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Review Mabcampath Safety Reports submitted to FDA

Total Mabcampath reports: 10.
Mabcampath FDA safety alerts: No.
   Reported hospitalizations: 7.
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FDA Reported Mabcampath Side Effects: injection site pain, hyperkinesia, pyrexia, hypotension, graft haemorrhage, coagulopathy, activated partial thromboplastin time prolonged, restlessness, refusal of treatment by patient, injection site swelling, injection site mass.
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Mabcampath Side Effects Report #5243140-X
Consumer or non-health professional from AUSTRALIA reported MABCAMPATH problem on Feb 08, 2007. Female patient was treated with MABCAMPATH. After drug was administered, patient experienced the following problems/side effects: injection site pain, injection site reaction. MABCAMPATH dosage: unknown. Patient recovered.

Mabcampath Side Effects Report #5298194-1
MABCAMPATH problem was reported by a Consumer or non-health professional from CANADA on Apr 08, 2007. Female patient, 52 years of age, was treated with MABCAMPATH. After drug was administered, patient experienced the following problems/side effects: gait disturbance, injection site cellulitis, injection site erythema, injection site mass, injection site pain, injection site swelling, local swelling, oedema peripheral. MABCAMPATH dosage: 3 MG, DOSE ESCALATION. During the same period patient was treated with TYLENOL, BENADRYL. Patient was hospitalized. Patient recovered.

Mabcampath Side Effects Report #5316174-4
Physician from ISRAEL reported MABCAMPATH problem on Apr 23, 2007. Male patient, 60 years of age, was treated with MABCAMPATH. After drug was administered, patient experienced the following problems/side effects: aplasia pure red cell, melanoma recurrent, metastases to nervous system, metastatic malignant melanoma. MABCAMPATH dosage: unknown. During the same period patient was treated with FLUDARA. Patient recovered.

Mabcampath Side Effects Report #5320747-2
MABCAMPATH problem was reported by a Consumer or non-health professional from CANADA on May 03, 2007. Female patient, 53 years of age, was treated with MABCAMPATH. After drug was administered, patient experienced the following problems/side effects: gait disturbance, injection site erythema, injection site mass, injection site pain, injection site swelling, pyrexia, skin reaction. MABCAMPATH dosage: 3 MG, DOSE ESCALATION. During the same period patient was treated with TYLENOL, BENADRYL. Patient was hospitalized. Patient recovered.

Mabcampath Side Effects Report #5330375-0
Consumer or non-health professional from AUSTRALIA reported MABCAMPATH problem on May 11, 2007. Female patient was treated with MABCAMPATH. After drug was administered, patient experienced the following problems/side effects: injection site pain, injection site reaction. MABCAMPATH dosage: unknown. Patient recovered.

Mabcampath Side Effects Report #5092058-4
MABCAMPATH problem was reported by a Health Professional from NETHERLANDS on Aug 16, 2006. Female patient, 80 years of age, was diagnosed with chronic lymphocytic leukaemia, prophylaxis and was treated with MABCAMPATH. After drug was administered, patient experienced the following problems/side effects: hyperkinesia. MABCAMPATH dosage: unknown. During the same period patient was treated with HYDROCORTISON. Patient was hospitalized. Patient recovered.

Mabcampath Side Effects Report #5150297-8
Health Professional from NETHERLANDS reported MABCAMPATH problem on Oct 26, 2006. Female patient, 80 years of age, was diagnosed with chronic lymphocytic leukaemia, pyrexia and was treated with MABCAMPATH. After drug was administered, patient experienced the following problems/side effects: hyperkinesia, pyrexia, refusal of treatment by patient, restlessness. MABCAMPATH dosage: 3.10,30 MG, 1 DOSE 30 MG 3/WEEK, SUBCUTANEOUS. During the same period patient was treated with HYDROCORTISON, TAVEGIL, ACTONEL, CALCICHEW, FAMVIR. Patient was hospitalized. Patient recovered.

Mabcampath Side Effects Report #5150314-5
MABCAMPATH problem was reported by a Health Professional from NETHERLANDS on Oct 26, 2006. Female patient, 80 years of age, was diagnosed with chronic lymphocytic leukaemia, pyrexia and was treated with MABCAMPATH. After drug was administered, patient experienced the following problems/side effects: hyperkinesia, pyrexia, refusal of treatment by patient, restlessness. MABCAMPATH dosage: 3,10,30 M, 1 DOSE 30 MG 3/WEEK, SUBCUTANEOUS. During the same period patient was treated with HYDROCORTISON, TAVEGIL, ACTONEL, CALCICHEW, FAMVIR. Patient was hospitalized. Patient recovered.

Mabcampath Side Effects Report #5412695-4
Physician from SINGAPORE reported MABCAMPATH problem on Aug 01, 2007. Male patient, 45 years of age, was diagnosed with immunosuppression, renal transplant and was treated with MABCAMPATH. After drug was administered, patient experienced the following problems/side effects: activated partial thromboplastin time prolonged, coagulopathy, graft haemorrhage, hypotension. MABCAMPATH dosage: 20 MG, 1X/DAY. During the same period patient was treated with PIRITION, ROCEPHIN, ANAESTHETICS, CIPROFLOXACIN, ZANTAC, DOPAMINE. Patient was hospitalized and became disabled. Patient recovered.

Mabcampath Side Effects Report #5429667-6
MABCAMPATH problem was reported by a Physician from SINGAPORE on Aug 21, 2007. Male patient, 45 years of age, was diagnosed with immunosuppression, renal transplant and was treated with MABCAMPATH. After drug was administered, patient experienced the following problems/side effects: activated partial thromboplastin time prolonged, coagulopathy, graft haemorrhage, hypotension. MABCAMPATH dosage: 20 MG, 1X/DAY. During the same period patient was treated with PIRITION, ROCEPHIN, ANAESTHETICS, CIPRO, ZANTAC, DOPAMINE. Patient was hospitalized and became disabled. Patient recovered.

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