Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Blumyne 40 mg/5 mL, solution for injection
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Indigo carmine may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
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 take it
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. Children and adolescents Not applicable. 1
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. Blumyne 40 mg/5 mL, solution for injection with food, drink and alcohol Not applicable. 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. Driving and using machines Not applicable. 3.
How to take it
Considering the dark blue colour of Blumyne, filtration is recommended during 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). 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 [email protected] or directly via the Yellow Card Schema Website :
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www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5.
How to store it
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. <————————————————————————————————————————> 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 3
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.
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Frequently asked questions about Blumyne 40 mg/5 mL, solution for injection
How do I take Blumyne 40 mg/5 mL, solution for injection?
Blumyne 40 mg/5 mL, solution for injection comes as injection containing 40mg / 5ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Blumyne 40 mg/5 mL, solution for injection?
The active substance in Blumyne 40 mg/5 mL, solution for injection is indigo carmine.
Are there equivalent medicines to Blumyne 40 mg/5 mL, solution for injection?
Medicines with the same active substance, strength and form include: Indigo carmine 40 mg/5 mL, solution for injection. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Blumyne 40 mg/5 mL, solution for injection, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Blumyne 40 mg/5 mL, solution for injection without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: indigo carmine
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
This medicinal product is for diagnostic use only.
Blumyne is indicated for the intra-operative detection of suspected ureteral injuries during abdominal and pelvic surgery.
4.2. Posology and method of administration
Posology
This medicinal product is to be injected by intravenous route. The recommended initial 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.
Paediatric population
The safety and efficacy of Blumyne in children has not been established (see section 4.4).
Patients with renal impairment
Blumyne may be administered in patients with a clearance of creatinine ≥ 10 mL/min.
However, Blumyne should not be used in patients with a clearance of creatinine < 10 mL/min (see section 4.4).
Patients with hepatic impairment
The excretion of indigo carmine is mainly renal. There is no data in patients with hepatic impairment, however no dosage adjustment is necessary.
Elderly
No adjustment is necessary.
Method of administration
Slow intravenous injection under monitoring of arterial pressure and heart rate.
Precautions to be taken before administering the medicinal product.
Considering the dark blue colour of Blumyne, filtration is recommended during 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).”
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Special warnings
Indigo carmine may cause a transient elevation of blood pressure and reflex bradycardia especially in patients under general anaesthesia or under spinal anaesthesia. Rare idiosyncratic reactions with bradycardia and hypotension have also been reported. It is therefore necessary to monitor heart rate and blood pressure during and a few minutes after the injection.
Intravenous injection should be stopped if the following symptoms occur: bradycardia, tachycardia, hypotension, hypertension, rash or erythema, respiratory symptoms such as dyspnea or bronchospasm.
In patients with a clearance of creatinine < 10 mL/min, the time to onset of indigo carmine in urines may be delayed for several minutes. Therefore, it should not be used in patients with clearance of creatinine < 10 mL/min.
Indigo carmine may interfere with pulse oxymetric methods.
A discolouration of urine may be observed following administration of indigo carmine.
Precautions for use
Indigo carmine should be used with caution in case of:
- concomitant use of medicines inducing bradycardia,
- heart rate and conduction disorders,
- high blood pressure,
- low heart rate,
- coronary disorders due to its peripheral vasoconstrictor effect.
The use of indigo carmine should be avoided in patients with:
- uncontrolled heart failure,
- history of allergic reactions,
- hemodynamic instability.
Paediatric population
The efficacy and safety of Blumyne in children has not been established.
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no or limited amount of data from the use of indigo carmine in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
Indigo carmine Blumyne is not recommended during pregnancy and in women of childbearing potential not using contraception.
Breast-feeding
It is unknown whether indigo carmine or its metabolites are excreted in human milk. A risk to the suckling child cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to abstain from indigo carmine administration taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
4.7. Effects on ability to drive and use machines
Not applicable.
4.8. Undesirable effects
The most common adverse reactions of indigo carmine are mainly related to its alpha-adrenergic activity and are of cardiovascular origin.
Other idiosyncratic reactions such as changes in blood pressure or heart rate or anaphylactoid reactions have also been described. Serious adverse reactions of indigo carmine are very rare.
Adverse reactions are listed below by system organ class and frequency, using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
System Organ Class
Adverse reaction
Frequency
Cardiac disorders
Hypertension (transient)
Very common
Bradycardia
Very common
Tachycardia
Very rare
Hypotension
Very rare
Atrioventricular block
Very rare
Respiratory, thoracic and mediastinal disorders
Dyspnea
Very rare
Bronchial hyperreactivity
Very rare
Skin and subcutaneous tissue disorders
Rash
Very rare
Erythema
Very rare
Skin discolouration
Very rare
Immune system disorders
Anaphylactoid reaction
Very rare
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9. Overdose
No case of overdose has been reported in the literature for doses up to 80 mg of indigo carmine administered intravenously.
Symptoms
An overdose could induce a hypertensive crisis and severe bradycardia.
Management
In case of overdose, a peripheral vasodilator therapy may be considered.
💬 Ask about this leaflet
Ask anything about Blumyne 40 mg/5 mL, solution for injection. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.