Nchi: Israeli
Lugha: Kiingereza
Chanzo: Ministry of Health
PATENT BLUE V SODIUM
PROMEDICO LTD
V04CX
SOLUTION FOR INJECTION
PATENT BLUE V SODIUM 25 MG/ML
S.C, INTRA-ARTERIAL
Required
GUERBET, FRANCE
OTHER DIAGNOSTIC AGENTS
Marking lymph vessels and arterial regions.Marking sentinel nodes before biopsy in patients with operable breast cancer.
2023-06-30
העדוה העדוה לע לע הרמחה הרמחה ( ( עדימ עדימ )תוחיטב )תוחיטב :ךיראת 01.1.13 םש רישכת :תילגנאב PATENT BLUE V רפסמ :םושיר 060-28-27291-05 םש לעב :םושירה PROMEDICO LTD םייונישה ןולעב םינמוסמ לע עקר בוהצ אפורל ןולעב אפורל ןולעב םיטרפ לע םי/יונישה םי/שקובמה קרפ ןולעב טסקט יחכונ טסקט שדח 4.1 THERAPEUTIC INDICATIONS Marking lymph vessels and arterial regions. Marking sentinel nodes before biopsy in patients with operable breast cancer. This medicinal product is for diagnostic use only. Marking lymph vessels and arterial regions. Marking sentinel nodes before biopsy in patients with operable breast cancer. 4.6 PREGNANCY AND LACTATION Consequently, the use of this medicinal product is not recommended during pregnancy. Pregnancy No reliable animal teratogenesis data are available. There are no or limited amount of data from the use of Patent Blue V in pregnant women. Consequently, the use of Patent Blue V is not recommended during pregnancy. Lactation It is unknown whether Patent Blue V is excreted in human milk. Pregnancy No reliable animal teratogenesis data are available. Currently, there are no, or limited data, to evaluate a possible malformative or foetotoxic effect of Patent Blue V when it is administered during pregnancy. Consequently, the use of this medicinal product is not recommended during pregnancy. Lactation There are no data concerning excretion of Patent Blue V into breast milk. 4.8 UNDESIRABLE EFFECTS 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. Immediate hypersensitivity reactions can occur. These reactions may comprise one or mor Soma hati kamili
_ _ SUMMARY OF PRODUCT CHARACHTERISTICS 1. NAME OF THE MEDICINAL PRODUCT PATENT BLUE V 2. QUALITATIVE AND QUANTITATIVE COMPOSITION PATENT BLUE V SODIUM ....................................................................................... 2.50 g per 100 ml of solution for injection For a full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Solution for injection 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. Marking lymph vessels and arterial regions. Marking sentinel nodes before biopsy in patients with operable breast cancer. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION 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. 4.3. CONTRAINDICATIONS Hypersensitivity to Patent Blue V, to any of the excipients or to triphenylmethane dyes. This medicinal product is generally not recommended during pregnancy. 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. Soma hati kamili