EUTHANASIN N solutio pro injectionibus
ﾐ｡ﾑびﾐｰﾐｽﾐｰ: ﾐ帯諌ｻﾐｳﾐｰﾑﾐｸﾑ
ﾐ片ｷﾐｸﾐｺ: ﾐｱﾑ諌ｻﾐｳﾐｰﾑﾑﾐｺﾐｸ
ﾐ侑ｷﾑひｾﾑﾐｽﾐｸﾐｺ: ﾐ岱籍岱･ (ﾐ帯諌ｻﾐｳﾐｰﾑﾑﾐｺﾐｰ ﾐｰﾐｳﾐｵﾐｽﾑﾐｸﾑ ﾐｿﾐｾ ﾐｱﾐｵﾐｷﾐｾﾐｿﾐｰﾑﾐｽﾐｾﾑﾑ ﾐｽﾐｰ ﾑﾑﾐｰﾐｽﾐｸﾑひｵ)
ﾐ頒ｰﾐｽﾐｽﾐｸ ﾐｷﾐｰ ﾐｿﾑﾐｾﾐｴﾑσｺﾑひｰ
(SPC)
25-06-2022
ﾐ渙ｾﾐｽﾐｰﾑﾑひｾﾑ肖禍ｵﾐｼ ﾐｽﾑ紹ｺﾐｾﾐｸ ﾐｴﾐｾﾐｺﾑσｼﾐｵﾐｽﾑひｸ ﾐｷﾐｰ ﾑひｾﾐｷﾐｸ ﾐｿﾑﾐｾﾐｴﾑσｺﾑ ﾐｽﾐｵ ﾑﾐｰ ﾐｽﾐｰﾐｻﾐｸﾑﾐｽﾐｸ, ﾐｼﾐｾﾐｶﾐｵﾑひｵ ﾐｴﾐｰ ﾐｸﾐｷﾐｿﾑﾐｰﾑひｸﾑひｵ ﾐｷﾐｰﾑ紹ｲﾐｺﾐｰ ﾐｴﾐｾ ﾐｽﾐｰﾑ威ｰﾑひｰ ﾑﾐｻﾑσｶﾐｱﾐｰ ﾐｷﾐｰ ﾐｺﾐｻﾐｸﾐｵﾐｽﾑひｸ ﾐｸ ﾐｽﾐｸﾐｵ ﾑ禍ｵ ﾐｲﾐｸ ﾑσｲﾐｵﾐｴﾐｾﾐｼﾐｸﾐｼ ﾐｲﾐｵﾐｴﾐｽﾐｰﾐｳﾐｰ ﾑ禍ｾﾐｼ ﾑτﾐｿﾐｵﾐｵﾐｼ ﾐｴﾐｰ ﾐｳﾐｸ ﾐｿﾐｾﾐｻﾑτﾐｸﾐｼ.
ﾐ侑ｷﾐｿﾑﾐｰﾑひｸ ﾐｷﾐｰﾑ紹ｲ.
ﾐ侑ｷﾐｿﾑﾐｰﾑひｸ ﾐｷﾐｰﾑ紹ｲ.
ﾐ籍ｺﾑひｸﾐｲﾐｽﾐｰ ﾑﾑ貫ﾑひｰﾐｲﾐｺﾐｰ:
Procain ﾑﾐｸﾐｴﾑﾐｾﾑﾐｻﾐｾﾑﾐｸﾐｴ, ﾐｺﾐｰﾐｻﾐｸﾐｵﾐｲ ﾑﾐｻﾐｾﾑﾐｸﾐｴ
ﾐ湲ﾐｵﾐｴﾐｻﾐｰﾐｳﾐｰ ﾑﾐｵ ﾐｾﾑ:
ﾐ漬片｢ﾐ渙ﾐ榧 ﾐ籍
ﾐ籍｢ﾐ｡ ﾐｺﾐｾﾐｴ:
QA12BA51
INN (ﾐ慴ｵﾐｶﾐｴﾑσｽﾐｰﾑﾐｾﾐｴﾐｽﾐｾ Name):
Procain hydrochloride, Potassium chloride
