Trade Name: PINPOINT Lymphatics Kit

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Novadaq Technologies Inc

Presentation: KIT, HUMAN PRESCRIPTION DRUG

Storage and handling

Disclaimer:
  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
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  • SPY AGENTu2122 GREEN is an optical imaging agent indicated for use with a fluorescence imaging device for:
  • Visualization of vessels (micro and macro vasculature), blood flow and tissue perfusion before, during, and after vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgeries including general minimally invasive surgical procedures in adults and pediatric patients one month of age and older. (n n n n n n ) n n n n n n
  • Visualization of extrahepatic biliary ducts in adults and pediatric patients aged 12 to 17 years. (n n n n n n )n n n n n n
  • Visualization of lymph nodes and lymphatic vessels during lymphatic mapping in women with cervical and uterine tumors. (n n n n n n )n n n n n n
  • Visualization of Vessels, Blood Flow and Tissue Perfusion (2.5 mg/ml solution):
  • Additional doses may be administered to obtain additional imaging sequences during the procedure, however, do not exceed a total dose of 2 mg/kg. (n n n n n n )n nn n nn
  • Visualization of Extrahepatic Biliary Ducts (2.5 mg/ml solution):
  • Additional doses may be administered to obtain additional imaging sequences during the procedure, however, do not exceed a total dose of 2 mg/kg. (n n n n n n )n nn n nn
  • Visualization of Lymph Nodes and Lymphatic Vessels During Lymphatic Mapping for cervical and uterine tumors (1.25 mg/ml solution):
  • See Full Prescribing Information for instructions on reconstitution of the lyophilized powder, and preparation and administration of injections. (n n n n n n )n nn n nn
  • SPY AGENT GREEN (indocyanine green for injection, USP) is a sterile lyophilized green powder containing 25 mg of indocyanine green with no more than 5% sodium iodide provided in a 20 mL single-patient use vial.
  • For injection: SPY AGENT GREEN is a sterile lyophilized green powder containing 25 mg indocyanine green in a single-patient use vial for reconstitution. (n n n n n n )n nn n nn
  • SPY AGENT GREEN is contraindicated in patients with a history of hypersensitivity to indocyanine green. Reactions have included anaphylaxis n n n n n n .n nn n nn
  • History of hypersensitivity to indocyanine green. (n n n n n n )n nn n nn
  • To report SUSPECTED ADVERSE REACTIONS, contact Stryker Corp. at 1-800-624-4422 or n n n n n n .n n n n n n
  • Hypersensitivity reactions: Hypersensitivity reactions including anaphylaxis and urticaria have occurred with administration of indocyanine green. Always have cardiopulmonary resuscitation personnel and equipment readily available and monitor all patients for hypersensitivity reactions. (n n n n n n )n n n n n n
  • Interference with Radioactive Iodine Uptake Studies: Do not perform radioactive iodine uptake studies for at least a week following the use of SPY AGENT GREEN (n n n n n n )n n n n n n
  • The following adverse reactions are discussed in greater detail in other sections of the label:
  • The following adverse reactions have been identified during post-approval use of indocyanine green. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • Immune System Disorders
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  • SPY AGENT GREEN (indocyanine green for injection, USP) is a water soluble, optical imaging agent which is reconstituted with Sterile Water for Injection, USP, for intravenous or interstitial use. Each vial contains a sterile, lyophilized green powder containing 25 mg of indocyanine green with not more than 5% sodium iodide.
  • The chemical name for Indocyanine Green is 1 HBenz[e]indolium, 2-[7-[1,3-dihydro-1,1-dimethyl-3-(4-sulfobutyl)-2H-benz[e] indol-2-ylidene]-1,3,5-heptatrienyl]-1,1-dimethyl-3-(4-sulfobutyl)-, hydroxide, inner salt, sodium salt.
  • Molecular Formula: Cn n n n n n Hn n n n n n Nn n n n n n NaOn n n n n n Sn n n n n n ; Molecular Mass: 774.96 g/mol, with the following structural formula:n nn n nn
  • Indocyanine green has a peak spectral absorption at 800 nm. SPY AGENT GREEN has a pH of 5.5 to 7.5 when reconstituted with Sterile Water for Injection, USP.
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  • Arrayn- Visualization of Lymph Nodes and Lymphatic Vessels During Lymphatic Mapping of Cervical and Uterine Tumors
  • FILM Study (NCT 02209532)
  • NDC 66259-146-01n n nSPY AGENT GREEN (indocyanine green for injection, USP) is supplied as 25 mg of lyophilized powder in a 20 mL single patient use vial in the following configurations:n
  • NDC 63323-185-10 (or NDC 0409-4887-10) Sterile Water for Injection, USP, 10 mL fill in 10 mL plastic vials.
  • STORAGE: Store at 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F) [See USP Controlled Room Temperature].
  • PATIENT COUNSELING INFORMATION
  • Hypersensitivity Reactions
  • Advise patients to seek medical attention for reactions following injection of SPY AGENT GREEN such as difficulty breathing, swollen tongue or throat, skin reactions including hives, itching and flushed or pale skin, low blood pressure, a weak and rapid pulse and other symptoms or signs of an anaphylactic reaction n .n
  • Manufactured by:n n nPatheon Italia S.p.A.n n nFerentino (FR), Italyn
  • Distributed by:n n nNovadaq Technologies ULCn n n8329 Eastlake Drive, Unit 101,n n nBurnaby, BC, Canada V5A 4W2n
  • Sterile Water for Injection, USP is manufactured by:n n nFresenius Kabi USA, LLCn n nGrand Island, NY 14072 U.S.A.n n norn n nHospira, Inc.n n nRocky Mount, NC 27804 U.S.A.n
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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of indocyanine green (PINPOINT Lymphatics Kit) which is also known as PINPOINT Lymphatics Kit and Manufactured by Novadaq Technologies Inc. It is available in strength of .

indocyanine green (PINPOINT Lymphatics Kit) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.

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Name Patient Supply

Validated Cold Chain Shipment

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Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

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Our Process - The Gnh Way

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