Kit For the Prepartion of Technetium Tc99m Sulfur Colloid (Page 5 of 5)

15 REFERENCES

Bergqvist L, Strand S-E, Persson B, et al. Dosimetry in Lymphoscintigraphy of Tc 99m Antimony Sulfide Colloid, J Nucl Med., 23: 698-705, 1982.
Summary of Current Radiation Dose Estimates to Humans with Various Liver Conditions from 99m Tc-Sulfur Colloid, MIRD Dose Estimate Report No 3, J Nucl Med., 16: 108A — 108B, 1975
Henrichs et al. Estimation of age-dependent internal dose from radiopharmaceuticals, Phys. Med. Biol., 27: 775-784, 1982.
Kocher DC: Radioactive decay data tables. DOE/TIC-11026: 108, 1981.

16 HOW SUPPLIED/STORAGE AND HANDLING

Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection is supplied in a package that contains 5 kits. All kit components are sterile and non-pyrogenic. Each 10mL multi-dose Reaction Vial contains, in lyophilized form, 2 mg sodium thiosulfate anhydrous, 2.3 mg edetate disodium and 18.1 mg bovine gelatin; each Solution A vial contains 1.8 mL 0.148 N hydrochloric acid solution and each Solution B vial contains 1.8 mL aqueous solution of 24.6 mg/mL sodium biphosphate anhydrous and 7.9 mg/mL sodium hydroxide. Included in each 5-kit package are one package insert and 10 radiation labels.

Store the kit at 20-25°C (68-77°F) as packaged and after reconstitution.

This reagent kit for 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 to the U.S. Nuclear Regulatory Commission or an Agreement State.

NDC #45567-0030-1

17 PATIENT COUNSELING INFORMATION

Inform patients they may experience a burning sensation at the injection site.

Inform lactating woman to pump and discard breast milk for 24 hours after administration of Technetium Tc 99m Sulfur Colloid Injection and minimize close contact with infants for 6 hours after receiving a Technetium Tc 99m Sulfur Colloid Injection (8.2).

Manufactured By:

Sun Pharmaceutical Industries, Inc.

29 Dunham Road

Billerica, MA 01821

1-800-221-7554

(for International dial: 1-781-275-7120)

PL-000001

Rev 2.0

Mar 2020

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL — VIAL CONTAINER (PART 1 — 10mL multi-dose Reaction Vial)

NDC 045567-0030-1

STERILE DIAGNOSTIC MULTIDOSE NON-PYROGENIC

Multi-Dose Reaction Vial

for use in the Preparation of Technetium Tc 99m Sulfur Colloid Injection.

Each 10 mL reaction vial contains in lyophilized form 2.0 mg sodium thiosulfate anhydrous, 2.3 mg edetate disodium and 18.1 mg bovine gelatin. Usual Dosage: See complete prescribing information.

Manufactured by:

Sun Pharmaceutical Industries, Inc.

Billerica, MA 01821

PL-000004

Rev 0.3

Mar 2020

CONTAINS NO BACTERIOSTATIC PRESERVATIVE FOR
USE ONLY AFTER LABELING WITH OCIDANT-FREE
TECHENTIUM Tc 99m. Store the kit at 20-25°C

(68-77°F) [See USP] as packaged and after reconstitution with Technetium Tc 99m.

Use within 6 hours after reconstitution.

Rx ONLY

PL-000004
(click image for full-size original)

PACKAGE/LABEL — PRINCIPAL DISPLAY PANEL — VIAL CONTAINER (PART 2 — 3mL Solution A Vial)

NDC 045567-0030-1

A

Solution A vial contains 1.8mL sterile, non pyrogenic 0.148 N hydrochloric acid solution.

To be used only with the Sulfur Colloid Multi-dose Reaction Vial.

Single Use Vial-Discard Unused Portion

NOT FOR DIRECT INTRAVENOUS INJECTION.

RX ONLY. STORE AT 20-25°C (68-77°F) [See USP]

Manufactured By: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821

PL-000002

Rev 0.2

Mar 2020

VIAL CONTAINER (PART 2- 3 mL Solution A Vial)
(click image for full-size original)

PACKAGE/LABEL — PRINCIPAL DISPALY PANEL — VIAL CONTAINER (PART 3 — 3mL Solution B Vial)

NDC 045567-0030-1

B

Solution B vial contains 1.8mL sterile, non pyrogenic aqueous solution of 24.6 mg/mL sodium biphosphate anhydrous and 7.9 mg/mL sodium hydroxide. To be used only with the Sulfur Colloid Multi-dose Reaction Vial.

Single Use Vial-Discard Unused Portion.

NOT FOR DIRECT INTRAVENOUS INJECTION.

