Package leaflet: Information for the user

Indygokarmin SERB, 40 mg/5 mL, solution for injection
Indigotinum
Please read all of this leaflet carefully before the medicine is administered, because it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Indygokarmin SERB is and what it is used for
Important information before using Indygokarmin SERB
How to use Indygokarmin SERB
Possible side effects
How to store Indygokarmin SERB
Contents of the pack and other information

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

Pharmacotherapeutic group: Diagnostic agent, ATC code: V04CH02
Indygokarmin SERB solution for injection contains the active substance indigotin (indigo carmine).
This medicine is intended for diagnostic use only in adults.
It is a dye used by the surgeon and anesthesiologist during abdominal surgery.
The product causes a change in urine color (to dark blue) within 5 to 15 minutes after injection.
This color change allows identification of the course of the ureters (tubes carrying urine from the kidneys to the bladder) and helps verify whether they have been injured during the procedure.

2. Important information before using Indygokarmin SERB

When not to use Indygokarmin SERB

if the patient is allergic to indigo carmine (the active substance).

Warnings and precautions
Before starting to use Indygokarmin SERB, discuss this with a doctor or
pharmacist:

if the patient has arterial hypertension (blood pressure that is too high in the arteries),
if the patient has heart failure (impaired heart function) or angina pectoris (a heart condition characterized by severe chest pain that may radiate to adjacent areas),
if the patient has cardiac arrhythmias (heartbeats that are too fast, too slow, or irregular) or conduction disorders in the heart,
if the patient is taking medications that slow heart rate, affect blood pressure, or affect nitric oxide production (nitric oxide is a chemical substance naturally present in the body that causes relaxation of the muscles lining blood vessels),
if the patient's arterial blood pressure is unstable,
if the patient has previously experienced allergic reactions,
if the patient is pregnant,
if the patient is breastfeeding. After administration of this medicine, discoloration of urine should occur.

Indygokarmin SERB and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Pregnancy and breastfeeding
As a precaution, it is recommended not to use this product during pregnancy or breastfeeding.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

3. How to use Indygokarmin SERB

Dosage and method of administration
The medicine will be administered by a qualified healthcare professional as a slow
intravenous injection.
The doctor will determine the dose to be given to the patient and will monitor the injection of this medicine. Usually, the administered dose is 1 vial of 5 ml, and if necessary, this dose may be repeated once.

In case of administration of a higher than recommended dose of Indygokarmin SERB:

the doctor will monitor blood pressure and heart rate,
overdose may cause hypertensive crisis (sudden increase in blood pressure) and bradycardia (slowing of heart rate). Treatment with a peripheral vasodilator medicine (which helps lower blood pressure) may be considered.

If you have any further questions concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
The following adverse reactions may very commonly occur:

increase in blood pressure,
slowing of the heart rate.

The following adverse reactions may very rarely occur:

anaphylactoid reactions,
breathing difficulties,
cardiac conduction disorders,
drop in blood pressure,
rash, erythema or skin discoloration,
rapid heartbeat.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions allows the collection of further information on the safety of the medicine.

5. How to store Indygokarmin SERB

Keep this 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 specified month.
Before opening: no special storage precautions are required for this medicine.
After opening the ampoule: the medicine should be used immediately.
Medicines must not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Indygokarmin SERB contains

The active substance is indigo carmine. Each 5 mL ampoule contains 40 mg.
The other component is water for injections.

What Indygokarmin SERB looks like and contents of the pack
This medicine is available as an injection solution in ampoules. One pack contains 10
ampoules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
SERB SA
Avenue Louise 480
1050 Brussels
Belgium
tel: +48 22 153 08 47
Manufacturer
SERB
32 rue de Monceau
75008 Paris
France
SERB SA
Avenue Louise 480
1050 Brussels
Belgium
This medicine is authorised in the European Economic Area countries 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

Information intended exclusively for medical professionals:

Due to the dark blue color of Indygokarmin SERB, filtration is required during intravenous administration (e.g., a 0.45 μm filter with a filtration area of at least 2.8 cm² or a 0.2 μm filter with a filtration area of 4.3 cm² composed of a hydrophilic polyethersulfone membrane).
Dosage
This medicinal product must be administered intravenously. The initial recommended dose is 1 vial of 5 mL given as a slow intravenous injection.
If necessary, a second vial may be administered 20 to 30 minutes after the first injection.
In children:
The efficacy and safety of Indygokarmin SERB in children have not been established.
In patients with renal impairment:
Indygokarmin 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 Indygokarmin SERB occurs primarily via the kidneys. Although data in patients with hepatic impairment are lacking, dose adjustment is not required.
Storage
Before opening: no special storage requirements for this medicinal product.
After opening the vial: the solution should be used immediately.
The solution may only be administered if the vial is undamaged.
Any unused solution should be discarded.