Pulmotech MAA (Page 4 of 4)

13.1 Carcinogenesis, M u tagenesis, Impairment of Fertility

No long-term animal studies have been performed to evaluate carcinogenic or mutagenic potential or whether technetium Tc 99m albumin aggregated affects fertility in males or females.

15 REFER E NCES

1. Method of calculation: “S” Absorbed Dose per Unit Cumulated Activity for Selected Radionuclides and Organs, MIRD Pamphlet No. 11 (1975).
   
2. Used biologic data from Kaul et al., Berlin, 1973.
   
3. For the newborn, 1-year old, and 5-year old, the “S” values calculated form the preliminary phantoms of ORNL were used. The 10-year old, 15-year old and adult “S” values are from Henrichs, et al., Berlin, 1980.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Pulmotech MAA (kit for the preparation of technetium Tc 99m albumin aggregated injection) is supplied either as a 5 vial clam shell (NDC 69945-139-20) or as a carton of 30 vials (NDC 69945-139-40).

Each 5 vial kit contains 5 multiple dose Pulmotech MAA vials, 1 prescribing information and 5 radioassay information labels. Each 30 vial carton contains 30 multiple dose Pulmotech MAA vials, 1 prescribing information and 30 radioassay information labels.

16.2 Storage and Disposal

Store Pulmotech MAA (kit for the preparation of Tc 99m albumin aggregated injection) at 2° to 25°C (36° to 77ºF) before preparation (radiolabeling).

After preparation with sodium pertechnetate Tc 99m injection, store radiolabeled technetium Tc 99m albumin aggregated Injection in a refrigerator at 2° to 8°C (36° to 46ºF).

Do not use and discard radiolabeled Pulmotech MAA at 18 hours after preparation.

17 PATIENT COUNSELING INFORMATION

Adequate Hydration

Advise patients to drink a sufficient amount of water to ensure adequate hydration before their study and urge them to drink and urinate as often as possible during the first hours following the administration of Technetium Tc 99m Albumin Aggregated Injection in order to reduce radiation exposure.

Pregnancy

Advise pregnant women of the risk of fetal exposure to radiation doses if they undergo a radionucleotide procedure [see Use in Specific Populations ( 8.1)].

Lactation

Advise a lactating woman to interrupt breastfeeding and pump and discard breast milk for 13 hours after Technetium Tc 99m Albumin Aggregated Injection administration in order to minimize radiation exposure to a breastfed infant [see Use in Specific Populations ( 8.2)].

Pulmotech is a trademark of a Curium company.

©2020 Curium US LLC. All Rights Reserved.

A139I0

Manufactured by:

CIS bio International for
Curium US LLC
2703 Wagner Place
Maryland Heights, MO 63043

Issued: R03/2020

CURIUM™

PRINCIPAL DISPLAY PANEL – CARTON

NDC 69945-139-40

P ulmotech ™ MAA

(kit for the preparation of technetium Tc 99m albumin aggregated injection)

For intravenous and intraperitoneal use after radiolabeling with sodium pertechnetate Tc 99m.

Rx only

Before radiolabeling, store at 2° to 25°C (36° to 77°F). After radiolabeling, store shielded in refrigerator at 2° to 8°C (36° to 46°F). Use within 18 hours of radiolabeling.

CURIUM™

30 Vial Multiple-dose Carton

PINCH AT CORNERS / PULL OUT

Dosage: See prescribing information.

CARTON CONTAINS:

30 sterile, multiple-dose Pulmotech MAA vials

30 radioassay information labels

1 Prescribing Information

Each Pulmotech MAA vial contains:

2 mg Albumin Aggregated

7.1 mg Albumin Human

0.22 mg (maximum) stannous chloride

0.1 mg (minimum) stannous chloride

9 mg sodium chloride

Hydrochloric acid for pH adjustment

Sealed under nitrogen

Manufactured for:

Curium US LLC

2703 Wagner Place

Maryland Heights, MO 63043

Convenient Reorder Point

Maximum Six Vials Remaining

Open Flap For Package Insert and Radioassay Information Labels

A139DK

R03/2020

PRINCIPAL DISPLAY PANEL – VIAL LABEL

NDC 69945-139-10 P ulmotech ™ MAA Sterile, Multiple-Dose Vial

(kit for the preparation of technetium Tc 99m albumin aggregated injection)

For intravenous and intraperitoneal use after radiolabeling with sodium pertechnetate Tc 99m.

Vial contains: 2 mg Albumin Aggregated , 7.1 mg Albumin Human, 0.1 mg (minimum) Stannous Chloride and 9 mg Sodium Chloride. HCl used for pH adjustment. Sealed under nitrogen.

Before radiolabeling, store at 2° to 25°C (36° to 77°F). After radiolabeling, store shielded in refrigerator at 2° to 8°C (36° to 46°F). Use within 18 hours.

Dosage: See prescribing information.

Rx only

Manufactured for: Curium US LLC , Maryland Heights, MO 63043

A139VO

R03/2020

PULMOTECH MAA kit for the preparation of technetium tc 99m albumin aggregated injection, powder, lyophilized, for suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69945-139 Route of Administration INTRAPERITONEAL, INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALBUMIN AGGREGATED (ALBUMIN AGGREGATED) ALBUMIN AGGREGATED 2 mg in 15 mL

Inactive Ingredients Ingredient Name Strength ALBUMIN HUMAN 7.1 mg in 15 mL STANNOUS CHLORIDE 0.1 mg in 15 mL SODIUM CHLORIDE 9 mg in 15 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69945-139-20 5 VIAL, MULTI-DOSE in 1 CELLO PACK contains a VIAL, MULTI-DOSE (69945-139-10) 1 NDC:69945-139-10 15 mL in 1 VIAL, MULTI-DOSE This package is contained within the CELLO PACK (69945-139-20) 2 NDC:69945-139-40 30 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE (69945-139-10) 2 NDC:69945-139-10 15 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (69945-139-40)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA210089 03/20/2020

Labeler — Curium US LLC (079875617)

Revised: 12/2020 Curium US LLC