Consumer medicine information

Verdye 25 mg Powder for injection

Indocyanine green

BRAND INFORMATION

Brand name

Verdye

Active ingredient

Indocyanine green

Schedule

Unscheduled

1. Why am I using Verdye Injection?


Verdye Injection contains the active ingredient indocyanine green. Verdye Injection is used for the diagnosis of eye, heart and liver conditions.
For more information, see Section 1. Why am I using Verdye Injection? in the full CMI.

2. What should I know before I am given Verdye Injection?


Do not use if you have ever had an allergic reaction to indocyanine green.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I am given Verdye Injection? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with Verdye Injection and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Verdye Injection?

  • Your doctor will decide the correct dosage of Verdye Injection for you. This will depend on your age, weight and the investigation being performed.
  • The doctor or nurse injects this medicine directly into a vein using a needle, catheter or cardiac (heart) catheter, depending on the kind of investigation you are having.

More instructions can be found in Section 4. How do I use Verdye Injection? in the full CMI.

5. What should I know while being given Verdye Injection?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you have been given Verdye Injection.
  • Check with your doctor if you are pregnant or intend to become pregnant.
  • Talk to your doctor if you are breastfeeding or intend to breastfeed.
Things you should not do
  • Do not use Verdye Injection if you are allergic to indocyanine green, sodium iodide or iodine.
  • Do not use Verdye Injection if you suffer from an over-active thyroid or from benign tumours of the thyroid.
  • Do not use Verdye Injection if you have ever had any side effects after receiving these injections.
Driving or using machines
  • Check with your doctor before you consider driving or operating machinery immediately after an injection.
Looking after your medicine
  • Store below 25°C. Keep the glass vials in the outer carton in order to protect from light.
  • The vials will usually be stored in the clinic for you.

For more information, see Section 5. What should I know while being given Verdye Injection? in the full CMI.

6. Are there any side effects?


Symptoms of severe allergic reactions include: tightness in the throat, itchy skin, blotchy skin, nettle-rash, coronary artery spasm, facial swelling, breathing difficulties, tightness and/or pain in the chest, faster heart-beat, a fall in blood pressure and shortness of breath, heart failure (cardiac arrest), restlessness, feeling sick, feeling of warmth or flushes.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

BRAND INFORMATION

Brand name

Verdye

Active ingredient

Indocyanine green

Schedule

Unscheduled

1 Name of Medicine

Indocyanine green.

2 Qualitative and Quantitative Composition

Each vial contains 25 mg indocyanine green (to be reconstituted with 5 mL of water for injections).
1 mL of the reconstituted solution for injection contains 5 mg indocyanine green, a lyophilised sterile dark green powder. The reconstituted solution is clear and free from visible particles.
This product contains no more than 5% sodium iodide.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Powder for Injection. Dark-green powder.

4 Clinical Particulars

4.9 Overdose

Up to now no case of medicinal product overdose or laboratory findings accompanying overdose of Verdye has been reported.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Indocyanine green was not found to be mutagenic or clastogenic in three in vitro tests (a bacterial reverse mutation assay (Ames test), gene mutation assay in mouse lymphoma L5178Y cells and an in vitro chromosome aberration test in Chinese hamster V79 cells).
Carcinogenicity. No studies have been performed with indocyanine green to evaluate carcinogenicity.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSINDOGR.gif CAS number. 3599-32-4.

7 Medicine Schedule (Poisons Standard)

Non-scheduled.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/VERDYEST.gif