ZOFRAN TABLETS 8 MG

Israel - English - Ministry of Health

Buy It Now

Active ingredient:
ONDANSETRON AS HYDROCHLORIDE DIHYDRATE
Available from:
NOVARTIS ISRAEL LTD
ATC code:
A04AA01
Pharmaceutical form:
TABLETS
Composition:
ONDANSETRON AS HYDROCHLORIDE DIHYDRATE 8 MG
Administration route:
PER OS
Prescription type:
Required
Manufactured by:
ASPEN BAD OLDESLOE GMBH, GERMANY
Therapeutic group:
ONDANSETRON
Therapeutic area:
ONDANSETRON
Therapeutic indications:
Adults:Zofran is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. Zofran is indicated for the prevention and treatment of post-operative nausea and vomiting (PONV). Paediatric Population:Zofran is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy.
Authorization number:
049 95 26560 22
Authorization date:
2020-07-31

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

17-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

16-07-2020

:ﻝﺎﻔﻃﻷﺍ ﻱﻭﺎﻤﻴﻜﻟﺍ ﺝﻼﻌﻟﺍ ﺀﺍﺮﺟ ﺕﺍﺆﻴﻘﺘﻟﺍﻭ ﻥﺎﻴﺜﻐﻟﺍ ﺝﻼﻌﻟ ﺔﺣﺎﺴﻣ) ﻞﻔﻄﻟﺍ ﺲﻴﻳﺎﻘﻣ ﺭﺎﺒﺘﻋﻹﺍ ﻦﻴﻌﺑ

ﺍﺬﺧﺁ ﺔﻴﺋﺍﻭﺪﻟﺍ ﺔﻋﺮﺠﻟﺍ ﺐﻴﺒﻄﻟﺍ ﺩﺪﺤﻳ .(ﻢﺴﺠﻟﺍ (ﻂﻘﻓ ﺭﺎﺒﻜﻟﺍ) ﺔﻴﺣﺍﺮﺟ ﺔﻴﻠﻤﻋ ﺪﻌﺑ ﺕﺍﺆﻴﻘﺘﻟﺍﻭ ﻥﺎﻴﺜﻐﻟﺍ ﺝﻼﻋﻭ ﻊﻨﻤﻟ ﺔﺻﺎﺨﻟﺍ ﺔﻴﺣﺍﺮﺠﻟﺍ ﺔﻴﻠﻤﻌﻟﺍ ﻞﺒﻗ ﻎﻠﻣ 16 ﻲﻫ ﺭﺎﺒﻜﻠﻟ ﺔﻳﺩﺎﻴﺘﻋﻹﺍ ﺔﻴﺋﺍﻭﺪﻟﺍ ﺔﻋﺮﺠﻟﺍ .ﻚﺑ (ﻂﻘﻓ ﺭﺎﺒﻜﻟﺍ) ﺪﺒﻜﻟﺍ ﻲﻓ ﺓﺪﻳﺪﺷ ﻭﺃ ﺔﻟﺪﺘﻌﻣ ﻞﻛﺎﺸﻣ ﻢﻬﻳﺪﻟ ﻥﻮﺠﻟﺎﻌﻣ .ﻎﻠﻣ 8 ﺯﻭﺎﺠﺘﺗ ﻻﺃ ﺐﺠﻳ ﺔﻴﻟﺎﻤﺟﻹﺍ ﺔﻴﻣﻮﻴﻟﺍ ﺔﻴﺋﺍﻭﺪﻟﺍ ﺔﻋﺮﺠﻟﺍ .ﺔﻴﺋﺍﻭﺪﻟﺍ ﺔﻋﺮﺠﻟﺍ ﻝﻭﺎﻨﺗ ﻦﻣ ﻦﻴﺘﻋﺎﺳ ﻭﺃ ﺔﻋﺎﺳ ﻝﻼﺧ ﻥﺍﺮﻓﻭﺯ ﺹﺍﺮﻗﺃ ﻝﻮﻌﻔﻣ ﺃﺪﺒﻳ ﺎﻬﺑ ﻰﺻﻮﻤﻟﺍ ﺔﻴﺋﺍﻭﺪﻟﺍ ﺔﻋﺮﺠﻟﺍ ﺯﻭﺎﺠﺗ ﺯﻮﺠﻳ ﻻ ﺔﻴﺋﺍﻭﺪﻟﺍ ﺔﻋﺮﺠﻟﺍ ﻝﻭﺎﻨﺗ ﻦﻣ ﺔﻋﺎﺳ ﻝﻼﺧ ﺕﺄﻴﻘﺗ ﺍﺫﺇ ﺔﻴﻧﺎﺛ ﺓﺮﻣ ﺔﻴﺋﺍﻭﺪﻟﺍ ﺔﻋﺮﺠﻟﺍ ﺲﻔﻧ ﻝﻭﺎﻨﺗ .ﺐﻴﺒﻄﻟﺍ ﻪﺑ ﻙﺎﺻﻭﺃ ﺎﻤﻣ ﺮﺜﻛﺃ ﻥﺍﺮﻓﻭﺯ ﺹﺍﺮﻗﺃ ﻝﻭﺎﻨﺘﺗ ﻼﻓ ،ﻻﺇﻭ .ﻚﺒﻴﺒﻄﻟ ﻚﺣﺇ ،ﻚﻳﺪﻟ ﻥﺎﻴﺜﻐﻟﺎﺑ ﺭﻮﻌﺸﻟﺍ ﺮﻤﺘﺳﺇ ﺍﺫﺇ .ﺎﻬﻐﻀﻣ ﻭﺃ ﺎﻫﺮﻄﺷ ،ﺎﻬﻘﺤﺳ ﺯﻮﺠﻳ ﻻﻭ ﺔﻴﻠﻄﻣ ﺹﺍﺮﻗﻷﺍ ﻥﺇ ﺮﺒﻛﺃ ﺔﻴﺋﺍﻭﺩ ﺔﻋﺮﺟ ﺄﻄﺨﻟﺎﺑ ﺖﻟﻭﺎﻨﺗ ﺍﺫﺇ ﺐﻴﺒﻄﻠﻟ

