Special Warning : אזהרת שימוש

4.4.      Special warnings and precautions for use
There is always a risk of hypersensitivity regardless of the route of administration and the dose administered.
Patent Blue V can induce minor or major, possibly life-threatening immediate hypersensitivity reactions that can sometimes be fatal (anaphylactic shock). These reactions are often unpredictable, but occur more frequently in patients with a history of hypersensitivity reaction to Patent Blue V or triphenylmethane dyes contained in medicinal products, foods and cosmetics.
Due to the risk of major hypersensitivity reactions, resuscitation equipment must be immediately at hand, especially for patients on beta-blockers, in whom adrenaline and intravascular infusions may be less effective. Consequently, Patent Blue V must be administered only in a setting able to adequately treat these major hypersensitivity reactions.

Before administering Patent Blue V:
•         Identify high-risk subjects by means of a detailed clinical interview concerning the patient’s history;
•         Insert a venous catheter.
During the examination, ensure:
•         Medical surveillance;
•         Maintenance of a venous line;
•         That resuscitation equipment and medications are immediately at hand.

After administration of Patent Blue V, the patient must be kept under observation for at least 60 minutes.
In the event of an allergic reaction, an investigation must be conducted to determine whether, among all of the medicinal products used during a surgical procedure with general anaesthesia, this reaction can be truly attributed to Patent Blue V. The result of this investigation is important when another surgical procedure is required (e.g. contralateral cancer).

All the team managing the patient must be trained in the sentinel node identification technique.

Data of the literature demonstrate improvement of the sentinel node identification rate by performing double detection with a radiopharmaceutical and a dye.

This medicine contains less than 1 mmol (23 mg) of sodium per 1 mL, meaning that it is essentially "sodium- free."

Effects on Driving