ﾐｴﾐｾﾐｷﾐｸﾑﾐｰﾐｽﾐｵ:
40 000 g/100 ml; 5 000 g/100 ml
ﾐ嶢ｵﾐｺﾐｰﾑﾑﾑひｲﾐｵﾐｽﾐｰ ﾑﾐｾﾑﾐｼﾐｰ:
ﾐｸﾐｽﾐｶﾐｵﾐｺﾑﾐｸﾐｾﾐｽﾐｵﾐｽ ﾑﾐｰﾐｷﾑひｲﾐｾﾑ
ﾐ斷ｰﾑﾐｸﾐｽ ﾐｽﾐｰ ﾐｿﾑﾐｸﾐｻﾐｾﾐｶﾐｵﾐｽﾐｸﾐｵ:
ﾐｸﾐｽﾑびﾐｰﾐｲﾐｵﾐｽﾐｾﾐｷﾐｽﾐｾ ﾐｿﾑﾐｸﾐｻﾐｾﾐｶﾐｵﾐｽﾐｸﾐｵ, ﾐｸﾐｽﾑびﾐｰﾐｺﾐｰﾑﾐｴﾐｸﾐｰﾐｻﾐｽﾐｾ ﾐｿﾑﾐｸﾐｻﾐｾﾐｶﾐｵﾐｽﾐｸﾐｵ, ﾐｸﾐｽﾑびﾐｰﾐｿﾑσｻﾐｼﾐｾﾐｽﾐｰﾐｻﾐｽﾐｾ ﾐｿﾑﾐｸﾐｻﾐｾﾐｶﾐｵﾐｽﾐｸﾐｵ
ﾐ漬ｸﾐｴ ﾐｿﾑﾐｵﾐｴﾐｿﾐｸﾑﾐｰﾐｽﾐｸﾐｵ :
ﾐ渙ｾ ﾐｻﾐｵﾐｺﾐｰﾑﾑﾐｺﾐｾ ﾐｿﾑﾐｵﾐｴﾐｿﾐｸﾑﾐｰﾐｽﾐｸﾐｵ
ﾐ湲ﾐｾﾐｸﾐｷﾐｲﾐｵﾐｴﾐｵﾐｽﾐｾ ﾐｾﾑ:
ﾐ漬片｢ﾐ渙ﾐ榧 ﾐ籍
ﾐ｢ﾐｵﾑﾐｰﾐｿﾐｵﾐｲﾑひｸﾑﾐｽﾐｰ ﾐｳﾑﾑσｿﾐｰ:
ﾐｺﾐｾﾑひｺﾐｸ, ﾐｺﾑτﾐｵﾑひｰ
ﾐ墟ｰﾑひｰﾐｻﾐｾﾐｳ ﾐｽﾐｰ ﾑﾐｵﾐｷﾑ社ｼﾐｵ:
ﾐ墟ｰﾑﾐｵﾐｽﾑひｵﾐｽ ﾑﾑﾐｾﾐｺ: ﾐｽﾐｵ ﾐｵ ﾐｿﾑﾐｸﾐｻﾐｾﾐｶﾐｸﾐｼﾐｾ
ﾐ｡ﾑひｰﾑびτ ﾐ樮ひｾﾑﾐｸﾐｷﾐｰﾑﾐｸﾑ:
ﾐｲﾐｰﾐｻﾐｸﾐｴﾐｵﾐｽ
ﾐ頒ｰﾑひｰ ﾐ樮ひｾﾑﾐｸﾐｷﾐｰﾑﾐｸﾑ:
2014-10-17
ﾐ頒ｰﾐｽﾐｽﾐｸ ﾐｷﾐｰ ﾐｿﾑﾐｾﾐｴﾑσｺﾑひｰ
1
ﾐ墟ﾐ籍｢ﾐ墟 ﾐ･ﾐ籍ﾐ籍墟｢ﾐ片ﾐ侑｡ﾐ｢ﾐ侑墟 ﾐ斷
ﾐ漬片｢ﾐ片ﾐ侑斷籍ﾐ斷榧慴片頒侑ｦﾐ侑斷｡ﾐ墟
ﾐ渙ﾐ榧頒｣ﾐ墟｢ ﾐ｡ ﾐ嶢侑ｦﾐ片斷 ﾐ厘 ﾐ｣ﾐ渙榧｢ﾐﾐ片岱 邃
0022-2393/17.10.2014
1.