ﻻﺎﺣ ﻪﺟﻮﺗ ،ﺀﺍﻭﺪﻟﺍ ﻦﻣ ﺄﻄﺨﻟﺎﺑ ﻞﻔﻃ ﻊﻠﺑ ﺍﺫﺇ ﻭﺃ ﺔﻃﺮﻔﻣ ﺔﻴﺋﺍﻭﺩ ﺔﻋﺮﺟ ﺖﻟﻭﺎﻨﺗ ﺍﺫﺇ .ﻚﻌﻣ ﺀﺍﻭﺪﻟﺍ ﺔﺒﻠﻋ ﺮﻀﺣﺃﻭ ﻰﻔﺸﺘﺴﻤﻟﺍ ﻲﻓ ﺉﺭﺍﻮﻄﻟﺍ ﺔﻓﺮﻐﻟ ﻭﺃ ﺀﺍﻭﺪﻟﺍ ﻝﻭﺎﻨﺗ ﺖﻴﺴﻧ ﺍﺫﺇ :ﺄﻴﻘﺘﺗ ﻭﺃ ﻥﺎﻴﺜﻐﺑ ﺮﻌﺸﺗ ﺖﻨﻛﻭ ﺔﻴﺋﺍﻭﺩ ﺔﻋﺮﺟ ﺖﻴﺴﻧ ﺍﺫﺇ ﻢﺛ ﻦﻣﻭ ،ﻦﻜﻤﻳ ﺎﻣ ﻉﺮﺳﺃ ﻲﻓ ﻥﺍﺮﻓﻭﺯ ﺹﺍﺮﻗﺃ ﻝﻭﺎﻨﺗ .ﻱﺩﺎﻴﺘﻋﻹﺍ ﺪﻋﻮﻤﻟﺍ ﻲﻓ ﻚﺑ ﺹﺎﺨﻟﺍ ﻲﻟﺎﺘﻟﺍ ﺹﺮﻘﻟﺍ ﻝﻭﺎﻨﺗ ﺔﻴﺋﺍﻭﺪﻟﺍ ﺔﻋﺮﺠﻟﺍ ﻦﻋ ﺾﻳﻮﻌﺘﻠﻟ ﺔﻔﻋﺎﻀﻣ ﺔﻴﺋﺍﻭﺩ ﺔﻋﺮﺟ ﻝﻭﺎﻨﺗ ﺯﻮﺠﻳ ﻻ

