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Total Novoseven reports: 441.Novoseven FDA safety alerts: 2005 .
Reported deaths: 317 Reported hospitalizations: 187.
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FDA Reported Novoseven Side Effects: multi-organ failure, sepsis, cardiac arrest, pulmonary embolism, cerebral infarction, haemorrhage intracranial, renal failure acute, shock haemorrhagic, disseminated intravascular coagulation, intestinal infarction, acute respiratory distress syndrome.
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Novoseven Side Effects Report #5427270-5Physician from SOUTH AFRICA reported NOVOSEVEN problem on Aug 21, 2007. Female patient was diagnosed with traumatic haemorrhage, pain management, sedation, prophylaxis, pyrexia and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: anastomotic leak, intra-abdominal haemorrhage, renal failure, sepsis. NOVOSEVEN dosage: unknown. During the same period patient was treated with MORPHINE, DORMICUM, CIMETIDINE, ADRENALINE, AUGMENTIN, PERFALGAN. Patient was hospitalized. Patient died on 08/20/2007.
Novoseven Side Effects Report #5429147-8
NOVOSEVEN problem was reported by a Physician from CROATIA (local name: Hrvatska) on Aug 23, 2007. Male patient, 49 years of age, weighting 165.3 lb, was diagnosed with haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: shock haemorrhagic. NOVOSEVEN dosage: 4.8 MG, UNK. Patient was hospitalized. Patient died on 04/14/2007.
Novoseven Side Effects Report #5431279-5
Physician from GERMANY reported NOVOSEVEN problem on Aug 20, 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 problems/side effects: acute respiratory distress syndrome, cerebral haematoma, cyanosis, embolism, renal failure acute, thrombosis, venous thrombosis. NOVOSEVEN dosage: unknown. During the same period patient was treated with FENTANYL, DORMICUM, LASIX, PANCURONIUM, ESMERON, PROPOFOL. Patient was hospitalized. Patient recovered.
Novoseven Side Effects Report #5433623-1
NOVOSEVEN problem was reported by a Physician from TURKEY on Aug 20, 2007. Female patient, weighting 3.22 lb, was diagnosed with disseminated intravascular coagulation and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: disseminated intravascular coagulation. NOVOSEVEN dosage: unknown. During the same period patient was treated with AMPICILLIN, AMIKACINE, FENTANYL. Patient was hospitalized. Patient died.
Novoseven Side Effects Report #5379935-1
Physician from JAPAN reported NOVOSEVEN problem on June 28, 2007. Male patient, weighting 174.2 lb, was diagnosed with muscle haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: systemic lupus erythematosus. NOVOSEVEN dosage: 9.6 MG, UNK. During the same period patient was treated with URSO. Patient recovered.
Novoseven Side Effects Report #5379936-3
NOVOSEVEN problem was reported by a Physician from JAPAN on June 28, 2007. Female patient, 37 years of age, weighting 147.7 lb, was diagnosed with haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: haemorrhage. NOVOSEVEN dosage: unknown. Patient died on 05/27/2007.
Novoseven Side Effects Report #5381428-2
Physician from UNITED STATES reported NOVOSEVEN problem on July 02, 2007. Female patient, 43 years of age, was diagnosed with haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: pulmonary hypertension. NOVOSEVEN dosage: unknown. Patient was hospitalized. Patient recovered.
Novoseven Side Effects Report #5381429-4
NOVOSEVEN problem was reported by a Physician from UNITED STATES on July 02, 2007. Male patient was diagnosed with post procedural haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: thrombosis in device. NOVOSEVEN dosage: unknown. Patient recovered.
Novoseven Side Effects Report #5386320-5
Physician from SWEDEN reported NOVOSEVEN problem on July 04, 2007. Female patient, child 6 years of age, weighting 74.96 lb, was diagnosed with haematemesis and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: multi-organ failure, nervous system disorder, renal failure, respiratory failure. NOVOSEVEN dosage: unknown. During the same period patient was treated with OCTREOTIDE ACETATE, OCTREOTIDE ACETATE, CLAFORAN, PROTOVIT. Patient was hospitalized. Patient died on 03/06/2000.
Novoseven Side Effects Report #5386322-9
NOVOSEVEN problem was reported by a Physician from SWEDEN on July 04, 2007. Female patient, child 8 years of age, weighting 81.57 lb, was diagnosed with haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: fungal sepsis, multi-organ failure, portal vein thrombosis. NOVOSEVEN dosage: unknown. During the same period patient was treated with OCTREOTIDE ACETATE, URSO FALK, LOSEC, SPIRONOLAKTON. Patient was hospitalized. Patient died.
Novoseven Side Effects Report #5386324-2
Physician from SWEDEN reported NOVOSEVEN problem on July 04, 2007. Female patient, weighting 11.02 lb, was diagnosed with haematemesis and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: multi-organ failure. NOVOSEVEN dosage: unknown. During the same period patient was treated with OCTREOTIDE ACETATE, OCTREOTIDE ACETATE, OCTREOTIDE ACETATE. Patient was hospitalized. Patient died on 11/14/2000.
Novoseven Side Effects Report #5386638-6
NOVOSEVEN problem was reported by a Physician from UNITED STATES on July 02, 2007. Male patient was diagnosed with post procedural haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: arterial thrombosis limb, atrial thrombosis. NOVOSEVEN dosage: unknown. Patient recovered.
