Akynzeo
ｵｭｰ: 悛淇 硫鮒
椋牟: ｶ一ｰｦｬ符牟
ｶ懍ｲ: EMA (European Medicines Agency)
劍梵 簿ｳｴ 卿 悛圷 ┳ｶ:
netupitant, palonosetron ﾑﾐｸﾐｴﾑﾐｾﾑﾐｻﾐｾﾑﾐｸﾐｴ
懋ｳｵｲ:
Helsinn Birex Pharmaceuticals Ltd
ATC ｽ罷糖:
A04AA
INN (International Name):
netupitant, palonosetron
ｹ俯｣ ｷｸ｣ｹ:
ﾐ籍ｽﾑひｸﾐｵﾐｼﾐｵﾑひｸﾑﾐｽﾐｸ ﾐｸ antinauseants,
ｹ俯｣ 溜:
Vomiting; Neoplasms; Nausea; Cancer
ｹ俯｣ ｧ倣寇:
Akynzeo ﾐｿﾐｾﾐｺﾐｰﾐｷﾐｰﾐｽ ﾐｿﾑﾐｸ ﾐｲﾑ諌ｷﾑﾐｰﾑﾑひｽﾐｸ ﾐｷﾐｰ ﾐｿﾑﾐｾﾑﾐｸﾐｻﾐｰﾐｺﾑひｸﾐｺﾐｰ ﾐｽﾐｰ ﾐｾﾑﾑびﾐｰ ﾐｸ ﾐｾﾑびﾑﾐｾﾑﾐｵﾐｽﾐｽﾐｾﾐｹ ﾐｽﾐｰ ﾐｳﾐｰﾐｴﾐｵﾐｽﾐｵ ﾐｸ ﾐｿﾐｾﾐｲﾑﾑ貫禍ｰﾐｽﾐｵ, ﾑﾐｲﾑ貫ﾐｷﾐｰﾐｽﾐｸ ﾑ ﾐｲﾐｸﾑﾐｾﾐｺﾐｾ emetogenic ﾐｽﾐｰ ﾑﾐｰﾐｺ ﾑ ﾑﾐｸﾐｼﾐｸﾐｾﾑひｵﾑﾐｰﾐｿﾐｸﾑ ﾐｽﾐｰ ﾐｱﾐｰﾐｷﾐｰﾑひｰ ﾐｽﾐｰ ﾑﾐｸﾑﾐｿﾐｻﾐｰﾑひｸﾐｽﾐｰ. ﾐ湲ﾐｾﾑﾐｸﾐｻﾐｰﾐｺﾑひｸﾐｺﾐｰ ﾐｽﾐｰ ﾐｾﾑﾑびﾐｰ ﾐｸ ﾐｾﾑびﾑﾐｾﾑﾐｵﾐｽﾐｽﾐｾﾐｹ ﾐｽﾐｰ ﾐｳﾐｰﾐｴﾐｵﾐｽﾐｵ ﾐｸ ﾐｿﾐｾﾐｲﾑﾑ貫禍ｰﾐｽﾐｵ, ﾑﾐｲﾑ貫ﾐｷﾐｰﾐｽﾐｸ ﾑ ﾑσｼﾐｵﾑﾐｵﾐｽﾐｾ emetogenic ﾑﾐｰﾐｺ ﾐｽﾐｰ ﾑﾐｸﾐｼﾐｸﾐｾﾑひｵﾑﾐｰﾐｿﾐｸﾑ.
