PIPERACILLIN/TAZOBACTAM KABI POWDER FOR SOLUTION FOR INFUSION 4G/0.5G

Approval Number

SIN15308P

Drug Name

Product Name

PIPERACILLIN/TAZOBACTAM KABI POWDER FOR SOLUTION FOR INFUSION 4G/0.5G

Approval Date

July 31, 2017

Registrant

FRESENIUS KABI (SINGAPORE) PTE LTD

Licence Holder

FRESENIUS KABI (SINGAPORE) PTE LTD

Regulatory Information

Registrant

FRESENIUS KABI (SINGAPORE) PTE LTD

Licence Holder

FRESENIUS KABI (SINGAPORE) PTE LTD

Drug Type

Therapeutic

Forensic Classification

Prescription Only

Formulation Information

Dosage Form

INJECTION, POWDER, FOR SOLUTION

Route of Administration

INTRAVENOUS

Medical Information

ATC Code

J01CR05

ATC Item Name

piperacillin and beta-lactamase inhibitor

Manufacturer Information

Pharmaceutical Manufacturer

FRESENIUS KABI (SINGAPORE) PTE LTD

Manufacturers

Labesfal - Laboratorios Almiro S.A. (Fresenius Kabi Group)

Fresenius Kabi iPSUM Srl (Pozzilli plant) (Intermediate)

Active Ingredients

Ingredient Name

Tazobactam sodium sterile 536.6 mg corresponding to Tazobactam

Strength

0.5g

Drug MonographTazobactam

Ingredient Name

Piperacillin sodium sterile 4.170 g corresponding to Piperacillin

Strength

4.0 g

Drug MonographPiperacillin

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PIPERACILLIN/TAZOBACTAM KABI POWDER FOR SOLUTION FOR INFUSION 4G/0.5G

Regulatory Information

Formulation Information

Medical Information

Manufacturer Information

Active Ingredients