Novoseven and hydrocephalus Patient Reports February 10, 2010

Novoseven Side Effects Report #5521736-5
Novoseven side effect was reported by a Physician from GERMANY on Nov 09, 2007. Female patient was diagnosed with traumatic haemorrhage, analgesia, anaesthesia, prophylaxis, sedation and was treated with Novoseven. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, cerebral haematoma, cyanosis, embolism, hepatic failure, hydrocephalus , renal failure acute, venous thrombosis, venous thrombosis limb. Novoseven dosage: unknown. During the same period patient was treated with FENTANYL, DORMICUM, LASIX, PANCURONIUM, ROCURONIUM BROMIDE, PROPOFOL. Patient was hospitalized and became disabled. Patient died on 10/31/2007.

Novoseven Side Effects Report #5576439-8
Novoseven side effect was reported by a Physician from GERMANY on Dec 18, 2007. Female patient was diagnosed with traumatic haemorrhage, analgesia, anaesthesia, prophylaxis, sedation and was treated with Novoseven. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, cerebral haematoma, cyanosis, embolism, hepatic failure, hydrocephalus , renal failure acute, venous thrombosis, venous thrombosis limb. Novoseven dosage: unknown. During the same period patient was treated with FENTANYL, DORMICUM, LASIX, PANCURONIUM, ROCURONIUM BROMIDE, PROPOFOL. Patient was hospitalized and became disabled. Patient died on 10/31/2007.

Novoseven Side Effects Report #5668920-8
Novoseven side effect was reported by a Physician from GERMANY on Mar 06, 2008. Male patient, weighting 187.4 lb, was diagnosed with traumatic haemorrhage, analgesia, anaesthesia, prophylaxis, sedation and was treated with Novoseven. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, cerebral haematoma, cyanosis, embolism, hepatic failure, hydrocephalus , renal failure acute, venous thrombosis, venous thrombosis limb. Novoseven dosage: unknown. During the same period patient was treated with FENTANYL, DORMICUM, LASIX, PANCURONIUM, ROCURONIUM BROMIDE, PROPOFOL. Patient was hospitalized and became disabled. Patient died on 10/31/2007.

Novoseven Side Effects Report #5674101-4
Novoseven side effect was reported by a Physician from GERMANY on Mar 14, 2008. Male patient, weighting 187.4 lb, was diagnosed with traumatic haemorrhage, analgesia, anaesthesia, prophylaxis, sedation and was treated with Novoseven. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, cerebral haematoma, cyanosis, embolism, hepatic failure, hydrocephalus , renal failure acute, venous thrombosis, venous thrombosis limb. Novoseven dosage: unknown. During the same period patient was treated with FENTANYL, DORMICUM, LASIX, PANCURONIUM, ROCURONIUM BROMIDE, PROPOFOL. Patient was hospitalized and became disabled. Patient died on 10/31/2007.


Novoseven Side Effects Report #5822272-9
Novoseven side effect was reported by a Physician from GERMANY on July 21, 2008. Male patient, weighting 187.4 lb, was diagnosed with traumatic haemorrhage, analgesia, anaesthesia, prophylaxis, sedation and was treated with Novoseven. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, cyanosis, embolism, hepatic failure, hydrocephalus , renal failure acute, subarachnoid haemorrhage, venous thrombosis, venous thrombosis limb. Novoseven dosage: unknown. During the same period patient was treated with FENTANYL, DORMICUM, LASIX, PANCURONIUM, ROCURONIUM BROMIDE, PROPOFOL. Patient was hospitalized and became disabled. Patient died on 10/31/2007.

Novoseven Side Effects Report #5897584-3
Novoseven side effect was reported by a Physician from GERMANY on Sept 18, 2008. Male patient, weighting 187.4 lb, was diagnosed with traumatic haemorrhage, cardiovascular insufficiency, analgesia, anaesthesia, prophylaxis, sedation and was treated with Novoseven. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, brain oedema, continuous haemodiafiltration, cyanosis, embolism, hepatic failure, hydrocephalus , necrosis, renal failure acute. Novoseven dosage: unknown. During the same period patient was treated with FENTANYL, DORMICUM, LASIX, PANCURONIUM, ROCURONIUM BROMIDE, PROPOFOL. Patient was hospitalized and became disabled. Patient died on 10/31/2007.

