GAMUNEX Side Effects

7040027-7 | Deep Vein Thrombosis, Unevaluable Event
on Sep 08, 2010 Female patient from UNITED STATES , 44 years of age, weighting 162.0 lb, was diagnosed with immunodeficiency common variable, contraception and was treated with Gamunex (View Usage). Patient experienced the following unwanted or unexpected effects: deep vein thrombosis (What is deep vein thrombosis?), unevaluable event. Gamunex dosage: Iv. During the same period patient was treated with OCTAGAM (View Octagam Review and Octagam Label ), DESOGESTREL AND ETHINYL ESTRADIOL (Po) (View Desogestrel And Ethinyl Estradiol Review and Desogestrel And Ethinyl Estradiol Label ).

7028909-3 | Convulsion
Patient was taking Gamunex (View Usage). Patient had the following side effects: convulsion on Aug 30, 2010 from UNITED STATES Additional patient health information: Female patient , child 12 years of age, weighting 185.2 lb, was diagnosed with hypogammaglobulinaemia and. Gamunex dosage: 475 Mg/kg; Qm; Iv.

7028769-0 | White Blood Cell Count Increased
Adverse event was reported on Aug 16, 2010 by a Female patient taking Gamunex (View Usage) (Dosage: 28 Gm; Iv) was diagnosed with kawasaki's disease and. Location: UNITED STATES , child 2 years of age, weighting 30.86 lb, After Gamunex was administered, patient had the following side effects: white blood cell count increased. During the same period patient was treated with CETRIAXONE (View Cetriaxone Review and Cetriaxone Label ), IBUPROFEN (View Ibuprofen Review and Ibuprofen Label ), TYLENOL REGULAR (View Tylenol Regular Review and Tylenol Regular Label ). Patient was hospitalized.

7028502-2 | Dysarthria, Dysphagia, Headache, Hemiparesis, Infusion Related Reaction, Nausea
on Aug 09, 2010 Female patient from UNITED STATES , 43 years of age, weighting 220.0 lb, was diagnosed with myasthenia gravis, headache (What is headache?) and was treated with Gamunex (View Usage). Patient experienced the following unwanted or unexpected effects: dysarthria, dysphagia, headache (What is headache?), hemiparesis, infusion related reaction, nausea (What is nausea?). Gamunex dosage: 50 Gm Qd Iv. During the same period patient was treated with MIDRIN /00920701/ (View Midrin /00920701/ Review and Midrin /00920701/ Label ), LASIX (View Lasix Review and Lasix Label ), VITAMIN B 12 (View Vitamin B-12 Review and Vitamin B-12 Label ), PREDNISONE (View Prednisone Review and Prednisone Label ), K DUR (View K-dur Review and K-dur Label ), CALCIUM (View Calcium Review and Calcium Label ), OMEPRAZOLE (View Omeprazole Review and Omeprazole Label ). Patient was hospitalized.


7028021-3 | Abdominal Pain, Cardiac Murmur, Haemolytic Anaemia, Mean Cell Volume Decreased, Red Blood Cell Sedimentation Rate Increased, Red Blood Cell Spherocytes Present, Tachycardia, Tonsillar Hypertrophy
on Sep 09, 2010 Female patient from CANADA , weighting 26.46 lb, was diagnosed with lymphadenitis and was treated with Gamunex (View Usage). Patient had the following side effects: abdominal pain (What is abdominal pain?), cardiac murmur, haemolytic anaemia, mean cell volume decreased, red blood cell sedimentation rate increased, red blood cell spherocytes present, tachycardia, tonsillar hypertrophy. Gamunex dosage: 25 Gm; Qd; Iv. During the same period patient was treated with CLAVULIN /01000301/ (View Clavulin /01000301/ Review and Clavulin /01000301/ Label ), CEFUROXIME (View Cefuroxime Review and Cefuroxime Label ), ASPIRIN (View Aspirin Review and Aspirin Label ), ACETAMINOPHEN (View Acetaminophen Review and Acetaminophen Label ), ADVIL LIQUI GELS (View Advil Liqui-gels Review and Advil Liqui-gels Label ), CEFZIL (View Cefzil Review and Cefzil Label ). Patient was hospitalized.

7028020-1 | Anxiety, Cyanosis, Dyspnoea, Infusion Related Reaction, Pyrexia, Rales, Tachypnoea, Wheezing
Patient was taking Gamunex (View Usage). After Gamunex was administered, patient had the following side effects: anxiety (What is anxiety?), cyanosis, dyspnoea, infusion related reaction, pyrexia, rales, tachypnoea, wheezing on Aug 25, 2010 from CANADA Additional patient health information: Female patient , 66 years of age, weighting 125.0 lb, was diagnosed with lymphoma (What is lymphoma?), pneumonia (What is pneumonia?) and. Gamunex dosage: 1x; Iv. Patient was hospitalized.