懦宙 囈平:
Revision: 16
柑攤 メ:
ﾑσｿﾑ諌ｻﾐｽﾐｾﾐｼﾐｾﾑ禍ｵﾐｽ
柑攤 あｧ:
2015-05-27
劍梵 簿ｳｴ 卿
76
ﾐ. ﾐ嶢侑｡ﾐ｢ﾐ榧漬墟
77
ﾐ嶢侑｡ﾐ｢ﾐ榧漬墟: ﾐ侑斷､ﾐ榧ﾐ慴籍ｦﾐ侑ｯ ﾐ厘 ﾐ渙籍ｦﾐ侑片斷｢ﾐ
AKYNZEO 300 MG/0,5 MG ﾐ｢ﾐ漬ｪﾐﾐ頒 ﾐ墟籍渙｡ﾐ｣ﾐ嶢
ﾐｽﾐｵﾑびσｿﾐｸﾑひｰﾐｽﾑ/ﾐｿﾐｰﾐｻﾐｾﾐｽﾐｾﾑﾐｵﾑびﾐｾﾐｽ
(netupitant/palonosetron)
ﾐ渙ﾐ榧ｧﾐ片｢ﾐ片｢ﾐ ﾐ漬斷侑慴籍｢ﾐ片嶢斷 ﾐｦﾐｯﾐ嶢籍｢ﾐ ﾐ嶢侑｡ﾐ｢ﾐ榧漬墟,
ﾐ渙ﾐ片頒 ﾐ頒 ﾐ厘籍渙榧ｧﾐ斷片｢ﾐ ﾐ頒 ﾐ渙ﾐ侑片慴籍｢ﾐ ﾐ｢ﾐ榧漬
ﾐ嶢片墟籍ﾐ｡ﾐ｢ﾐ漬,
ﾐ｢ﾐｪﾐ ﾐ墟籍｢ﾐ ﾐ｢ﾐｯ ﾐ｡ﾐｪﾐ頒ｪﾐﾐ孟 ﾐ漬籍孟斷 ﾐ厘 ﾐ漬籍｡
ﾐ侑斷､ﾐ榧ﾐ慴籍ｦﾐ侑ｯ.
窶｢
ﾐ厘ｰﾐｿﾐｰﾐｷﾐｵﾑひｵ ﾑひｰﾐｷﾐｸ ﾐｻﾐｸﾑﾑひｾﾐｲﾐｺﾐｰ. ﾐ慴ｾﾐｶﾐｵ ﾐｴﾐｰ ﾑﾐｵ
ﾐｽﾐｰﾐｻﾐｾﾐｶﾐｸ ﾐｴﾐｰ ﾑ ﾐｿﾑﾐｾﾑﾐｵﾑひｵﾑひｵ ﾐｾﾑひｽﾐｾﾐｲﾐｾ.
窶｢
ﾐ籍ｺﾐｾ ﾐｸﾐｼﾐｰﾑひｵ ﾐｽﾑ紹ｺﾐｰﾐｺﾐｲﾐｸ ﾐｴﾐｾﾐｿﾑ諌ｻﾐｽﾐｸﾑひｵﾐｻﾐｽﾐｸ
ﾐｲﾑ諌ｿﾑﾐｾﾑﾐｸ, ﾐｿﾐｾﾐｿﾐｸﾑひｰﾐｹﾑひｵ ﾐ漬ｰﾑ威ｸﾑ ﾐｻﾐｵﾐｺﾐｰﾑ,
ﾑﾐｰﾑﾐｼﾐｰﾑﾐｵﾐｲﾑ ﾐｸﾐｻﾐｸ
ﾐｼﾐｵﾐｴﾐｸﾑﾐｸﾐｽﾑﾐｺﾐｰ ﾑﾐｵﾑﾑびﾐｰ.
