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Octagam Safety Reports
Total Octagam reports: 25.Octagam FDA safety alerts: No.
Reported hospitalizations: 8.
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Reported Octagam Side Effects: vomiting, infusion related reaction, pyrexia, htlv-1 test positive, hepatitis b, chills, chest pain, myocarditis, diarrhoea, cholestasis, blood alkaline phosphatase increased.
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Octagam Side Effects Report #5209801-3
Pharmacist from FRANCE reported OCTAGAM problem on Dec 21, 2006. Male patient, 55 years of age, was diagnosed with polymyositis and was treated with OCTAGAM. After drug was administered, patient experienced the following problems/side effects: catheter related complication, international normalised ratio increased, localised oedema, vascular insufficiency. OCTAGAM dosage: 1000 MG/KG. Patient recovered.
Octagam Side Effects Report #5266847-7
OCTAGAM problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Jan 16, 2007. Female patient, 14 years of age, was diagnosed with bone marrow transplant and was treated with OCTAGAM. After drug was administered, patient experienced the following problems/side effects: hepatitis b. OCTAGAM dosage: unknown. Patient recovered.
Octagam Side Effects Report #5235096-0
Consumer or non-health professional from GERMANY reported OCTAGAM problem on Jan 24, 2007. Male patient, 28 years of age, was diagnosed with immunodeficiency common variable and was treated with OCTAGAM. After drug was administered, patient experienced the following problems/side effects: anaphylactoid reaction, capillary leak syndrome, infection, pulmonary oedema, renal failure acute. OCTAGAM dosage: unknown. Patient recovered.
Octagam Side Effects Report #5258252-4
OCTAGAM problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Jan 16, 2007. Female patient, 14 years of age, was diagnosed with bone marrow transplant and was treated with OCTAGAM. After drug was administered, patient experienced the following problems/side effects: anti-hbc antibody positive, hepatitis b, therapeutic product contamination. OCTAGAM dosage: unknown. Patient recovered.
Octagam Side Effects Report #5460362-3
Pharmacist from UNITED STATES reported OCTAGAM problem on Jan 22, 2007. Female patient, 50 years of age, weighting 189.6 lb, was diagnosed with myasthenia gravis and was treated with OCTAGAM. After drug was administered, patient experienced the following problems/side effects: meningitis aseptic. OCTAGAM dosage: 400MG/KG IV. Patient was hospitalized. Patient recovered.
Octagam Side Effects Report #5325853-4
OCTAGAM problem was reported by a Consumer or non-health professional from FRANCE on Apr 16, 2007. Male patient, 55 years of age, was diagnosed with hypogammaglobulinaemia and was treated with OCTAGAM. After drug was administered, patient experienced the following problems/side effects: aspartate aminotransferase increased, blood alkaline phosphatase increased, cholestasis, diarrhoea, electrocardiogram repolarisation abnormality, left ventricular hypertrophy, liver disorder, malaise, myocarditis. OCTAGAM dosage: unknown. During the same period patient was treated with LASIX, HYDROCORTISONE, POLARAMINE. Patient was hospitalized. Patient recovered.
Octagam Side Effects Report #5378256-0
Consumer or non-health professional from BELGIUM reported OCTAGAM problem on June 06, 2007. Female patient, 54 years of age, was diagnosed with chronic inflammatory demyelinating polyradiculoneuropathy and was treated with OCTAGAM. After drug was administered, patient experienced the following problems/side effects: csf protein increased, electromyogram abnormal, muscle contractions involuntary, nerve conduction studies abnormal, red blood cell sedimentation rate increased, wheelchair user. OCTAGAM dosage: 400 MG/KG I.V.. Patient recovered.
Octagam Side Effects Report #5076842-9
OCTAGAM problem was reported by a Consumer or non-health professional from AUSTRALIA on July 17, 2006. Female patient, 52 years of age, was treated with OCTAGAM. After drug was administered, patient experienced the following problems/side effects: htlv-1 test positive. OCTAGAM dosage: unknown. During the same period patient was treated with RED BLOOD CELLS, PLATELETS. Patient recovered.