.ﺔﻴﺴﻨﻤﻟﺍ :ﻥﺎﻴﺜﻐﺑ ﺮﻌﺸﺗ ﻻ ﻚﻨﻜﻟ ﺔﻴﺋﺍﻭﺩ ﺔﻋﺮﺟ ﺖﻴﺴﻧ ﺍﺫﺇ .ﻱﺩﺎﻴﺘﻋﻹﺍ ﺪﻋﻮﻤﻟﺍ ﻲﻓ ﺔﻴﻟﺎﺘﻟﺍ ﺔﻴﺋﺍﻭﺪﻟﺍ ﺔﻋﺮﺠﻟﺍ ﻝﻭﺎﻨﺗ .ﺔﻴﺴﻨﻤﻟﺍ ﺔﻴﺋﺍﻭﺪﻟﺍ ﺔﻋﺮﺠﻟﺍ ﻦﻋ ﺾﻳﻮﻌﺘﻠﻟ ﺔﻔﻋﺎﻀﻣ ﺔﻴﺋﺍﻭﺩ ﺔﻋﺮﺟ ﻝﻭﺎﻨﺗ ﺯﻮﺠﻳ ﻻ

.ﺐﻴﺒﻄﻟﺍ ﺔﻴﺻﻮﺗ ﺐﺴﺣ ﺝﻼﻌﻟﺍ ﻰﻠﻋ ﺔﺒﻇﺍﻮﻤﻟﺍ ﺐﺠﻳ ﺔﻋﺮﺠﻟﺍ ﻦﻣ ﺪﻛﺄﺘﻟﺍﻭ ﺀﺍﻭﺪﻟﺍ ﻊﺑﺎﻃ ﺺﻴﺨﺸﺗ ﺐﺠﻳ !ﺔﻤﺘﻌﻟﺍ ﻲﻓ ﺔﻳﻭﺩﻷﺍ ﻝﻭﺎﻨﺗ ﺯﻮﺠﻳ ﻻ .ﻚﻟﺫ ﺮﻣﻷﺍ ﻡﺰﻟ ﺍﺫﺇ ﺔﻴﺒﻄﻟﺍ ﺕﺍﺭﺎﻈﻨﻟﺍ ﻊﺿ .ﺀﺍﻭﺩ ﺎﻬﻴﻓ ﻝﻭﺎﻨﺘﺗ ﺓﺮﻣ ﻞﻛ ﻲﻓ ﺔﻴﺋﺍﻭﺪﻟﺍ ﻭﺃ ﺐﻴﺒﻄﻟﺍ ﺮﺸﺘﺳﺇ ،ﺀﺍﻭﺪــﻟﺍ ﻝﺎﻤﻌﺘﺳﺇ ﻝﻮﺣ ﺔﻴﻓﺎﺿﺇ ﺔﻠﺌﺳﺃ ﻚﻳﺪﻟ ﺕﺮﻓﻮﺗ ﺍﺫﺇ .ﻲﻟﺪﻴﺼﻟﺍ ﺔﻴﺒﻧﺎﺠﻟﺍ ﺽﺍﺮﻋﻷﺍ (4 .ﻦﻴﻠﻤﻌﺘﺴﻤﻟﺍ ﺾﻌﺑ ﺪﻨﻋ ﺔﻴﺒﻧﺎﺟ