Novoseven Side Effects Report #5387371-7
Physician from AUSTRALIA reported NOVOSEVEN problem on July 05, 2007. Male patient, weighting 220.5 lb, was diagnosed with traumatic haemorrhage, sedation, antiemetic supportive care, hyperkalaemia, blood electrolytes abnormal and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: coagulopathy. NOVOSEVEN dosage: unknown. During the same period patient was treated with MORPHINE, MAXOLON, MIDAZOLAM, DEXTROSE, ACTRAPID, CALCIUM GLUCONATE, ADRENALINE, NORADRENALINE. Patient died on 02/15/2007.
Novoseven Side Effects Report #5387372-9
NOVOSEVEN problem was reported by a Physician from TURKEY on July 09, 2007. Female patient was diagnosed with disseminated intravascular coagulation and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: haemorrhage. NOVOSEVEN dosage: unknown. Patient died.
Novoseven Side Effects Report #5387374-2
Physician from TURKEY reported NOVOSEVEN problem on July 09, 2007. Male patient was diagnosed with disseminated intravascular coagulation and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: haematuria, haemorrhage intracranial. NOVOSEVEN dosage: unknown. During the same period patient was treated with RED BLOOD CELLS, FRESH FROZEN PLASMA, CRYOPRECIPITATES, PLATELETS. Patient died.
Novoseven Side Effects Report #5387375-4
NOVOSEVEN problem was reported by a Physician from KOREA, REPUBLIC OF on July 09, 2007. Male patient, child 11 years of age, was diagnosed with factor vii deficiency and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: gastrointestinal haemorrhage. NOVOSEVEN dosage: unknown. Patient died.
Novoseven Side Effects Report #5389043-1
Physician from FRANCE reported NOVOSEVEN problem on May 14, 2007. Female patient, 83 years of age, was diagnosed with acquired haemophilia with anti fviii, xi, or xiii and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: condition aggravated, muscle haemorrhage, shock haemorrhagic. NOVOSEVEN dosage: unknown. During the same period patient was treated with CORTICOSTEROIDS. Patient died.
Novoseven Side Effects Report #5389046-7
NOVOSEVEN problem was reported by a Physician from TURKEY on July 09, 2007. Male patient was diagnosed with disseminated intravascular coagulation and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, disseminated intravascular coagulation, haematoma, haemorrhage intracranial. NOVOSEVEN dosage: unknown. During the same period patient was treated with RED BLOOD CELLS, FRESH FROZEN PLASMA, CRYOPRECIPITATES, PLATELETS. Patient died.
Novoseven Side Effects Report #5392052-X
Physician from AUSTRALIA reported NOVOSEVEN problem on July 16, 2007. Female patient, 65 years of age, weighting 187.4 lb, was diagnosed with haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: bradycardia, jaundice acholuric, multi-organ failure, sepsis. NOVOSEVEN dosage: 7.2 MG, UNK. During the same period patient was treated with ASPIRIN, HEPARIN, GELOFUSINE, PROTAMINE SULPHATE. Patient was hospitalized. Patient died on 12/11/2006.
Novoseven Side Effects Report #5393609-2
NOVOSEVEN problem was reported by a Physician from JAPAN on July 17, 2007. Male patient, 82 years of age, weighting 132.3 lb, was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: shock haemorrhagic. NOVOSEVEN dosage: 4.8 MG, UNK. Patient died.
Novoseven Side Effects Report #5393611-0
Physician from SWITZERLAND reported NOVOSEVEN problem on July 16, 2007. Male patient, weighting 158.7 lb, was diagnosed with traumatic haemorrhage, analgesia, prophylaxis against gastrointestinal ulcer, sedation, polyuria, thrombosis prophylaxis and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: affective disorder, cardiac tamponade, cerebral infarction, cerebral ischaemia, completed suicide, fatigue, flat affect, haemodynamic instability. NOVOSEVEN dosage: unknown. During the same period patient was treated with MORPHIN, RANITIDINE, LORAZEPAM, ZOLPIDEM TARTRATE, BROMAZEPAN, SPIRONOLACTONE, ENOXAPARIN, THIAMINE. Patient was hospitalized. Patient died on 07/15/2007.
Novoseven Side Effects Report #5393613-4
NOVOSEVEN problem was reported by a Physician from AUSTRALIA on July 16, 2007. Male patient, 40 years of age, was diagnosed with haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: basal ganglia haemorrhage, deep vein thrombosis, hypoxic encephalopathy. NOVOSEVEN dosage: 6 MG, UNK. During the same period patient was treated with PROTAMINE SULPHATE, HEPARIN, PROTHROMBINEX. Patient was hospitalized. Patient recovered.
Novoseven Side Effects Report #5397462-2
Physician from FINLAND reported NOVOSEVEN problem on July 20, 2007. Female patient, weighting 116.8 lb, was diagnosed with traumatic haemorrhage, pain and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: disseminated intravascular coagulation. NOVOSEVEN dosage: unknown. During the same period patient was treated with FENTANYL TRANSDERMAL SYSTEM, PROPOFOL, KETANEST, ESMERON, SUKOLIN. Patient was hospitalized. Patient died on 07/19/2007.