Octagam Side Effects Report #5076846-6
Consumer or non-health professional from AUSTRALIA reported OCTAGAM problem on July 17, 2006. Male patient, 30 years of age, was treated with OCTAGAM. After drug was administered, patient experienced the following problems/side effects: htlv-1 test positive. OCTAGAM dosage: unknown. During the same period patient was treated with RED BLOOD CELLS, PLATELETS. Patient recovered.
Octagam Side Effects Report #5076851-X
OCTAGAM problem was reported by a Consumer or non-health professional from AUSTRALIA on July 17, 2006. Male patient, 64 years of age, was treated with OCTAGAM. After drug was administered, patient experienced the following problems/side effects: htlv-1 test positive. OCTAGAM dosage: unknown. During the same period patient was treated with RED BLOOD CELLS, PLATELETS. Patient recovered.
Octagam Side Effects Report #5085902-8
Consumer or non-health professional from SWEDEN reported OCTAGAM problem on Aug 07, 2006. Male patient, 59 years of age, was diagnosed with demyelinating polyneuropathy and was treated with OCTAGAM. After drug was administered, patient experienced the following problems/side effects: grand mal convulsion, injury. OCTAGAM dosage: unknown. During the same period patient was treated with OMEPRAZOL, ATACAND, SELOKEN ZOC. Patient recovered.
Octagam Side Effects Report #5107540-0
OCTAGAM problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 25, 2006. Male patient, weighting 220.5 lb, was diagnosed with neuropathy and was treated with OCTAGAM. After drug was administered, patient experienced the following problems/side effects: blood glucose increased, hypoglycaemia, laboratory test interference. OCTAGAM dosage: unknown. During the same period patient was treated with HUMALOG, MORPHINE, WELLBUTRION. Patient recovered.
Octagam Side Effects Report #5108555-9
Consumer or non-health professional from BRAZIL reported OCTAGAM problem on Aug 25, 2006. Female patient, 34 years of age, was diagnosed with renal transplant and was treated with OCTAGAM. After drug was administered, patient experienced the following problems/side effects: blood calcium decreased, blood glucose decreased, blood magnesium decreased, dehydration, depressed level of consciousness, device malfunction, diabetes mellitus, dry mouth, false positive laboratory result. OCTAGAM dosage: 1000 MG/KG. Patient recovered.
Octagam Side Effects Report #5176251-8
OCTAGAM problem was reported by a Health Professional from UNITED STATES on May 23, 2006. Male patient, 22 years of age, was diagnosed with immune system disorder and was treated with OCTAGAM. After drug was administered, patient experienced the following problems/side effects: anaphylactoid reaction, body temperature decreased, hypoaesthesia, loss of consciousness, movement disorder, syncope. OCTAGAM dosage: unknown. During the same period patient was treated with NEXIUM, ATENOLOL, FLORINEF, SINGLUAR, PREDNISOLONE, FLORADIL, FLOVENT, ZANAFLEX. Patient was hospitalized. Patient recovered.
Octagam Side Effects Report #5176263-4
Consumer or non-health professional from FRANCE reported OCTAGAM problem on Nov 06, 2006. Male patient, 55 years of age, was diagnosed with hypogammaglobulinaemia and was treated with OCTAGAM. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, cardiac valve disease, cholestasis, diarrhoea, ejection fraction decreased, hypokinesia, myocarditis. OCTAGAM dosage: unknown. During the same period patient was treated with FUROSEMIDE, HYDROCORTISONE, DEXCHLORPHENIRAMINE MALEATE. Patient was hospitalized. Patient recovered.
Octagam Side Effects Report #5171164-X
OCTAGAM problem was reported by a Pharmacist from UNITED STATES on Dec 07, 2006. Female patient, 85 years of age, weighting 144.4 lb, was treated with OCTAGAM. After drug was administered, patient experienced the following problems/side effects: anaemia. OCTAGAM dosage: unknown. Patient recovered.
Octagam Side Effects Report #5186240-5
Consumer or non-health professional from FRANCE reported OCTAGAM problem on Nov 21, 2006. Female patient, 62 years of age, was diagnosed with hypogammaglobulinaemia and was treated with OCTAGAM. After drug was administered, patient experienced the following problems/side effects: arthralgia, myalgia, pyrexia. OCTAGAM dosage: unknown. Patient was hospitalized. Patient recovered.