Novoseven Side Effects Report #5266908-2
Novoseven side effect was reported by a Physician from LEBANON on Mar 05, 2007. Female patient was diagnosed with haemorrhage intracranial and was treated with Novoseven. After drug was administered, patient experienced the following side effects: hydrocephalus , subarachnoid haemorrhage. Novoseven dosage: unknown. Patient was hospitalized. Patient recovered.

Novoseven Side Effects Report #5297637-7
Novoseven side effect was reported by a Physician from LEBANON on Apr 04, 2007. Female patient, weighting 9.04 lb, was diagnosed with haemorrhage intracranial and was treated with Novoseven. After drug was administered, patient experienced the following side effects: hydrocephalus , subarachnoid haemorrhage. Novoseven dosage: unknown. During the same period patient was treated with GARDENAL, FENTANYL, ZANTAC, ROCEPHIN. Patient was hospitalized. Patient recovered.

Novoseven Side Effects Report #5304563-3
Novoseven side effect was reported by a Physician from LEBANON on Apr 12, 2007. Female patient, weighting 9.04 lb, was diagnosed with haemorrhage intracranial and was treated with Novoseven. After drug was administered, patient experienced the following side effects: hydrocephalus , subarachnoid haemorrhage. Novoseven dosage: unknown. During the same period patient was treated with GARDENAL, FENTANYL, ZANTAC, ROCEPHIN. Patient was hospitalized. Patient recovered.


Novoseven Side Effects Report #5874873-X
Novoseven side effect was reported by a Physician from JAPAN on Aug 29, 2008. Male patient, 70 years of age, weighting 110.2 lb, was diagnosed with haemorrhage and was treated with Novoseven. After drug was administered, patient experienced the following side effects: gastrointestinal necrosis, hydrocephalus , intestinal ischaemia. Novoseven dosage: 4.8 MG, SINGLE. Patient died.

Novoseven Side Effects Report #5688601-4
Novoseven side effect was reported by a Physician from JAPAN on Mar 19, 2008. Male patient, 61 years of age, was diagnosed with haemorrhage and was treated with Novoseven. After drug was administered, patient experienced the following side effects: condition aggravated, hydrocephalus . Novoseven dosage: unknown. During the same period patient was treated with OMEPRAL, ADONA, TRANSAMIN, MEROPEN, FRESH FROZEN PLASMA, RED BLOOD CELLS. Patient died on 09/20/2007.

Novoseven Side Effects Report #5195470-8
Novoseven side effect was reported by a Physician from ISRAEL on Dec 24, 2006. Male patient, 59 years of age, was diagnosed with haemorrhage, cerebral haemorrhage and was treated with Novoseven. After drug was administered, patient experienced the following side effects: hydrocephalus . Novoseven dosage: 6 MG, QD. During the same period patient was treated with COUMADIN. Patient was hospitalized. Patient died on 12/23/2006.

Novoseven Side Effects Report #5101540-2
Novoseven side effect was reported by a Physician from ISRAEL on Sept 04, 2006. Female patient, 78 years of age, was diagnosed with cerebral haemorrhage and was treated with Novoseven. After drug was administered, patient experienced the following side effects: hydrocephalus , pneumonia , sepsis . Novoseven dosage: 4.8 MG, QD. Patient died on 08/31/2006.

Novoseven Side Effects Report #5202230-8
Novoseven side effect was reported by a Physician from ISRAEL on Dec 31, 2006. Female patient, child 3 years of age, was diagnosed with cerebral haemorrhage and was treated with Novoseven. After drug was administered, patient experienced the following side effects: hernia , hydrocephalus , ischaemic stroke. Novoseven dosage: 1.2 MG, QID. During the same period patient was treated with HEXAKAPRON, PROTEIN C. Patient was hospitalized. Patient recovered.


