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Review Albuminar Safety Reports submitted to FDA

Total Albuminar reports: 13.
Albuminar FDA safety alerts: No.
Reported deaths: 2    Reported hospitalizations: 6.
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FDA Reported Albuminar Side Effects: hepatitis c antibody positive, hepatic failure, antinuclear antibody positive, blood pressure decreased, anaphylactic reaction, infusion related reaction, laboratory test abnormal, crohn's disease, pulmonary congestion, oxygen saturation abnormal, oedema peripheral.
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Albuminar Side Effects Report #5695380-3
Pharmacist from UNITED STATES reported ALBUMINAR problem on Mar 13, 2008. Female patient, 65 years of age, weighting 238.3 lb, was diagnosed with myasthenia gravis, plasmapheresis and was treated with ALBUMINAR. After drug was administered, patient experienced the following problems/side effects: blood fibrinogen decreased, blood glucose increased, catheter site haemorrhage, haemolysis, international normalised ratio increased, platelet count decreased, prothrombin time prolonged, rectal haemorrhage, upper gastrointestinal haemorrhage. ALBUMINAR dosage: unknown. Patient was hospitalized. Patient recovered.

Albuminar Side Effects Report #5625201-6
ALBUMINAR problem was reported by a Consumer or non-health professional from CANADA on Jan 23, 2008. Female patient, 74 years of age, was diagnosed with hypoalbuminaemia and was treated with ALBUMINAR. After drug was administered, patient experienced the following problems/side effects: body temperature increased, cardio-respiratory arrest, coombs direct test positive, coronary artery insufficiency, oxygen saturation decreased. ALBUMINAR dosage: 1100 ML;TOTAL;IV. Patient died.

Albuminar Side Effects Report #5573059-6
Consumer or non-health professional from CANADA reported ALBUMINAR problem on Dec 05, 2007. Male patient, 88 years of age, was treated with ALBUMINAR. After drug was administered, patient experienced the following problems/side effects: adverse event, blood pressure decreased. ALBUMINAR dosage: 50 ML; 1X; IV. Patient recovered.

Albuminar Side Effects Report #5581303-4
ALBUMINAR problem was reported by a Consumer or non-health professional from CANADA on Dec 12, 2007. Male patient, 88 years of age, was treated with ALBUMINAR. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased, hypersensitivity. ALBUMINAR dosage: 50 ML;1X;IV. Patient recovered.

Albuminar Side Effects Report #5507187-8
Physician from UNITED STATES reported ALBUMINAR problem on Oct 19, 2007. Male patient was diagnosed with nephrotic syndrome and was treated with ALBUMINAR. After drug was administered, patient experienced the following problems/side effects: bacterial infection. ALBUMINAR dosage: unknown. During the same period patient was treated with LASIX, PREDNISONE. Patient recovered.

Albuminar Side Effects Report #5544613-2
ALBUMINAR problem was reported by a Physician from UNITED STATES on Nov 20, 2007. Male patient was diagnosed with nephrotic syndrome and was treated with ALBUMINAR. After drug was administered, patient experienced the following problems/side effects: abdominal discomfort, bacterial infection, chills, hypersensitivity, nosocomial infection. ALBUMINAR dosage: unknown. During the same period patient was treated with LASIX, PREDNISONE. Patient recovered.

Albuminar Side Effects Report #5468050-4
Physician from JAPAN reported ALBUMINAR problem on May 07, 2004. Male patient, 59 years of age, was diagnosed with coronary artery bypass and was treated with ALBUMINAR. After drug was administered, patient experienced the following problems/side effects: anaphylactic shock, capillary permeability increased, flushing, haemorrhage, hypovolaemia, oedema peripheral, oxygen saturation abnormal, pulmonary congestion. ALBUMINAR dosage: 250 ML DAILY IV. During the same period patient was treated with DIAZEPAM, ROXATIDINE ACETATE, PROPOFOL, FENTANYL, KETAMINE, VECURONIUM BROMIDE. Patient recovered.