6943285-X | Hepatitis B
Adverse event was reported on Aug 04, 2010 by a Male patient taking Gamunex (View Usage) (Dosage: 175 Gm; Total; Iv) was diagnosed with myasthenia gravis and. Location: CANADA , 68 years of age, weighting 165.0 lb, Patient experienced the following unwanted or unexpected effects: hepatitis b (What is hepatitis b?). During the same period patient was treated with CORTICOSTEROIDS (CORTICOSTEROIDS) (View Corticosteroids (corticosteroids) Review and Corticosteroids (corticosteroids) Label ), AZATHIOPRINE (View Azathioprine Review and Azathioprine Label ), NAPROSYN (View Naprosyn Review and Naprosyn Label ), TYLENOL WITH CODEIN #3 (View Tylenol With Codein #3 Review and Tylenol With Codein #3 Label ), SPIRIVA (View Spiriva Review and Spiriva Label ), GLUCOPHAGE (View Glucophage Review and Glucophage Label ).

6943094-1 | Abdominal Pain Upper, Back Pain, Chest Pain, Confusional State, Erythema, Facial Pain, Flank Pain, Flushing, Hypersensitivity
on Jul 23, 2010 Female patient from CANADA , 86 years of age, weighting 105.8 lb, was diagnosed with primary immunodeficiency syndrome and was treated with Gamunex (View Usage). Patient had the following side effects: abdominal pain upper, back pain (What is back pain?), chest pain (What is chest pain?), confusional state, erythema, facial pain, flank pain, flushing, hypersensitivity. Gamunex dosage: 6 Gm; 1x; Iv, 1x; Iv, 4 Gm; 1x; Iv, 20 Gm; 1x; Iv. During the same period patient was treated with IGIVNEX (Iv ; 20 Gm; Iv) (View Igivnex Review and Igivnex Label ).

6924394-8 | Treponema Test Positive
on Jul 27, 2010 Female patient from UNITED STATES , 36 years of age, weighting 136.0 lb, was diagnosed with myasthenia gravis and was treated with Gamunex (View Usage). After Gamunex was administered, patient had the following side effects: treponema test positive. Gamunex dosage: 70 Gm;qm;iv. During the same period patient was treated with METHOTREXATE (CON.) (View Methotrexate (con.) Review and Methotrexate (con.) Label ), VITAMIN D NOS (CON.) (View Vitamin D Nos (con.) Review and Vitamin D Nos (con.) Label ), FOLATE (CON.) (View Folate (con.) Review and Folate (con.) Label ), PRENATAL VITAMINS/ 02014401/ (CON.) (View Prenatal Vitamins/ 02014401/ (con.) Review and Prenatal Vitamins/ 02014401/ (con.) Label ), CALCIUM (CON.) (View Calcium (con.) Review and Calcium (con.) Label ), NOVOLOG (CON.) (View Novolog (con.) Review and Novolog (con.) Label ), LEVOTHYROXINE (CON.) (View Levothyroxine (con.) Review and Levothyroxine (con.) Label ), VITAMIN B6 (CON.) (View Vitamin B6 (con.) Review and Vitamin B6 (con.) Label ).

6924389-4 | Aspiration, Blood Bilirubin Increased, Blood Lactate Dehydrogenase Increased, Cardiac Arrest, Haemoglobin Decreased, Haemolytic Anaemia, Pneumothorax
Patient was taking Gamunex (View Usage). Patient experienced the following unwanted or unexpected effects: aspiration, blood bilirubin increased, blood lactate dehydrogenase increased, cardiac arrest (What is cardiac arrest?), haemoglobin decreased, haemolytic anaemia, pneumothorax on Mar 24, 2010 from CANADA Additional patient health information: Female patient , 74 years of age, weighting 220.5 lb, was diagnosed with necrotising fasciitis and. Gamunex dosage: 20 Gm; Iv. During the same period patient was treated with IGIVNEX (30 Gm; Iv) (View Igivnex Review and Igivnex Label ), GAMMAGARD (10 Gm; Iv) (View Gammagard Review and Gammagard Label ), VITAMIN B COMPLEX /90004601/ (View Vitamin B-complex /90004601/ Review and Vitamin B-complex /90004601/ Label ), ASCORBIC ACID (View Ascorbic Acid Review and Ascorbic Acid Label ), ZINC (View Zinc Review and Zinc Label ), DIMENHYDRINATE (View Dimenhydrinate Review and Dimenhydrinate Label ), LACTULOSE (View Lactulose Review and Lactulose Label ).

