Patient leaflet - Blumyne 40 mg/5 ml, solution for injection
1. WHAT Blumyne 40 mg/5 mL, solution for injection IS AND WHAT IT IS USED FOR
Pharmacotherapeutic group: diagnostic agents, ATC code: V04CH02
Blumyne contains the active substance indigo carmine (indigotin).
This medicine is for diagnostic use only. It is a blue dye used by the surgeons and anesthetists during abdominal surgery. It discolours the urine (in dark blue) within 4 to 9 minutes after injection.
This colouration allows to identify the ureter tracks (channels that evacuate the urine from the kidney to the bladder) and check that they have not been damaged during the surgery.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN Blumyne 40 mg/5 mL, solution for injection
Blumyne 40 mg/5 mL, solution for injection must not be given
if you are allergic to indigo carmine
(indigotin) or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given Blumyne
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 (impairement
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 are breast-feeding
You should observe a discolouration of the urine after administration of this medicine. Other medicines and Blumyne 40 mg/5 mL, solution for injection
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before having this medicine.
As a precaution, it is preferable not to use this medicine during pregnancy or if you are breast-feeding.
3. HOW Blumyne 40 mg/5 mL, solution for injection IS GIVEN
Considering the dark blue colour of Blumyne, filtration is recommended during intravenous administration (for example, a filter of 0.45μm, with a filtering surface of at least 2.8 cm², composed of a hydrophilic polyethersulfone membrane).
The following information is intended for healthcare professionals only: Dosage
This medicine is intended to be injected intravenously. The initial recommended dose is 1 ampoule of 5 mL by slow IV injection. A second ampoule may be injected 20 to 30 minutes after the first injection, if necessary. Children
The efficacy and safety of Blumyne in children have not been established. Patients with renal impairement
Blumyne may be administered in patients with a clearance of creatinine ≥ 10 mL/min. Blumyne should not be used in patients with a clearance of creatinine < 10 mL/min. Patients with hepatic impairement
The excretion of Blumyne is mainly renal. Although there is no data in patients with hepatic failure, no dosage adjustment is required. Elderly
No dosage adjustment is necessary.
Storage
Do not refrigerate or freeze.
After opening the ampoule: this medicine should be used immediately. Any unused product or waste material should be disposed of in accordance with local requirements.
A healthcare professional will administer this medicine to you by slow injection into a vein. The recommended dose 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.
If you are given more Blumyne 40 mg/5 mL, solution for injection than you should
Your doctor will monitor your blood pressure and heart rate.
An overdose could induce a hypertensive crisis (sudden increase in blood pressure) and bradycardia (low heart rate).
A treatment with peripheral vasodilatator 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, pharmacist or nurse.
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 heart rate, • Cardiac conduction disorder,
- Breath discomfort,
- Rash or skin discolouration.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects via Provepharm at safetyuk@provepharm.com or directly via the Yellow Card Schema Website :
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple AppStore.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE Blumyne 40 mg/5 mL, solution for injection
Keep this medicine out of the sight and reach of children.
You must not be given this medicine after the expiry date which is stated on the ampoule label and on the carton after EXP. The expiry date refers to the last day of that month. Do not refrigerate or freeze.
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 Blumyne 40 mg/5 mL, solution for injection contains
The active substance is indigo carmine
(indigotin). Each mL of solution contains 8 mg of indigo carmine. Each ampoule of 5 mL contains 40 mg of indigo carmine. • The other ingredients are: water for injections, citric acid monohydrate and/or sodium citrate (for pH adjustment). What Blumyne 40 mg/5 mL, solution for injection looks like and contents of the pack
This medicine is a blue to bluish-purple solution for injection packed in brown glass ampoules. Each box contains a tray with 5 ampoules of 5 mL.
Marketing Authorisation Holder
Provepharm
22, Rue Marc Donadille
13013 Marseille
France
Manufacturer
Cenexi
52, Rue Marcel et Jacques Gaucher 94120 Fontenay-sous-Bois
France
This leaflet was last revised in 07/2024.
28069680
CENEXI for PROVEPHARM
ARTICLE : 28069680
BLUMYNE 5X5ML UK
PACKAGING LINE : FB320 FORMAT UNFOLDED: 148 x 630 mm FORMAT FOLDED : 148 x 315 mm
VERSION 6 : 07/08/2024 UPDATE OF STORAGE CONDITION, URINE COLORATION TIME,
APPROVAL DATE, REPLACING TM WITH ® 1 COLOR
CENEXI for PROVEPHARM
ARTICLE : 28069680 BLUMYNE 5X5ML UK PACKAGING LINE : FB320 FORMAT UNFOLDED: 148 x 630 mm FORMAT FOLDED : 148 x 315 mm
VERSION 6 : 07/08/2024 UPDATE OF STORAGE CONDITION, URINE COLORATION TIME,
APPROVAL DATE, REPLACING TM WITH ® 1 COLOR