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SPY AGENT GREEN is a brand name for Indocyanine Green, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 11/2023 1 INDICATIONS, 1.1 Pediatrics 11/2023 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 11/2023 4 DOSAGE AND ADMINISTRATION, 4.3 Reconstitution 11/2023 4 DOSAGE AND ADMINISTRATION, 4.4 Administration 11/2023 7 WARNINGS AND PRECAUTIONS 11/2023 7 WARNINGS AND PRECAUTIONS, 7.1.3 Pediatrics…
Verbatim from this product's HC label. Tap a section to expand.
4 Geriatrics 11/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed . Recent Major Label Changes ................................................................................................
2 TABLE OF CONTENTS .......................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION............................................................... 4 1 INDICATIONS..............................................................................................................
1 Pediatrics....................................................................................................... 2 Geriatrics .......................................................................................................
4 2 CONTRAINDICATIONS............................................................................................... 5 4 DOSAGE AND ADMINISTRATION.............................................................................. 1 Dosing Considerations ...................................................................................
2 Recommended Dose and Dosage Adjustment ................................................ 3 Reconstitution ................................................................................................ 4 Administration ................................................................................................
5 Missed Dose .................................................................................................. 9 5 OVERDOSAGE ...........................................................................................................
9
1 Adverse Reaction Overview Anaphylactic or urticarial reactions have been reported in patients with or without history of allergy to iodides. , epinephrine, antihistamines, and corticosteroids. 2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. In an open label, within subject comparison clinical trial, 176 subjects with uterine or cervical malignancies received SPY AGENT® GREEN (indocyanine green for injection, USP).
No subjects experienced adverse drug reactions or serious adverse reactions. In an open-label, single arm, clinical trial, 151 subjects with breast cancer received SPY AGENT® GREEN intradermally into the peri-areolar area. No subjects experienced serious adverse reactions.
7%). 5 Post-Market Adverse Reactions Anaphylactic or urticarial reactions have been reported in the literature in patients with or without history of allergy to iodides. , epinephrine, antihistamines, and corticosteroids. 5 mg has resulted in one report of an anaphylactic reaction to a single intravenous dose of 5 mg indocyanine green.
Skin discolouration has been reported in the literature in patients who received indocyanine green for lymphatic mapping for breast cancers.
4 Geriatrics 11/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed . Recent Major Label Changes ................................................................................................
2 TABLE OF CONTENTS .......................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION............................................................... 4 1 INDICATIONS..............................................................................................................
1 Pediatrics....................................................................................................... 2 Geriatrics .......................................................................................................
4 2 CONTRAINDICATIONS............................................................................................... 5 4 DOSAGE AND ADMINISTRATION.............................................................................. 1 Dosing Considerations ...................................................................................
2 Recommended Dose and Dosage Adjustment ................................................ 3 Reconstitution ................................................................................................ 4 Administration ................................................................................................
5 Missed Dose .................................................................................................. 9 5 OVERDOSAGE ...........................................................................................................
9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ........................ 9 7 WARNINGS AND PRECAUTIONS ............................................................................ 1 Special Populations......................................................................................
• Indocyanine green is contraindicated in patients who are hypersensitive to this drug or any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• SPY AGENT® GREEN (indocyanine green for injection, USP) contains sodium iodide and is contraindicated in patients who have a history of allergy to iodides because of the risk of anaphylaxis.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Indocyanine Green in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
1 Pregnant Women ............................................................................................. 2 Breast-feeding.................................................................................................. 3 Pediatrics .........................................................................................................
4 Geriatrics ........................................................................................................ 11 8 ADVERSE REACTIONS ............................................................................................
1 Adverse Reaction Overview ......................................................................... 2 Clinical Trial Adverse Reactions ................................................................... 5 Post-Market Adverse Reactions....................................................................
12 9 DRUG INTERACTIONS ............................................................................................. 2 Overview...................................................................................................... 4 Drug-Drug Interactions .................................................................................
5 Drug-Food Interactions................................................................................. 6 Drug-Herb Interactions ................................................................................. 7 Drug-Laboratory Test Interactions ................................................................
13 10 ACTION AND CLINICAL PHARMACOLOGY ............................................................ 1 Mechanism of Action .................................................................................... 2 Pharmacodynamics......................................................................................
3 Pharmacokinetics......................................................................................... 13 11 STORAGE, STABILITY AND DISPOSAL .................................................................. 14 12 SPECIAL HANDLING INSTRUCTIONS .....................................................................
14 PART II: SCIENTIFIC INFORMATION .................................................................................. 15 13 PHARMACEUTICAL INFORMATION ........................................................................ 15 14 CLINICAL TRIALS ....................................................................................................
1 Trial Design and Study Demographics .......................................................... 2 Study Results............................................................................................... 1Imaging Blood Flow and Tissue Perfusion.........................................................
2Imaging Extrahepatic Biliary Anatomy ............................................................... 3Imaging of Lymph Nodes and Lymphatic Vessels During Lymphatic Mapping for Cervical and Uterine Cancers .......................................................................
4Imaging of Lymph Nodes and Lymphatic Vessels During Lymphatic Mapping for Breast Cancers ............................................................................................ 19 15 NON-CLINICAL TOXICOLOGY .................................................................................
1 Carcinogenesis, Mutagenesis, Impairment of Fertility .................................... 20 PATIENT MEDICATION INFORMATION .............................................................................. 21 SPY AGENT® GREEN (indocyanine green for […]