6924388-2 | Abdominal Pain Upper, Back Pain, Blood Pressure Decreased, Blood Pressure Increased, Chest Pain, Chills, Facial Pain, Feeling Cold, Flank Pain
Adverse event was reported on Jul 23, 2010 by a Female patient taking Gamunex (View Usage) (Dosage: 6 Gm; 1x; Iv, 1x; Iv, 4 Gm; 1x; Iv, 20 Gm; 1x; Iv, Iv) was diagnosed with primary immunodeficiency syndrome and. Location: CANADA , 86 years of age, weighting 105.8 lb, Patient had the following side effects: abdominal pain upper, back pain (What is back pain?), blood pressure decreased, blood pressure increased, chest pain (What is chest pain?), chills, facial pain, feeling cold, flank pain. During the same period patient was treated with IGIVNEX (Iv, 20 Gm; Iv) (View Igivnex Review and Igivnex Label ).

6896399-7 | Balance Disorder, Subarachnoid Haemorrhage
on Jul 12, 2010 Female patient from UNITED STATES , 60 years of age, weighting 158.0 lb, was diagnosed with myasthenia gravis and was treated with Gamunex (View Usage). After Gamunex was administered, patient had the following side effects: balance disorder, subarachnoid haemorrhage. Gamunex dosage: 35 Gm; Qow; Iv, 45 Gm; Qow; Iv. During the same period patient was treated with IMURAN (100 Mg;, 25 Mg;) (View Imuran Review and Imuran Label ), PREDNISONE (View Prednisone Review and Prednisone Label ), SIMVASTATIN (View Simvastatin Review and Simvastatin Label ), MESTINON (View Mestinon Review and Mestinon Label ), LEXAPRO (View Lexapro Review and Lexapro Label ). Patient was hospitalized.

6894695-0 | Infusion Related Reaction, Oedema Peripheral, Pruritus, Throat Tightness, Tongue Disorder
on Jul 30, 2010 Male patient from UNITED STATES , weighting 197.3 lb, was diagnosed with chronic inflammatory demyelinating polyradiculoneuropathy and was treated with Gamunex (View Usage). Patient experienced the following unwanted or unexpected effects: infusion related reaction, oedema peripheral, pruritus, throat tightness, tongue disorder. Gamunex dosage: 20 Gms Every Month Iv.

6885322-7 | Hyponatraemia
Patient was taking Gamunex (View Usage). Patient had the following side effects: hyponatraemia on Jul 29, 2010 from UNITED STATES Additional patient health information: Female patient , 28 years of age, weighting 156.0 lb, was diagnosed with immunodeficiency common variable and. Gamunex dosage: 35 Gm/350 Ml Q5-6 Wks Iv Drip 2 Doses In A Months.

6877395-2 | Headache, Muscle Spasms, Myalgia, Pain
Adverse event was reported on Jul 02, 2010 by a Female patient taking Gamunex (View Usage) (Dosage: Iv) was diagnosed with multifocal motor neuropathy and. Location: UNITED STATES , 65 years of age, weighting 139.0 lb, After Gamunex was administered, patient had the following side effects: headache (What is headache?), muscle spasms, myalgia, pain (What is pain?). During the same period patient was treated with BENADRYL (View Benadryl Review and Benadryl Label ), ACETAMINOPHEN (View Acetaminophen Review and Acetaminophen Label ), LOTREL (View Lotrel Review and Lotrel Label ), XANAX (View Xanax Review and Xanax Label ), NEXIUM (View Nexium Review and Nexium Label ), PREMARIN (View Premarin Review and Premarin Label ), WELLBUTRIN (View Wellbutrin Review and Wellbutrin Label ).

6877287-9 | Incorrect Dose Administered, Multi-organ Failure, Respiratory Failure
on Jun 30, 2010 Female patient from CANADA , 78 years of age, weighting 132.3 lb, was diagnosed with guillain-barre syndrome (What is guillain-barre syndrome?) and was treated with Gamunex (View Usage). Patient experienced the following unwanted or unexpected effects: incorrect dose administered, multi-organ failure, respiratory failure. Gamunex dosage: 385 Gm; Total; Iv. Patient was hospitalized.

6877286-7 | Blood Lactate Dehydrogenase Increased, Haemolytic Anaemia, Tachycardia
on Jun 29, 2010 Female patient from CANADA , weighting 26.46 lb, was diagnosed with kawasaki's disease, lymphadenitis and was treated with Gamunex (View Usage). Patient had the following side effects: blood lactate dehydrogenase increased, haemolytic anaemia, tachycardia. Gamunex dosage: 25 Gm; Qd; Iv. During the same period patient was treated with CLAVULIN /01000301/ (View Clavulin /01000301/ Review and Clavulin /01000301/ Label ), CEFUROXIME (View Cefuroxime Review and Cefuroxime Label ), ASPIRIN (View Aspirin Review and Aspirin Label ), ACETAMINOPHEN (View Acetaminophen Review and Acetaminophen Label ). Patient was hospitalized.

6877284-3 | Hepatitis E
Patient was taking Gamunex (View Usage). After Gamunex was administered, patient had the following side effects: hepatitis e on Jul 06, 2010 from GERMANY Additional patient health information: Male patient , 61 years of age, weighting 227.1 lb, was diagnosed with secondary immunodeficiency and. Gamunex dosage: 10 Gm; Qm; Iv.

