INDOCYANINE GREEN- indocyanine green and water kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

INDOCYANINE GREEN (UNII: IX6J1063HV) (INDOCYANINE GREEN ACID FORM - UNII:C4V974V932)

Available from:

Renew Pharmaceuticals Limited

INN (International Name):

INDOCYANINE GREEN

Composition:

INDOCYANINE GREEN 25 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Indocyanine Green for injection is indicated: Indocyanine Green for injection 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. Animal reproduction studies have not been conducted with Indocyanine Green for injection. It is also not known whether Indocyanine Green for injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Indocyanine Green for injection 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 is administered to a nursing woman. Safety and effectiveness in pediatric patients have been established. See DOSAGE AND ADMINISTRATION (2) for specific dosing information in pediatric patients. No overall differences in safety or effectiveness have been observed between elderly and

Product summary:

Indocyanine Green for injection USP is supplied in a kit (NDC 70100-424-02) containing six 25 mg Indocyanine Green for injection USP vials and six 10 mL Sterile Water for injection, USP plastic vials: NDC 70100-424-01 Indocyanine Green for injection USP vial. 25 mg fill in 25 mL vial. NDC 63323-185-10 (or NDC 0409-4887-17) Sterile Water for injection, USP, 10 mL fill in 10 mL plastic vials. Each combination of Indocyanine Green for injection USP vial and Sterile Water for injection, USP plastic vial is intended for single-patient-use. STORAGE: Store at 20° to 25°C (68° to 77°F). Manufactured by: Patheon Italia S.p.A. 20900 Monza (MB), ITALY Distributed by: Diagnostic Green LLC Farmington Hills, MI 48331 USA Sterile Water for injection, USP is manufactured by: Fresenius Kabi USA, LLC Grand Island, NY 14072 USA or Hospira, Inc. Rocky Mount, NC 27804 USA 50426

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

INDOCYANINE GREEN- INDOCYANINE GREEN AND WATER
RENEW PHARMACEUTICALS LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
INDOCYANINE GREEN FOR
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
INDOCYANINE GREEN
FOR INJECTION.
INDOCYANINE GREEN FOR INJECTION, FOR INTRAVENOUS INJECTION
INITIAL U.S. APPROVAL: 1959
INDICATIONS AND USAGE
Indocyanine Green for injection a tricarbocyanine dye, is indicated:
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•
DOSAGE AND ADMINISTRATION
INDICATOR-DILUTION STUDIES. (2.1)
Under sterile conditions, the Indocyanine Green for injection powder
should be dissolved with the Sterile
Water for injection provided and the solution used within 6 hours
after it is prepared. The usual doses of
Indocyanine Green for injection for dilution curves are: Adults 5.0
mg, Children - 2.5 mg, and Infants - 1.25
mg.
HEPATIC FUNCTION STUDIES. (2.2)
Under sterile conditions, the Indocyanine Green for injection powder
should be dissolved with the Sterile
Water for injection provided. The patient should be weighed and the
dosage calculated on the basis of 0.5
mg/kg of body weight. Exactly 5 mL of Sterile Water for injection
should be added to the 25 mg vial giving 5
mg of dye per mL of solution.
OPHTHALMIC ANGIOGRAPHY STUDIES. (2.3)
Dosages up to 40 mg Indocyanine Green for injection dye in 2 mL of
Sterile Water for injection should be
administered. A 5 mL bolus of normal saline should immediately follow
the injection of the dye.
DOSAGE FORMS AND STRENGTHS
Indocyanine Green for injection is a sterile, lyophilized green powder
containing 25 mg of indocyanine
green with no more than 5% sodium iodide. (3)
CONTRAINDICATIONS
Indocyanine Green for injection 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. (4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions are anaphylactic or urticarial
reactions. These have been reported in
patien