Ambisome and haemodialysis Patient Reports February 12, 2012

Ambisome Side Effects Report #5501372-7
Ambisome side effect was reported by a Health Professional from JAPAN on Oct 02, 2007. Male patient, 55 years of age, was diagnosed with systemic candida and was treated with Ambisome. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, blood potassium decreased, blood urine present, cytomegalovirus infection , haematocrit decreased, haemodialysis, haemoglobin decreased. Ambisome dosage: 200 MG, UID/QD, IV DRIP. During the same period patient was treated with PROGRAF, MYCAMINE, VANCOMYCIN HYDROCHLORIDE, DENOSINE, TARGOCID, BACTRAMIN, NEUPOGEN, PREDNISONE. Patient died on 06/29/2007.

Ambisome Side Effects Report #5633838-3
Ambisome side effect was reported by a Health Professional from JAPAN on Feb 05, 2008. Male patient, 55 years of age, was diagnosed with systemic candida and was treated with Ambisome. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, blood creatine increased, blood potassium decreased, blood urea increased, blood urine present, haemodialysis, interstitial lung disease. Ambisome dosage: 200 MG, UID/QD, IV DRIP. During the same period patient was treated with PROGRAF, MYCAMINE, NEUPOGEN, VANCOMYCIN HYDROCHLORIDE, GANCICLOVIR, TARGOCID, BACTRIM, PREDNISOLONE. Patient died on 06/29/2007.

Ambisome Side Effects Report #5911486-5
Ambisome side effect was reported by a Health Professional from UNITED STATES on Sept 19, 2008. Male patient, 28 years of age, was diagnosed with fungal skin infection, candidiasis and was treated with Ambisome. After drug was administered, patient experienced the following side effects: haemodialysis, histoplasmosis disseminated, hypotension, renal failure acute, respiratory distress, tachycardia, trichosporon infection. Ambisome dosage: unknown. During the same period patient was treated with MYCAMINE. Patient was hospitalized. Patient recovered.

Ambisome Side Effects Report #5633050-8
Ambisome side effect was reported by a Physician from JAPAN on Feb 01, 2008. Male patient, 77 years of age, was diagnosed with bronchopulmonary aspergillosis and was treated with Ambisome. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, antithrombin iii deficiency, aspartate aminotransferase increased, blood bilirubin increased, blood creatine increased, blood urea increased, creatinine renal clearance increased, haemodialysis, hyperkalaemia. Ambisome dosage: 3.9 MG/KG, UID/QD, IV NOS, 200 MG, UID/QD, IV NOS. During the same period patient was treated with DECADRON, DIFLUCAN, FUNGUARD, MAXIPIME, VFEND, DENOSINE, POLYGLOBIN. Patient was hospitalized. Patient died on 10/14/2007.


Ambisome Side Effects Report #5688145-X
Ambisome side effect was reported by a Physician from JAPAN on Mar 12, 2008. Male patient, 77 years of age, was diagnosed with bronchopulmonary aspergillosis and was treated with Ambisome. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, antithrombin iii deficiency, aspartate aminotransferase increased, blood bilirubin increased, blood creatine increased, blood urea increased, condition aggravated, haemodialysis, hepatic function abnormal. Ambisome dosage: 3.9 MG/KG, UID/QD, IV NOS, 200 MG, UID/QD, IV NOS. During the same period patient was treated with DECADRON, DIFLUCAN, FUNGUARD, MAXIPIME, VFEND, GANCICLOVIR, POLYGLOBIN. Patient was hospitalized. Patient died on 10/14/2007.

Ambisome Side Effects Report #5822367-X
Ambisome side effect was reported by a Physician from JAPAN on July 09, 2008. Male patient, 77 years of age, weighting 142.6 lb, was diagnosed with bronchopulmonary aspergillosis and was treated with Ambisome. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, antithrombin iii deficiency, aspartate aminotransferase increased, blood bilirubin increased, bronchopulmonary aspergillosis, condition aggravated, haemodialysis, hepatic function abnormal, hyperkalaemia. Ambisome dosage: 3.9 MG/KG, UID/QD, IV NOS, 200 MG, UID/QD, IV NOS. During the same period patient was treated with DECADRON, DIFLUCAN, FUNGUARD, MAXIPIME, VFEND, GANCICLOVIR, POLYGLOBIN. Patient was hospitalized. Patient died on 10/14/2007.

