ICG Pharmaceutical
Product

Diagnostic Green’s Indocyanine Green for Injection, USP is the
leading fluorescence product trusted by physicians,
to visualize fluorescence and guide their procedures.

Green wave in motion
injection full of ICG dye

ICG Injection

green circle with colour gradient

Binds to Plasma
proteins & quickly
circulates

icon of computer screen

Flouresence can
be imaged in
minutes

3 arrows going in a circular motion

Removed by the liver
& eliminated in
the bile

Key Features

Indocyanine Green for Injection, USP is well known and accepted by physicians worldwide (over 11,000 published articles on use and applications)*

  • Well tolerated**
  • Excellent safety profile***
  • Cleared exclusively through the liver
  • Half-life of 3-4 minutes
  • Rapidly bound to plasma protein
  • Undergoes no significant extrahepatic or enterohepatic circulation
  • Secreted entirely into the bile 

*Pubmed
** https://radiologykey.com/clinical-applications-of-diagnostic-indocyanine-green-angiography/
***https://www.ncbi.nlm.nih.gov/pubmed/635011

ICG Dye Chemical Structure
  • Chemical Description: Tricarbocyanine Dye
  • Appearance: Lypophilized green powder 
  • Empirical Formula: C43H47N2NaO6S2
Diagnostic Greens product
Diagnostic Greens ICG packaging and Vile
Prescription Only Medicine (POM)

How it’s Supplied

Active Substance: Indocyanine Green for Injection, USP (lyophilized powder). 

  • Package configuration: available in vial kit of 6 vials of the lyophilized green powder and 6 vials of 10 mL Sterile Water for Injection, USP (USA and Canada)
  • Vial Strength: 25 mg Click Here

Conditions of use

  • Storage: Store at 20° to 25°C (68° to 77°F).
  • Under sterile conditions, the Indocyanine Green for Injection, USP powder should be dissolved with the Sterile Water for Injection, USP provided with this product, and the solution used within 6 hours after it is prepared. If a precipitate is present, discard the solution.
  • Sterile product, intended for a single patient use only.
  • Dosage depends on the indication and weight of the patient.


Contraindictions

  • Indocyanine Green for Injection, USP contains sodium iodide and should be used with caution in patients who have a history of allergy to iodides because of the risk of anaphylaxis.

Warnings and Precautions

  • Anaphylaxis – Deaths from anaphylaxis have been reported following Indocyanine Green for Injection USP administration during cardiac catheterization.
  • Drug Instability – Indocyanine Green for Injection USP is unstable in aqueous solution and must be used within 6 hours. However, the dye is stable in plasma and whole blood so that samples obtained in discontinuous sampling techniques may be read hours later. Sterile techniques should be used in handling the dye solution as well as in the performance of the dilution curves. 
  • Drug/Laboratory Test Interactions – Radioactive iodine uptake studies should not be performed for at least a week following the use of Indocyanine Green for Injection USP.

To report SUSPECTED ADVERSE REACTIONS
Contact Diagnostic Green LLC (24/7) at 1-844-424-3784 (1-844-ICG-DRUG) or e-mail: Pharmacovigilance at drugsafety@diagnosticgreen.com
or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

INDICATIONS AND USAGE: For determining cardiac output, hepatic function and liver blood flow, and for ophthalmic angiography. CONTRAINDICATIONS: Indocyanine Green for Injection USP contains sodium iodide and should be used with caution in patients who have a history of allergy to iodides because of the risk of anaphylaxis. WARNINGS Deaths from anaphylaxis have been reported following Indocyanine Green for Injection USP administration during cardiac catheterization. PRECAUTIONS: Drug Instability: Indocyanine Green for Injection USP is unstable in aqueous solution and must be used within 6 hours. However, the dye is stable in plasma and whole blood so that samples obtained in discontinuous sampling techniques may be read hours later. Sterile techniques should be used in handling the dye solution as well as in the performance of the dilution curves. Drug Interactions: Preparations containing sodium bisulfite, including some heparin products reduce the absorption peak of Indocyanine Green for Injection USP in blood and, therefore, should not be used as an anticoagulant for the collection of samples for analysis. Drug/ Laboratory Test Interactions: Radioactive iodine uptake studies should not be performed for at least a week following the use of Indocyanine Green for Injection USP. Carcinogenesis, Mutagenesis, Impairment of Fertility: No studies have been performed to evaluate the carcinogenicity, mutagenicity, or impairment of fertility. Pregnancy and Nursing Mothers: Teratogenic Effects: Animal reproduction studies have not been conducted with Indocyanine Green for Injection USP. It is also not known whether Indocyanine Green for Injection USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Indocyanine Green for Injection USP should be given to a pregnant woman only if clearly indicated. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Indocyanine Green for Injection USP is administered to a nursing woman. Pediatric Use: Safety and effectiveness in pediatric patients have been established. Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients. ADVERSE REACTIONS: Anaphylactic or urticarial reactions have been reported in patients with or without history of allergy to iodides. If such reactions occur, treat with the appropriate agents, e.g., epinephrine, antihistamines, and corticosteroids. OVERDOSAGE: There are no data available describing the signs, symptoms, or laboratory findings accompanying overdosage. The LD50 after I.V. administration ranges between 60 and 80 mg/kg in mice, 50 and 70 mg/kg in rats and 50 and 80 mg/kg in rabbits.

Diagnostic Green graphic wave concepts