Novoseven Side Effects Report #5400057-5
NOVOSEVEN problem was reported by a Physician from GERMANY on July 18, 2007. Female patient was diagnosed with prophylaxis and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: shunt occlusion. NOVOSEVEN dosage: unknown. During the same period patient was treated with PLATELET AGGREGATION INHIBITORS, ASPIRIN, PLAVIX. Patient was hospitalized. Patient recovered.
Novoseven Side Effects Report #5401127-8
Physician from ISRAEL reported NOVOSEVEN problem on July 24, 2007. Female patient, 25 years of age, was diagnosed with haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: cardiac failure. NOVOSEVEN dosage: 4.8 MG, UNK. Patient died on 05/01/2007.
Novoseven Side Effects Report #5401128-X
NOVOSEVEN problem was reported by a Physician from GERMANY on July 19, 2007. Male patient was diagnosed with factor viii deficiency and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: hepatitis c. NOVOSEVEN dosage: unknown. Patient recovered.
Novoseven Side Effects Report #5401135-7
Physician from ISRAEL reported NOVOSEVEN problem on July 25, 2007. Female patient was diagnosed with haemorrhage and was treated with NOVOSEVEN. NOVOSEVEN dosage: 7.2 MG, UNK. Patient died on 07/17/2007.
Novoseven Side Effects Report #5379935-1
NOVOSEVEN problem was reported by a Physician from JAPAN on June 28, 2007. Male patient, weighting 174.2 lb, was diagnosed with muscle haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: systemic lupus erythematosus. NOVOSEVEN dosage: 9.6 MG, UNK. During the same period patient was treated with URSO. Patient recovered.
Novoseven Side Effects Report #5379936-3
Physician from JAPAN reported NOVOSEVEN problem on June 28, 2007. Female patient, 37 years of age, weighting 147.7 lb, was diagnosed with haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: haemorrhage. NOVOSEVEN dosage: unknown. Patient died on 05/27/2007.
Novoseven Side Effects Report #5381428-2
NOVOSEVEN problem was reported by a Physician from UNITED STATES on July 02, 2007. Female patient, 43 years of age, was diagnosed with haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: pulmonary hypertension. NOVOSEVEN dosage: unknown. Patient was hospitalized. Patient recovered.
Novoseven Side Effects Report #5381429-4
Physician from UNITED STATES reported NOVOSEVEN problem on July 02, 2007. Male patient was diagnosed with post procedural haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: thrombosis in device. NOVOSEVEN dosage: unknown. Patient recovered.
Novoseven Side Effects Report #5386320-5
NOVOSEVEN problem was reported by a Physician from SWEDEN on July 04, 2007. Female patient, child 6 years of age, weighting 74.96 lb, was diagnosed with haematemesis and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: multi-organ failure, nervous system disorder, renal failure, respiratory failure. NOVOSEVEN dosage: unknown. During the same period patient was treated with OCTREOTIDE ACETATE, OCTREOTIDE ACETATE, CLAFORAN, PROTOVIT. Patient was hospitalized. Patient died on 03/06/2000.
Novoseven Side Effects Report #5386322-9
Physician from SWEDEN reported NOVOSEVEN problem on July 04, 2007. Female patient, child 8 years of age, weighting 81.57 lb, was diagnosed with haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: fungal sepsis, multi-organ failure, portal vein thrombosis. NOVOSEVEN dosage: unknown. During the same period patient was treated with OCTREOTIDE ACETATE, URSO FALK, LOSEC, SPIRONOLAKTON. Patient was hospitalized. Patient died.
Novoseven Side Effects Report #5386324-2
NOVOSEVEN problem was reported by a Physician from SWEDEN on July 04, 2007. Female patient, weighting 11.02 lb, was diagnosed with haematemesis and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: multi-organ failure. NOVOSEVEN dosage: unknown. During the same period patient was treated with OCTREOTIDE ACETATE, OCTREOTIDE ACETATE, OCTREOTIDE ACETATE. Patient was hospitalized. Patient died on 11/14/2000.
Novoseven Side Effects Report #5386638-6
Physician from UNITED STATES reported NOVOSEVEN problem on July 02, 2007. Male patient was diagnosed with post procedural haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: arterial thrombosis limb, atrial thrombosis. NOVOSEVEN dosage: unknown. Patient recovered.
Novoseven Side Effects Report #5387371-7
NOVOSEVEN problem was reported by a Physician from AUSTRALIA on July 05, 2007. Male patient, weighting 220.5 lb, was diagnosed with traumatic haemorrhage, sedation, antiemetic supportive care, hyperkalaemia, blood electrolytes abnormal and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: coagulopathy. NOVOSEVEN dosage: unknown. During the same period patient was treated with MORPHINE, MAXOLON, MIDAZOLAM, DEXTROSE, ACTRAPID, CALCIUM GLUCONATE, ADRENALINE, NORADRENALINE. Patient died on 02/15/2007.
Novoseven Side Effects Report #5387372-9
Physician from TURKEY reported NOVOSEVEN problem on July 09, 2007. Female patient was diagnosed with disseminated intravascular coagulation and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: haemorrhage. NOVOSEVEN dosage: unknown. Patient died.
