ICG- indocyanine green and water kit

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

KARL STORZ Endoscopy-America, Inc.

INN (আন্তর্জাতিক নাম):

INDOCYANINE GREEN

রচনা:

INDOCYANINE GREEN 25 mg

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

ICG for Injection Set, a tricarbocyanine dye, is indicated for use with the KARL STORZ ICG Imaging System to provide real-time endoscopic visible and near-infrared fluorescence imaging. Indocyanine Green for Injection, USP used in conjunction with the KARL STORZ ICG Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as:    Visual assessment of at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the KARL STORZ ICG Imaging System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization. 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. Animal reproduction studies ha

পণ্য সারাংশ:

ICG for Injection Set is a kit (NDC 70599-424-02) containing one Indocyanine Green for Injection, USP kit (NDC 70100-424-02) and these Instructions For Use with the KARL STORZ ICG Imaging System. The Indocyanine Green for Injection, USP kit (NDC 70100-424-02) contains 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. ICG for Injection Set Distributed by: KARL STORZ Endoscopy-America, Inc. El Segundo, CA 90245 USA 50441

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

ICG- INDOCYANINE GREEN AND WATER
KARL STORZ ENDOSCOPY-AMERICA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ICG
FOR INJECTION SET SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR INDOCYANINE GREEN FOR INJECTION,
USP.
INITIAL U.S. APPROVAL: 1959
INDICATIONS AND USAGE
ICG for Injection Set, a tricarbocyanine dye, is indicated for use
with the KARL STORZ ICG Imaging System to provide
real-time endoscopic visible and near-infrared fluorescence imaging.
ICG for Injection Set used in conjunction with the
KARL STORZ ICG Imaging System enables surgeons to perform minimally
invasive surgery using standard endoscopic
visible light as well as:
•
•
DOSAGE AND ADMINISTRATION
PERFUSION ASSESSMENT (2.1)
Under sterile conditions, reconstitute one (1) 25 mg vial of
Indocyanine Green for Injection, USP using one (1) 10 mL
Sterile Water for Injection, USP vial located in the ICG for Injection
Set. Shake the ICG vial gently to dissolve. After
reconstitution, a 25 mg vial of ICG contains 2.5 mg of dye per mL of
solution, so a 1.0 mL injection contains a 2.5 mg dose
of ICG. ICG must be used within 6 hours after reconstitution.
A 3 mL (7.5 mg) dose, followed by a 10 mL bolus of saline, is
recommended. Multiple doses can be administered as
re quire d.
EXTRA-HEPATIC BILIARY ANATOMY (2.2)
Under sterile conditions, reconstitute one (1) 25 mg vial of
Indocyanine Green for Injection, USP using one (1) 10 mL
Sterile Water for Injection, USP vial located in the ICG for Injection
Set. Shake the ICG vial gently to dissolve. After
reconstitution, a 25 mg vial of ICG contains 2.5 mg of dye per mL of
solution, so a 1.0 mL injection contains a 2.5 mg dose
of ICG. ICG must be used within 6 hours after reconstitution.
A 0.02 mL/kg dose that is scaled to the patient’s weight, followed
by a 10 mL bolus of saline, is recommended. This
provides 0.05 mg/kg of ICG.
DOSAGE FORMS AND STRENGTHS
Indocyanine Green for Injection, USP is a sterile, lyophilized green
powder