ﺎﺿﺍﺮﻋﺃ ﺐﺒﺴﻳ ﺪﻗ ﻥﺍﺮﻓﻭﺯ ﻝﺎﻤﻌﺘﺳﺇ ﻥﺇ ،ﺀﺍﻭﺩ ﻞﻜﺑ ﺎﻤﻛ .ﺎﻬﻨﻣ

ﺎﻳﺃ ﻲﻧﺎﻌﺗ ﻻﺃ ﺰﺋﺎﺠﻟﺍ ﻦﻣ .ﺔﻴﺒﻧﺎﺠﻟﺍ ﺽﺍﺮﻋﻷﺍ ﺔﻤﺋﺎﻗ ﻦﻣ ﺶﻫﺪﻨﺗ ﻻ ﺔﻴﺴﺴﺤﺗ ﻞﻌﻓ ﺩﻭﺩﺭ

ﻻﺎﺣ ﺐﻴﺒﻄﻟﺍ ﻊﺟﺍﺭﻭ ﺀﺍﻭﺪﻟﺍ ﻝﻭﺎﻨﺗ ﻦﻋ ﻒﻗﻮﺗ ،ﻲﺴﺴﺤﺗ ﻞﻌﻓ ﺩﺭ ﻚﻳﺪﻟ ﺙﺪﺣ ﺍﺫﺇ :ﻞﻤﺸﺗ ﻥﺃ ﺎﻬﻧﺄﺷ ﻦﻣ ﺕﺎﻣﻼﻌﻟﺍ ﻞﻜﺸﺑ ﺮﻬﻈﺗ ﻲﺘﻟﺍ ﺭﺪﺼﻟﺍ ﻲﻓ ﻂﻐﺿ ﻭﺃ ﺭﺪﺼﻟﺍ ﻲﻓ ﻡﻻﺁﻭ ﺲﻔﻨﺘﻟﺍ ﻲﻓ ﺮﻴﻔﺻ ﺊﺟﺎﻔﻣ .ﻥﺎﺴﻠﻟﺍ ﻲﻓ ﻭﺃ ﻢﻔﻟﺍ ﻲﻓ ،ﻦﻴﺘﻔﺸﻟﺍ ﻲﻓ ،ﻪﺟﻮﻟﺍ ﻲﻓ ،ﻦﻴﻨﻔﺠﻟﺍ ﻲﻓ ﺥﺎﻔﺘﻧﺇ ﻥﺎﻜﻣ ﻞﻛ ﻲﻓ (ﻯﺮﺷ) ﻙﺪﻠﺟ ﺖﺤﺗ ﻞﺘﻛ ﻭﺃ ﺀﺍﺮﻤﺣ ﻁﺎﻘﻧ ـ ﺪﻠﺠﻟﺍ ﻲﻓ ﺢﻔﻃ ﻚﻤﺴﺟ ﺢﻄﺳ ﻰﻠﻋ ﺭﺎﻴﻬﻧﺇ ﻯﺮﺧﺃ ﺔﻴﺒﻧﺎﺟ ﺽﺍﺮﻋﺃ (ﺹﺎﺨﺷﺃ 10 ﻞﻛ ﻦﻣ 1 ﻦﻣ ﺮﺜﻛﺃ ﻯﺪﻟ ﺮﻬﻈﺗ ﻥﺃ ﺎﻬﻧﺄﺷ ﻦﻣ)