Novoseven Side Effects Report #5387374-2
NOVOSEVEN problem was reported by a Physician from TURKEY on July 09, 2007. Male patient was diagnosed with disseminated intravascular coagulation and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: haematuria, haemorrhage intracranial. NOVOSEVEN dosage: unknown. During the same period patient was treated with RED BLOOD CELLS, FRESH FROZEN PLASMA, CRYOPRECIPITATES, PLATELETS. Patient died.
Novoseven Side Effects Report #5387375-4
Physician from KOREA, REPUBLIC OF reported NOVOSEVEN problem on July 09, 2007. Male patient, child 11 years of age, was diagnosed with factor vii deficiency and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: gastrointestinal haemorrhage. NOVOSEVEN dosage: unknown. Patient died.
Novoseven Side Effects Report #5389043-1
NOVOSEVEN problem was reported by a Physician from FRANCE on May 14, 2007. Female patient, 83 years of age, was diagnosed with acquired haemophilia with anti fviii, xi, or xiii and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: condition aggravated, muscle haemorrhage, shock haemorrhagic. NOVOSEVEN dosage: unknown. During the same period patient was treated with CORTICOSTEROIDS. Patient died.
Novoseven Side Effects Report #5389046-7
Physician from TURKEY reported NOVOSEVEN problem on July 09, 2007. Male patient was diagnosed with disseminated intravascular coagulation and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, disseminated intravascular coagulation, haematoma, haemorrhage intracranial. NOVOSEVEN dosage: unknown. During the same period patient was treated with RED BLOOD CELLS, FRESH FROZEN PLASMA, CRYOPRECIPITATES, PLATELETS. Patient died.
Novoseven Side Effects Report #5392052-X
NOVOSEVEN problem was reported by a Physician from AUSTRALIA on July 16, 2007. Female patient, 65 years of age, weighting 187.4 lb, was diagnosed with haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: bradycardia, jaundice acholuric, multi-organ failure, sepsis. NOVOSEVEN dosage: 7.2 MG, UNK. During the same period patient was treated with ASPIRIN, HEPARIN, GELOFUSINE, PROTAMINE SULPHATE. Patient was hospitalized. Patient died on 12/11/2006.
Novoseven Side Effects Report #5393609-2
Physician from JAPAN reported NOVOSEVEN problem on July 17, 2007. Male patient, 82 years of age, weighting 132.3 lb, was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: shock haemorrhagic. NOVOSEVEN dosage: 4.8 MG, UNK. Patient died.
Novoseven Side Effects Report #5393611-0
NOVOSEVEN problem was reported by a Physician from SWITZERLAND on July 16, 2007. Male patient, weighting 158.7 lb, was diagnosed with traumatic haemorrhage, analgesia, prophylaxis against gastrointestinal ulcer, sedation, polyuria, thrombosis prophylaxis and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: affective disorder, cardiac tamponade, cerebral infarction, cerebral ischaemia, completed suicide, fatigue, flat affect, haemodynamic instability. NOVOSEVEN dosage: unknown. During the same period patient was treated with MORPHIN, RANITIDINE, LORAZEPAM, ZOLPIDEM TARTRATE, BROMAZEPAN, SPIRONOLACTONE, ENOXAPARIN, THIAMINE. Patient was hospitalized. Patient died on 07/15/2007.
Novoseven Side Effects Report #5393613-4
Physician from AUSTRALIA reported NOVOSEVEN problem on July 16, 2007. Male patient, 40 years of age, was diagnosed with haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: basal ganglia haemorrhage, deep vein thrombosis, hypoxic encephalopathy. NOVOSEVEN dosage: 6 MG, UNK. During the same period patient was treated with PROTAMINE SULPHATE, HEPARIN, PROTHROMBINEX. Patient was hospitalized. Patient recovered.
Novoseven Side Effects Report #5397462-2
NOVOSEVEN problem was reported by a Physician from FINLAND on July 20, 2007. Female patient, weighting 116.8 lb, was diagnosed with traumatic haemorrhage, pain and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: disseminated intravascular coagulation. NOVOSEVEN dosage: unknown. During the same period patient was treated with FENTANYL TRANSDERMAL SYSTEM, PROPOFOL, KETANEST, ESMERON, SUKOLIN. Patient was hospitalized. Patient died on 07/19/2007.
Novoseven Side Effects Report #5400057-5
Physician from GERMANY reported NOVOSEVEN problem on July 18, 2007. Female patient was diagnosed with prophylaxis and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: shunt occlusion. NOVOSEVEN dosage: unknown. During the same period patient was treated with PLATELET AGGREGATION INHIBITORS, ASPIRIN, PLAVIX. Patient was hospitalized. Patient recovered.
Novoseven Side Effects Report #5401127-8
NOVOSEVEN problem was reported by a Physician from ISRAEL on July 24, 2007. Female patient, 25 years of age, was diagnosed with haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: cardiac failure. NOVOSEVEN dosage: 4.8 MG, UNK. Patient died on 05/01/2007.
Novoseven Side Effects Report #5401128-X
Physician from GERMANY reported NOVOSEVEN problem on July 19, 2007. Male patient was diagnosed with factor viii deficiency and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: hepatitis c. NOVOSEVEN dosage: unknown. Patient recovered.
