דצמבר 2009

 

 

רופא/ה נכבד/ה
רוקח/ת נכבד/ה

 

הנדון: החמרות בעלון לצרכן במתכונת עלון לרופא של התכשיר


Carboplatin "Ebewe" 10 mg/ml

 

ברצוננו להביא לידיעתכם את ההחמרות שהוספו לעלון לצרכן במתכונת עלון לרופא של התכשיר בנדון:


Precautions: Carboplatin may cause
nausea and vomiting, indirectly
impairing the ability to drive and use
.machines

 

Warnings: Premedication with
antiemetics and slower drug
administration have been reported to
be useful in reducing the incidence and
.intensity of these effects
In patients pretreated with platinum
containing medicinal products the
risk of allergic reactions, including
.anaphylaxis is increased
Safety and efficacy of carboplatin
in pediatric patients have not been
.established

 

Contraindications: Carboplatin
is contraindicated in patients with
.bleeding tumors
.Pregnancy and lactation period

 

Drug Interactions: Concomitant
administration of carboplatin and
complex forming compounds should
be avoided as theoretically, the
antineoplastic effects of carboplatin
might be decreased. However, in
animals and clinically, the antineoplastic
effects of carboplatin were not
.influenced by diethylthiocarbamate
A decrease in phenytoin serum
level has been reported following
concomitant administration of
carboplatin and phenytoin. This may
lead to reappearance of seizures and
may require an increase of phenytoin
.dosages

 


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