Patient leaflet - Indigo Carmine 40 mg / 5 ml solution for injection
1. WHAT Indigo carmine 40 mg/5 mL solution for injection
IS AND WHAT IT IS USED FOR
Pharmacotherapeutic class: diagnostic agent, ATC code: V04CH02 Indigo carmine 40 mg/5 mL solution for injection contains the active substance indigotin (indigo carmine).
This medicine is for a diagnostic use only in adults.
It is a dye used by the surgeon and anaesthetist during abdominal surgery. The product discolours urine (to dark blue) within 5 to 15 minutes after injection. This colour allows the identification of the ureter track (channels that evacuate urine from the kidneys to the bladder) and check that they have not been damaged during the surgery.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE Indigo
carmine 40 mg/5 mL solution for injection Do not use Indigo carmine 40 mg/5 mL solution for injection:
- If you are allergic to indigo carmine (the drug substance).
Warnings and precautions
Talk to your doctor or pharmacist before using Indigo carmine 40 mg/5 mL solution for injection:
- if you suffer from arterial hypertension (excessively high pressure of the blood in the arteries),
- if you suffer from heart failure (impairment of the heart functions) or angina pectoris (heart disease characterised by a sharp pain in the chest that can irradiate towards neighbouring regions),
- if you suffer from heart rhythm disorders (heart beats that are too fast, too slow or irregular) or cardiac conduction disorders,
- if you take medicines that slow your heart rhythm, affect your blood pressure or nitric oxide production (nitric oxide is a naturally occurring chemical in the body, which causes the muscles in the lining of the blood vessels to relax),
- if your blood pressure is instable,
- if you have a history of allergy,
- if you are pregnant,
- if you breast-feed.
You should observe a discolouration of urine after administration of this medicinal product.
Other medicines and Indigo carmine 40 mg/5 mL solution for injection:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy and breast-feeding
As a precaution, it is preferable not to use this product during pregnancy or if you breast-feed.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
3. HOW TO USE Indigo carmine 40 mg/5 mL solution for injection
Posology and method of administration
A healthcare professional will administer this medicine to you by slow injection into a vein.
Your doctor will determine the dose you will receive and will control the injection of this medicine. The dose usually injected is of 1 ampoule of 5 mL and may be repeated once if necessary.
If you were administered more Indigo carmine 40 mg/5 mL solution for injection than you should:
- your doctor will check your blood pressure and your heart rate,
- an overdose could induce a hypertensive crisis (sudden increase in blood pressure) and bradycardia (low heart rate).
A treatment with peripheral vasodilator may be considered (which will help lowering the blood pressure).
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them:
very commonly, the following reactions can occur:
o increase in blood pressure,
o slow down of the pulse,
very rarely, the following reactions can occur:
o anaphylactoid reactions,
o breath discomfort,
o cardiac conduction disorder,
o decrease in blood pressure,
o rash, erythema or skin discolouration,
o acceleration of the pulse.
Reporting of side effects
If you get any side effect, tell your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report the side effects directly via the Yellow Card Scheme.
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE Indigo carmine 40 mg/5 mL solution for injection
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton or ampoule after “EXP”.
The expiry date refers to the last day of that month.
Before opening: this medicinal product does not require any special storage conditions.
After opening the ampoule: this medicine must be used immediately. Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Indigo carmine 40 mg/5 mL solution for injection contains
- The active substance is indigotin (indigo carmine). Each ampoule of 5 mL contains 40 mg.
- The other ingredient is water for injections.
What Indigo carmine 40 mg/5 mL solution for injection looks like and content of the pack
This medicine is available as a solution for injection in ampoule. One box contains 10 ampoules.
Marketing Authorisation Holder
SERB S.A.
Avenue Louise 480
1050 Brussels
Belgium
Manufacturer
SERB
32 rue de Monceau,
75008 Paris
France
This leaflet was last revised in November 2025.
The following information is intended for healthcare professionals only:
Considering the dark blue colour of Indigo carmine, a filtration is necessary during the intravenous administration (for example a filter of 0.45 µm, with a filtering surface of at least 2.8 cm², or a filter of 0.2 µm with a filtering surface of 4.3 cm², composed of a hydrophilic polyethersulfone membrane).
Dosage
This medicinal product is to be injected by intravenous route. The initial recommended dosage is 1 ampoule of 5 mL by slow intravenous injection. A second ampoule may be injected 20 to 30 minutes after the first injection, if necessary.
In children:
The efficacy and safety of Indigo carmine in children has not been established. In patients with renal insufficiency:
Indigo carmine 40 mg/5 mL solution for injection is not recommended for use in patients with glomerular filtration rate (GFR) < 30 mL/min.
In elderly:
No dosage adjustment is necessary.
In patients with liver insufficiency:
The excretion of Indigo carmine is mainly renal. Although there is no data in patients with hepatic failure, no dosage adjustment is required. Storage
Before opening: this medicinal product does not require any special storage conditions.
After opening the ampoule: this medicine should be used immediately. The solution must only be used if the ampoule is not damaged. Any unused solution should be thrown away.
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