ﺍﺪﺟ ﺔﻌﺋﺎﺷ ﻉﺍﺪﺻ (ﺹﺎﺨﺷﺃ 10 ﻞﻛ ﻦﻣ 1 ﻰﺘﺣ ﻯﺪﻟ ﺮﻬﻈﺗ ﻥﺃ ﺎﻬﻧﺄﺷ ﻦﻣ) ﺔﻌﺋﺎﺷ ﺩﺭﻮﺗ ﻭﺃ ﺔﻧﻮﺨﺴﺑ ﺭﻮﻌﺸﻟﺍ ﻙﺎﺴﻣﺇ ﻊﻣ ﻥﺍﺮﻓﻭﺯ ﺹﺍﺮﻗﺃ ﻝﻭﺎﻨﺘﺗ ﺖﻨﻛ ﺍﺫﺇ) ﺪﺒﻜﻟﺍ ﻒﺋﺎﻇﻭ ﺕﺎﺻﻮﺤﻓ ﺞﺋﺎﺘﻧ ﻲﻓ ﺕﺍﺮﻴﻐﺗ (ﻊﺋﺎﺷ ﺮﻴﻏ ﻲﺒﻧﺎﺠﻟﺍ ﺽﺮﻌﻟﺍ ﺍﺬﻫ ﻥﺈﻓ ﻻﺇﻭ ،ﻦﻴﺗﻼﭙﺴﻴﺳ ﻰﻤﺴﻳ ﺀﺍﻭﺩ (ﺺﺨﺷ 100 ﻞﻛ ﻦﻣ 1 ﻰﺘﺣ ﻯﺪﻟ ﺮﻬﻈﺗ ﻥﺃ ﺎﻬﻧﺄﺷ ﻦﻣ) ﺔﻌﺋﺎﺷ ﺮﻴﻏ ﻕﺍﻮﻓ ﺭﺍﻭﺩ ﻭﺃ ﺀﺎﻤﻏﺈﺑ ﺭﻮﻌﺸﻟﺍ ﻚﻟ ﺐﺒﺴﻳ ﺪﻗ ﻱﺬﻟﺍ ،ﺾﻔﺨﻨﻣ ﻡﺩ ﻂﻐﺿ ﺐﻠﻘﻟﺍ ﻢﻈﻧ ﻡﺎﻈﺘﻧﺇ ﻡﺪﻋ ﺭﺪﺼﻟﺍ ﻲﻓ ﻢﻟﺃ (ﺕﺎﺑﻮﻧ) ﺕﺎﺟﻼﺘﺧﺇ ﻑﺎﺠﺗﺭﺇ ﻭﺃ ﻢﺴﺠﻠﻟ ﺓﺫﺎﺷ ﺕﺎﻛﺮﺣ (ﺺﺨﺷ 1,000 ﻞﻛ ﻦﻣ 1 ﻰﺘﺣ ﻯﺪﻟ ﺮﻬﻈﺗ ﻥﺃ ﺎﻬﻧﺄﺷ ﻦﻣ) ﺓﺭﺩﺎﻧ ﻥﺍﺭﻭﺪﺑ ﺭﻮﻌﺸﻟﺍ ﻭﺃ ﺭﺍﻭﺩ ﺔﻳﺅﺮﻟﺍ ﺵﻮﺸﺗ (ﻲﻋﻮﻠﻟ ﺊﺟﺎﻔﻣ ﻥﺍﺪﻘﻓ

ﺎﻧﺎﻴﺣﺃ ﺐﺒﺴﻳ ) ﺐﻠﻘﻟﺍ ﻢﻈﻧ ﻲﻓ ﺏﺍﺮﻄﺿﺇ (ﺺﺨﺷ 10,000 ﻞﻛ ﻦﻣ 1 ﻰﺘﺣ ﻯﺪﻟ ﺮﻬﻈﺗ ﻥﺃ ﺎﻬﻧﺄﺷ ﻦﻣ)

ﺍﺪﺟ ﺓﺭﺩﺎﻧ ﺔﻘﻴﻗﺩ 20 ﻝﻼﺧ ﺩﻮﻌﻳ ﺓﺩﺎﻋ ﻱﺬﻟﺍ ،ﺔﻳﺅﺮﻠﻟ ﺖﻗﺆﻣ ﻥﺍﺪﻘﻓ ﻭﺃ ﺔﻳﺅﺮﻟﺍ ﻲﻓ ﻞﻠﺧ ﻦﻣ ﻲﻧﺎﻌﺗ ﺎﻣﺪﻨﻋ ﻭﺃ ﺔﻴﺒﻧﺎﺠﻟﺍ ﺽﺍﺮﻋﻷﺍ ﻯﺪﺣﺇ ﺖﻤﻗﺎﻔﺗ ﺍﺫﺇ ،ﻲﺒﻧﺎﺟ ﺽﺮﻋ ﺮﻬﻇ ﺍﺫﺇ .ﺐﻴﺒﻄﻟﺍ ﺓﺭﺎﺸﺘﺳﺇ ﻚﻴﻠﻋ ،ﺓﺮﺸﻨﻟﺍ ﻩﺬﻫ ﻲﻓ ﺮﻛﺬﻳ ﻢﻟ ﻲﺒﻧﺎﺟ ﺽﺮﻋ ﺔﻴﺒﻧﺎﺟ ﺽﺍﺮﻋﺃ ﻦﻋ ﻎﻴﻠﺒﺘﻟﺍ ﻂﺑﺍﺮﻟﺍ ﻰﻠﻋ ﻂﻐﻀﻟﺍ ﺔﻄﺳﺍﻮﺑ ﺔﺤﺼﻟﺍ ﺓﺭﺍﺯﻮﻟ ﺔﻴﺒﻧﺎﺟ ﺽﺍﺮﻋﺃ ﻦﻋ ﻎﻴﻠﺒﺘﻟﺍ ﻥﺎﻜﻣﻹﺎﺑ ﺔﻴﺴﻴﺋﺮﻟﺍ ﺔﺤﻔﺼﻟﺍ ﻰﻠﻋ ﺩﻮﺟﻮﻤﻟﺍ «ﻲﺋﺍﻭﺩ ﺝﻼﻋ ﺐﻘﻋ ﺔﻴﺒﻧﺎﺟ ﺽﺍﺮﻋﺃ ﻦﻋ ﻎﻴﻠﺒﺗ» ﺮﺷﺎﺒﻤﻟﺍ ﺝﺫﻮﻤﻨﻟﺍ ﻰﻟﺇ ﻚﻬﺟﻮﻳ ﻱﺬﻟﺍ (

