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Review Iveegam Safety Reports submitted to FDA

Total Iveegam reports: 7.
Iveegam FDA safety alerts: No.
   Reported hospitalizations: 4.
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FDA Reported Iveegam Side Effects: pyrexia, chest discomfort, anxiety, anaphylactic reaction, false negative laboratory result, dyspnoea, dizziness, blood pressure increased, blood pressure decreased, infusion related reaction, headache.
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Iveegam Side Effects Report #5626401-1
Consumer or non-health professional from CANADA reported IVEEGAM problem on Feb 04, 2008. Male patient, 20 years of age, weighting 127.9 lb, was diagnosed with immunodeficiency common variable, hypogammaglobulinaemia, selective iga immunodeficiency, blood immunoglobulin m decreased and was treated with IVEEGAM. After drug was administered, patient experienced the following problems/side effects: chest discomfort, dizziness, dyspnoea. IVEEGAM dosage: unknown. Patient was hospitalized. Patient recovered.

Iveegam Side Effects Report #5532435-8
IVEEGAM problem was reported by a Consumer or non-health professional from CANADA on Nov 21, 2007. Male patient, 20 years of age, weighting 127.9 lb, was diagnosed with immunodeficiency common variable, hypogammaglobulinaemia, selective iga immunodeficiency, blood immunoglobulin m decreased and was treated with IVEEGAM. After drug was administered, patient experienced the following problems/side effects: chest discomfort, dizziness, dyspnoea. IVEEGAM dosage: unknown. Patient was hospitalized. Patient recovered.

Iveegam Side Effects Report #5529853-0
Consumer or non-health professional from CANADA reported IVEEGAM problem on Nov 19, 2007. Male patient, 20 years of age, weighting 127.9 lb, was diagnosed with immunodeficiency common variable, hypogammaglobulinaemia, selective iga immunodeficiency, blood immunoglobulin m decreased and was treated with IVEEGAM. After drug was administered, patient experienced the following problems/side effects: chest discomfort, dizziness, dyspnoea. IVEEGAM dosage: unknown. Patient was hospitalized. Patient recovered.

Iveegam Side Effects Report #5477818-X
IVEEGAM problem was reported by a Consumer or non-health professional from CANADA on Sept 27, 2007. Male patient, 20 years of age, weighting 127.9 lb, was diagnosed with immunodeficiency common variable, hypogammaglobulinaemia, selective iga immunodeficiency, blood immunoglobulin m decreased and was treated with IVEEGAM. After drug was administered, patient experienced the following problems/side effects: chest discomfort, dizziness, dyspnoea. IVEEGAM dosage: unknown. Patient was hospitalized. Patient recovered.

Iveegam Side Effects Report #5470019-0
Consumer or non-health professional from CANADA reported IVEEGAM problem on Sept 18, 2007. Male patient, 20 years of age, weighting 127.9 lb, was diagnosed with immunodeficiency common variable, hypogammaglobulinaemia, selective iga immunodeficiency, blood immunoglobulin m decreased and was treated with IVEEGAM. After drug was administered, patient experienced the following problems/side effects: chest discomfort, dizziness, dyspnoea. IVEEGAM dosage: unknown. During the same period patient was treated with TYLENOL, BENADRYL, ZANTAC. Patient recovered.

Iveegam Side Effects Report #5382369-7
IVEEGAM problem was reported by a Consumer or non-health professional from CANADA on June 28, 2007. Male patient, 20 years of age, weighting 127.9 lb, was diagnosed with immunodeficiency and was treated with IVEEGAM. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction, anxiety, chest discomfort. IVEEGAM dosage: unknown. During the same period patient was treated with PREDNISONE, PENTASA, IMURAN, LOSEC, HYDRODIURIL. Patient recovered.

Iveegam Side Effects Report #5382369-7
Consumer or non-health professional from CANADA reported IVEEGAM problem on June 28, 2007. Male patient, 20 years of age, weighting 127.9 lb, was diagnosed with immunodeficiency and was treated with IVEEGAM. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction, anxiety, chest discomfort. IVEEGAM dosage: unknown. During the same period patient was treated with PREDNISONE, PENTASA, IMURAN, LOSEC, HYDRODIURIL. Patient recovered.


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chest discomfort, dizziness, dyspnoea, chest discomfort, dizziness, dyspnoea, chest discomfort, dizziness, dyspnoea, , was diagnosed with immunodeficiency common variable, hypogammaglobulinaemia, selective iga immunodeficiency, blood immunoglobulin m decreased and