ﾐ斷籍侑慴片斷榧漬籍斷侑 ﾐ斷
ﾐ漬片｢ﾐ片ﾐ侑斷籍ﾐ斷榧慴片頒侑ｦﾐ侑斷｡ﾐ墟侑ｯ
ﾐ渙ﾐ榧頒｣ﾐ墟｢
ﾐ片漬｢ﾐ籍斷籍厘侑 窶榧昶
ﾂｮ
ﾐｸﾐｽﾐｶﾐｵﾐｺﾑﾐｸﾐｾﾐｽﾐｵﾐｽ ﾑﾐｰﾐｷﾑひｲﾐｾﾑ
EUTHANASIN 窶廸窶
ﾂｮ
solutio pro injectionibus
2. ﾐ墟籍ｧﾐ片｡ﾐ｢ﾐ漬片 ﾐ ﾐ墟榧嶢侑ｧﾐ片｡ﾐ｢ﾐ漬片 ﾐ｡ﾐｪﾐ｡ﾐ｢ﾐ籍
ﾐ籍ｺﾑひｸﾐｲﾐｽﾐｰ ﾑﾑσｱﾑﾑひｰﾐｽﾑﾐｸﾑ:
Procain hydrochloride 40,000 g/100 ml
Potassium chloride 5,000 g/100 ml
ﾐ片ｺﾑﾑﾐｸﾐｿﾐｸﾐｵﾐｽﾑひｸ:
ﾐ厘ｰ ﾐｿﾑ諌ｻﾐｽﾐｸﾑ ﾑﾐｿﾐｸﾑﾑ諌ｺ ﾐｽﾐｰ ﾐｵﾐｺﾑﾑﾐｸﾐｿﾐｸﾐｵﾐｽﾑひｸﾑひｵ, ﾐｲﾐｶ.
ﾑひｾﾑﾐｺﾐｰ 6.1.
3. ﾐ､ﾐ籍ﾐ慴籍ｦﾐ片漬｢ﾐ侑ｧﾐ斷 ﾐ､ﾐ榧ﾐ慴
ﾐ侑ｽﾐｶﾐｵﾐｺﾑﾐｸﾐｾﾐｽﾐｵﾐｽ ﾑﾐｰﾐｷﾑひｲﾐｾﾑ.
4. ﾐ墟嶢侑斷侑ｧﾐ斷 ﾐ頒籍斷斷
4.1 ﾐ漬ｸﾐｴﾐｾﾐｲﾐｵ ﾐｶﾐｸﾐｲﾐｾﾑひｽﾐｸ, ﾐｷﾐｰ ﾐｺﾐｾﾐｸﾑひｾ ﾐｵ
ﾐｿﾑﾐｵﾐｴﾐｽﾐｰﾐｷﾐｽﾐｰﾑﾐｵﾐｽ ﾐ漬慴
ﾐ墫τﾐｵﾑひｰ ﾐｸ ﾐｺﾐｾﾑひｺﾐｸ.
4.2
ﾐ｢ﾐｵﾑﾐｰﾐｿﾐｵﾐｲﾑひｸﾑﾐｽﾐｸ
ﾐｿﾐｾﾐｺﾐｰﾐｷﾐｰﾐｽﾐｸﾑ,
ﾐｾﾐｿﾑﾐｵﾐｴﾐｵﾐｻﾐｵﾐｽﾐｸ
ﾐｷﾐｰ
ﾐｾﾑひｴﾐｵﾐｻﾐｽﾐｸﾑひｵ
ﾐｲﾐｸﾐｴﾐｾﾐｲﾐｵ ﾐｶﾐｸﾐｲﾐｾﾑひｽﾐｸ
ﾐ厘ｰ ﾐｱﾐｵﾐｷﾐｱﾐｾﾐｻﾐｵﾐｷﾐｽﾐｵﾐｽﾐｾ, ﾑﾑσｼﾐｰﾐｽﾐｽﾐｾ ﾐｸ ﾐｱﾐｵﾐｷ
ﾑﾑびﾐｰﾑﾐｾﾐｲﾐｸ ﾑﾐｵﾐｰﾐｺﾑﾐｸﾐｸ ﾐｸ
ﾐｱﾐｵﾐｷﾐｿﾐｾﾐｺﾐｾﾐｹﾑﾑひｲﾐｸﾐｵ
ﾑσｼﾑ貫ﾑひｲﾑ紹ｲﾐｰﾐｽﾐｵ
ﾐｽﾐｰ
ﾐｽﾐｵﾐｻﾐｵﾑﾐｸﾐｼﾐｾ
ﾐｱﾐｾﾐｻﾐｽﾐｸ
ﾐｸﾐｻﾐｸ
ﾐｿﾑﾐｵﾑﾑひｰﾑﾐｵﾐｻﾐｸ
ﾐｺﾑτﾐｵﾑひｰ
ﾐｸ
ﾐｺﾐｾﾑひｺﾐｸ,
ﾐｿﾐｾ
ﾐｲﾐｾﾐｻﾑ肖ひｰ
ﾐｸ
ﾐｴﾐｵﾐｺﾐｻﾐｰﾑﾐｸﾑﾐｰﾐｽﾐｾﾑひｾ
ﾑﾑ諌ｳﾐｻﾐｰﾑﾐｸﾐｵ ﾐｽﾐｰ ﾑﾑひｾﾐｿﾐｰﾐｽﾐｸﾑひｵ ﾐｸ ﾐｿﾑﾐｵﾑﾐｵﾐｽﾐｺﾐｰ ﾐｽﾐｰ
ﾐｻﾐｵﾐｺﾑσｲﾐｰﾑ禍ｸﾑ ﾐｲﾐｵﾑひｵﾑﾐｸﾐｽﾐｰﾑﾐｵﾐｽ
ﾐｻﾐｵﾐｺﾐｰﾑ.
