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

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

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
EXPORT ONLY		03/05/2018

Labeler - BioQ Pharma Incorporated (783975480)

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

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

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

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

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