Glofil-125 .275 mCi/mL
Sodium Iothalamate I-125 injection · INJECTION, SOLUTION · Iso-Tex Diagnostics, Inc.
Glofil-125 is a injection, solution containing sodium iothalamate i-125 injection at .275 mCi/mL, taken intravenous. Manufactured by Iso-Tex Diagnostics, Inc..
Key Facts
- Brand Name
- Glofil-125
- Generic Name
- Sodium Iothalamate I-125 injection
- NDC Code (Product)
50914-7729- Manufacturer
- Iso-Tex Diagnostics, Inc.
- Strength
- .275 mCi/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA017279
- Marketing Start
- 05/01/1983
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
INDICATIONS AND USAGE GLOFIL-125 (Sodium Iothalamate I-125 Injection) is indicated for evaluation of glomerular filtration in the diagnosis or monitoring of patients with renal disease.
Dosage & Administration
Dosage The suggested dose range employed in the average patient (70 kg) is as follows: Continuous intravenous infusion: 20 to 100 μCi (0.74-3.7 megabecquerels) (Sigman, et al (1) method). Single intravenous injection: 10 to 30 µCi (0.37-1.11 megabecquerels) Cohen, et al (2) method) The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. Technique Continuous intravenous infusion Sigman 1 method I. Preparation: Adequate diuresis (a urine flow exceeding 3 mL/min.) is established, preferably by an oral water load of 1,500 mL two hours prior to the beginning of the clearance study. 2. It is not necessary to withhold breakfast or admit the patient the night before. II. Procedure: After the establishment of adequate diuresis, a number 14 or 16 French Foley catheter is aseptically inserted into the bladder. An intravenous infusion of Lactated Ringers (Hartmanns) solution is started in each arm, one to maintain a site for injection of the GLOFIL-125, the other to serve as a site for serial withdrawal of blood. A two-way stopcock connects the needle and intravenous tubing of each arm. The dose is equally divided into (1) an intr…
Warnings
WARNINGS None known
Contraindications
CONTRAINDICATIONS GLOFIL-125 should not be administered via a central venous line.
Adverse Reactions
ADVERSE REACTIONS None Reported
Frequently Asked Questions
What is Glofil-125 used for?
Glofil-125 contains Sodium Iothalamate I-125 injection. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Glofil-125 a controlled substance?
Glofil-125 is not classified as a controlled substance by the DEA.
What is the generic name for Glofil-125?
The generic name for Glofil-125 is Sodium Iothalamate I-125 injection. There are no other listed brand versions of Sodium Iothalamate I-125 injection.
What is the NDC code for Glofil-125 .275 mCi/mL?
The NDC (National Drug Code) for Glofil-125 .275 mCi/mL is 50914-7729, listed by Iso-Tex Diagnostics, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)