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INDIGO CARMINE 40 MG/5 ML SOLUTION FOR INJECTION

Active substance(s): INDIGOTINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Indigo carmine 40 mg/5 mL, solution for injection
Indigotin (indigo carmine)
For Intravenous Injection Only
Read all of this leaflet carefully before you start using this medicine because it
contains important information for you.
• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.

Nom : Notice Indigo Carmine GB
Réf. SERB : 208_GB_20151_NO
Version : 6
Code fabricant : 5036676
Date : 26/10/16
Auteur : Antonin Lorain
Format à plat : 127 x 500 mm
Format plié : 127 x 32 mm

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Helvetica Neue LT Std.

What is in this leaflet
1. What Indigo carmine 40 mg/5 mL, solution for injection is and what it is used for
2. What you need to know before you use Indigo carmine 40 mg/5 mL, solution for injection
3. How to use Indigo carmine 40 mg/5 mL, solution for injection
4. Possible side effects
5. How to store Indigo carmine 40 mg/5 mL, solution for injection
6. Contents of the pack and other information

n 1. WHAT Indigo carmine 40 mg/5 mL, solution for injection IS AND WHAT IT IS USED
FOR
Indigo carmine 40 mg/5 mL, solution for injection contains the active substance indigotin
(indigo carmine).
This medicine is for a diagnostic use only.
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.

n 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) or any other dye.

Couleurs
Noir
TRACÉS (ne pas imprimer)

Pharmacode
65

Validation
Date :

Signature accompagnée de la mention
« Bon pour à graver » :

Warnings and precautions
Talk to your doctor or pharmacist before using Indigo carmine 40 mg/5 mL, solution for
injection:
• if you take medicines that slow your heart rhythm,
• if you suffer from heart rhythm disorders (heart beats that are too fast, too slow or
irregular) or cardiac conduction disorders,
• 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 radiate towards neighbouring
regions),
• 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 breastfeed.
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.

n 3. HOW TO USE Indigo carmine 40 mg/5 mL, solution for injection
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.

n 4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them:
• increase or decrease in blood pressure,
• slow down or acceleration of the pulse,
• cardiac conduction disorder,
• breath discomfort,
• rash or skin discolouration.

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 at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this
medicine.

n 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.

n 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
medinfo.uk1@serb.eu

Manufacturer
SERB
40 avenue George V
75008 Paris
France

This medicinal product is authorised in the Member States of the EEA under the
following names:
United Kingdom

France

Germany

Belgium



Luxemburg

Netherlands

Indigo carmine 40 mg/5 mL, solution for injection
Carmyne 40 mg/5 mL, solution injectable
Indigokarmin Serb 40 mg/5 ml, Injektionslösung
Carmin d’indigo Serb 40 mg/5 ml, solution injectable
Indigokarmijn Serb 40 mg/5 ml, oplossing voor injectie
Indigokarmin Serb 40 mg/5 ml, Injektionslösung
Carmin d’indigo Serb 40 mg/5 ml, solution injectable
Indigokarmijn Serb 40 mg/5 ml, oplossing voor injectie

This leaflet was last revised in May 2016.

NB. La validation concerne aussi bien la
composition graphique en elle-même, que
les textes mis en page et les spécifications
ci-dessus.

THE FOLLOWING INFORMATION IS INTENDED
FOR HEALTHCARE PROFESSIONALS ONLY:
Considering the dark blue colour of Indigo carmine, a filtration is recommended during the
intravenous administration (for example a filter of 0,45 µm, with a filtering surface of at least
2,8 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.

Nom : Notice Indigo Carmine GB
Réf. SERB : 208_GB_20151_NO
Version : 6
Code fabricant : 5036676
Date : 26/10/16
Auteur : Antonin Lorain
Format à plat : 127 x 500 mm
Format plié : 127 x 32 mm

0

In patients with renal insufficiency:
In patients with a clearance of creatinine ≥ 10 mL/min, Indigo carmine may be administered.
In patients with a clearance of creatinine < 10 mL/min, Indigo carmine should not be used.

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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.

Couleurs

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.

50mm

Fontes

In elderly:
No dosage adjustment is necessary.

Storage

40

Noir
TRACÉS (ne pas imprimer)

Pharmacode
65

Validation
Date :

Signature accompagnée de la mention
« Bon pour à graver » :

NB. La validation concerne aussi bien la
composition graphique en elle-même, que
les textes mis en page et les spécifications
ci-dessus.

208_GB_20151_NO
5036676

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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