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

NCT01793688 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 982

Last updated 2017-04-26

Study results available
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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

Conditions

Interventions

DRUG

Sulbactam Sodium/Ampicillin Sodium

Intravenous use; The usual adult dosage is 6 g of sulbactam sodium and ampicillin sodium (potency) per day given in two divided doses via intravenous injection or drip infusion. In the case of severe infection, the dosage may be increased if appropriate. Maximum dosage should not exceed 3 g (potency) 4 times daily (daily dose of 12 g (potency)). Kit for intravenous use; The usual adult dosage is 6 g of sulbactam sodium and ampicillin sodium (potency) per day given in two divided doses via intravenous injection after dissolved in an accompanying reconstitution diluent. In the case of severe infection, the dosage may be increased if appropriate. Maximum dosage should not exceed 3 g (potency) 4 times daily (daily dose of 12 g (potency)).

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Eligibility

Min Age
15 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-12
Primary Completion
2016-01-27
Completion
2016-01-27

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01793688 on ClinicalTrials.gov