www.health.gov.il

) ﺔﺤﺼﻟﺍ ﺓﺭﺍﺯﻭ ﻊﻗﻮﻤﻟ :ﻂﺑﺍﺮﻟﺍ ﺢﻔﺼﺗ ﻖﻳﺮﻃ ﻦﻋ ﻭﺃ ،ﺔﻴﺒﻧﺎﺟ ﺽﺍﺮﻋﺃ ﻦﻋ ﻎﻴﻠﺒﺘﻠﻟ

https://sideeffects.health.gov.il/

؟ﺀﺍﻭﺪﻟﺍ ﻦﻳﺰﺨﺗ ﺔﻴﻔﻴﻛ (5

ﺍﺪﻴﻌﺑ ﻖﻠﻐﻣ ﻥﺎﻜﻣ ﻲﻓ ﺮﺧﺁ ﺀﺍﻭﺩ ﻞﻛﻭ ﺀﺍﻭﺪﻟﺍ ﺍﺬﻫ ﻆﻔﺣ ﺐﺠﻳ !ﻢﻤﺴﺘﻟﺍ ﺐﻨﺠﺗ ﻢﻬﺘﺑﺎﺻﺇ ﻱﺩﺎﻔﺘﻟ ﻚﻟﺫﻭ ﻊﺿﺮﻟﺍ ﻭﺃ/ﻭ ﻝﺎﻔﻃﻷﺍ ﺔﻳﺅﺭ ﻝﺎﺠﻣﻭ ﻱﺪﻳﺃ ﻝﻭﺎﻨﺘﻣ ﻦﻋ .ﺐﻴﺒﻄﻟﺍ ﻦﻣ ﺔﺤﻳﺮﺻ ﺕﺎﻤﻴﻠﻌﺗ ﻥﻭﺪﺑ ﺆﻴﻘﺘﻟﺍ ﺐﺒﺴﺗ ﻻ .ﻢﻤﺴﺘﻟﺎﺑ ﻱﺬﻟﺍ (

date

) ﺔﻴﺣﻼﺼﻟﺍ ﺦﻳﺭﺎﺗ ﺀﺎﻀﻘﻧﺇ ﺪﻌﺑ ﺀﺍﻭﺪﻟﺍ ﻝﺎﻤﻌﺘﺳﺇ ﺯﻮﺠﻳ ﻻ ﺲﻔﻧ ﻦﻣ ﺮﻴﺧﻷﺍ ﻡﻮﻴﻟﺍ ﻰﻟﺇ ﺔﻴﺣﻼﺼﻟﺍ ﺦﻳﺭﺎﺗ ﺮﻴﺸﻳ .ﺔﺒﻠﻌﻟﺍ ﺮﻬﻇ ﻰﻠﻋ ﺮﻬﻈﻳ .ﺮﻬﺸﻟﺍ .ﺔﻳﻮﺌﻣ ﺔﺟﺭﺩ 30 ﻥﻭﺩ ﻦﻳﺰﺨﺘﻟﺍ ﺐﺠﻳ ﻲﻟﺪﻴﺼﻟﺍ ﺮﺸﺘﺳﺇ .ﺔﻴﻟﺰﻨﻤﻟﺍ ﺔﻣﺎﻤﻘﻟﺍ ﻲﻓ ﻭﺃ ﻱﺭﺎﺠﻤﻟﺍ ﻲﻓ ﺔﻳﻭﺩﻷﺍ ﻲﻣﺭ ﺯﻮﺠﻳ ﻻ ﺕﺍﻮﻄﺨﻟﺍ ﻩﺬﻫ ﺪﻋﺎﺴﺗ .ﻝﺎﻤﻌﺘﺳﻹﺍ ﺪﻴﻗ ﺪﻌﺗ ﻢﻟ ﺔﻳﻭﺩﺃ ﻦﻣ ﺺﻠﺨﺘﻟﺍ ﻚﻨﻜﻤﻳ ﻦﻳﺃ .ﺔﺌﻴﺒﻟﺍ ﻰﻠﻋ ﻅﺎﻔﺤﻟﺍ ﻲﻓ ﺔﻴﻓﺎﺿﺇ ﺕﺎﻣﻮﻠﻌﻣ (6