窶｢
ﾐ｢ﾐｾﾐｲﾐｰ ﾐｻﾐｵﾐｺﾐｰﾑﾑﾑひｲﾐｾ ﾐｵ ﾐｿﾑﾐｵﾐｴﾐｿﾐｸﾑﾐｰﾐｽﾐｾ ﾐｻﾐｸﾑﾐｽﾐｾ ﾐｽﾐｰ
ﾐ漬ｰﾑ. ﾐ斷ｵ ﾐｳﾐｾ ﾐｿﾑﾐｵﾐｾﾑびﾑび諌ｿﾐｲﾐｰﾐｹﾑひｵ ﾐｽﾐｰ ﾐｴﾑﾑσｳﾐｸ
ﾑﾐｾﾑﾐｰ. ﾐ｢ﾐｾ ﾐｼﾐｾﾐｶﾐｵ
ﾐｴﾐｰ ﾐｸﾐｼ ﾐｽﾐｰﾐｲﾑﾐｵﾐｴﾐｸ, ﾐｽﾐｵﾐｷﾐｰﾐｲﾐｸﾑﾐｸﾐｼﾐｾ ﾑﾐｵ
ﾐｿﾑﾐｸﾐｷﾐｽﾐｰﾑﾐｸﾑひｵ ﾐｽﾐｰ ﾑび肖ﾐｽﾐｾﾑひｾ ﾐｷﾐｰﾐｱﾐｾﾐｻﾑ紹ｲﾐｰﾐｽﾐｵ ﾑﾐｰ
ﾑﾑ貫禍ｸﾑひｵ ﾐｺﾐｰﾑひｾ ﾐ漬ｰﾑ威ｸﾑひｵ.
窶｢
ﾐ籍ｺﾐｾ ﾐｿﾐｾﾐｻﾑτﾐｸﾑひｵ ﾐｽﾑ紹ｺﾐｰﾐｺﾐｲﾐｸ ﾐｽﾐｵﾐｶﾐｵﾐｻﾐｰﾐｽﾐｸ
ﾑﾐｵﾐｰﾐｺﾑﾐｸﾐｸ, ﾑσｲﾐｵﾐｴﾐｾﾐｼﾐｵﾑひｵ ﾐ漬ｰﾑ威ｸﾑ ﾐｻﾐｵﾐｺﾐｰﾑ,
ﾑﾐｰﾑﾐｼﾐｰﾑﾐｵﾐｲﾑ ﾐｸﾐｻﾐｸ
ﾐｼﾐｵﾐｴﾐｸﾑﾐｸﾐｽﾑﾐｺﾐｰ ﾑﾐｵﾑﾑびﾐｰ. ﾐ｢ﾐｾﾐｲﾐｰ ﾐｲﾐｺﾐｻﾑ紗ﾐｲﾐｰ ﾐｸ
ﾐｲﾑﾐｸﾑﾐｺﾐｸ ﾐｲﾑ諌ｷﾐｼﾐｾﾐｶﾐｽﾐｸ ﾐｽﾐｵﾐｶﾐｵﾐｻﾐｰﾐｽﾐｸ ﾑﾐｵﾐｰﾐｺﾑﾐｸﾐｸ,
ﾐｽﾐｵﾐｾﾐｿﾐｸﾑﾐｰﾐｽﾐｸ ﾐｲ
ﾑひｰﾐｷﾐｸ ﾐｻﾐｸﾑﾑひｾﾐｲﾐｺﾐｰ. ﾐ漬ｸﾐｶﾑひｵ ﾑひｾﾑﾐｺﾐｰ 4.
ﾐ墟籍墟漬 ﾐ｡ﾐｪﾐ頒ｪﾐﾐ孟 ﾐ｢ﾐ籍厘 ﾐ嶢侑｡ﾐ｢ﾐ榧漬墟
1.
ﾐ墟ｰﾐｺﾐｲﾐｾ ﾐｿﾑﾐｵﾐｴﾑﾑひｰﾐｲﾐｻﾑ紹ｲﾐｰ Akynzeo ﾐｸ ﾐｷﾐｰ ﾐｺﾐｰﾐｺﾐｲﾐｾ ﾑﾐｵ
ﾐｸﾐｷﾐｿﾐｾﾐｻﾐｷﾐｲﾐｰ
2.
ﾐ墟ｰﾐｺﾐｲﾐｾ ﾑびﾑ紹ｱﾐｲﾐｰ ﾐｴﾐｰ ﾐｷﾐｽﾐｰﾐｵﾑひｵ, ﾐｿﾑﾐｵﾐｴﾐｸ ﾐｴﾐｰ
ﾐｿﾑﾐｸﾐｵﾐｼﾐｵﾑひｵ Akynzeo
3.
