However, long-term studies in rats (oral) and mice (subcutaneous) have not revealed any carcinogenic effects. < 10 mL/min, Indigo carmine should not be. Indigo carmine is reported as an ingredient of indigo carmine in the following countries: Important Notice: The international database is in BETA release. Graziano S et al; Int Urogynecol J Pelvic Floor Dysfunct 16 (5): 418-9 (2005) Hazardous Substances Data Bank (HSDB) The hemodynamic effects most often encountered on intravascular indigo carmine administration are increases in diastolic and … Marketing Authorisation Holder SERB S.A. Avenue Louise 480 1050 Brussels Belgium. After opening: this product should be used immediately. US matches: Indigo Carmine; UK matches: INDIGO CARMINE 40 MG/5 ML SOLUTION FOR INJECTION (Leaflet); Ingredient matches for indigo carmine The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. In patients with a clearance of creatinine may be administered. For storage conditions after first opening of the medicinal product, see section 6.3. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. This medicinal product is for diagnostic use only. In case of overdose, a peripheral vasodilator therapy may be considered. There is no data in patients with liver impairement, however no dosage adjustment is necessary. Indigotin (indigo carmine) is a dye clinically used for diagnostic purposes. Serious adverse reactions of indigotin (indigo carmine) are very rare. In obstetric surgery, indigo carmine solutions are sometimes employed to detect amniotic fluid leaks. In patients with a clearance of creatinine < 10 mL/min, the time to onset of indigotin (indigo carmine) in urines may be delayed for several minutes. Elimination of the dye begins soon after injection, appearing in the urine within 10 minutes in average cases.The biological half-life is 4 to 5 minutes following intravenous injection. 8    MARKETING AUTHORISATION    NUMBER(S). In the US, indigo carmine (indigo carmine systemic) is a member of the drug class miscellaneous diagnostic dyes. The recommended initial dosage is 1 ampoule of 5 mL by slow intravenous injection. It allows continued monitoring of the benefit/risk balance of the medicinal product. Indigo Carmine (indigotindisulfonate) solution is injected either by the intravenous or intramuscular route, and its appearance at the ureteral orifices is watched with the cystoscope in place. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). Indigotin (indigo carmine) has a plasma half-life of 4.5 minutes. Consult with your healthcare professional before taking any medication. color dark blue shape No data. The dye is filtered rapidly by the kidneys from the blood, and colors the urine blue. In oral dosing studies performed in rats and rabbits, doses of indigotin (indigo carmine) up to 250 mg/kg/day did not produce any teratogenic effects. pH adjusted, when necessary, with Citric Acid and/or Sodium Citrate. ‹ Back to Gallery. INDIGO CARMINE INJECTION (Indigotindisulfonate Sodium Injection, USP) 0.8% Solution. Indigo carmine is indicated for the intra-operative detection of suspected ureteral injuries during abdominal and pelvic surgery. It is therefore necessary to monitor heart rate and blood pressure during and a few minutes after the injection. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: The recommended initial dosage is 1 ampoule of 5 mL by slow intravenous injection. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. 1 Indigo carmine. Indigo Carmine 8 mg/mL (0.8 %) injection solution. No clinical study has been conducted. Indigo Carmine is excreted largely by the kidneys, retaining its blue color during passage through the body. The efficacy and safety of Indigo carmine in children has not been established (see section 4.4). No carcinogenicity study has been conducted by intravenous route with indigotin (indigo carmine). Management. 9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION, 2    QUALITATIVE AND QUANTITATIVE    COMPOSITION, 4.2    Posology and method of administration, Considering the dark blue colour of Indigo carmine, a filtration is recommended during the intravenous administration (for example a filter of 0.45 pm, with a filtering surface of at least 2.8 cm, 4.4 Special warnings and precautions for use, 4.5 Interaction with other medicinal products and other forms of interaction, 4.7 Effects on ability to drive and use machines. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Intravenous injection should be stopped if the following symptoms occur: bradycardia, tachycardia, hypotension, hypertension, rash or erythema, respiratory symptoms such as dyspnea or bronchospasm. Pharmacotherapeutic class: DIAGNOSTIC AGENTS, ATC Code: V04CH02. Indigotin (indigo carmine) may interfere with pulse oxymetric methods. Indigo Carmine (indigotindisulfonate) is excreted largely by the kidneys, retaining its blue color during passage through the body. Indigo carmine 40 mg/5 mL solution for injection, Indigotin (indigo carmine)............................................................40 mg. For the full list of excipients, see section 6.1. Indigotin (indigo carmine) may cause a transient elevation of blood pressure and reflex bradycardia especially in patients under general anaesthesia or under spinal anaesthesia. The use of indigotin (indigo carmine) should be avoided in patients with: No interaction studies have been performed. Posology. Solution for injection. However, a meta-analysis of published studies was used to evaluate the diagnostic performance of indigotin (indigo carmine) in the detection of ureteral injury in abdominal and pelvic surgery.