6877283-1 | Blood Lactate Dehydrogenase Increased, Blood Urine Present, Haemoglobinuria, Haemolytic Transfusion Reaction, Red Blood Cell Spherocytes Present, Renal Failure
Adverse event was reported on Jul 02, 2010 by a Male patient taking Gamunex (View Usage) (Dosage: 200 Gm; Qd; Iv) was diagnosed with guillain-barre syndrome (What is guillain-barre syndrome?) and. Location: CANADA , 55 years of age, weighting 233.7 lb, Patient experienced the following unwanted or unexpected effects: blood lactate dehydrogenase increased, blood urine present, haemoglobinuria, haemolytic transfusion reaction, red blood cell spherocytes present, renal failure. Patient was hospitalized.

6862034-7 | Asthenia, Blood Glucose Increased, Blood Urea Increased, Bundle Branch Block Left, Fall, Fatigue, Hyperhidrosis, Hypertension, Hypoaesthesia Oral
on Jun 22, 2010 Male patient from UNITED STATES , 71 years of age, weighting 248.0 lb, was diagnosed with chronic inflammatory demyelinating polyradiculoneuropathy and was treated with Gamunex (View Usage). Patient had the following side effects: asthenia, blood glucose increased, blood urea increased, bundle branch block left, fall (What is fall?), fatigue, hyperhidrosis, hypertension, hypoaesthesia oral. Gamunex dosage: 25 Gm;total; Iv. During the same period patient was treated with CARIMUNE (0.4 Gm/kg;qd) (View Carimune Review and Carimune Label ), VIGAMOX (View Vigamox Review and Vigamox Label ), PREDNISOLONE ACETATE (View Prednisolone Acetate Review and Prednisolone Acetate Label ), CELL CEPT (View Cell Cept Review and Cell Cept Label ), LYRICA (View Lyrica Review and Lyrica Label ), M.V.I. (View M.v.i. Review and M.v.i. Label ), ULTRAM (View Ultram Review and Ultram Label ). Patient was hospitalized.

6832242-X | Blood Creatine Phosphokinase Increased
on Jun 15, 2010 Male patient from UNITED STATES , 45 years of age, weighting 200.0 lb, was diagnosed with blood immunoglobulin g, thrombocytopenia and was treated with Gamunex (View Usage). After Gamunex was administered, patient had the following side effects: blood creatine phosphokinase increased. Gamunex dosage: 40 Gm; Qow; Iv. During the same period patient was treated with IMMUNE GLOBULIN (HUMAN) (40 Gm; Qow; Iv) (View Immune Globulin (human) Review and Immune Globulin (human) Label ), SEROSTIM (View Serostim Review and Serostim Label ), ANTIVIRALS NOS (View Antivirals Nos Review and Antivirals Nos Label ), TESTOSTERONE (View Testosterone Review and Testosterone Label ).

6829408-1 | Chills, Haemoglobin Decreased, Pyrexia
Patient was taking Gamunex (View Usage). Patient experienced the following unwanted or unexpected effects: chills, haemoglobin decreased, pyrexia on Jun 07, 2010 from CANADA Additional patient health information: Female patient , 58 years of age, . Gamunex dosage: 60 Gm; Iv. Patient was hospitalized.

6829382-8 | Hepatitis B
Adverse event was reported on Jun 02, 2010 by a Male patient taking Gamunex (View Usage) (Dosage: 175 Gm; Total; Iv) was diagnosed with myasthenia gravis and. Location: CANADA , 68 years of age, Patient had the following side effects: hepatitis b (What is hepatitis b?). During the same period patient was treated with CORTICOSTEROIDS (CORTICOSTEROIDS) (View Corticosteroids (corticosteroids) Review and Corticosteroids (corticosteroids) Label ), AZATHIOPRINE (View Azathioprine Review and Azathioprine Label ).

6829353-1 | Hepatitis B
on Jun 17, 2010 Male patient from CANADA , 68 years of age, was diagnosed with myasthenia gravis and was treated with Gamunex (View Usage). After Gamunex was administered, patient had the following side effects: hepatitis b (What is hepatitis b?). Gamunex dosage: 175 Gm; Total; Iv. During the same period patient was treated with CORTICOSTEROIDS (CORTICOSTEROIDS) (View Corticosteroids (corticosteroids) Review and Corticosteroids (corticosteroids) Label ), AZATHIOPRINE (View Azathioprine Review and Azathioprine Label ).

6829347-6 | Back Pain, Chest Pain, Facial Pain, Hypersensitivity, Hypertension, Parotid Duct Obstruction, Presyncope, Pyrexia
on Jun 16, 2010 Female patient from CANADA , 86 years of age, weighting 105.8 lb, was diagnosed with primary immunodeficiency syndrome and was treated with Gamunex (View Usage). Patient experienced the following unwanted or unexpected effects: back pain (What is back pain?), chest pain (What is chest pain?), facial pain, hypersensitivity, hypertension, parotid duct obstruction, presyncope, pyrexia. Gamunex dosage: 6 Gm; 1x; Iv, 1x; Iv, 40 Ml; 1x; Iv, 20 Gm; Iv, 20 Gm; Qm; Iv. During the same period patient was treated with IGIVNEX (Iv) (View Igivnex Review and Igivnex Label ).