Albuminar Side Effects Report #5411934-3
ALBUMINAR problem was reported by a Pharmacist from UNITED STATES on Aug 09, 2007. Male patient, 81 years of age, weighting 165.3 lb, was diagnosed with renal failure acute and was treated with ALBUMINAR. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, chills, dyspnoea, haemoglobin decreased, hypotension, hypoxia, neutrophil count decreased, orthopnoea, platelet count decreased. ALBUMINAR dosage: unknown. Patient died on 08/06/2007.

Albuminar Side Effects Report #5326588-4
Pharmacist from UNITED STATES reported ALBUMINAR problem on Apr 17, 2007. Female patient, child 8 years of age, weighting 49.60 lb, was diagnosed with hypoalbuminaemia, kawasaki's disease and was treated with ALBUMINAR. After drug was administered, patient experienced the following problems/side effects: antinuclear antibody positive, crohn's disease, hepatic failure, hepatitis, hepatitis c antibody positive, laboratory test abnormal. ALBUMINAR dosage: unknown. During the same period patient was treated with CARIMUNE, ASPIRIN, FLUOXETINE, ACETAMINOPHEN, FUROSEMIDE. Patient was hospitalized. Patient recovered.

Albuminar Side Effects Report #5326588-4
ALBUMINAR problem was reported by a Pharmacist from UNITED STATES on Apr 17, 2007. Female patient, child 8 years of age, weighting 49.60 lb, was diagnosed with hypoalbuminaemia, kawasaki's disease and was treated with ALBUMINAR. After drug was administered, patient experienced the following problems/side effects: antinuclear antibody positive, crohn's disease, hepatic failure, hepatitis, hepatitis c antibody positive, laboratory test abnormal. ALBUMINAR dosage: unknown. During the same period patient was treated with CARIMUNE, ASPIRIN, FLUOXETINE, ACETAMINOPHEN, FUROSEMIDE. Patient was hospitalized. Patient recovered.

Albuminar Side Effects Report #5368998-5
Health Professional from UNITED STATES reported ALBUMINAR problem on June 21, 2007. Female patient, 52 years of age, weighting 130.1 lb, was diagnosed with multiple sclerosis and was treated with ALBUMINAR. After drug was administered, patient experienced the following problems/side effects: burning sensation, cardio-respiratory arrest, convulsion, hypoaesthesia, infusion related reaction. ALBUMINAR dosage: 75GM/1500ML AS DIRECTED IV DRIP. Patient was hospitalized. Patient recovered.

Albuminar Side Effects Report #5309100-5
ALBUMINAR problem was reported by a Pharmacist from UNITED STATES on Apr 04, 2007. Male patient, child 8 years of age, weighting 49.60 lb, was diagnosed with kawasaki's disease and was treated with ALBUMINAR. After drug was administered, patient experienced the following problems/side effects: antinuclear antibody positive, hepatic failure, hepatitis c antibody positive. ALBUMINAR dosage: unknown. During the same period patient was treated with CARIMUNE, ASPIRIN, FLUOXETINE, ACETAMINOPHEN. Patient was hospitalized. Patient recovered.

Albuminar Side Effects Report #5326588-4
Pharmacist from UNITED STATES reported ALBUMINAR problem on Apr 17, 2007. Female patient, child 8 years of age, weighting 49.60 lb, was diagnosed with hypoalbuminaemia, kawasaki's disease and was treated with ALBUMINAR. After drug was administered, patient experienced the following problems/side effects: antinuclear antibody positive, crohn's disease, hepatic failure, hepatitis, hepatitis c antibody positive, laboratory test abnormal. ALBUMINAR dosage: unknown. During the same period patient was treated with CARIMUNE, ASPIRIN, FLUOXETINE, ACETAMINOPHEN, FUROSEMIDE. Patient was hospitalized. Patient recovered.


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blood fibrinogen decreased, blood glucose increased, catheter site haemorrhage, haemolysis, international normalised ratio increased, platelet count decreased, prothrombin time prolonged, rectal haemorrhage, upper gastrointestinal haemorrhage, , was diagnosed with myasthenia gravis, plasmapheresis and was diagnosed with hypoalbuminaemia and was diagnosed with nephrotic syndrome and