Bleu Patente V Guerbet 2.5 g/100 ml inj. sol. s.c. vial

Country: Belgium

Language: English

Source: AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

Active ingredient:

Sodium Patent Blue V - Eq. Patent Blue V 50 mg/2 ml

Available from:

Guerbet

ATC code:

V04CX

INN (International Name):

Patent Blue V

Dosage:

2,5/100 ml

Pharmaceutical form:

Solution for injection

Composition:

Patent Blue V 50 mg

Administration route:

Subcutaneous use

Therapeutic area:

Other Diagnostic Agents

Product summary:

CTI code: 017211-01 - Pack size: 5 x 2 ml - Commercialisation status: YES - FMD code: 03596470112543 - CNK code: 0835041 - Delivery mode: Medical prescription

Authorization status:

Commercialised: Yes

Authorization date:

1971-03-01

Patient Information leaflet

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