6821772-2 | Haemolysis
Patient was taking Gamunex (View Usage). Patient had the following side effects: haemolysis on Jul 07, 2010 from UNITED STATES Additional patient health information: Male patient , 36 years of age, weighting 185.2 lb, was diagnosed with bruton's agammaglobulinaemia and. Gamunex dosage: .

6767660-1 | Dehydration, Meningitis Aseptic
Adverse event was reported on May 26, 2010 by a Male patient taking Gamunex (View Usage) (Dosage: 70 Gm; Qm; Iv) was diagnosed with dermatomyositis and. Location: CANADA , 19 years of age, weighting 173.0 lb, After Gamunex was administered, patient had the following side effects: dehydration, meningitis aseptic. During the same period patient was treated with IGIVNEX (10 Gm; Total; Iv) (View Igivnex Review and Igivnex Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ).

6762489-2 | Asthenia, Fall, Hyperhidrosis, Tremor
on May 10, 2010 Male patient from UNITED STATES , 71 years of age, was diagnosed with chronic inflammatory demyelinating polyradiculoneuropathy and was treated with Gamunex (View Usage). Patient experienced the following unwanted or unexpected effects: asthenia, fall (What is fall?), hyperhidrosis, tremor. Gamunex dosage: 50 Gm;total; Iv. During the same period patient was treated with CARIMUNE (View Carimune Review and Carimune Label ), VIGAMOX (View Vigamox Review and Vigamox Label ), PREDNISOLONE ACETATE (View Prednisolone Acetate Review and Prednisolone Acetate Label ), CELLCEPT (View Cellcept Review and Cellcept Label ), LYRICA (View Lyrica Review and Lyrica Label ), M.V.I. (View M.v.i. Review and M.v.i. Label ), ULTRAM (View Ultram Review and Ultram Label ). Patient was hospitalized.

6762283-2 | Activated Partial Thromboplastin Time Prolonged, Blood Urine Present, Complications Of Bone Marrow Transplant, Glucose Urine Present, Haematocrit Decreased, Haemoglobin Decreased, Haemolysis, Platelet Count Decreased, Protein Urine Present
on Apr 27, 2010 Male patient from UNITED STATES , child 3 years of age, weighting 24.69 lb, was treated with Gamunex (View Usage). Patient had the following side effects: activated partial thromboplastin time prolonged, blood urine present, complications of bone marrow transplant, glucose urine present, haematocrit decreased, haemoglobin decreased, haemolysis, platelet count decreased, protein urine present. Gamunex dosage: X1;iv. During the same period patient was treated with FUROSEMIDE (View Furosemide Review and Furosemide Label ), HYDROCORTISONE (View Hydrocortisone Review and Hydrocortisone Label ), LANSOPRAZOLE (View Lansoprazole Review and Lansoprazole Label ), LEVABUTEROL HYDROCHLORIDE (View Levabuterol Hydrochloride Review and Levabuterol Hydrochloride Label ).

6762268-6 | Chest X-ray Abnormal, Haematocrit Decreased, Haemoglobin Decreased, Platelet Count Decreased, Renal Failure, Respiratory Failure
Patient was taking Gamunex (View Usage). After Gamunex was administered, patient had the following side effects: chest x-ray abnormal, haematocrit decreased, haemoglobin decreased, platelet count decreased, renal failure, respiratory failure on Apr 27, 2010 from UNITED STATES Additional patient health information: Male patient , child 12 years of age, weighting 101.9 lb, was diagnosed with kawasaki's disease and. Gamunex dosage: 7.3 Gm;1x;iv; 10.0 Gm;1x;iv; 4.5 Gm;1x;iv. During the same period patient was treated with HYDROCORTISONE (View Hydrocortisone Review and Hydrocortisone Label ), LANSOPRAZOLE (View Lansoprazole Review and Lansoprazole Label ), MAGNESIUM OXIDE (View Magnesium Oxide Review and Magnesium Oxide Label ), METHADONE (View Methadone Review and Methadone Label ). Patient was hospitalized.

6762251-0 | Antibody Test Positive, Haemolysis
Adverse event was reported on Apr 27, 2010 by a Female patient taking Gamunex (View Usage) (Dosage: 30 Gm;qd;iv) was diagnosed with viral infection (What is viral infection?) and. Location: UNITED STATES , 13 years of age, weighting 125.7 lb, Patient experienced the following unwanted or unexpected effects: antibody test positive, haemolysis. During the same period patient was treated with FLUCONAZOLE (View Fluconazole Review and Fluconazole Label ), GRANISETRON (View Granisetron Review and Granisetron Label ), METHADONE (View Methadone Review and Methadone Label ), METHYLPREDNISOLONE (View Methylprednisolone Review and Methylprednisolone Label ), LORAZEPAM (View Lorazepam Review and Lorazepam Label ), ESCITALOPRAM (View Escitalopram Review and Escitalopram Label ). Patient was hospitalized.

