Pulmolite - Technetium Tc99m Albumin Aggregated

Technetium Tc99m Albumin Aggregated Injection is a lung imaging agent which may be used as an adjunct in the evaluation of pulmonary perfusion in adults and children.

Technetium Tc99m Albumin Aggregated may be used in adults as an imaging agent to aid in the evaluation of peritoneo-venous (LaVeen) shunt patency.

Although adverse reactions specifically attributable to the Technetium Tc99m Albumin Aggregated have not been noted, the literature contains reports of deaths occurring after the administration of Albumin Aggregates to patients with pre-existing severe pulmonary hypertension. Instances of hemodynamic or idiosyncratic reactions to preparations of Technetium Tc99m Albumin Aggregated have been reported.

The literature contains reports of deaths occurring after the administration of Albumin Aggregates to patients with pre-existing severe pulmonary hypertension. Instances of hemodynamic or idiosyncratic reactions to preparations of Technetium Tc99m Albumin Aggregated have been reported. (See Warnings.)

Pulmolite® Kit for the Preparation of Technetium Tc99m Albumin Aggregated for Injection is supplied in kits of five (5) or thirty (30) vials, sterile and non-pyrogenic.

The contents of the vial are lyophilized and stored under sterile filtered air. Store at controlled room temperature (20-25°C) before reconstitution. Protect from light. Store at 2-8°C after reconstitution. Technetium Tc99m Albumin Aggregated contains no preservatives. Included in each five (5) vial kit is one (1) package insert and twelve (12) radiation labels. Included in each thirty (30) vial kit is one (1) package insert and seventy-two (72) radiation labels.

This reagent kit for the preparation of a radiopharmaceutical is approved for use by persons licensed pursuant to Section 120.547, Code of Massachusetts Regulation 105, or under equivalent license of the U.S. Nuclear Regulatory Commission or an Agreement State.

Manufactured by

Pharmalucence, Inc.

10 DeAngelo Drive

Bedford, MA 01730

for ordering Tel. Toll free: 800-221-7554

(For International, Call: 781-275-7120)

RM 2P-011

03/08

NDC 45567-0415-1

 Pharmalucence, Inc.

Pulmolite®

Kit for the Preparation of Technetium Tc99m Albumin Aggregated for Injection

Sterile

Non-Pyrogenic

Diagnostic Agent for Intravenous Use

Contents and Storage Conditions

Albumin Aggregated - 1.0mg Albumin Human - 10mg

Stannous Chloride, minimum (SnCl2) – 2.4µg

Stannous Chloride, (SnCl2) – 7.0µg

Tin Chloride (stannous and stannic), dihydrate, maximum (as SnCl2·2H2O) – 0.13mg

Sodium Chloride – 10mg

Store at controlled room temperature (20°-25°C). Protect from light.

Rx only.

Tc99m Activity

Time/Date Prepared

See Package Insert for dosage information.

Reconstitute with additive-free Tc99m and store at 2-8°C. Use within 6 hours.

CONTAINS NO PRESERVATIVE

RM 2P-012

03/08

NDC 45567-0415-2

 Pharmalucence, Inc.

Pulmolite®

Kit for the Preparation of Technetium Tc99m Albumin Aggregated for Injection

STERILE

NON-PYROGENIC

DIAGNOSTIC AGENT FOR INTRAVENOUS USE.

Contents & Storage Conditions:

1 Package Insert, 72 Radiation Labels and 30 Vials, each containing:

Albumin Aggregated - 1mg

Albumin Human - 10mg

Stannous Chloride, minimum (SnCl2) – 2.4µg

Stannous Chloride (SnCl2) - 7.0µg

Tin Chloride (stannous and stannic), dihydrate, maximum (as SnCl2·2H20) – 0.13mg

Sodium Chloride - 10mg

Store at controlled room temperature (20°-25°C)

Protect from light.

CONTAINS NO PRESERVATIVE.

See Package Insert for dosage information.

Reconstitute with additive-free Tc99m and store at 2-8°C.

Use within 6 hours.

Rx only.

IMPORTANT: Read enclosed Package Insert for full information on preparation, use and indications.

WARNING: Radiopharmaceuticals should be used by the persons who are qualified by specific training in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides.

RM 2P-017

03/08