READYFUSOR ROPIVACAINE FIXED RATE DELIVERY SYSTEM- ropivacaine hydrochloride anhydrous injection, solution

ReadyfusOR Ropivacaine by

Drug Labeling and Warnings

ReadyfusOR Ropivacaine by is a Prescription medication manufactured, distributed, or labeled by BioQ Pharma Incorporated, Holopack Verpackungstechnik (DE), Steris AST (Frmrly Synergy San Diego), Steris AST (Frmrly Synergy Daventry ), A&M Stabtest (Mainz, DE), Pioneer Agro Industries. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL - 250 mL Bottle Carton

GALEN
Distributed by:
Galen Limited
Craigavon
BT63 5UA
UK

Ropivacaine
ReadyfusOR™
Infusion pump

Ropivacaine 2 mg/ml Solution for Infusion in Administration System

Ropivacaine Hydrochloride
250 ml
5 ml/hr

INGREDIENTS AND APPEARANCE

READYFUSOR ROPIVACAINE  FIXED RATE DELIVERY SYSTEM
ropivacaine hydrochloride anhydrous injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 71807-011
Route of Administration	INFILTRATION

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ROPIVACAINE HYDROCHLORIDE ANHYDROUS (UNII: 35504LBE2T) (ROPIVACAINE - UNII:7IO5LYA57N)	ROPIVACAINE HYDROCHLORIDE ANHYDROUS	2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Product Characteristics
Color	ORANGE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71807-011-01	1 in 1 BOX	03/05/2018
1		250 mL in 1 BOTTLE, DISPENSING; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
EXPORT ONLY		03/05/2018

Labeler - BioQ Pharma Incorporated (783975480)

Establishment
Name	Address	ID/FEI	Business Operations
Holopack Verpackungstechnik (DE)		343390324	MANUFACTURE(71807-011)

Establishment
Name	Address	ID/FEI	Business Operations
Steris AST (Frmrly Synergy San Diego)		173008660	STERILIZE(71807-011)

Establishment
Name	Address	ID/FEI	Business Operations
Steris AST (Frmrly Synergy Daventry )		214479987	STERILIZE(71807-011)

Establishment
Name	Address	ID/FEI	Business Operations
A&M Stabtest (Mainz, DE)		341843679	ANALYSIS(71807-011)

Establishment
Name	Address	ID/FEI	Business Operations
Pioneer Agro Industries		677604359	API MANUFACTURE(71807-011)