Optison Perflutren Protein-Type A Microspheres: Package Insert and Label Information (Page 3 of 3)

16.2 Storage and Handling

Store OPTISON refrigerated between 2° to 8°C (36° to 46°F). Storage at room temperature (up to 25°C or 77°F) for up to 24 hours is permitted. Do not freeze.

17 PATIENT COUNSELING INFORMATION

Advise patients to inform their healthcare provider if they develop any symptoms of hypersensitivity after OPTISON administration including rash, wheezing, or shortness of breath.

Distributed by GE Healthcare Inc., Marlborough, MA 01752 U.S.A.
Manufactured by GE Healthcare AS, Oslo, Norway
OPTISON™ is a trademark of GE Healthcare or one of its subsidiaries
GE and the GE Monogram are trademarks of General Electric Company.
Product of Norwegian Origin.

© 2021 General Electric Company — All rights reserved.

PRINCIPAL DISPLAY PANEL — 3 mL Vial Carton Label

GE Healthcare
NDC 0407-2707-18
Rx ONLY

OPTISON™
(Perflutren Protein-Type A
Microspheres Injectable
Suspension, USP)
3 mL

2707-18
Contains
18 x 3 mL Vials

(01)20304072707183

EXP.: DD MMM YYYY
LOT: 12345678

1200602 USA

OPTISON PERFLUTREN PROTEIN-TYPE A MICROSPHERES human albumin microspheres and perflutren injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0407-2707 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HUMAN ALBUMIN MICROSPHERES (HUMAN ALBUMIN MICROSPHERES) HUMAN ALBUMIN MICROSPHERES 10 mg in 1 mL PERFLUTREN (PERFLUTREN) PERFLUTREN 0.22 mg in 1 mL

Inactive Ingredients Ingredient Name Strength N-ACETYL-DL-TRYPTOPHAN 0.2 mg in 1 mL CAPRYLIC ACID 0.12 mg in 1 mL SODIUM CHLORIDE

Product Characteristics Color white (Clear lower layer and white upper layer) Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0407-2707-03 5 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE 1 3 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (0407-2707-03) 2 NDC:0407-2707-18 18 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE 2 3 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (0407-2707-18)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020899 01/02/2002

Labeler — GE Healthcare Inc. (053046579)

Establishment
Name	Address	ID/FEI	Operations
GE Healthcare AS		515048908	manufacture (0407-2707)

Establishment
Name	Address	ID/FEI	Operations
Octapharma Pharmazeutika Produktionsgesellschaft, m.b.H		301119178	manufacture (0407-2707)

Establishment
Name	Address	ID/FEI	Operations
Octapharma AB		558833179	manufacture (0407-2707)

Revised: 12/2022 GE Healthcare Inc.