Ambisome Side Effects Report #5832946-1
Ambisome side effect was reported by a Physician from JAPAN on July 18, 2008. Male patient, 77 years of age, weighting 142.6 lb, was diagnosed with bronchopulmonary aspergillosis and was treated with Ambisome. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, antithrombin iii deficiency, aspartate aminotransferase increased, blood bilirubin increased, blood creatinine increased, blood urea increased, bronchopulmonary aspergillosis, haemodialysis, hyperkalaemia. Ambisome dosage: 3.9 MG/KG, UID/QD, IV NOS; 200 MG, UID/QD, IV NOS. During the same period patient was treated with DECADRON, DIFLUCAN, FUNGUARD, MAXIPIME, VFEND, GANCICLOVIR, POLYGLOBIN. Patient was hospitalized. Patient died on 10/14/2007.

Ambisome Side Effects Report #5903382-4
Ambisome side effect was reported by a Physician from JAPAN on Sept 18, 2008. Male patient, 77 years of age, weighting 142.6 lb, was diagnosed with bronchopulmonary aspergillosis, thrombocytopenic purpura and was treated with Ambisome. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, antithrombin iii deficiency, aspartate aminotransferase increased, bronchopulmonary aspergillosis, cytomegalovirus infection , haemodialysis, hyperkalaemia, liver disorder, pneumonia . Ambisome dosage: 3.9 MGKG, UID/QD, IV NOS; 200 MG, UID/QD, IV NOS. During the same period patient was treated with DECADRON, DIFLUCAN, FUNGUARD, MAXIPIME, VFEND, GANCICLOVIR, POLYGLOBIN. Patient was hospitalized. Patient died on 10/14/2007.

Ambisome Side Effects Report #5313512-3
Ambisome side effect was reported by a Physician from JAPAN on Apr 17, 2007. Female patient, 68 years of age, was diagnosed with bronchopulmonary aspergillosis and was treated with Ambisome. After drug was administered, patient experienced the following side effects: haemodialysis, hepatic failure, hepatic function abnormal, jaundice , pancytopenia. Ambisome dosage: 125 MG, UID/QD. During the same period patient was treated with OLMETEC, NORVASC, BACTRIM, LANSOPRAZOLE, HONKUNALIN, DIPRIVAN. Patient recovered.


Ambisome Side Effects Report #5324517-0
Ambisome side effect was reported by a Physician from JAPAN on Apr 26, 2007. Female patient, 68 years of age, was diagnosed with bronchopulmonary aspergillosis and was treated with Ambisome. After drug was administered, patient experienced the following side effects: haemodialysis, hepatic failure, pancytopenia. Ambisome dosage: 125 MG, UID/QD. During the same period patient was treated with OLMETEC, NORVASC, BACTRIM, TAKEPRON, HOKUNALIN, DIPRIVAN, SOLU MEDROL. Patient recovered.

Ambisome Side Effects Report #5673964-6
Ambisome side effect was reported by a Health Professional from JAPAN on Feb 28, 2008. Male patient, 55 years of age, weighting 114.6 lb, was diagnosed with bronchopulmonary aspergillosis and was treated with Ambisome. After drug was administered, patient experienced the following side effects: blood bilirubin increased, haemodialysis, metabolic acidosis, pneumonia , renal failure, respiratory failure. Ambisome dosage: 250 MG, UID/QD, IV NOS. During the same period patient was treated with FUNGUARD, PROGRAF, AZACTAM, BACTRIM, ACICLOVIR, FOSCAVIR, VANCOMYCIN HYDROCHLORIDE. Patient died on 11/21/2007.

Ambisome Side Effects Report #5817454-6
Ambisome side effect was reported by a Health Professional from JAPAN on July 08, 2008. Male patient, 55 years of age, weighting 114.6 lb, was diagnosed with bronchopulmonary aspergillosis and was treated with Ambisome. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, blood bilirubin increased, blood potassium increased, blood pressure decreased, haematocrit decreased, haemodialysis, haemoglobin decreased, metabolic acidosis, multi-organ failure. Ambisome dosage: 250 MG, UID/QD, IV NOS. During the same period patient was treated with FUNGUARD, PROGRAF, AZACTAM, BACTRIM, ACICLOVIR, FOSCAVIR, VANCOMYCIN HYDROCHLORIDE. Patient died on 11/21/2007.

