Indigokarmin Serb

B. PATIENT LEAFLET

Leaflet enclosed with the packaging: information for the user

Indigocarmine SERB, 40 mg/5 mL, solution for injection

Indigotinum

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Indigocarmine SERB and what is it used for
• 2. Important information before using Indigocarmine SERB
• 3. How to use Indigocarmine SERB
• 4. Possible side effects
• 5. How to store Indigocarmine SERB
• 6. Contents of the pack and other information

1. What is Indigocarmine SERB and what is it used for

Pharmacotherapeutic group: diagnostic agent, ATC code: V04CH02
Indigocarmine SERB solution for injection contains the active substance indigotin (indigocarmine).
This medicine is intended for diagnostic use in adults only.
It is a dye used by the surgeon and anesthesiologist during abdominal surgery.
The product changes the color of the urine (to dark blue) within 5 to 15 minutes after injection.
This color allows for the identification of the course of the ureters (channels that carry urine from the kidneys to the bladder) and to check if they have been damaged during the procedure.

2. Important information before using Indigocarmine SERB

When not to use Indigocarmine SERB

• if the patient is allergic to indigotin (the active substance).

Warnings and precautions

Before starting treatment with Indigocarmine SERB, discuss it with your doctor or pharmacist:

• if the patient has high blood pressure (hypertension),
• if the patient has heart failure (disorders of heart function) or angina pectoris (a heart disease characterized by sudden chest pain that may radiate to neighboring areas),
• if the patient has arrhythmias (too fast, too slow, or irregular heartbeat) or conduction disorders in the heart,
• if the patient is taking medications that slow down the heart rate, affect blood pressure, or produce nitric oxide (nitric oxide is a chemical substance that naturally occurs in the body and causes relaxation of the muscles lining blood vessels),
• if the patient's blood pressure is unstable,
• if the patient has had allergies in the past,
• if the patient is pregnant,
• if the patient is breastfeeding. After administration of this medicine, the patient's urine should turn blue.

Indigocarmine SERB and other medicines

Tell your doctor or pharmacist about all the medicines the patient is taking, has recently taken, or might take.

Pregnancy and breastfeeding

As a precaution, it is recommended not to use this product during pregnancy or breastfeeding.
If the patient is pregnant, breastfeeding, thinks she may be pregnant, or plans to have a baby, she should consult her doctor or pharmacist before using this medicine.

3. How to use Indigocarmine SERB

Dosage and administration

The medicine will be administered by a qualified healthcare professional in a slow intravenous injection.
The doctor will determine the dose the patient will receive and will monitor the injection of this medicine. The usual dose is 1 ampoule of 5 mL and, if necessary, this dose may be repeated once.

In case of overdose of Indigocarmine SERB:

• the doctor will measure blood pressure and heart rate,
• overdose may cause a hypertensive crisis (sudden increase in blood pressure) and bradycardia (slow heart rate). Treatment with a vasodilator (which will help lower blood pressure) may be considered.

For any further questions about using 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 common side effects may include:

• increase in blood pressure,
• slow heart rate. Rare side effects may include:
• anaphylactoid reactions,
• breathing difficulties,
• conduction disorders in the heart,
• decrease in blood pressure,
• skin rash, redness, or discoloration,
• rapid heart rate.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Indigocarmine SERB

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the month.
Before opening: no special precautions for storage.
After opening the ampoule: use immediately.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Indigocarmine SERB contains

• The active substance is indigotin. Each 5 mL ampoule contains 40 mg.
• The other ingredient is water for injections.

What Indigocarmine SERB looks like and contents of the pack

This medicine is available as a solution for injection in ampoules. One pack contains 10 ampoules.

Marketing authorization holder and manufacturer

Marketing authorization holder

SERB SA
Avenue Louise 480
1050 Brussels
Belgium
phone: +48 22 307 03 61

Manufacturer

SERB
40 Avenue George V
75008 Paris
France
SERB SA
Avenue Louise 480
1050 Brussels
Belgium

This medicine is authorized for use in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Belgium
Carmin d’indigo Serb
Indigokarmijn Serb
Indigokarmin Serb
Denmark
Carmyne
Finland
Carmyne
France
Carmyne
Netherlands
Indigokarmijn Serb
Luxembourg
Carmin d’indigo Serb
Germany
Indigokarmin Serb
Norway
Carmyne
Poland
Indygokarmin SERB
Sweden
Carmyne
United Kingdom
(Northern Ireland)
Indigo carmine

Date of last revision of the leaflet: 04/2024

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Information intended for healthcare professionals only:

Due to the dark blue color of Indigocarmine SERB, during intravenous administration, filtration is necessary (e.g., 0.45 μm filter with a filtration area of at least 2.8 cm² or 0.2 μm filter with a filtration area of 4.3 cm², consisting of a hydrophilic polyethersulfone membrane).

Dosage

This medicine should be administered intravenously. The initial recommended dose is 1 ampoule of 5 mL in slow intravenous injection.
If necessary, a second ampoule can be administered 20 to 30 minutes after the first injection.
In children:
The efficacy and safety of Indigocarmine SERB in children have not been established.
In patients with renal impairment:
Indigocarmine SERB is not recommended in patients with a glomerular filtration rate (GFR) <30 ml min.
In elderly patients:
Dose adjustment is not necessary.
In patients with hepatic impairment:
Elimination of Indigocarmine SERB is mainly through the kidneys. Although there are no data on patients with hepatic impairment, no dose adjustment is required.

Storage

Before opening: no special precautions for storage.
After opening the ampoule: use immediately.
The solution can only be administered if the ampoule is not damaged.
Unused solution should be discarded.