Negara: Belgia
Bahasa: Inggris
Sumber: AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)
Sodium Patent Blue V - Eq. Patent Blue V 50 mg/2 ml
Guerbet
V04CX
Patent Blue V
2,5/100 ml
Solution for injection
Patent Blue V 50 mg
Subcutaneous use
Other Diagnostic Agents
CTI code: 017211-01 - Pack size: 5 x 2 ml - Commercialisation status: YES - FMD code: 03596470112543 - CNK code: 0835041 - Delivery mode: Medical prescription
Commercialised: Yes
1971-03-01
PATENT BLUE V Composition: PATENT BLUE V SODIUM 2.50 g per 100 ml of solution for injection. List of excipients: Sodium chloride, disodium phosphate dodecahydrate, water for injection. Indications (**): Diagnostic use only – Marking lymph vessels and arterial regions – Marking sentinel nodes before biopsy in patients with operable breast cancer. Posology and method of administration (*): – Marking arterial regions: not more than 10 ml intra-arterially – Marking lymph vessels: 0.5 to 2 ml subcutaneously, marking the sentinel node: 1 to 2 ml subcutaneously around the tumor or areola. Contraindications (*): Hypersensitivity to Patent Blue V, tryphenylmethane dyes or any of the excipients. Special warnings and special precautions for use (*): – There is a risk of allergic reactions whatever the administration route or dose. Patent Blue V may cause minor or major immediate allergic reactions that may be life-threatening or even fatal (anaphylactic shock). They are often unpredictable but they occur more frequently in patients with a history of hypersensitivity reactions to Patent Blue V or related triphenylmethane dyes contained in drugs, food and cosmetics. The indication should be very carefully assessed in these predisposed patients. – Corticosteroids and H1-type antihistamines have been suggested as premedication in patients at risk for intolerance reactions (history of intolerance to Patent Blue V or related triphenylmethane dyes). However, they do not prevent the occurrence of serious or fatal anaphylactic shock. – The risk of a major reaction implies that emergency measures must be immediately available especially in patients on beta blockers in whom adrenaline and vascular perfusion would be insufficiently effective. Therefore, Patent Blue V must only be administered in an establishment capable of adequate treatment. – Before the administration of Patent Blue V: Identify subjects at risk by a precise interview on their history. Insert an indwelling venous catheter. Throughout the examination, m Baca dokumen lengkapnya