Novoseven Side Effects Report #5237352-9
Novoseven side effect was reported by a Physician from ISRAEL on Feb 01, 2007. Female patient, child 3 years of age, weighting 24.25 lb, was diagnosed with cerebral haemorrhage and was treated with Novoseven. After drug was administered, patient experienced the following side effects: brain herniation, hydrocephalus , ischaemic stroke. Novoseven dosage: 1.2 MG, QID. During the same period patient was treated with HEXAKAPRON, PROTEIN C. Patient was hospitalized. Patient recovered.

Novoseven Side Effects Report #5195630-6
Novoseven side effect was reported by a Physician from CANADA on Dec 19, 2006. Male patient, weighting 136.7 lb, was diagnosed with cerebral haemorrhage and was treated with Novoseven. After drug was administered, patient experienced the following side effects: cerebral haemorrhage, coma, hydrocephalus . Novoseven dosage: unknown. During the same period patient was treated with MIDAZOLAM HYDROCHLORIDE, FLUMAZENIL. Patient recovered.

Novoseven Side Effects Report #5233418-8
Novoseven side effect was reported by a Physician from CANADA on Jan 30, 2007. Male patient, weighting 136.7 lb, was diagnosed with cerebral haemorrhage and was treated with Novoseven. After drug was administered, patient experienced the following side effects: cerebral haemorrhage, hydrocephalus , pneumonia . Novoseven dosage: unknown. During the same period patient was treated with MIDAZOLAM, FLUMAZENIL, COMBIVENT, ECTOSONE, HEPARIN, METOPROLOL, OMEPRAZOLE. Patient was hospitalized. Patient recovered.

Novoseven Side Effects Report #5907104-2
Novoseven side effect was reported by a Physician from JAPAN on Sept 22, 2008. Male patient, 70 years of age, weighting 110.2 lb, was diagnosed with acquired haemophilia, diabetes mellitus, cerebral infarction and was treated with Novoseven. After drug was administered, patient experienced the following side effects: catheter related complication, gastrointestinal necrosis, hydrocephalus , intestinal ischaemia, pneumonia aspiration. Novoseven dosage: 4.8 MG, SINGLE. During the same period patient was treated with PREDNISOLONE, PENFILL, HUMULIN R, HUMALOG, LANTUS, ASPIRIN. Patient died on 08/23/2008.

Novoseven Side Effects Report #5913762-9
Novoseven side effect was reported by a Physician from JAPAN on Oct 03, 2008. Male patient, 70 years of age, weighting 110.2 lb, was diagnosed with acquired haemophilia, diabetes mellitus, cerebral infarction and was treated with Novoseven. After drug was administered, patient experienced the following side effects: catheter related complication, gastrointestinal necrosis, hydrocephalus , intestinal ischaemia, pneumonia aspiration. Novoseven dosage: 4.8 MG, SINGLE. During the same period patient was treated with PREDNISOLONE, PENFILL, HUMULIN R, HUMALOG, LANTUS, ASPIRIN. Patient died on 08/23/2008.


Novoseven Side Effects Report #6019005-2
Novoseven side effect was reported by a Physician from JAPAN on Dec 19, 2008. Male patient, 70 years of age, weighting 110.2 lb, was diagnosed with acquired haemophilia, diabetes mellitus, cerebral infarction and was treated with Novoseven. After drug was administered, patient experienced the following side effects: catheter related complication, gastrointestinal necrosis, hydrocephalus , intestinal ischaemia, pneumonia aspiration. Novoseven dosage: 4.8 MG, SINGLE. During the same period patient was treated with PREDNISOLONE, PENFILL, HUMULIN R, HUMALOG, LANTUS, ASPIRIN. Patient died on 08/23/2008.

Novoseven Side Effects Report #6076710-X
Novoseven side effect was reported by a Physician from JAPAN on Feb 02, 2009. Male patient, 70 years of age, weighting 110.2 lb, was diagnosed with acquired haemophilia, diabetes mellitus, cerebral infarction and was treated with Novoseven. After drug was administered, patient experienced the following side effects: catheter related complication, gastrointestinal necrosis, hydrocephalus , intestinal ischaemia, pneumonia aspiration. Novoseven dosage: 4.8 MG, SINGLE. During the same period patient was treated with PREDNISOLONE, PENFILL, HUMULIN R, HUMALOG, LANTUS, ASPIRIN. Patient died on 08/23/2008.