PATENT BLUE V

Nchi: Israeli

Lugha: Kiingereza

Chanzo: Ministry of Health

Nunua Sasa

Taarifa za kipeperushi Taarifa za kipeperushi (PIL)
17-08-2016
Tabia za bidhaa Tabia za bidhaa (SPC)
11-10-2022

Viambatanisho vya kazi:

PATENT BLUE V SODIUM

Inapatikana kutoka:

PROMEDICO LTD

ATC kanuni:

V04CX

Dawa fomu:

SOLUTION FOR INJECTION

Tungo:

PATENT BLUE V SODIUM 25 MG/ML

Njia ya uendeshaji:

S.C, INTRA-ARTERIAL

Dawa ya aina:

Required

Viwandani na:

GUERBET, FRANCE

Kundi la matibabu:

OTHER DIAGNOSTIC AGENTS

Matibabu dalili:

Marking lymph vessels and arterial regions.Marking sentinel nodes before biopsy in patients with operable breast cancer.

Idhini ya tarehe:

2023-06-30

Taarifa za kipeperushi

                                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
                                
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Tabia za bidhaa

                                _ _
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.

                                
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