Octagam Side Effects Report #5193644-3
OCTAGAM problem was reported by a Consumer or non-health professional from SWEDEN on Nov 21, 2006. Male patient, 47 years of age, was diagnosed with chronic inflammatory demyelinating polyradiculoneuropathy and was treated with OCTAGAM. After drug was administered, patient experienced the following problems/side effects: atrial septal defect, blood creatine phosphokinase mb increased, chest pain, dyspnoea, fatigue, myopericarditis, troponin t increased, ventricular hypertrophy, ventricular tachycardia. OCTAGAM dosage: 75 MG I.V.. Patient was hospitalized. Patient recovered.
Octagam Side Effects Report #5200990-3
Consumer or non-health professional from UNITED KINGDOM reported OCTAGAM problem on Dec 07, 2006. Female patient, 14 years of age, was diagnosed with bone marrow transplant and was treated with OCTAGAM. After drug was administered, patient experienced the following problems/side effects: hepatitis acute, hepatitis b, therapeutic product contamination. OCTAGAM dosage: unknown. Patient recovered.
Octagam Side Effects Report #5381473-7
OCTAGAM problem was reported by a Health Professional from UNITED STATES on July 05, 2007. Female patient, weighting 177.0 lb, was diagnosed with immunodeficiency common variable and was treated with OCTAGAM. After drug was administered, patient experienced the following problems/side effects: body temperature increased, chest discomfort, headache, infusion related reaction, nausea, vomiting. OCTAGAM dosage: unknown. Patient was hospitalized. Patient recovered.
Octagam Side Effects Report #5390825-0
Consumer or non-health professional from GERMANY reported OCTAGAM problem on June 28, 2007. Female patient, 54 years of age, was diagnosed with myasthenia gravis and was treated with OCTAGAM. After drug was administered, patient experienced the following problems/side effects: myasthenia gravis crisis. OCTAGAM dosage: unknown. During the same period patient was treated with AZATHIOPRIN. Patient was hospitalized. Patient recovered.
Octagam Side Effects Report #5413040-0
OCTAGAM problem was reported by a Consumer or non-health professional from ARUBA on July 13, 2007. Female patient, 79 years of age, was diagnosed with idiopathic thrombocytopenic purpura and was treated with OCTAGAM. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation, chest pain, infusion related reaction, tachycardia. OCTAGAM dosage: unknown. Patient recovered.
Octagam Side Effects Report #5442953-9
Consumer or non-health professional from SWEDEN reported OCTAGAM problem on Aug 02, 2007. Female patient was diagnosed with guillain-barre syndrome and was treated with OCTAGAM. After drug was administered, patient experienced the following problems/side effects: bacterial infection, blood culture positive, chills, pyrexia, vomiting. OCTAGAM dosage: 700 ML I.V.. During the same period patient was treated with DALTEPARINNATRIUM, KARBOMER, NYSTATIN, ACETAMINOPHEN. Patient recovered.
Octagam Side Effects Report #5443031-5
OCTAGAM problem was reported by a Consumer or non-health professional from AUSTRIA on Aug 13, 2007. Male patient was diagnosed with idiopathic thrombocytopenic purpura and was treated with OCTAGAM. After drug was administered, patient experienced the following problems/side effects: dysphasia, infusion related reaction, platelet count abnormal. OCTAGAM dosage: unknown. During the same period patient was treated with ATENOLOL, CANDESARTAN, METFORMIN, PANTOPRAZOLE, PREDNISOLONE. Patient recovered.
Octagam Side Effects Report #5468554-4
Consumer or non-health professional from SWEDEN reported OCTAGAM problem on Sept 07, 2007. Female patient was diagnosed with guillain-barre syndrome and was treated with OCTAGAM. After drug was administered, patient experienced the following problems/side effects: bacterial test positive, chills, pyrexia, vomiting. OCTAGAM dosage: 700 ML I.V.. During the same period patient was treated with DALTEPARINNATRIUM, KARBOMER, NYSTATIN, ACETAMINOPHEN. Patient recovered.