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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.

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

Nom : Notice Indigo Carmine GB
Réf. SERB : 208_GB_20151_NO
Version : 4
Code fabricant : en attente
Date : 20/04/16
Auteur : Antonin Lorain
Format à plat : 140 x 315 mm
Format plié : 140 x xx mm

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Fontes
Helvetica Neue LT Std.
Couleurs
Noir
TRACÉS (ne pas imprimer)

Pharmacode
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Validation
Date :

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.

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 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.

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.

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.

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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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