ﺎﻀﻳﺃ ﺔﻟﺎﻌﻔﻟﺍ ﺓﺩﺎﻤﻠﻟ ﺔﻓﺎﺿﻹﺎﺑ ﺀﺍﻭﺪﻟﺍ ﻱﻮﺘﺤﻳ ﺔﺒﻠﻌﻟﺍ ﻯﻮﺘﺤﻣ ﻮﻫ ﺎﻣﻭ ﺀﺍﻭﺪﻟﺍ ﻭﺪﺒﻳ ﻒﻴﻛ .ﻦﻴﻴﺋﺍﻭﺩ ﻦﻳﺭﺎﻴﻌﺑ ﻕ

ﻮﺴﺗﻭ ﺔﻴﻠﻄﻣ ،ﺔﻳﻮﻀﻴﺑ ،ﺀﺍﺮﻔﺻ ﺹﺍﺮﻗﺃ ﻲﻫ ﻥﺍﺮﻓﻭﺯ ﺹﺍﺮﻗﺃ

ﺔﻤﻠﻌﻣ ﻲﻫﻭ ﻥﻭﺮﺘﻴﺴﻧﺍﺪﻧﻭﺃ ﻝﺎﻌﻔﻟﺍ ﺐﻛﺮﻤﻟﺍ ﻦﻣ ﻎﻠﻣ 4 ﻰﻠﻋ ﻱﻮﺘﺤﺗ ﻎﻠﻣ 4 ﺹﺍﺮﻗﺃ

.ﻲﻧﺎﺜﻟﺍ ﺐﻧﺎﺠﻟﺍ ﻲﻓ ﺔﻣﻼﻋ ﻥﻭﺪﺑﻭ ﺪﺣﺍﻭ ﺐﻧﺎﺟ ﻲﻓ «

GXET3

» ﺔﻣﻼﻌﺑ ﺔﻤﻠﻌﻣ ﻲﻫﻭ ﻥﻭﺮﺘﻴﺴﻧﺍﺪﻧﻭﺃ ﻝﺎﻌﻔﻟﺍ ﺐﻛﺮﻤﻟﺍ ﻦﻣ ﻎﻠﻣ 8 ﻰﻠﻋ ﻱﻮﺘﺤﺗ ﻎﻠﻣ 8 ﺹﺍﺮﻗﺃ

.ﻲﻧﺎﺜﻟﺍ ﺐﻧﺎﺠﻟﺍ ﻲﻓ ﺔﻣﻼﻋ ﻥﻭﺪﺑﻭ ﺪﺣﺍﻭ ﺐﻧﺎﺟ ﻲﻓ «

GXET5

» ﺔﻣﻼﻌﺑ :ﻦﻤﺿ ﻥﺍﺮﻓﻭﺯ ﺹﺍﺮﻗﺃ ﻕ

ﻮﺴﺗ

.ﺹﺍﺮﻗﺃ 10 ﺕﺍﺫ (ﺮﺘﺴﻴﻠﺑ) ﺔﺤﻳﻮﻟ ﺐﻠﻋ

.ﺐﻴﺑﺃ ـ ﻞﺗ ،7126 .ﺏ.ﺹ ،.ﺽ.ﻡ ﻞﻴﺋﺍﺮﺳﺇ ﺲﻴﺗﺭﺎﭬﻮﻧ :ﺯﺎﻴﺘﻣﻹﺍ ﺐﺣﺎﺻ .ﺎﻴﻧﺎﻤﻟﺃ ،ﻮﻠﺳﺪﻟﻭﺃ ﺩﺎﺑ ،