Novoseven Side Effects Report #5401135-7
NOVOSEVEN problem was reported by a Physician from ISRAEL on July 25, 2007. Female patient was diagnosed with haemorrhage and was treated with NOVOSEVEN. NOVOSEVEN dosage: 7.2 MG, UNK. Patient died on 07/17/2007.
Novoseven Side Effects Report #5755211-X
Physician from AUSTRIA reported NOVOSEVEN problem on Oct 30, 2007. Female patient, 77 years of age, weighting 176.4 lb, was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction. NOVOSEVEN dosage: 14.4 MG, UNK. During the same period patient was treated with CHLORIDE, DIBONDRIN, SOLUDACORTIN, APREDNISLON, ENDOXAN. Patient recovered.
Novoseven Side Effects Report #5756826-5
NOVOSEVEN problem was reported by a Physician from JAPAN on May 30, 2008. Female patient, child 2 years of age, was diagnosed with haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: multi-organ failure. NOVOSEVEN dosage: unknown. Patient died.
Novoseven Side Effects Report #5771745-6
Physician from PHILIPPINES reported NOVOSEVEN problem on June 03, 2008. Female patient was diagnosed with haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: sepsis. NOVOSEVEN dosage: unknown. Patient was hospitalized. Patient recovered.
Novoseven Side Effects Report #5774296-8
NOVOSEVEN problem was reported by a Physician from FINLAND on June 03, 2008. Female patient, weighting 127.9 lb, was diagnosed with traumatic haemorrhage, pain and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: disseminated intravascular coagulation. NOVOSEVEN dosage: unknown. During the same period patient was treated with FENTANYL, PROPOFOL, KETANEST, ROCURONIUM BROMIDE, SUKOLIN. Patient was hospitalized. Patient died on 07/19/2007.
Novoseven Side Effects Report #5774846-1
Physician from SPAIN reported NOVOSEVEN problem on June 06, 2008. Female patient, weighting 121.3 lb, was diagnosed with traumatic haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: deep vein thrombosis, peripheral ischaemia. NOVOSEVEN dosage: unknown. Patient was hospitalized and became disabled. Patient recovered.
Novoseven Side Effects Report #5775124-7
NOVOSEVEN problem was reported by a Physician from AUSTRALIA on June 06, 2008. Female patient, weighting 1.33 lb, was diagnosed with haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: ischaemia. NOVOSEVEN dosage: unknown. Patient was hospitalized. Patient recovered.
Novoseven Side Effects Report #5775329-5
Physician from ITALY reported NOVOSEVEN problem on June 10, 2008. Male patient, 70 years of age, was diagnosed with acquired haemophilia and was treated with NOVOSEVEN. NOVOSEVEN dosage: unknown. Patient died on 06/10/2008.
Novoseven Side Effects Report #5776579-4
NOVOSEVEN problem was reported by a Physician from UNITED STATES on June 07, 2008. Male patient, 52 years of age, was diagnosed with haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: haemorrhage. NOVOSEVEN dosage: 4.8 MG, SINGLE. Patient died on 06/07/2008.
Novoseven Side Effects Report #5778278-1
Physician from HONG KONG reported NOVOSEVEN problem on June 10, 2008. Female patient, 39 years of age, weighting 106.9 lb, was diagnosed with postpartum haemorrhage, uterine hypotonus and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: cavernous sinus thrombosis, sinusitis. NOVOSEVEN dosage: 1.2 MG, UNK. During the same period patient was treated with RED BLOOD CELLS, PLATELETS, FRESH FROZEN PLASMA, SYNTOCINON. Patient recovered.
Novoseven Side Effects Report #5778303-8
NOVOSEVEN problem was reported by a Physician from ISRAEL on June 11, 2008. Male patient, 72 years of age, was diagnosed with haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: multi-organ failure. NOVOSEVEN dosage: 7.2 MG, SINGLE. Patient died on 06/01/2008.
Novoseven Side Effects Report #5778555-4
Physician from JAPAN reported NOVOSEVEN problem on June 11, 2008. Female patient, 85 years of age, was diagnosed with cerebral haemorrhage, acquired haemophilia and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: myocardial infarction, renal disorder, septic shock. NOVOSEVEN dosage: 4.8 MG, UNK. During the same period patient was treated with MANNITOL. Patient died on 05/07/2008.
Novoseven Side Effects Report #5778556-6
NOVOSEVEN problem was reported by a Health Professional from SWITZERLAND on June 12, 2008. Female patient, 42 years of age, was diagnosed with haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: premature baby. NOVOSEVEN dosage: 2.4 MG, SINGLE. During the same period patient was treated with HEXOPRENALINE, BETAMETHASONE. Patient recovered.
Novoseven Side Effects Report #5783006-X
Physician from AUSTRALIA reported NOVOSEVEN problem on June 19, 2008. Male patient, 33 years of age, weighting 154.3 lb, was diagnosed with haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: cerebral infarction, intracranial aneurysm, subarachnoid haemorrhage. NOVOSEVEN dosage: 7.2 MG, SINGLE. During the same period patient was treated with TRANEXAMIC, PROTAMINE SULPHATE, HEPARIN, RED BLOOD CELLS, RED BLOOD CELLS, FRESH FROZEN PLASMA, FRESH FROZEN PLASMA, CRYOPRECIPITATES. Patient recovered.