6761862-6 | Deep Vein Thrombosis
on Apr 26, 2010 Female patient from UNITED STATES , 44 years of age, weighting 162.0 lb, was diagnosed with immunodeficiency common variable, contraception and was treated with Gamunex (View Usage). Patient had the following side effects: deep vein thrombosis (What is deep vein thrombosis?). Gamunex dosage: Iv. During the same period patient was treated with OCTAGAM (View Octagam Review and Octagam Label ), DESOGESTREL AND ETHINYL ESTRADIOL (Po) (View Desogestrel And Ethinyl Estradiol Review and Desogestrel And Ethinyl Estradiol Label ).

6761843-2 | Renal Failure Acute
on Apr 21, 2010 Male patient from UNITED STATES , 39 years of age, weighting 169.8 lb, was diagnosed with immunodeficiency common variable and was treated with Gamunex (View Usage). After Gamunex was administered, patient had the following side effects: renal failure acute. Gamunex dosage: 900 Mg/kg; Qm; Iv.

6761806-7 | Dysarthria, Dysphagia, Headache, Hemiparesis, Infusion Related Reaction
Patient was taking Gamunex (View Usage). Patient experienced the following unwanted or unexpected effects: dysarthria, dysphagia, headache (What is headache?), hemiparesis, infusion related reaction on Apr 07, 2010 from UNITED STATES Additional patient health information: Female patient , 43 years of age, weighting 220.0 lb, was diagnosed with myasthenia gravis, headache (What is headache?) and. Gamunex dosage: 50 Gm;qd;iv. During the same period patient was treated with MIDRIN /00920701/ (View Midrin /00920701/ Review and Midrin /00920701/ Label ), LASIX (View Lasix Review and Lasix Label ), VITAMIN B 12 (View Vitamin B-12 Review and Vitamin B-12 Label ), PREDNISONE (View Prednisone Review and Prednisone Label ), K DUR (View K-dur Review and K-dur Label ), CALCIUM CARBONATE (View Calcium Carbonate Review and Calcium Carbonate Label ), OMEPRAZOLE (View Omeprazole Review and Omeprazole Label ). Patient was hospitalized.

6761728-1 | Coombs Direct Test Positive, Haemoglobin Decreased
Adverse event was reported on Apr 20, 2010 by a Male patient taking Gamunex (View Usage) (Dosage: 40 Gm; Total; Iv) was diagnosed with myasthenia gravis and. Location: CANADA , 77 years of age, weighting 213.8 lb, Patient had the following side effects: coombs direct test positive, haemoglobin decreased. During the same period patient was treated with PRIVIGEN (NO PREF. NAME) (10 PCT) (40 Gm; Qd; Iv) (View Privigen (no Pref. Name) (10 Pct) Review and Privigen (no Pref. Name) (10 Pct) Label ), FELODIPINE (View Felodipine Review and Felodipine Label ), MORPHINE (View Morphine Review and Morphine Label ), ACETAMINOPHEN (View Acetaminophen Review and Acetaminophen Label ), HYDROMORPHONE HCL (View Hydromorphone Hcl Review and Hydromorphone Hcl Label ), HEPARIN (View Heparin Review and Heparin Label ). Patient was hospitalized.

6761720-7 | Haemoglobin Decreased
on Apr 12, 2010 Male patient from CANADA , 77 years of age, weighting 213.8 lb, was diagnosed with myasthenia gravis and was treated with Gamunex (View Usage). After Gamunex was administered, patient had the following side effects: haemoglobin decreased. Gamunex dosage: 40 Gm; Qd; Iv. During the same period patient was treated with PRIVIGEN (NO PREF. NAME) (10 PCT) (40 Gm; Qd; Iv) (View Privigen (no Pref. Name) (10 Pct) Review and Privigen (no Pref. Name) (10 Pct) Label ), FELODIPINE (View Felodipine Review and Felodipine Label ), MORPHINE (View Morphine Review and Morphine Label ), ACETAMINOPHEN (View Acetaminophen Review and Acetaminophen Label ), HYDROMORPHONE HCL (View Hydromorphone Hcl Review and Hydromorphone Hcl Label ), HEPARIN (View Heparin Review and Heparin Label ), PREDNISONE (View Prednisone Review and Prednisone Label ), LORAZEPAM (View Lorazepam Review and Lorazepam Label ).

