Reporting suspected adverse reactions after authorisation of the medicinal product is important. Indigo carmine 40 mg/5 mL solution for injection, Indigotin (indigo carmine)............................................................40 mg. For the full list of excipients, see section 6.1. It allows continued monitoring of the benefit/risk balance of the medicinal product. This enables structures of the urinary tract to be seen in the surgical field, and demonstrate if there is a leak. There are no or limited amount of data from the use of indigotin (indigo carmine) in pregnant women. FOR INTRAVENOUS OR INTRAMUSCULAR USE. Elimination of the dye begins soon after injection, appearing in the urine within 10 minutes in average cases. Indigo Carmine (indigotindisulfonate) is excreted largely by the kidneys, retaining its blue color during passage through the body. 8    MARKETING AUTHORISATION    NUMBER(S). This medicinal product is to be injected by intravenous route. imprint No data. Indigotin (indigo carmine) with its alpha-adrenergic properties triggers an increase of peripheral vascular resistance, resulting in moderate and transient increase of blood pressure and a probably reactional moderate decrease of heart rate. No case of overdose has been reported in the literature for doses up to 80 mg of indigotin (indigo carmine) administered intravenously. - The other ingredient is water for injections. In patients with a clearance of creatinine used (see section 4.4). Slow intravenous injection under monitoring of arterial pressure and heart rate. An overdose could induce a hypertensive crisis and severe bradycardia. INDIGO CARMINE INJECTION (Indigotindisulfonate Sodium Injection, USP) 0.8% Solution. Select one or more newsletters to continue. The most common adverse reactions of indigotin (indigo carmine) are mainly related to its alpha-adrenergic activity and are of cardiovascular origin. 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. Rx Only. 5 mL ampoules in type I brown glass. It allows continued monitoring of the benefit/risk balance of the medicinal product. Indigotin (indigo carmine) should be used with caution in case of: •    concomitant use of medicines inducing bradycardia. However, long-term studies in rats (oral) and mice (subcutaneous) have not revealed any carcinogenic effects. ‹ Back to Gallery. Each mL contains: Indigotindisulfonate Sodium 8 mg, Water for Injection q.s. This means it is still under development and may contain inaccuracies. Indigo Carmine is excreted largely by the kidneys, retaining its blue color during passage through the body. In case of renal function impairment, the average time of excretion can be extended for several minutes. 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 … Subscribe to newsletters for the latest medication news, new drug approvals, alerts and updates. There is no data in patients with liver impairement, however no dosage adjustment is necessary. The intravenous method is preferred because a 5 mL injection is sufficient. Hypersensitivity to the active substance or to dyes. Indigo carmine is reported as an ingredient of indigo carmine in the following countries: Important Notice: The international database is in BETA release. Indigotin (indigo carmine) is a dye clinically used for diagnostic purposes. Indigotin (indigo carmine) may cause a transient elevation of blood pressure and reflex bradycardia especially in patients under general anaesthesia or under spinal anaesthesia. < 10 mL/min, Indigo carmine should not be. Changes in ORi within 20 min after indigo carmine injection were observed. Data sources include IBM Watson Micromedex (updated 2 Nov 2020), Cerner Multum™ (updated 2 Nov 2020), ASHP (updated 23 Oct 2020) and others. This medicinal product is to be injected by intravenous route. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. The use of indigotin (indigo carmine) should be avoided in patients with: No interaction studies have been performed. NDC 0517-0375-05 5 x 5 mL AMPULES. 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. Indigotin (indigo carmine) has a plasma half-life of 4.5 minutes. Available for Android and iOS devices. It is not intended as a substitute for the expertise and judgement of your physician, pharmacist or other healthcare professional. A small amount is excreted in the bile. 1 Indigo carmine. A case of severe hypotension and bradycardia following intravenous indigo carmine injection in a patient with known sulfa allergy /is reported/. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. PMID:16027953. 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. For storage conditions after first opening of the medicinal product, see section 6.3. Sterile, nonpyrogenic. After opening: this product should be used immediately. •    heart rate and conduction disorders. In rats, the LD50 (median lethal single dose) is 93 mg/kg by intravenous route while in mice the LD50 is 405 mg/kg by subcutaneous route. pH adjusted, when necessary, with Citric Acid and/or Sodium Citrate. Box of 10 ampoules. Management. The efficacy and safety of Indigo carmine in children has not been established. Pharmacotherapeutic class: DIAGNOSTIC AGENTS, ATC Code: V04CH02. The recommended initial dosage is 1 ampoule of 5 mL by slow intravenous injection. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: Any unused medicinal product or waste material should be disposed of in accordance with local requirements. •    coronary disorders due to its peripheral vasoconstrictor effect. This product does not require any special storage conditions. Indigo carmine is not recommended during pregnancy and in women of childbearing potential not using contraception.


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