INDOCYANINE GREEN FOR INJECTION, USP 25 MG
INDOCYANINE GREEN : 25 MG · DIN 02485796 · DIAGNOSTIC GREEN LIMITED
Health Canada status: MARKETED
What is INDOCYANINE GREEN FOR INJECTION, USP?
INDOCYANINE GREEN FOR INJECTION, USP 25 MG contains INDOCYANINE GREEN : 25 MG. It is listed in the Health Canada Drug Product Database under DIN 02485796, held by DIAGNOSTIC GREEN LIMITED, supplied as POWDER FOR SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 11-Jun-2019. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.
What is INDOCYANINE GREEN FOR INJECTION, USP used for?
Indocyanine Green for Injection, USP is indicated for: determining cardiac output, hepatic function and liver blood flow, and ophthalmic angiography.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Product details and regulatory record
| DIN | 02485796 |
|---|---|
| Brand name | INDOCYANINE GREEN FOR INJECTION, USP |
| Generic / active ingredient | INDOCYANINE GREEN : 25 MG |
| Manufacturer | DIAGNOSTIC GREEN LIMITED |
| Strength | 25 MG |
| Dosage form | POWDER FOR SOLUTION |
| Route of administration | INTRAVENOUS |
| Schedule | Ethical |
| ATC code | V04CX01 INDOCYANINE GREEN |
| AHFS class | 36:44.00 ; 36:18.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 11-Jun-2019 |
| Original market date | 2019-06-11 00:00:00 |
How is it administered?
The powder should be dissolved with Sterile Water for Injection, USP, and the solution used within 6 hours after it is prepared. Do not use product if mixture shows haziness, particulate matter, discolouration, or leakage. For indicator-dilution studies, the usual doses are: Adults - 5.0 mg, Children - 2.5 mg, Infants - 1.25 mg. These doses are usually injected in 1 mL volume. The total dose of dye injected should be kept below 2 mg/kg. For hepatic function studies, the dosage is calculated on the basis of 0.5 mg/kg of body weight. Exactly 5 mL of Sterile Water for Injection, USP should be added to the 25 mg vial giving 5 mg of dye per mL of solution. Inject the calculated amount of dye (0.5 mg/kg of body weight) into the lumen of an arm vein as rapidly as possible. For ophthalmic angiography studies, dosages up to 40 mg Indocyanine Green for Injection, USP dye in 2 mL of Sterile Water for Injection, USP should be used, depending on the imaging equipment and technique used. The antecubital vein can be injected with an Indocyanine Green for Injection, USP dye bolus and should immediately be followed by a 5 mL bolus of normal saline.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Store at 15° to 25°C. Keep out of reach and sight of children. Indocyanine Green for Injection, USP is unstable in aqueous solution and must be used within 6 hours after it is prepared.
How is it supplied?
Indocyanine Green for Injection, USP is supplied as: a kit containing six 25 mg Indocyanine Green for Injection, USP vials (25 mg fill in 25 mL vial) and six 10 mL Sterile Water for Injection, USP vials (10 mL fill in 10 mL vial); a carton containing six 25 mg Indocyanine Green for Injection, USP vials only (25 mg fill in 25 mL vial) to be used with Sterile Water for Injection.
Contraindications
Indocyanine Green for Injection, USP is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. It 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
Deaths from anaphylaxis have been reported following Indocyanine Green for Injection, USP administration during cardiac catheterization. Indocyanine Green for Injection, USP is unstable in aqueous solution and must be used within 6 hours. If a precipitate is present, discard the solution. Radioactive iodine uptake studies should not be performed for at least a week following the use of Indocyanine Green for Injection, USP. Animal reproduction studies have not been conducted. It is 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. Caution should be exercised when Indocyanine Green for Injection, USP is administered to a nursing woman.
What can be used instead?
Other Canadian products sharing ATC code V04CX01 INDOCYANINE GREEN. 7 of 9 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.
| Product | Strength | Form | Manufacturer | Health Canada status | DIN |
|---|---|---|---|---|---|
| SPY AGENT GREEN | 25 MG | POWDER FOR SOLUTION | NOVADAQ TECHNOLOGIES ULC | MARKETED | DIN 02483653 |
| SPY AGENT GREEN KIT FOR ADVANCED IMAGING MODALITY (AIM) AND PINPOINT | 25 MG | POWDER FOR SOLUTION ; KIT | NOVADAQ TECHNOLOGIES ULC | MARKETED | DIN 02483688 |
| SPY AGENT GREEN KIT FOR ADVANCED IMAGING MODALITY (AIM) AND PINPOINT | 25 MG | POWDER FOR SOLUTION ; KIT | NOVADAQ TECHNOLOGIES ULC | MARKETED | DIN 02527839 |
| SPY AGENT GREEN KIT FOR SPY ELITE | 25 MG | KIT ; POWDER FOR SOLUTION | NOVADAQ TECHNOLOGIES ULC | MARKETED | DIN 02483661 |
| SPY AGENT GREEN KIT FOR SPY-PHI | 25 MG | KIT ; POWDER FOR SOLUTION | NOVADAQ TECHNOLOGIES ULC | MARKETED | DIN 02498677 |
| SPY AGENT GREEN LYMPHATICS KIT FOR ADVANCED IMAGING MODALITY (AIM) AND PINPOINT | 25 MG | POWDER FOR SOLUTION ; KIT | NOVADAQ TECHNOLOGIES ULC | MARKETED | DIN 02483696 |
| INDOCYANINE GREEN FOR INJECTION KIT | 25 MG | POWDER FOR SOLUTION ; KIT | DIAGNOSTIC GREEN LIMITED | CANCELLED PRE MARKET | DIN 02485818 |
| INDOCYANINE GREEN FOR INJECTION KIT | 25 MG | KIT ; POWDER FOR SOLUTION | DIAGNOSTIC GREEN LIMITED | CANCELLED POST MARKET | DIN 02485826 |
Who else supplies INDOCYANINE GREEN worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. INDOCYANINE GREEN appears in 3 registered pack listings across 2 markets, published on 2 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.
Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.
How can I get it?
Nexara Health supplies this product to licensed Canadian buyers — pharmacies, hospitals, clinics, licensed distributors, and clinical trial sponsors or their CROs. We confirm stock, pack size, expiry and pricing at the time of quotation. If the product is on backorder or in shortage, we identify equivalent alternatives and import options where permitted.
Ordering questions
Who can buy this from Nexara?
Licensed entities only. Nexara holds Health Canada establishment licence DEL 3-002896-A and ships only to a licensed address.
Is there a minimum order?
Yes, set per product line and per pack multiple rather than on the order total, so you are never asked to buy a part-pack. The minimum for this line is confirmed with your quote.
What is the lead time?
Confirmed per order at quotation, and it depends on current stock position and whether the product is in shortage.
Can Nexara supply this for a clinical trial?
Yes — comparator and background-therapy supply, including sourcing from other markets where a Canadian pack will not satisfy the protocol. Clinical trial supply.