6761700-1 | Coombs Direct Test Positive, Haemoglobin Decreased, Pulmonary Embolism
on May 05, 2010 Male patient from CANADA , 77 years of age, weighting 213.8 lb, was diagnosed with myasthenia gravis and was treated with Gamunex (View Usage). Patient experienced the following unwanted or unexpected effects: coombs direct test positive, haemoglobin decreased, pulmonary embolism (What is pulmonary embolism?). Gamunex dosage: 40 Gm; Total; Iv. During the same period patient was treated with PRIVIGEN (40 Gm; Qd; Iv) (View Privigen Review and Privigen Label ), FELODIPINE (View Felodipine Review and Felodipine Label ), MORPHINE (View Morphine Review and Morphine Label ), ACETAMINOPHEN (View Acetaminophen Review and Acetaminophen Label ), HYDROMORPHONE HCL (View Hydromorphone Hcl Review and Hydromorphone Hcl Label ), HEPARIN (View Heparin Review and Heparin Label ). Patient was hospitalized.

6685773-X | Hypertension
Patient was taking Gamunex (View Usage). Patient had the following side effects: hypertension on Apr 15, 2010 from UNITED STATES Additional patient health information: Female patient , child 2 years of age, was diagnosed with acute myeloid leukaemia and. Gamunex dosage: 7.5gm Iv. During the same period patient was treated with METHYLPREDNISOLONE (20mg Iv) (View Methylprednisolone Review and Methylprednisolone Label ), CYCLOSPORINE (View Cyclosporine Review and Cyclosporine Label ), FLUCONAZOLE (View Fluconazole Review and Fluconazole Label ), CO TRIMAZOLE (View Co-trimazole Review and Co-trimazole Label ). Patient was hospitalized.

6681949-6 | Cardio-respiratory Arrest, Crying, Cyanosis, Hypotension, Transfusion Reaction
Adverse event was reported on Mar 30, 2010 by a Female patient taking Gamunex (View Usage) (Dosage: 25 Gm; Iv, ; Iv, 50 Ml; Total; Iv) was diagnosed with headache (What is headache?), muscular weakness and. Location: CANADA , 79 years of age, weighting 227.1 lb, After Gamunex was administered, patient had the following side effects: cardio-respiratory arrest, crying, cyanosis, hypotension, transfusion reaction.

6681911-3 | Chills, Dehydration, Delirium, Headache, Nausea
on Mar 24, 2010 Male patient from CANADA , 19 years of age, weighting 173.0 lb, was diagnosed with dermatomyositis and was treated with Gamunex (View Usage). Patient experienced the following unwanted or unexpected effects: chills, dehydration, delirium, headache (What is headache?), nausea (What is nausea?). Gamunex dosage: 70 Gm;qm; Iv. During the same period patient was treated with IGIVNEX (10 Gm; Total; Iv) (View Igivnex Review and Igivnex Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ).

6656765-1 | Diabetes Mellitus, Hepatic Steatosis, Hepatitis B Antibody, Liver Function Test Abnormal, Metabolic Syndrome, Transmission Of An Infectious Agent Via A Medicinal Product
on Mar 09, 2010 Female patient from UNITED STATES , 44 years of age, weighting 248.0 lb, was diagnosed with immunodeficiency common variable and was treated with Gamunex (View Usage). Patient had the following side effects: diabetes mellitus, hepatic steatosis, hepatitis b antibody, liver function test abnormal, metabolic syndrome (What is metabolic syndrome?), transmission of an infectious agent via a medicinal product. Gamunex dosage: 40 Gm; Every 28 Days; Iv.

6623548-8 | Arrhythmia, Asthenia, Blood Pressure Systolic Increased, Chest Discomfort, Disease Recurrence, Dizziness, Dyspnoea, Extrasystoles, Heart Rate Irregular
Patient was taking Gamunex (View Usage). After Gamunex was administered, patient had the following side effects: arrhythmia (What is arrhythmia?), asthenia, blood pressure systolic increased, chest discomfort, disease recurrence, dizziness (What is dizziness?), dyspnoea, extrasystoles, heart rate irregular on Feb 15, 2010 from UNITED STATES Additional patient health information: Male patient , 50 years of age, weighting 205.0 lb, was diagnosed with chronic inflammatory demyelinating polyradiculoneuropathy and. Gamunex dosage: 20 Gm,1x,iv; 35 Gm;q3w;iv; 25 Gm;qd;iv; 40 Gm;q3w; Iv.

6619570-8 | Blood Pressure Increased, Chest Discomfort, Dizziness, Dyspnoea, Extrasystoles, Heart Rate Increased, Infusion Related Reaction, Pallor, Palpitations
Adverse event was reported on Feb 05, 2010 by a Male patient taking Gamunex (View Usage) (Dosage: 20 Gm;qm;iv, 20 Gm;1x;iv, 20 Gm;1x;iv, 35 Gm;q3w;iv, 25 Gm;qd;iv, 25 Gm;qd;iv) was diagnosed with chronic inflammatory demyelinating polyradiculoneuropathy and. Location: UNITED STATES , 50 years of age, weighting 215.0 lb, Patient experienced the following unwanted or unexpected effects: blood pressure increased, chest discomfort, dizziness (What is dizziness?), dyspnoea, extrasystoles, heart rate increased, infusion related reaction, pallor, palpitations. During the same period patient was treated with SOLU CORTEF (View Solu-cortef Review and Solu-cortef Label ).