ﾐ墟ｰﾐｺ ﾐｴﾐｰ ﾐｿﾑﾐｸﾐｵﾐｼﾐｰﾑひｵ Akynzeo
4.
ﾐ柘諌ｷﾐｼﾐｾﾐｶﾐｽﾐｸ ﾐｽﾐｵﾐｶﾐｵﾐｻﾐｰﾐｽﾐｸ ﾑﾐｵﾐｰﾐｺﾑﾐｸﾐｸ
5.
ﾐ墟ｰﾐｺ ﾐｴﾐｰ ﾑﾑ貫ﾑﾐｰﾐｽﾑ紹ｲﾐｰﾑひｵ Akynzeo
6.
ﾐ｡ﾑ諌ｴﾑ貫ﾐｶﾐｰﾐｽﾐｸﾐｵ ﾐｽﾐｰ ﾐｾﾐｿﾐｰﾐｺﾐｾﾐｲﾐｺﾐｰﾑひｰ ﾐｸ
ﾐｴﾐｾﾐｿﾑ諌ｻﾐｽﾐｸﾑひｵﾐｻﾐｽﾐｰ ﾐｸﾐｽﾑﾐｾﾑﾐｼﾐｰﾑﾐｸﾑ
1.
ﾐ墟籍墟漬 ﾐ渙ﾐ片頒｡ﾐ｢ﾐ籍漬嶢ｯﾐ漬 AKYNZEO ﾐ ﾐ厘 ﾐ墟籍墟漬 ﾐ｡ﾐ
ﾐ侑厘渙榧嶢厘漬
ﾐ墟籍墟漬 ﾐ渙ﾐ片頒｡ﾐ｢ﾐ籍漬嶢ｯﾐ漬 AKYNZEO
Akynzeo ﾑﾑ諌ｴﾑ貫ﾐｶﾐｰ ﾐｴﾐｲﾐｵ ﾐｻﾐｵﾐｺﾐｰﾑﾑﾑひ
ｲｴ ｬｸ 攷ｸｰ
懦宙 柑┳ 囈平
1
ﾐ渙ﾐ侑嶢榧孟片斷侑 I
ﾐ墟ﾐ籍｢ﾐ墟 ﾐ･ﾐ籍ﾐ籍墟｢ﾐ片ﾐ侑｡ﾐ｢ﾐ侑墟 ﾐ斷 ﾐ渙ﾐ榧頒｣ﾐ墟｢ﾐ
2
1.
ﾐ侑慴 ﾐ斷 ﾐ嶢片墟籍ﾐ｡ﾐ｢ﾐ漬片斷侑ｯ ﾐ渙ﾐ榧頒｣ﾐ墟｢
Akynzeo 300 mg/0,5 mg ﾑひｲﾑ貫ﾐｴﾐｸ ﾐｺﾐｰﾐｿﾑﾑσｻﾐｸ
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
ﾐ柘ﾑ紹ｺﾐｰ ﾑひｲﾑ貫ﾐｴﾐｰ ﾐｺﾐｰﾐｿﾑﾑσｻﾐｰ ﾑﾑ諌ｴﾑ貫ﾐｶﾐｰ 300 mg
ﾐｽﾐｵﾑびσｿﾐｸﾑひｰﾐｽﾑ (netupitant) ﾐｸ ﾐｿﾐｰﾐｻﾐｾﾐｽﾐｾﾑﾐｵﾑびﾐｾﾐｽﾐｾﾐｲ
ﾑﾐｸﾐｴﾑﾐｾﾑﾐｻﾐｾﾑﾐｸﾐｴ,
ﾐｵﾐｺﾐｲﾐｸﾐｲﾐｰﾐｻﾐｵﾐｽﾑひｵﾐｽ ﾐｽﾐｰ 0,5 mg ﾐｿﾐｰﾐｻﾐｾﾐｽﾐｾﾑﾐｵﾑびﾐｾﾐｽ
(palonosetron).
