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Review Monozeclar Safety Reports submitted to FDA

Total Monozeclar reports: 8.
Monozeclar FDA safety alerts: No.
   Reported hospitalizations: 7.
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FDA Reported Monozeclar Side Effects: haemangioma, cyst, peripheral ischaemia, pancreatitis acute, pain, asthenia, jaw cyst, toxic skin eruption, lymphadenopathy, folliculitis, eczema.
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Monozeclar Side Effects Report #5747192-X
Health Professional from FRANCE reported MONOZECLAR problem on May 19, 2008. Male patient, 39 years of age, was diagnosed with gastroenteritis viral, influenza, musculoskeletal stiffness, pyrexia and was treated with MONOZECLAR. After drug was administered, patient experienced the following problems/side effects: blood blister, purpura, pyrexia. MONOZECLAR dosage: unknown. During the same period patient was treated with IBUPROFEN, OXYDE OF LOPERAMIDE, DOMPERIDONE, KETOPROFEN, TETRAZEPAM, PAROXETINE, ACETAMINOPHEN. Patient was hospitalized. Patient recovered.

Monozeclar Side Effects Report #5749648-2
MONOZECLAR problem was reported by a Health Professional from FRANCE on May 19, 2008. Female patient, weighting 112.4 lb, was diagnosed with nasopharyngitis and was treated with MONOZECLAR. After drug was administered, patient experienced the following problems/side effects: myalgia, rhabdomyolysis. MONOZECLAR dosage: unknown. During the same period patient was treated with FENOFIBRATE, PREDNISOLONE, TIAPROFENIC ACID, ACETYLCYSTEINE, CODEIN, ACARBOSE, METFORMIN HYDROCHLORIDE, GLYBURIDE. Patient was hospitalized. Patient recovered.

Monozeclar Side Effects Report #5752614-4
Health Professional from FRANCE reported MONOZECLAR problem on May 29, 2008. Female patient, weighting 112.4 lb, was diagnosed with nasopharyngitis and was treated with MONOZECLAR. After drug was administered, patient experienced the following problems/side effects: myalgia, rhabdomyolysis. MONOZECLAR dosage: unknown. During the same period patient was treated with FENOFIBRATE, PREDNISOLONE, TIAPROFENIC ACID, ACETYLCYSTEINE, CODEIN, ACARBOSE, METFORMIN HYDROCHLORIDE, GLYBURIDE. Patient was hospitalized. Patient recovered.

Monozeclar Side Effects Report #5754403-3
MONOZECLAR problem was reported by a Health Professional from FRANCE on May 27, 2008. Female patient, weighting 187.4 lb, was diagnosed with bronchopneumopathy, atrial fibrillation and was treated with MONOZECLAR. After drug was administered, patient experienced the following problems/side effects: abdominal distension, escherichia sepsis, fall, flank pain, heart rate irregular, mitral valve incompetence, nephropathy, rales, renal failure acute. MONOZECLAR dosage: unknown. During the same period patient was treated with CLAVULANATE POTASSIUM, FLUINDIONE, AMIODARONE, LOSARTAN POTASSIUM, ESCITALOPRAM. Patient was hospitalized. Patient recovered.

Monozeclar Side Effects Report #5754408-2
Health Professional from FRANCE reported MONOZECLAR problem on May 26, 2008. Male patient, 39 years of age, was diagnosed with gastroenteritis viral, influenza, musculoskeletal stiffness, pyrexia and was treated with MONOZECLAR. After drug was administered, patient experienced the following problems/side effects: blood blister, leukocytosis, neutrophil count abnormal, purpura, pyrexia. MONOZECLAR dosage: unknown. During the same period patient was treated with IBUROFEN, OXYDE OF LOPERAMIDE, DOMPERIDONE, KETOPROFEN, TETRAZEPAM, PAROXETINE, ACETAMINOPHEN. Patient was hospitalized. Patient recovered.

Monozeclar Side Effects Report #5329392-6
MONOZECLAR problem was reported by a Health Professional from FRANCE on May 10, 2007. Female patient, 47 years of age, was diagnosed with asthma, migraine and was treated with MONOZECLAR. After drug was administered, patient experienced the following problems/side effects: ecchymosis, peripheral ischaemia. MONOZECLAR dosage: unknown. During the same period patient was treated with BUDESONIDE, METHYLPREDNISOLONE, CTIRIZINE DICHLORHYDRATE, PARACETAMOL, TIOTROPIUM BROMURE. Patient was hospitalized. Patient recovered.

Monozeclar Side Effects Report #5266484-4
Physician from FRANCE reported MONOZECLAR problem on Mar 08, 2007. Male patient, 64 years of age, was treated with MONOZECLAR. After drug was administered, patient experienced the following problems/side effects: abdominal distension, subileus. MONOZECLAR dosage: unknown. Patient recovered.

Monozeclar Side Effects Report #5269236-4
MONOZECLAR problem was reported by a Health Professional from FRANCE on Mar 09, 2007. Male patient, 73 years of age, was diagnosed with bronchitis, superinfection and was treated with MONOZECLAR. After drug was administered, patient experienced the following problems/side effects: hepatitis cholestatic, jaundice, renal failure. MONOZECLAR dosage: unknown. During the same period patient was treated with CEFTRIAXONE, PRAVASTATIN, RAMIPRIL, CLOPIDOGREL, FUROSEMIDE, REPAGLINIDE, FENSPIRIDE. Patient was hospitalized. Patient recovered.


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blood blister, purpura, pyrexia, myalgia, rhabdomyolysis, myalgia, rhabdomyolysis, abdominal distension, escherichia sepsis, fall, flank pain, heart rate irregular, mitral valve incompetence, nephropathy, rales, renal failure acute, , was diagnosed with gastroenteritis viral, influenza, musculoskeletal stiffness, pyrexia and was diagnosed with nasopharyngitis and