| Form
| Dosage
| Status
| Therapeutic Equivalence
| Active Ingred
| Ref.
| Sponsor
| Document
|
| INJECTABLE; INJECTION
| 2GM/VIAL
| Prescription
| AP (Reference Drug)
| DEFEROXAMINE MESYLATE
| Deferoxamine
| NOVARTIS
| 016267
2002-02-14 Letter 2001-04-09 Letter |
| INJECTABLE; INJECTION
| 500MG/VIAL
| Prescription
| AP (Reference Drug)
| DEFEROXAMINE MESYLATE
| Deferoxamine
| NOVARTIS
| " |
| Role code
| Indications
| Reaction
| # Reports
|
| PS
| APLASTIC ANAEMIA
| INJECTION SITE INFECTION
| 1
|
| PS
| BLOOD ALUMINIUM INCREASED
| GAMMA-GLUTAMYLTRANSFERASE INCREASED
| 2
|
| PS
| BLOOD ALUMINIUM INCREASED
| TRANSAMINASES INCREASED
| 2
|
| PS
| BLOOD IRON INCREASED
| ASTHENIA
| 1
|
| PS
| BLOOD IRON INCREASED
| BONE MARROW FAILURE
| 2
|
| PS
| BLOOD IRON INCREASED
| CHILLS
| 1
|
| PS
| BLOOD IRON INCREASED
| COUGH
| 1
|
| PS
| BLOOD IRON INCREASED
| DEHYDRATION
| 1
|
| PS
| BLOOD IRON INCREASED
| DYSPNOEA
| 1
|
| PS
| BLOOD IRON INCREASED
| PLEURITIC PAIN
| 1
|
| PS
| BLOOD IRON INCREASED
| PNEUMONIA
| 1
|
| PS
| BLOOD IRON INCREASED
| PYREXIA
| 1
|
| PS
| BLOOD IRON INCREASED
| RENAL FAILURE
| 1
|
| PS
| HAEMOCHROMATOSIS
| ASPERGILLOSIS
| 2
|
| PS
| HAEMOCHROMATOSIS
| CANDIDA SEPSIS
| 2
|
| PS
| HAEMOCHROMATOSIS
| CHILLS
| 2
|
| PS
| HAEMOCHROMATOSIS
| FEBRILE BONE MARROW APLASIA
| 2
|
| PS
| HAEMOCHROMATOSIS
| HAEMOGLOBIN DECREASED
| 2
|
| PS
| HAEMOCHROMATOSIS
| HERPES ZOSTER
| 2
|
| PS
| HAEMOCHROMATOSIS
| HISTIOCYTOSIS HAEMATOPHAGIC
| 2
|
| PS
| HAEMOCHROMATOSIS
| PANCYTOPENIA
| 2
|
| PS
| HAEMOCHROMATOSIS
| PLATELET COUNT DECREASED
| 2
|
| PS
| HAEMOCHROMATOSIS
| RETINAL DEGENERATION
| 1
|
| PS
| HAEMOCHROMATOSIS
| RETINITIS PIGMENTOSA
| 1
|
| PS
| HAEMOCHROMATOSIS
| VISION BLURRED
| 1
|
| PS
| HAEMOCHROMATOSIS
| VISUAL ACUITY REDUCED
| 1
|
| PS
| HAEMOCHROMATOSIS
| VISUAL DISTURBANCE
| 1
|
| PS
| HAEMOCHROMATOSIS
| VISUAL FIELD DEFECT
| 1
|
| PS
| HAEMOCHROMATOSIS
| WHITE BLOOD CELL COUNT DECREASED
| 2
|
| PS
| HAEMOSIDEROSIS
| AUTOIMMUNE DISORDER
| 1
|
| PS
| HAEMOSIDEROSIS
| CARDIAC DISCOMFORT
| 1
|
| PS
| HAEMOSIDEROSIS
| DYSPNOEA
| 1
|
| PS
| HAEMOSIDEROSIS
| GENERALISED OEDEMA
| 1
|
| PS
| HAEMOSIDEROSIS
| INCORRECT DOSE ADMINISTERED
| 1
|
| PS
| HAEMOSIDEROSIS
| LEUKOCYTOSIS
| 1
|
| PS
| HAEMOSIDEROSIS
| PLATELET COUNT INCREASED
| 1
|
| PS
| HAEMOSIDEROSIS
| PULMONARY OEDEMA
| 1
|
| PS
| HAEMOSIDEROSIS
| RHEUMATOID ARTHRITIS
| 1
|
| PS
| HAEMOSIDEROSIS
| VISUAL ACUITY REDUCED
| 1
|
| PS
| SERUM FERRITIN INCREASED
| HAEMOGLOBIN DECREASED
| 1
|
| PS
| SERUM FERRITIN INCREASED
| NEUTROPHIL COUNT DECREASED
| 1
|
| PS
| SERUM FERRITIN INCREASED
| RED BLOOD CELL COUNT DECREASED
| 1
|
| PS
| THALASSAEMIA
| BLISTER
| 1
|
| PS
| THALASSAEMIA
| PARESIS
| 1
|
| PS
| THALASSAEMIA
| SKIN DISORDER
| 1
|
| PS
| THALASSAEMIA
| SKIN INFLAMMATION
| 1
|
| PS
| THALASSAEMIA
| SKIN NECROSIS
| 1
|
| PS
| THALASSAEMIA BETA
| CAESAREAN SECTION
| 1
|
| PS
| THALASSAEMIA BETA
| DRUG EXPOSURE DURING PREGNANCY
| 1
|
| PS
| THALASSAEMIA BETA
| HYPOGLYCAEMIA
| 1
|
| PS
| THALASSAEMIA BETA
| METABOLIC ACIDOSIS
| 1
|
| PS
| THALASSAEMIA BETA
| NORMAL NEWBORN
| 1
|
| PS
| THALASSAEMIA BETA
| PREGNANCY
| 1
|
| PS
| THALASSAEMIA BETA
| UTERINE CONTRACTIONS ABNORMAL
| 1
|
| SS
| BLOOD IRON INCREASED
| ABDOMINAL PAIN UPPER
| 1
|
| SS
| BLOOD IRON INCREASED
| ALANINE AMINOTRANSFERASE INCREASED
| 1
|
| SS
| BLOOD IRON INCREASED
| ASPARTATE AMINOTRANSFERASE INCREASED
| 1
|
| SS
| BLOOD IRON INCREASED
| BLOOD BILIRUBIN INCREASED
| 1
|
| SS
| BLOOD IRON INCREASED
| BLOOD GLUCOSE INCREASED
| 1
|
| SS
| BLOOD IRON INCREASED
| DUODENAL ULCER
| 1
|
| SS
| BLOOD IRON INCREASED
| FATIGUE
| 1
|
| SS
| BLOOD IRON INCREASED
| GASTRITIS
| 1
|
| SS
| BLOOD IRON INCREASED
| NEPHROLITHIASIS
| 1
|
| SS
| BLOOD IRON INCREASED
| PAIN
| 1
|
| SS
| BLOOD IRON INCREASED
| RENAL PAIN
| 1
|
| SS
| BLOOD IRON INCREASED
| SERUM FERRITIN INCREASED
| 1
|
| SS
| BLOOD IRON INCREASED
| ULTRASOUND ABDOMEN ABNORMAL
| 1
|