6619441-7 | Anti-hbc Antibody Positive, Anti-hbs Antibody Positive
on Feb 12, 2010 Male patient from GERMANY , 18 years of age, was diagnosed with myelodysplastic syndrome, haemoglobin decreased and was treated with Gamunex (View Usage). Patient had the following side effects: anti-hbc antibody positive, anti-hbs antibody positive. Gamunex dosage: Iv. During the same period patient was treated with RED BLOOD CELLS (See Image) (View Red Blood Cells Review and Red Blood Cells Label ).

6611174-6 | Erythema, Infusion Related Reaction, Migraine, Photosensitivity Reaction, Rash Pruritic, Vomiting
on Feb 26, 2010 Female patient from UNITED STATES , weighting 150.4 lb, was diagnosed with myasthenia gravis and was treated with Gamunex (View Usage). After Gamunex was administered, patient had the following side effects: erythema, infusion related reaction, migraine (What is migraine?), photosensitivity reaction, rash pruritic, vomiting. Gamunex dosage: 70 Gm Q Month Iv.

6611156-4 | Chills, Headache, Pyrexia
Patient was taking Gamunex (View Usage). Patient experienced the following unwanted or unexpected effects: chills, headache (What is headache?), pyrexia on Mar 02, 2010 from UNITED STATES Additional patient health information: Male patient , weighting 183.0 lb, was diagnosed with immunodeficiency common variable and. Gamunex dosage: 50g Once Very 4 Weeks Iv Drip.

6609161-7 | Cardiac Failure Congestive, Chills, Condition Aggravated, Dialysis, Headache, Malaise, Nausea, Neck Pain, Renal Failure Acute
Adverse event was reported on Jan 26, 2010 by a Male patient taking Gamunex (View Usage) (Dosage: 80 Gm; Q3w; Iv) was diagnosed with off label use and. Location: UNITED STATES , 65 years of age, Patient had the following side effects: cardiac failure congestive, chills, condition aggravated, dialysis (What is dialysis?), headache (What is headache?), malaise, nausea (What is nausea?), neck pain, renal failure acute. During the same period patient was treated with FOLATE (View Folate Review and Folate Label ), EPLERENONE (View Eplerenone Review and Eplerenone Label ), ASPIRIN (View Aspirin Review and Aspirin Label ), AMIODARONE HCL (View Amiodarone Hcl Review and Amiodarone Hcl Label ), COLCHICINE (View Colchicine Review and Colchicine Label ), TIOTROPIUM (View Tiotropium Review and Tiotropium Label ), ALLOPURINOL (View Allopurinol Review and Allopurinol Label ), SENOKOT (View Senokot Review and Senokot Label ). Patient was hospitalized.

6607626-5 | Anxiety, Treponema Test False Positive
on Feb 01, 2010 Male patient from CANADA , 30 years of age, was diagnosed with myelitis and was treated with Gamunex (View Usage). After Gamunex was administered, patient had the following side effects: anxiety (What is anxiety?), treponema test false positive. Gamunex dosage: Qd; Iv. During the same period patient was treated with IGIVNEX (Qd; Iv) (View Igivnex Review and Igivnex Label ).

6607587-9 | Angioedema, Headache
on Feb 05, 2010 Female patient from UNITED STATES , 34 years of age, weighting 190.0 lb, was diagnosed with immunodeficiency common variable and was treated with Gamunex (View Usage). Patient experienced the following unwanted or unexpected effects: angioedema, headache (What is headache?). Gamunex dosage: 40 Gm; 1x; Iv. During the same period patient was treated with VIVAGLOBIN (Sc) (View Vivaglobin Review and Vivaglobin Label ), PREDNISONE TAB (View Prednisone Tab Review and Prednisone Tab Label ), BENADRYL (View Benadryl Review and Benadryl Label ), ZOFRAN (View Zofran Review and Zofran Label ), THYROID TAB (View Thyroid Tab Review and Thyroid Tab Label ), PREVACID (View Prevacid Review and Prevacid Label ), AMLODIPINE (View Amlodipine Review and Amlodipine Label ), ADVAIR DISKUS 100/50 (View Advair Diskus 100/50 Review and Advair Diskus 100/50 Label ).

6532546-4 | Lobar Pneumonia
Patient was taking Gamunex (View Usage). Patient had the following side effects: lobar pneumonia on Dec 08, 2009 from UNITED STATES Additional patient health information: Male patient , 27 years of age, was diagnosed with acquired immunodeficiency syndrome and. Gamunex dosage: Iv. Patient was hospitalized.