Simulect and cytomegalovirus antigen positive Patient Reports February 12, 2012

Simulect Side Effects Report #5472335-5
Simulect side effect was reported by a Consumer or non-health professional from JAPAN on Sept 20, 2007. Male patient, 55 years of age, was diagnosed with renal transplant and was treated with Simulect. After drug was administered, patient experienced the following side effects: anaemia, cytomegalovirus antigen positive, duodenal ulcer haemorrhage, faeces discoloured, gastrectomy, pylorectomy. Simulect dosage: 20 MG, ONCE/SINGLE. During the same period patient was treated with NEORAL, CELLCEPT, MEDROL, RITUXAN. Patient was hospitalized. Patient recovered.

Simulect Side Effects Report #4550985-8
Simulect side effect was reported by a Physician from on Dec 13, 2004. Male patient, 55 years of age, weighting 143.3 lb, was diagnosed with renal transplant and was treated with Simulect. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, cytomegalovirus antigen positive, hepatic function abnormal. Simulect dosage: 20 MG, ONCE/SINGLE. During the same period patient was treated with PROGRAF, CELLCEPT, PREDONINE, BREDININ, GASTER, ZYLORIC, AMLODIN. Patient recovered.

Simulect Side Effects Report #4550987-1
Simulect side effect was reported by a Physician from on Dec 13, 2004. Male patient, 55 years of age, weighting 143.3 lb, was diagnosed with renal transplant and was treated with Simulect. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, cytomegalovirus antigen positive, hepatic function abnormal. Simulect dosage: 20 MG, ONCE/SINGLE. During the same period patient was treated with PROGRAF, CELLCEPT, PREDONINE, BREDININ, GASTER, ZYLORIC, AMLODIN. Patient recovered.

Simulect Side Effects Report #5389834-7
Simulect side effect was reported by a Consumer or non-health professional from JAPAN on July 11, 2007. Male patient, 39 years of age, was diagnosed with renal transplant and was treated with Simulect. After drug was administered, patient experienced the following side effects: cytomegalovirus antigen positive, infection , lymphorrhoea, subcutaneous abscess. Simulect dosage: 20 MG, UNK. During the same period patient was treated with TACROLIMUS, METHYLPREDNISOLONE, CELLCEPT, BREDININ. Patient was hospitalized. Patient recovered.


Simulect Side Effects Report #5401134-5
Simulect side effect was reported by a Consumer or non-health professional from JAPAN on July 23, 2007. Male patient, 39 years of age, was diagnosed with renal transplant and was treated with Simulect. After drug was administered, patient experienced the following side effects: abscess drainage, cytomegalovirus antigen positive, infection , kidney transplant rejection, lymphorrhoea, pyrexia, subcutaneous abscess, wound infection staphylococcal. Simulect dosage: 20 MG, UNK. During the same period patient was treated with TACROLIMUS, METHYLPREDNISOLONE, CELLCEPT, BREDININ. Patient was hospitalized. Patient recovered.

Simulect Side Effects Report #5096215-2
Simulect side effect was reported by a Physician from JAPAN on Aug 09, 2006. Female patient, 31 years of age, weighting 132.3 lb, was diagnosed with renal transplant and was treated with Simulect. After drug was administered, patient experienced the following side effects: anaemia, complement fixation abnormal, cytomegalovirus antigen positive, cytomegalovirus infection , diarrhoea, dizziness , duodenal ulcer haemorrhage, haemoglobin decreased, malaise. Simulect dosage: unknown. During the same period patient was treated with CELLCEPT, PREDONINE, SANDIMMUNE. Patient was hospitalized. Patient recovered.

Simulect Side Effects Report #5803485-9
Simulect side effect was reported by a Physician from JAPAN on June 30, 2008. Male patient, weighting 152.1 lb, was diagnosed with renal transplant and was treated with Simulect. After drug was administered, patient experienced the following side effects: cytomegalovirus antigen positive, diarrhoea, gastroenteritis staphylococcal, histiocytosis haematophagic, immunodeficiency, pyrexia, respiratory distress, staphylococcal infection , surgery . Simulect dosage: 20 MG, ONCE/SINGLE. During the same period patient was treated with NEORAL, MEDROL, CELLCEPT, SANDIMMUNE. Patient was hospitalized. Patient recovered.

Simulect Side Effects Report #5953273-8
Simulect side effect was reported by a Physician from JAPAN on Nov 07, 2008. Male patient, weighting 152.1 lb, was diagnosed with renal transplant and was treated with Simulect. After drug was administered, patient experienced the following side effects: cytomegalovirus antigen positive, diarrhoea, gastroenteritis staphylococcal, histiocytosis haematophagic, immunodeficiency, kidney transplant rejection, pyrexia, respiratory distress, staphylococcal infection . Simulect dosage: 20 MG, ONCE/SINGLE. During the same period patient was treated with NEORAL, MEDROL, CELLCEPT, SANDIMMUNE. Patient was hospitalized. Patient recovered.

Simulect Side Effects Report #6031379-5
Simulect side effect was reported by a Physician from JAPAN on Jan 06, 2009. Male patient, weighting 152.1 lb, was diagnosed with renal transplant and was treated with Simulect. After drug was administered, patient experienced the following side effects: blood creatinine increased, cytomegalovirus antigen positive, diarrhoea, gastroenteritis staphylococcal, histiocytosis haematophagic, immunodeficiency, pyrexia, respiratory distress, staphylococcal infection . Simulect dosage: 20 MG/DAY. During the same period patient was treated with NEORAL, MEDROL, CELLCEPT, SANDIMMUNE. Patient was hospitalized. Patient recovered.


Simulect Side Effects Report #6099973-3
Simulect side effect was reported by a Physician from JAPAN on Feb 25, 2009. Male patient, weighting 152.1 lb, was diagnosed with renal transplant and was treated with Simulect. After drug was administered, patient experienced the following side effects: blood creatinine increased, cytomegalovirus antigen positive, diarrhoea, gastroenteritis staphylococcal, histiocytosis haematophagic, immunodeficiency, kidney transplant rejection, pyrexia, respiratory distress. Simulect dosage: 20 MG/DAY. During the same period patient was treated with NEORAL, MEDROL, CELLCEPT, SANDIMMUNE. Patient was hospitalized. Patient recovered.

Simulect Side Effects Report #5269199-1
Simulect side effect was reported by a Consumer or non-health professional from JAPAN on Mar 12, 2007. Male patient, 55 years of age, was treated with Simulect. After drug was administered, patient experienced the following side effects: cytomegalovirus antigen positive, duodenal ulcer. Simulect dosage: unknown. During the same period patient was treated with CYCLOSPORINE, CELLCEPT, METHYLPREDNISOLONE. Patient recovered.