Overview

Special Use-Result Surveillance of Unasyn-S (Kit) for Intravenous Use - A Surveillance on High-dose (>6 g Daily) Administration -

Status:
Completed
Trial end date:
2016-01-27
Target enrollment:
0
Participant gender:
All
Summary
The purpose of the survey is to study the followings under practical use, regarding the safety and effectiveness in high-dose administration (exceeding 6 g per day) of UNASYN-S and UNASYN-S KIT for intravenous use (UNASYN). 1. Adverse Drug Reaction(s) that cannot be expected from precautions (Unexpected Adverse Drug Reaction) 2. Incidence status of adverse drug reactions 3. Factors that may affect the safety and effectiveness
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Treatments:
Ampicillin
Sulbactam
Sultamicillin
Criteria
Inclusion Criteria:

- Patients with the following disease who received high doses of UNASYN (exceeding 6 g
per day) from the first dosing date or the second dosing date. 1) Pneumonia, 2) Lung
Abscess, 3) Peritonitis

- Patients aged 15 years or more

Exclusion Criteria:

- Patients with the following disease who received high doses of UNASYN (less than 6 g
per day) from the first dosing date or the second dosing date. 1) Pneumonia, 2) Lung
Abscess, 3) Peritonitis

- Patients aged less than 15 years.