SULFUR COLLOID injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GELATIN (UNII: 2G86QN327L) (GELATIN - UNII:2G86QN327L)

Available from:

AnazaoHealth Corporation

INN (International Name):

GELATIN

Composition:

GELATIN 4.5 mg

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Tc99m Sulfur Colloid is used in lymphoscintigraphy studies in breast cancer patients, for liver, spleen and bone marrow imaging and gastric transit studies and gastroesophageal reflux.

Authorization status:

unapproved drug other

Summary of Product characteristics

SULFUR COLLOID - SULFUR COLLOID INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
ANAZAOHEALTH CORPORATION
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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SULFUR COLLOID KIT
(FOR THE PREPARATION OF TC99M-SULFUR COLLOID INJECTION)
DESCRIPTION
Dear Medical Professional,
AnazaoHealth Sulfur Colloid Kit consists of three separate
nonradioactive components:
1. A 10 milliliter REACTION vial containing: Sodium Thiosulfate, 4.8
mg, Gelatin (Porcine), 3.6 mg and
Sodium Edetate, 2.3 mg. The contents of the vial are lyophilized and
are under vacuum
2. Vial A, a 5 ml. vial containing:0.25 N. Hydrochloric Acid. The
total volume in this vial is 1.2 mL.
3. Vial B, a 5 ml. vial containing:Sodium Hydroxide, 12 mg, Sodium
Phosphate dibasic,15.7 mg,
Sodium Phosphate, monobasic, 48.4 mg, Sterile Water for Injection. The
total volume in this vial is
1.2 mL
INDICATIONS AND USAGE
Tc99m Sulfur Colloid is used in lymphoscintigraphy studies in breast
cancer patients, for liver, spleen
and bone marrow imaging and gastric transit studies and
gastroesophageal reflux.
INSTRUCTIONS
Preparation of Technetium Tc 99m-Sulfur Colloid:
1. Collect components: 10 ml. Reaction Vial, Solution A, Solution B,
Lead Pig, Boiling Water Bath.
2. Draw up 1 ml. Solution A. (HCl solution) in syringe.
3. Draw up 2.5 ml. Tc-99m Pertechnetate containing desired activity,
dilute with sterile normal saline
if necessary.
4. Add the 2.5 ml Tc-99m Pertechnetate to the shielded reaction vial.
5. Immediately add the 1 ml. Solution A.
6. VENT VIAL TO RELEASE EXCESS VACUUM. REMOVE VENT BEFORE BOILING.
7. Shake gently to mix.
8. PLACE SHIELDED VIAL IN BOILING WATER BATH FOR 5 MINUTES FOR LIVER
IMAGING AND 3 MINUTES FOR
LYMPHOSCINTIGRAPHY IMAGING USE.
9. Remove from boiling water and let cool for a few minutes.
10. Draw up 1 ml. Solution B. (Phosphate Buffer) while reaction vial
is cooling
11. After cooling Reaction vial, add the 1 ml