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Review Protaphane Safety Reports submitted to FDA

Total Protaphane reports: 7.
Protaphane FDA safety alerts: No.
   Reported hospitalizations: 4.
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FDA Reported Protaphane Side Effects: necrobiosis, injection site reaction, injection site necrosis, swelling face, transient ischaemic attack, coronary artery bypass, cerebrovascular accident, blood glucose fluctuation.
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Protaphane Side Effects Report #5656723-X
Physician from GREECE reported PROTAPHANE problem on Feb 27, 2008. Female patient, child 7 years of age, was treated with PROTAPHANE. After drug was administered, patient experienced the following problems/side effects: abdominal pain, headache, injection site erythema, injection site induration, vasculitis. PROTAPHANE dosage: unknown. Patient recovered.

Protaphane Side Effects Report #5513702-0
PROTAPHANE problem was reported by a Physician from AUSTRALIA on Nov 02, 2007. Male patient, 17 years of age, weighting 163.1 lb, was treated with PROTAPHANE. After drug was administered, patient experienced the following problems/side effects: hypoglycaemia, intentional overdose. PROTAPHANE dosage: unknown. Patient was hospitalized. Patient recovered.

Protaphane Side Effects Report #5527532-7
Consumer or non-health professional from AUSTRALIA reported PROTAPHANE problem on Nov 20, 2007. Female patient was treated with PROTAPHANE. After drug was administered, patient experienced the following problems/side effects: anxiety, dysphagia, dyspnoea, panic attack, paraesthesia, swollen tongue. PROTAPHANE dosage: unknown. During the same period patient was treated with ACTRAPIDPENFILL. Patient recovered.

Protaphane Side Effects Report #5490356-3
PROTAPHANE problem was reported by a Consumer or non-health professional from AUSTRALIA on Oct 11, 2007. Female patient was treated with PROTAPHANE. After drug was administered, patient experienced the following problems/side effects: anxiety, dysphagia, dyspnoea, panic attack, paraesthesia, swollen tongue. PROTAPHANE dosage: unknown. During the same period patient was treated with ACTRAPIDPENFILL. Patient recovered.


Protaphane Side Effects Report #5787118-6
Physician from AUSTRALIA reported PROTAPHANE problem on June 18, 2008. Male patient, 64 years of age, was treated with PROTAPHANE. After drug was administered, patient experienced the following problems/side effects: atypical mycobacterial infection. PROTAPHANE dosage: unknown. During the same period patient was treated with NOVORAPID FLEXPEN. Patient recovered.

Protaphane Side Effects Report #5787119-8
PROTAPHANE problem was reported by a Physician from AUSTRALIA on June 18, 2008. Male patient, 64 years of age, was diagnosed with atypical mycobacterial infection and was treated with PROTAPHANE. After drug was administered, patient experienced the following problems/side effects: atypical mycobacterial infection, injection site abscess, injection site infection, therapeutic product contamination. PROTAPHANE dosage: unknown. During the same period patient was treated with NOVORAPID FLEXPEN, KLACID. Patient recovered.

Protaphane Side Effects Report #5326016-9
Consumer or non-health professional from AUSTRALIA reported PROTAPHANE problem on May 08, 2007. Male patient, weighting 189.6 lb, was diagnosed with insulin-requiring type ii diabetes mellitus and was treated with PROTAPHANE. After drug was administered, patient experienced the following problems/side effects: blood glucose fluctuation, cerebrovascular accident, coronary artery bypass, transient ischaemic attack. PROTAPHANE dosage: unknown. During the same period patient was treated with DIAMICRON. Patient was hospitalized. Patient recovered.


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abdominal pain, headache, injection site erythema, injection site induration, vasculitis, hypoglycaemia, intentional overdose, , %drugN% %drugN% %drugN% %drugN% %drugN% %drugN% was diagnosed with atypical mycobacterial infection and