ﾐ渙ｾﾐｼﾐｾﾑ禍ｽﾐｸ ﾐｲﾐｵﾑ禍ｵﾑﾑひｲﾐｰ ﾑ ﾐｸﾐｷﾐｲﾐｵﾑﾑひｽﾐｾ ﾐｴﾐｵﾐｹﾑﾑひｲﾐｸﾐｵ
ﾐ柘ﾑ紹ｺﾐｰ ﾑひｲﾑ貫ﾐｴﾐｰ ﾐｺﾐｰﾐｿﾑﾑσｻﾐｰ ﾑﾑ諌ｴﾑ貫ﾐｶﾐｰ 7 mg
ﾑﾐｾﾑﾐｱﾐｸﾑひｾﾐｻ (E420)
ﾐｸ 20 mg ﾐｷﾐｰﾑﾐｰﾑﾐｾﾐｷﾐｰ.
ﾐ慴ｾﾐｶﾐｵ ﾐｴﾐｰ ﾑﾑ諌ｴﾑ貫ﾐｶﾐｰ ﾑﾑ貫禍ｾ ﾑﾐｻﾐｵﾐｴﾐｸ ﾐｾﾑ ﾐｻﾐｵﾑﾐｸﾑひｸﾐｽ,
ﾐｿﾐｾﾐｻﾑτﾐｵﾐｽ ﾐｾﾑ ﾑﾐｾﾑ.
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 ﾐｿﾐｾﾐｼﾐｾﾑ禍ｽﾐｸﾑひｵ
ﾐｲﾐｵﾑ禍ｵﾑﾑひｲﾐｰ ﾐｲﾐｸﾐｶﾑひｵ ﾑひｾﾑﾐｺﾐｰ
6.1.
3.
ﾐ嶢片墟籍ﾐ｡ﾐ｢ﾐ漬片斷 ﾐ､ﾐ榧ﾐ慴
ﾐ｢ﾐｲﾑ貫ﾐｴﾐｰ ﾐｺﾐｰﾐｿﾑﾑσｻﾐｰ
ﾐ斷ｵﾐｿﾑﾐｾﾐｷﾑﾐｰﾑﾐｽﾐｰ ﾐｶﾐｵﾐｻﾐｰﾑひｸﾐｽﾐｾﾐｲﾐｰ ﾐｺﾐｰﾐｿﾑﾑσｻﾐｰ ﾑ
ﾑﾐｰﾐｷﾐｼﾐｵﾑ 窶0窶 (ﾐｴﾑ諌ｻﾐｶﾐｸﾐｽﾐｰ 21,7 mm) ﾑ ﾐｱﾑ紹ｻﾐｾ ﾑび紹ｻﾐｾ ﾐｸ
ﾐｺﾐｰﾐｿﾐｰﾑﾐｵ ﾑ
ﾐｺﾐｰﾑﾐｰﾐｼﾐｵﾐｻﾐｵﾐｽ ﾑﾐｲﾑ肖 ﾑ ﾐｾﾑひｿﾐｵﾑﾐｰﾑひｰﾐｽﾐｾ 窶曰E1窶
ﾐｲﾑ貫ﾑﾑ ﾑび紹ｻﾐｾﾑひｾ. ﾐ｢ﾐｲﾑ貫ﾐｴﾐｰﾑひｰ ﾐｺﾐｰﾐｿﾑﾑσｻﾐｰ ﾐｵ
ﾐｽﾐｰﾐｿﾑ諌ｻﾐｽﾐｵﾐｽﾐｰ ﾑ ﾑびﾐｸ ﾑひｰﾐｱﾐｻﾐｵﾑひｺﾐｸ
ﾐｸ ﾐｵﾐｴﾐｽﾐｰ ﾐｼﾐｵﾐｺﾐｰ ﾐｺﾐｰﾐｿﾑﾑσｻﾐｰ.