RX ONLY. STORE AT 20-25°C (68-77°F) [See USP]

Manufactured By: Sun Pharmaceutical Industries, Inc. Billerica MA 01821

PL-000003

Rev 0.2

Mar 2020

VIAL CONTAINER (PART 3-3 mL Solution B Vial)
(click image for full-size original)

PACKAGE/LABEL — PRINCIPAL DISPLAY PANEL — RADIATION LABEL

CAUTION RADIOACTIVE MATERIAL

STERILE, NON-PYROGENIC, DIAGNOSTIC MULTIDOSE TECHNETIUM Tc 99m SULFUR COLLOID

Subcutaneous, Intravenous, Oral, and Intraperitoneal Use

Total MBq (mCi)_____Volume_____

Assay_____MBq/mL(mCi/mL) as of _____

The 10 mL vial contents are made with 2 mg sodium thiosulfate anhydrous, 2.3 mg edetate disodium, 18.1 mg bovine gelatin, the added 1.5 mL of 0.148 N hydrochloric acid solution and the added 1.5 mL aqueous solution of 36.9 mg sodium biphosphate anhydrous and 11.9 mg sodium hydroxide. Contains no bacteriostatic preservative. For use only after labeling with oxidant-free Technetium Tc 99m. Store reconstituted vial at 20-25°C (68-77°F) [See USP]. Use within 6 hours after labeling with Technetium Tc 99m. Usual Dosage: See complete prescribing information. (SEE ENCLOSED PACKAGE INSERT) Rx only

Manufactured by:

Sun Pharmaceutical Industries, Inc. Billerica, MA 01821

PL-000005

Rev 0.2

Mar 2020

RADIATION LABEL
(click image for full-size original)

PACKAGE/LABEL — PRINCIPAL DISPLAY PANEL — 5 VIAL BOX

NDC 045567-0030-1

Kit for the Preparation of Technetium Tc99m Sulfur Colloid Injection

CAUTION: Federal (U.S.A.) law prohibits dispensing without prescription

Rx only.

Manufactured By:

Sun Pharmaceutical Industries, Inc. Billerica, MA 01821

For Customer Service call: 1-800-221-7554

Sterile Diagnostic Multidose Non-Pyrogenic

CONTENTS: 1 package insert, 10 radiation labels, 5 multi-dose reaction vials, 5 Solution A vials and 5 Solution B vials. Each 10 mL multi-dose reaction vial contains 2 mg sodium thiosulfate anhydrous, 2.3 mg edetate disodium and 18.1 mg bovine gelatin. Each Solution A vial contains 1.8 mL 0.148 N hydrochloric acid. Each solution B vial contains 1.8 mL aqueous solution of 24.6 mg/mL sodium biphosphate anhydrous and 7.9 mg/mL sodium hydroxide. Contains no bacteriostatic preservative. For intravenous use only after labeling with oxidant-free Technetium Tc 99m.

Store the kit at 20-25°C (68-77°F) [See USP] as packaged and after reconstitution

Use within 6 hours after labeling with Technetium Tc 99m.

Usual Dosage: See complete prescribing information.

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

PL-000006

Rev 0.3

Mar 2020

5 VIAL BOX
(click image for full-size original)
KIT FOR THE PREPARTION OF TECHNETIUM TC99M SULFUR COLLOID
technetium tc 99m sulfur colloid kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45567-0030
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45567-0030-1 1 KIT in 1 PACKAGE None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL 10 mL
Part 2 1 VIAL 3 mL
Part 3 1 VIAL 3 mL
Part 1 of 3
KIT FOR THE PREPARTION OF TECHNETIUM TC99M SULFUR COLLOID
reaction vial injection, powder, lyophilized, for solution
Product Information
Route of Administration INTRAVENOUS, ORAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TECHNETIUM TC-99M SULFUR COLLOID (TECHNETIUM TC-99M SULFUR COLLOID) GELATIN, UNSPECIFIED 18.1 mg in 10 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM THIOSULFATE ANHYDROUS 2.0 mg in 10 mL
EDETATE DISODIUM 2.3 mg in 10 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 10 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017858 04/19/1978
Part 2 of 3
KIT FOR THE PREPARTION OF TECHNETIUM TC99M SULFUR COLLOID
solution a solution
Product Information
Route of Administration INTRAVENOUS, ORAL, SUBCUTANEOUS DEA Schedule
Inactive Ingredients
Ingredient Name Strength
HYDROCHLORIC ACID 0.148 mol in 3 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 3 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017858 04/19/1978
Part 3 of 3
KIT FOR THE PREPARTION OF TECHNETIUM TC99M SULFUR COLLOID
solution b solution
Product Information
Route of Administration INTRAVENOUS, ORAL, SUBCUTANEOUS DEA Schedule
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE 7.9 mg in 3 mL
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS 24.6 mg in 3 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 3 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017858 04/19/1978
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017858 04/19/1978
Labeler — Sun Pharmaceutical Industries, Inc. (139261648)
Registrant — Sun Pharmaceutical Industries, Inc. (139261648)
Establishment
Name Address ID/FEI Operations
Sun Pharmaceutical Industries, Inc. 139261648 ANALYSIS (45567-0030), LABEL (45567-0030), PACK (45567-0030), MANUFACTURE (45567-0030)

Revised: 03/2020 Sun Pharmaceutical Industries, Inc.

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