Novoseven Side Effects Report #5783009-5
NOVOSEVEN problem was reported by a Physician from AUSTRALIA on June 19, 2008. Female patient, 74 years of age, weighting 110.2 lb, was diagnosed with haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: ventricular fibrillation. NOVOSEVEN dosage: 3.6 MG, UNK. During the same period patient was treated with RETEPLASE, HEPARIN, ASPIRIN, CLOPIDOGREL, PROTAMINE SULPHATE. Patient died on 05/11/2008.
Novoseven Side Effects Report #5783011-3
Health Professional from AUSTRALIA reported NOVOSEVEN problem on June 19, 2008. Male patient, 73 years of age, weighting 194.0 lb, was diagnosed with post procedural haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: arterial thrombosis limb, leg amputation, multi-organ failure, necrosis ischaemic, post procedural complication, renal failure acute. NOVOSEVEN dosage: 3.6 MG, UNK. During the same period patient was treated with ASPIRIN, RED BLOOD CELLS, RED BLOOD CELLS, FRESH FROZEN PLASMA, FRESH FROZEN PLASMA, PLATELETS. Patient was hospitalized. Patient died on 05/07/2007.
Novoseven Side Effects Report #5783025-3
NOVOSEVEN problem was reported by a Health Professional from AUSTRALIA on June 19, 2008. Male patient, 72 years of age, weighting 165.3 lb, was diagnosed with haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: electrocardiogram t wave inversion. NOVOSEVEN dosage: 7.2 MG, SINGLE. During the same period patient was treated with ASPIRIN. Patient was hospitalized. Patient recovered.
Novoseven Side Effects Report #5788724-5
Physician from HONG KONG reported NOVOSEVEN problem on June 20, 2008. Female patient, 39 years of age, weighting 106.9 lb, was diagnosed with postpartum haemorrhage, uterine hypotonus and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: cavernous sinus thrombosis, sinusitis. NOVOSEVEN dosage: 1.2 MG, UNK. During the same period patient was treated with RED BLOOD CELLS, PLATELETS, FRESH FROZEN PLASMA, SYNTOCINON. Patient recovered.
Novoseven Side Effects Report #5793031-0
NOVOSEVEN problem was reported by a Health Professional from AUSTRALIA on June 19, 2008. Male patient, 73 years of age, weighting 194.0 lb, was diagnosed with post procedural haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: arterial thrombosis limb. NOVOSEVEN dosage: 3.6 MG, UNK. During the same period patient was treated with ASPIRIN, RED BLOOD CELLS, RED BLOOD CELLS, FRESH FROZEN PLASMA, FRESH FROZEN PLASMA, PLATELETS. Patient was hospitalized. Patient died on 05/07/2007.
Novoseven Side Effects Report #5727235-X
Physician from JAPAN reported NOVOSEVEN problem on Apr 30, 2008. Male patient was diagnosed with acquired haemophilia and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: renal failure. NOVOSEVEN dosage: 4.8 MG, UNK. Patient died on 04/29/2008.
Novoseven Side Effects Report #5727375-5
NOVOSEVEN problem was reported by a Physician from UNITED STATES on Apr 24, 2008. Female patient, child 3 years of age, was diagnosed with gastrointestinal haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: respiratory failure, thrombosis in device. NOVOSEVEN dosage: unknown. Patient recovered.
Novoseven Side Effects Report #5734473-9
Physician from ISRAEL reported NOVOSEVEN problem on May 05, 2008. Male patient, child 1 years of age, weighting 19.84 lb, was diagnosed with haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: arterial thrombosis, cerebral haemorrhage, cerebral infarction. NOVOSEVEN dosage: .6 MG, BID. During the same period patient was treated with PLATELETS, CRYOPRECIPITATES. Patient recovered.
Novoseven Side Effects Report #5736287-2
NOVOSEVEN problem was reported by a Physician from UNITED KINGDOM on May 08, 2008. Male patient, 77 years of age, was diagnosed with post procedural haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: cerebral infarction. NOVOSEVEN dosage: unknown. During the same period patient was treated with TRANEXAMIC ACID. Patient died.
Novoseven Side Effects Report #5737148-5
Physician from ISRAEL reported NOVOSEVEN problem on May 05, 2008. Male patient, child 5 years of age, weighting 44.09 lb, was diagnosed with haemorrhage and was treated with NOVOSEVEN. NOVOSEVEN dosage: 1.2 MG, UNK. During the same period patient was treated with BLOOD CELLS, PLATELETS, CRYOPRECIPITATES, FRESH FROZEN PLASMA. Patient died on 03/05/2008.
Novoseven Side Effects Report #5742471-4
NOVOSEVEN problem was reported by a Physician from JAPAN on May 07, 2008. Male patient, weighting 110.2 lb, was diagnosed with haemorrhage, hypocoagulable state, platelet count decreased, sedation, hypotension, haemostasis and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: cardiac failure, pleural haemorrhage. NOVOSEVEN dosage: 4.8 MG, UNK. During the same period patient was treated with RED BLOOD CELLS, FRISCHPLASMA, PLATELETS, FENTANYL CITRATE, PROPOFOL, KAKODIN, FUTHAN, ADONA. Patient died on 08/31/2007.