4.
ﾐ墟嶢侑斷侑ｧﾐ斷 ﾐ頒籍斷斷
4.1
ﾐ｢ﾐ片ﾐ籍渙片漬｢ﾐ侑ｧﾐ斷 ﾐ渙榧墟籍厘籍斷侑ｯ
Akynzeo ﾐｵ ﾐｿﾐｾﾐｺﾐｰﾐｷﾐｰﾐｽ ﾐｿﾑﾐｸ ﾐｲﾑ諌ｷﾑﾐｰﾑﾑひｽﾐｸ ﾐｷﾐｰ:
-
ﾐ湲ﾐｵﾐｴﾐｾﾑひｲﾑﾐｰﾑび紹ｲﾐｰﾐｽﾐｵ ﾐｽﾐｰ ﾐｾﾑﾑびﾐｾ ﾐｸ ﾐｷﾐｰﾐｱﾐｰﾐｲﾐｵﾐｽﾐｾ
ﾐｳﾐｰﾐｴﾐｵﾐｽﾐｵ ﾐｸ ﾐｿﾐｾﾐｲﾑﾑ貫禍ｰﾐｽﾐｵ, ﾑﾐｲﾑ貫ﾐｷﾐｰﾐｽﾐｸ ﾑﾑ貫 ﾑﾐｸﾐｻﾐｽﾐｾ
ﾐｵﾐｼﾐｵﾑひｾﾐｳﾐｵﾐｽﾐｽﾐｰ
ﾐｱﾐｰﾐｷﾐｸﾑﾐｰﾐｽﾐｰ ﾐｽﾐｰ ﾑﾐｸﾑﾐｿﾐｻﾐｰﾑひｸﾐｽ ﾐｿﾑﾐｾﾑひｸﾐｲﾐｾﾑﾐｰﾐｺﾐｾﾐｲﾐｰ
ﾑﾐｸﾐｼﾐｸﾐｾﾑひｵﾑﾐｰﾐｿﾐｸﾑ.
-
ﾐ湲ﾐｵﾐｴﾐｾﾑひｲﾑﾐｰﾑび紹ｲﾐｰﾐｽﾐｵ ﾐｽﾐｰ ﾐｾﾑﾑびﾐｾ ﾐｸ ﾐｷﾐｰﾐｱﾐｰﾐｲﾐｵﾐｽﾐｾ
ﾐｳﾐｰﾐｴﾐｵﾐｽﾐｵ ﾐｸ ﾐｿﾐｾﾐｲﾑﾑ貫禍ｰﾐｽﾐｵ, ﾑﾐｲﾑ貫ﾐｷﾐｰﾐｽﾐｸ ﾑ ﾑσｼﾐｵﾑﾐｵﾐｽﾐｾ
ﾐｵﾐｼﾐｵﾑひｾﾐｳﾐｵﾐｽﾐｽﾐｰ ﾐｿﾑﾐｾﾑひｸﾐｲﾐｾﾑﾐｰﾐｺﾐｾﾐｲﾐｰ
ﾑﾐｸﾐｼﾐｸﾐｾﾑひｵﾑﾐｰﾐｿﾐｸﾑ.
4.2
ﾐ頒榧厘侑ﾐ榧漬墟 ﾐ ﾐ斷籍ｧﾐ侑 ﾐ斷 ﾐ渙ﾐ侑嶢榧孟片斷侑
ﾐ頒ｾﾐｷ
ﾐｸﾑﾐｾﾐｲﾐｺﾐｰ
ﾐ片ｴﾐｽﾐｰ ﾐｺﾐｰﾐｿﾑﾑσｻﾐｰ ﾐｾﾑ 300 mg/0,5 mg ﾑびﾑ紹ｱﾐｲﾐｰ ﾐｴﾐｰ ﾑﾐｵ
ﾐｿﾑﾐｸﾐｻﾐｰﾐｳﾐ
ｲｴ ｬｸ 攷ｸｰ
