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Index of reports
> Cases with Off Label Use (4)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Vivaglobin (Immune Globulin Subcutaneous Human) where reactions include off label use. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Vivaglobin side effects in 70 year old female
Reported by a health professional (non-physician/pharmacist) from Sweden on 2012-06-06
Patient: 70 year old female
Reactions: Dysphagia, Chills, Bone Pain, Pain, Headache, Eye Pain, Off Label Use, Syncope, Fatigue, Arthralgia, Diarrhoea Haemorrhagic, Vertigo, Disturbance in Attention, Vision Blurred, Ear Pain
Drug(s) suspected as cause:
Vivaglobin
Possible Vivaglobin side effects in 51 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-03-27
Patient: 51 year old male
Reactions: Polydipsia, Incorrect Route of Drug Administration, Graft Versus Host Disease, Cytomegalovirus Test Positive, Diabetes Mellitus, Polyuria, Off Label Use, Bone Marrow Disorder, Haemoglobin Decreased, Thrombocytopenia, Leukopenia, White Blood Cell Count Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Vivaglobin
Dosage: 6.4 g 1x/week, 160mg/ml every 7 days intravenous (not otherwise specified)
Indication: Chronic Lymphocytic Leukaemia
Start date: 2011-10-25
Noxafil
Start date: 2011-07-15
End date: 2011-09-26
ACT HIB (Haemophilus B Conjugate Vaccine)
Indication: Immunisation
Start date: 2011-09-26
End date: 2011-09-26
ACT HIB (Haemophilus B Conjugate Vaccine)
Indication: Immunisation
Start date: 2011-11-08
End date: 2011-11-08
Other drugs received by patient: Foscavir; Prednisone TAB; Ganciclovir
Possible Vivaglobin side effects in 51 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-03-05
Patient: 51 year old male
Reactions: Incorrect Route of Drug Administration, White Blood Cell Count Decreased, Polydipsia, Graft Versus Host Disease, Cytomegalovirus Test Positive, Polyuria, Haemoglobin Decreased, Bone Marrow Disorder, Off Label Use, Thrombocytopenia, White Blood Cell Count Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Vivaglobin
Other drugs received by patient: Ganciclovir; Voriconazole; Prednisone TAB; ACT HIB (Haemophilus B Conjugate Vaccine)
Possible Vivaglobin side effects in 70 year old female
Reported by a health professional (non-physician/pharmacist) from Sweden on 2012-02-07
Patient: 70 year old female
Reactions: Off Label Use, Fatigue, Arthralgia, Bone Pain, Vision Blurred, Vertigo, Ear Pain, Headache, Eye Pain
Drug(s) suspected as cause:
Vivaglobin
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