Patent blue V sodium, sodium chloride, sodium phosphate.
In 2 ml of solution for injection contains: Patent blue V Sodium 0.050 g, Sodium chloride 0.012 g, Sodium phosphate 0.001 g, Water for injection q.s. to 2 ml.
Pharmacotherapeutic Group: Dye for vascular marking. ATC Code: V04CX.
Pharmacology: Pharmacokinetics: The dye is eliminated in 24 to 48 hours, mainly in urine (which is highly coloured).
Toxicology: Preclinical Safety Data: Preclinical data derived from conventional single-dose and repeated-dose safety pharmacology and toxicology studies have not revealed any particular risk for humans.
A mutagenic effect was observed in vitro, at high concentrations, on a bacterial gene mutation test after metabolic activation. This effect was not confirmed on an in vitro gene mutation test on human mammalian cells (L5178Y murine lymphoma cells), or on a micronucleus test in rats by intravenous injection of doses significantly higher than the maximum dose in humans, and therefore has limited clinical significance.
Marking lymph vessels and arterial regions.
Marking sentinel nodes before biopsy in patients with operable breast cancer.
Marking arterial regions: not more than 10 ml intra-arterially.
Marking lymph vessels and the sentinel node: 1 to 2 ml subcutaneously around the tumour or areola.
No cases of overdose have been reported.
This medicinal product is contraindicated in patients with a history of hypersensitivity to Patent Blue.
This medicinal product is generally not recommended for use during pregnancy.
Before any injection, patients must be asked if they have a history of allergic reactions or intolerance.
Patent Blue may cause anaphylactic shock and must only be administered in an establishment capable of adequate treatment. In the event of an allergic reaction, an investigation must be carried out determine whether, among all the medicinal products used during the operation and general anesthesia, Patent Blue is actually responsible. This result is important in the event of subsequent surgery (for contralateral cancer, for example).
When marking the sentinel node, all staff caring for the patient must be trained in the technique.
Data in literature show that the rate of identification is improved by carrying out double detection with a radiopharmaceutical and a dye.
Effects on Ability to Drive and Use Machines: Not applicable.
Reliable data on teratogenicity in animal species are not available.
Relevant data are not currently available, or are not numerous enough to allow an evaluation of any teratogenicity or fetal toxicity related to Patent Blue administered during pregnancy.
Consequently, the use of this medicinal product is not recommended during pregnancy.
Immediate hypersensitivity reactions (several minutes to several hours): urticaria is common, angioneurotic oedema and anaphylactic shock are uncommon.
A bluish colouring of the integuments is observed after the injection, which disappears within 24 to 48 hours. In patients with lymph stasis or circulatory disorders, the colouring may last longer.
Medicinal products: In order to avoid any interactions between different medicinal products, the patient must systemically inform the physician or pharmacist of any concomitant treatment.
Effects on diagnostic tests: The value of partial oxygen pressure measured by spectrophotometry may show a transient false decrease of 5 to 10% below baselines values during examinations with Patent Blue. When in doubt, it is advisable to check by arterial blood gas analysis. The value of serum methaemoglobin measured by the same spectrophotometric method may be falsely increased.
V04CX - Other diagnostic agents ; Used as diagnostic agents.
Soln for inj (amp) 2 mL x 5's.