Ambisome Side Effects Report #5928956-6
Ambisome side effect was reported by a Health Professional from JAPAN on Oct 09, 2008. Female patient, child 10 years of age, was diagnosed with aspergillosis and was treated with Ambisome. After drug was administered, patient experienced the following side effects: blood potassium decreased, haemodialysis, hyperammonaemia, mydriasis. Ambisome dosage: 50 MG, UID/QD, IV NOS. During the same period patient was treated with VFEND, FULCALIQ. Patient was hospitalized. Patient recovered.

Ambisome Side Effects Report #6029372-1
Ambisome side effect was reported by a Health Professional from JAPAN on Dec 24, 2008. Female patient, child 10 years of age, was diagnosed with aspergillosis and was treated with Ambisome. After drug was administered, patient experienced the following side effects: depressed level of consciousness, gastrointestinal disorder, graft versus host disease, haemodialysis, hyperammonaemia, hypokalaemia, mydriasis, viral infection . Ambisome dosage: 50 MG, UID/QD, IV NOS; 100 MG, UID/QD, IV NOS. During the same period patient was treated with VFEND, FULCALIQ, VICCLOX MEIJI. Patient was hospitalized. Patient recovered.


Ambisome Side Effects Report #6079786-9
Ambisome side effect was reported by a Health Professional from JAPAN on Jan 29, 2009. Female patient, child 10 years of age, was diagnosed with aspergillosis and was treated with Ambisome. After drug was administered, patient experienced the following side effects: depressed level of consciousness, haemodialysis, hyperammonaemia, hypokalaemia, viral infection . Ambisome dosage: 50 MG, UID/QD, IV NOS; 100 MG, UID/QD, IV NOS. During the same period patient was treated with VFEND, FULCALIQ, VICCLOX MEIJI. Patient was hospitalized. Patient recovered.

Ambisome Side Effects Report #6104276-4
Ambisome side effect was reported by a Health Professional from JAPAN on Feb 18, 2009. Female patient, child 10 years of age, was diagnosed with aspergillosis and was treated with Ambisome. After drug was administered, patient experienced the following side effects: depressed level of consciousness, gastrointestinal disorder, graft versus host disease, haemodialysis, hyperammonaemia, hypokalaemia, mydriasis, viral infection . Ambisome dosage: 50 MG, UID/QD, IV NOS; 100 MG, UID/QD, IV NOS. During the same period patient was treated with VFEND, FULCALIQ, VICCLOX MEIJI, POTASSIUM CHLORIDE. Patient was hospitalized. Patient recovered.

Ambisome Side Effects Report #5546794-3
Ambisome side effect was reported by a Health Professional from ITALY on Nov 06, 2007. Female patient, 43 years of age, weighting 249.1 lb, was diagnosed with antifungal prophylaxis and was treated with Ambisome. After drug was administered, patient experienced the following side effects: anuria, atrial fibrillation , fluid overload, haemodialysis, hypotension, leukaemia, nephropathy toxic, no therapeutic response, pain . Ambisome dosage: 3 MG/KG, Q3D. During the same period patient was treated with RASBURICASE, HYDROXYUREA, OMEPRAZOLE, ACYCLOVIR, POTASSIUM CHLORIDE, SALINEX, BICARBONAT, ALLOPURINOL. Patient recovered.

Ambisome Side Effects Report #5608161-3
Ambisome side effect was reported by a Physician from JAPAN on Jan 11, 2008. Male patient, 77 years of age, was diagnosed with bronchopulmonary aspergillosis and was treated with Ambisome. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, antithrombin iii deficiency, aspartate aminotransferase increased, blood potassium decreased, condition aggravated, gastritis, haemodialysis, hyperkalaemia, liver disorder. Ambisome dosage: 300 MG, UID/QD, IV, NOS. During the same period patient was treated with DECADRON, DIFLUCAN, FUNGUARD, MAXIPIME, VFEND, DENOSINE, POLYGLOBIN, MINOCYCLINE. Patient was hospitalized. Patient died on 10/14/2007.