Novoseven Side Effects Report #5744002-1
Physician from JAPAN reported NOVOSEVEN problem on May 13, 2008. Male patient, child 3 years of age, was treated with NOVOSEVEN. NOVOSEVEN dosage: unknown. Patient died.
Novoseven Side Effects Report #5744005-7
NOVOSEVEN problem was reported by a Physician from JAPAN on May 15, 2008. Female patient, 97 years of age, was diagnosed with haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: haemorrhage, multi-organ failure. NOVOSEVEN dosage: 4.8 MG, UNK. Patient died.
Novoseven Side Effects Report #5744008-2
Physician from UNITED STATES reported NOVOSEVEN problem on May 15, 2008. Male patient, 65 years of age, was diagnosed with haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: cardiac tamponade, device occlusion. NOVOSEVEN dosage: unknown. Patient died.
Novoseven Side Effects Report #5747436-4
NOVOSEVEN problem was reported by a Health Professional from SWITZERLAND on May 15, 2008. Female patient, 42 years of age, was diagnosed with haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: premature baby. NOVOSEVEN dosage: 2.4 MG, SINGLE. Patient recovered.
Novoseven Side Effects Report #5747438-8
Health Professional from UNITED STATES reported NOVOSEVEN problem on May 12, 2008. Female patient, 31 years of age, weighting 156.0 lb, was diagnosed with operative haemorrhage, immunosuppression, ill-defined disorder, neoplasm malignant and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: ischaemic cerebral infarction. NOVOSEVEN dosage: unknown. During the same period patient was treated with FRESH FROZEN PLASMA, PLATELETS, CYTOXAN, PREDNISONE, ANALGESICS, ANTIHYPERTENSIVES. Patient was hospitalized. Patient recovered.
Novoseven Side Effects Report #5750415-4
NOVOSEVEN problem was reported by a Physician from SPAIN on May 22, 2008. Female patient, weighting 121.3 lb, was diagnosed with traumatic haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: deep vein thrombosis, peripheral ischaemia. NOVOSEVEN dosage: unknown. Patient was hospitalized and became disabled. Patient recovered.
Novoseven Side Effects Report #5750417-8
Physician from ISRAEL reported NOVOSEVEN problem on May 18, 2008. Female patient, weighting 132.3 lb, was diagnosed with haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: acidosis, disseminated intravascular coagulation, splenic artery aneurysm, thrombosis. NOVOSEVEN dosage: 4.8 MG, QD. During the same period patient was treated with FRESH FROZEN PLASMA, FRESH FROZEN PLASMA, PLATELETS, RED BLOOD CELLS, RED BLOOD CELLS. Patient died on 04/07/2008.
Novoseven Side Effects Report #5750420-8
NOVOSEVEN problem was reported by a Physician from ISRAEL on May 22, 2008. Female patient, 73 years of age, weighting 176.4 lb, was diagnosed with haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: anoxic encephalopathy. NOVOSEVEN dosage: 4.8 MG, QD. Patient recovered.
Novoseven Side Effects Report #5751995-5
Physician from JAPAN reported NOVOSEVEN problem on May 23, 2008. Male patient, child 3 years of age, was diagnosed with haemorrhage and was treated with NOVOSEVEN. NOVOSEVEN dosage: unknown. Patient died.
Novoseven Side Effects Report #5752480-7
NOVOSEVEN problem was reported by a Pharmacist from UNITED STATES on May 27, 2008. Male patient, 61 years of age, was diagnosed with coagulopathy, traumatic haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: deep vein thrombosis. NOVOSEVEN dosage: unknown. Patient was hospitalized. Patient recovered.
Novoseven Side Effects Report #5753427-X
Physician from JAPAN reported NOVOSEVEN problem on May 19, 2008. Male patient, 67 years of age, weighting 125.7 lb, was diagnosed with acquired haemophilia, diabetes mellitus, hypothyroidism, osteoporosis prophylaxis, renal failure, prophylaxis against gastrointestinal ulcer and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: blood lactate dehydrogenase increased, fibrin d dimer increased, hepatic function abnormal, hypoproteinaemia, platelet count decreased, renal failure, subcutaneous haematoma, white blood cell count increased. NOVOSEVEN dosage: 2.4 - 9.6 MG. During the same period patient was treated with NOVOLIN R, PREDONINE, THYRADIN S, ONEALFA, DIOVAN, LASIX, TAKEPRON. Patient died on 04/29/2008.
Novoseven Side Effects Report #5753430-X
NOVOSEVEN problem was reported by a Physician from GERMANY on May 21, 2008. Male patient, weighting 0.77 lb, was diagnosed with haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: anuria, cyanosis, hypotension, overdose, oxygen saturation decreased. NOVOSEVEN dosage: 1.2 MG, QD. During the same period patient was treated with NATRIUMBIKARBONAT, COFFEIN CITRATE, PIRITRAMIDE, THIOPENTAL, FRESH FROZEN PLASMA, RED BLOOD CELLS, PLATELETS, VANCOMYCIN. Patient died on 03/05/2008.