4.3.ﾐ湲ﾐｾﾑひｸﾐｲﾐｾﾐｿﾐｾﾐｺﾐｰﾐｷﾐｰﾐｽﾐｸﾑ
ﾐ旃紹ｼﾐｰ ﾐｴﾐｰﾐｽﾐｽﾐｸ.
4.4.ﾐ｡ﾐｿﾐｵﾑﾐｸﾐｰﾐｻﾐｽﾐｸ ﾐｿﾑﾐｵﾐｴﾐｿﾐｰﾐｷﾐｽﾐｸ ﾐｼﾐｵﾑﾐｺﾐｸ ﾐｷﾐｰ ﾐｲﾑﾐｵﾐｺﾐｸ
ﾐｲﾐｸﾐｴ ﾐｶﾐｸﾐｲﾐｾﾑひｽﾐｸ, ﾐｷﾐｰ
ﾐｺﾐｾﾐｸﾑひｾ ﾐｵ ﾐｿﾑﾐｵﾐｴﾐｽﾐｰﾐｷﾐｽﾐｰﾑﾐｵﾐｽ ﾐ漬慴
ﾐ湲ﾐｾﾐｴﾑσｺﾑび貫
ﾑﾐｵ
ﾐｿﾑﾐｸﾐｻﾐｰﾐｳﾐｰ
ﾑﾐｰﾐｼﾐｾ
ﾐｲﾑ諌ｲ
ﾐｲﾐｵﾑひｵﾑﾐｸﾐｽﾐｰﾑﾐｽﾐｰﾑひｰ
ﾐｼﾐｵﾐｴﾐｸﾑﾐｸﾐｽﾐｰ ﾐｾﾑ ﾐｲﾐｵﾑひｵﾑﾐｸﾐｽﾐｰﾑﾐｽﾐｸ ﾐｻﾐｵﾐｺﾐｰﾑﾐｸ.
4.5. ﾐ｡ﾐｿﾐｵﾑﾐｸﾐｰﾐｻﾐｽﾐｸ ﾐｿﾑﾐｵﾐｴﾐｿﾐｰﾐｷﾐｽﾐｸ ﾐｼﾐｵﾑﾐｺﾐｸ ﾐｿﾑﾐｸ
ﾑσｿﾐｾﾑびﾐｵﾐｱﾐｰ
ﾐ｡ﾐｿﾐｵﾑﾐｸﾐｰﾐｻﾐｽﾐｸ ﾐｿﾑﾐｵﾐｴﾐｿﾐｰﾐｷﾐｽﾐｸ ﾐｼﾐｵﾑﾐｺﾐｸ ﾐｷﾐｰ
ﾐｶﾐｸﾐｲﾐｾﾑひｽﾐｸﾑひｵ ﾐｿﾑﾐｿﾐｸ ﾑσｿﾐｾﾑびﾐｵﾐｱﾐｰﾑひｰ
ﾐｽﾐｰ ﾐｿﾑﾐｾﾐｴﾑσｺﾑひｰ
ﾐ斷ｵ ﾐｵ ﾐｿﾑﾐｸﾐｻﾐｾﾐｶﾐｸﾐｼﾐｾ.
2
ﾐ｡ﾐｿﾐｵﾑﾐｸﾐｰﾐｻﾐｽﾐｸ
ﾐｿﾑﾐｵﾐｴﾐｿﾐｰﾐｷﾐｽﾐｸ
ﾐｼﾐｵﾑﾐｺﾐｸ
ﾐｷﾐｰ
ﾐｻﾐｸﾑﾐｰﾑひｰ,
ﾐｿ
ﾐ湲ﾐｾﾑﾐｵﾑひｵﾑひｵ ﾑﾐｵﾐｻﾐｸﾑ ﾐｴﾐｾﾐｺﾑσｼﾐｵﾐｽﾑ
