HYPERTENSION DIZZINESS 2
C RENAL FAILURE CHRONIC CARDIAC FAILURE ACUTE 12
C RENAL FAILURE CHRONIC FLUID OVERLOAD 12
C RENAL FAILURE CHRONIC PULMONARY CONGESTION 12
C RHEUMATOID ARTHRITIS CARDIAC DISORDER 3
C RHEUMATOID ARTHRITIS DRUG INEFFECTIVE 1
C RHEUMATOID ARTHRITIS MYOCARDIAL INFARCTION 3
C RHEUMATOID ARTHRITIS OEDEMA PERIPHERAL 3
C RHEUMATOID ARTHRITIS SUFFOCATION FEELING 3
C STENT PLACEMENT ANAEMIA 3
C STENT PLACEMENT FLUID RETENTION 3
C STENT PLACEMENT HAEMATOCHEZIA 3
C STENT PLACEMENT HAEMORRHAGE 3
C STENT PLACEMENT HAEMORRHOIDAL HAEMORRHAGE 3
C STENT PLACEMENT LOSS OF CONSCIOUSNESS 3
C STENT PLACEMENT MOUTH HAEMORRHAGE 3
C STENT PLACEMENT OEDEMA 3
C STENT PLACEMENT OEDEMA PERIPHERAL 3
C STENT PLACEMENT PAIN IN EXTREMITY 1
C STENT PLACEMENT VOMITING 3
C SUPPLEMENTATION THERAPY CORONARY ARTERY BYPASS 1
C SUPPLEMENTATION THERAPY FLUSHING 1
C TYPE 1 DIABETES MELLITUS ANIMAL BITE 6
C TYPE 1 DIABETES MELLITUS ASTHENIA 5
C TYPE 1 DIABETES MELLITUS BLINDNESS UNILATERAL 6
C TYPE 1 DIABETES MELLITUS BLOOD GLUCOSE ABNORMAL 5
C TYPE 1 DIABETES MELLITUS BLOOD GLUCOSE FLUCTUATION 5
C TYPE 1 DIABETES MELLITUS BLOOD GLUCOSE INCREASED 11
C TYPE 1 DIABETES MELLITUS DRUG INEFFECTIVE 5
C TYPE 1 DIABETES MELLITUS DRUG INTOLERANCE 5
C TYPE 1 DIABETES MELLITUS EYE OPERATION 6
C TYPE 1 DIABETES MELLITUS FLANK PAIN 5
C TYPE 1 DIABETES MELLITUS GLYCOSYLATED HAEMOGLOBIN INCREASED 5
C TYPE 1 DIABETES MELLITUS HYPERHIDROSIS 5
C TYPE 1 DIABETES MELLITUS INCORRECT DOSE ADMINISTERED 3
C TYPE 1 DIABETES MELLITUS PAIN IN EXTREMITY 5
C TYPE 1 DIABETES MELLITUS RENAL DISORDER 6
C TYPE 1 DIABETES MELLITUS TREMOR 5
C TYPE 1 DIABETES MELLITUS VISUAL ACUITY REDUCED 6
C TYPE 1 DIABETES MELLITUS VISUAL FIELD DEFECT 6
C TYPE 1 DIABETES MELLITUS VISUAL IMPAIRMENT 5
C TYPE 2 DIABETES MELLITUS ANGIOGRAM PERIPHERAL 3
C TYPE 2 DIABETES MELLITUS APATHY 3
C TYPE 2 DIABETES MELLITUS ARTHRITIS 3
C TYPE 2 DIABETES MELLITUS BACK PAIN 3
C TYPE 2 DIABETES MELLITUS BLOOD GLUCOSE FLUCTUATION 3
C TYPE 2 DIABETES MELLITUS BLOOD GLUCOSE INCREASED 3
C TYPE 2 DIABETES MELLITUS CLOSTRIDIAL INFECTION 3
C TYPE 2 DIABETES MELLITUS CYSTITIS 3
C TYPE 2 DIABETES MELLITUS HEART RATE DECREASED 3
C TYPE 2 DIABETES MELLITUS HYPERHIDROSIS 3
C TYPE 2 DIABETES MELLITUS IMPAIRED HEALING 3
C TYPE 2 DIABETES MELLITUS KNEE OPERATION 3
C TYPE 2 DIABETES MELLITUS LIMB OPERATION 3
C TYPE 2 DIABETES MELLITUS MEMORY IMPAIRMENT 3
C TYPE 2 DIABETES MELLITUS MOBILITY DECREASED 3
C TYPE 2 DIABETES MELLITUS PNEUMONIA 3
C TYPE 2 DIABETES MELLITUS PYREXIA 3
C TYPE 2 DIABETES MELLITUS RHEUMATOID ARTHRITIS 3
C TYPE 2 DIABETES MELLITUS SPINAL FUSION SURGERY 3
C TYPE 2 DIABETES MELLITUS THERAPEUTIC REACTION TIME DECREASED 3
C TYPE 2 DIABETES MELLITUS VITREOUS HAEMORRHAGE 4
C TYPE 2 DIABETES MELLITUS WOUND 3
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