Novoseven Side Effects Report #5644347-X
Physician from FINLAND reported NOVOSEVEN problem on Feb 25, 2008. Female patient was diagnosed with traumatic haemorrhage, pain, infection prophylaxis, prophylaxis of nausea and vomiting and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: fat embolism. NOVOSEVEN dosage: unknown. During the same period patient was treated with FENTANYL, KETANEST, DIAZEPAM, DALACIN, NETILIN, ALFENTANIL, METOCLOPRAMIDE, ALFENTANYL. Patient was hospitalized. Patient recovered.
Novoseven Side Effects Report #5674828-4
NOVOSEVEN problem was reported by a Physician from UNITED STATES on Feb 08, 2007. Male patient, 45 years of age, was diagnosed with brain stem haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: venous thrombosis limb. NOVOSEVEN dosage: unknown. Patient recovered.
Novoseven Side Effects Report #5674831-4
Pharmacist from UNITED STATES reported NOVOSEVEN problem on May 04, 2007. Male patient was diagnosed with haematoma and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: therapeutic response decreased. NOVOSEVEN dosage: unknown. Patient was hospitalized. Patient recovered.
Novoseven Side Effects Report #5674833-8
NOVOSEVEN problem was reported by a Pharmacist from UNITED STATES on Aug 01, 2007. Female patient was diagnosed with ill-defined disorder and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: myocardial ischaemia. NOVOSEVEN dosage: unknown. Patient recovered.
Novoseven Side Effects Report #5674836-3
Pharmacist from UNITED STATES reported NOVOSEVEN problem on Nov 05, 2007. Male patient, 42 years of age, weighting 213.8 lb, was diagnosed with haemarthrosis and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: therapeutic response decreased. NOVOSEVEN dosage: 4.8 MG EVERY 4 HOURS, INTRAVENOUS; 4.8 MG EVERY 3 HOURS, INTRAVENOUS. Patient was hospitalized. Patient recovered.
Novoseven Side Effects Report #5675837-1
NOVOSEVEN problem was reported by a Physician from UNITED STATES on Nov 15, 2007. Female patient was diagnosed with haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: deep vein thrombosis. NOVOSEVEN dosage: unknown. Patient recovered.
Novoseven Side Effects Report #5694474-6
Physician from ISRAEL reported NOVOSEVEN problem on Mar 30, 2008. Male patient, 59 years of age, was diagnosed with haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: disease progression, head injury. NOVOSEVEN dosage: 7.2 MG, QD. Patient died on 02/27/2008.
Novoseven Side Effects Report #5699810-2
NOVOSEVEN problem was reported by a Physician from SWITZERLAND on Feb 08, 2008. Female patient, 53 years of age, was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: thrombosis. NOVOSEVEN dosage: unknown. Patient died.
Novoseven Side Effects Report #5699813-8
Physician from DENMARK reported NOVOSEVEN problem on Apr 01, 2008. Male patient, 40 years of age, was diagnosed with haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: asthma, urticaria. NOVOSEVEN dosage: unknown. During the same period patient was treated with FIBRINOGEN. Patient was hospitalized. Patient recovered.
Novoseven Side Effects Report #5700779-2
NOVOSEVEN problem was reported by a Physician from SOUTH AFRICA on Feb 25, 2008. Male patient, weighting 143.3 lb, was diagnosed with traumatic haemorrhage, prophylaxis, sedation, hypotension, vitamin supplementation, pulmonary oedema, infection prophylaxis and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: leg amputation, liver disorder, renal disorder, sepsis. NOVOSEVEN dosage: unknown. During the same period patient was treated with KEFZOL, MORPHINE, ADRENALINE, CYCLOKAPRON, VITAMIN K, PREMARIN, LASIX, TAZOCIN. Patient was hospitalized and became disabled. Patient recovered.
Novoseven Side Effects Report #5701586-7
Physician from FRANCE reported NOVOSEVEN problem on Mar 03, 2008. Female patient was diagnosed with postpartum haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: atelectasis, lung disorder, splenic infarction. NOVOSEVEN dosage: unknown. During the same period patient was treated with SYNTOCINON, NALADOR. Patient was hospitalized. Patient recovered.
Novoseven Side Effects Report #5701870-7
NOVOSEVEN problem was reported by a Physician from ISRAEL on Apr 08, 2008. Female patient, 70 years of age, was diagnosed with haemorrhage and was treated with NOVOSEVEN. NOVOSEVEN dosage: unknown. Patient died on 04/06/2008.
Novoseven Side Effects Report #5701872-0
Physician from HONG KONG reported NOVOSEVEN problem on Apr 04, 2008. Female patient, 39 years of age, weighting 106.9 lb, was diagnosed with postpartum haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: cavernous sinus thrombosis, sinusitis. NOVOSEVEN dosage: 1.2 MG, UNK. During the same period patient was treated with RED BLOOD CELLS, PLATELETS, FRESH FROZEN PLASMA. Patient recovered.
Novoseven Side Effects Report #5704012-7
NOVOSEVEN problem was reported by a Physician from SPAIN on Apr 03, 2008. Female patient, weighting 121.3 lb, was diagnosed with traumatic haemorrhage and was treated with NOVOSEVEN. After drug was administered, patient experienced the following problems/side effects: deep vein thrombosis, peripheral ischaemia. NOVOSEVEN dosage: unknown. Patient was hospitalized. Patient recovered.
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