GmbH

ﻮﻠﺳﺪﻟﻭﺃ ﺩﺎﺑ ﻦﭙﺳﺃ :ﺞﺘﻨﻤﻟﺍ .2020 ﻥﺍﺮﻳﺰﺣ ﻲﻓ ﺎﻫﺩﺍﺪﻋﺇ ﻢﺗ :ﺔﺤﺼﻟﺍ ﺓﺭﺍﺯﻭ ﻲﻓ ﻲﻣﻮﻜﺤﻟﺍ ﺔﻳﻭﺩﻷﺍ ﻞﺠﺳ ﻲﻓ ﺀﺍﻭﺪﻟﺍ ﻞﺠﺳ ﻢﻗﺭ

049 96 26549

ﻎﻠﻣ 4 ﺹﺍﺮﻗﺃ ﻥﺍﺮﻓﻭﺯ

049 95 26560

ﻎﻠﻣ 8 ﺹﺍﺮﻗﺃ ﻥﺍﺮﻓﻭﺯ

.ﺮﻛﺬﻤﻟﺍ ﺔﻐﻴﺼﺑ ﺓﺮﺸﻨﻟﺍ ﻩﺬﻫ ﺔﻏﺎﻴﺻ ﺖﻤﺗ ،ﺓﺀﺍﺮﻘﻟﺍ ﻦﻳﻮﻬﺗﻭ ﺔﻟﻮﻬﺳ ﻞﺟﺃ ﻦﻣ .ﻦﻴﺴﻨﺠﻟﺍ ﻼﻜﻟ ﺺﺼﺨﻣ ﺀﺍﻭﺪﻟﺍ ﻥﺈﻓ ،ﻚﻟﺫ ﻦﻣ ﻢﻏﺮﻟﺍ ﻰﻠﻋ

Lactose (anhydrous), microcrystalline cellulose, pre-gelatinised

maize starch, methylhydroxypropylcellulose, magnesium

stearate, titanium dioxide (E171) and iron oxide yellow

(E172).

To prevent and treat nausea and vomiting after an

operation (adults only)

The usual adult dose is 16 mg before your operation.

Patients with moderate or severe liver problems (adults

only)

The total daily dose should not be more than 8 mg.

Zofran tablets will start working within one or two hours of taking

a dose.

Do not exceed the recommended dose

If you are sick (vomit) within one hour of taking a dose

take the same dose again

otherwise, do not take more Zofran tablets than the physician

ordered.

If you continue to feel sick, tell your physician.

The tablets are film-coated and should not be crushed, halved

or chewed.

If you accidently have taken a higher dosage

If you have taken an overdose or if a child has accidentally

swallowed the medicine, refer immediately to a physician or

to a hospital emergency room and bring the package of the

medicine with you.

If you forgot to take the medicine

If you missed a dose and feel sick or vomit:

take Zofran tablets as soon as possible, then

take your next tablet at the usual time.

do not take a double dose to make up for a forgotten dose.

If you missed a dose but do not feel sick:

take the next dose at the usual time.

do not take a double dose to make up for a forgotten dose.

Persist with the treatment as recommended by the physician.

Do not take medicines in the dark! Check the label and

the dose each time you take medicine. Wear glasses if

you need them.

If you have any other questions regarding the use of the

medicine, consult the physician or the pharmacist.

4. SIDE EFFECTS

As with any medicine, use of Zofran may cause side effects in

some of the users. Do not be alarmed by reading the list of side

effects. You may not experience any of them.

Allergic reactions

If you have an allergic reaction, stop taking the medicine and

refer to a physician immediately.

The signs may include:

sudden wheezing and chest pain or chest tightness

swelling of the eyelids, face, lips, mouth or tongue

skin rash - red spots or lumps under your skin (hives) anywhere

on your body

collapse

Other side effects

Very common (may occur in more than 1 in 10 people)

headache

Common (may occur in up to 1 in 10 people)

a feeling of warmth or flushing

constipation

changes to liver function test results (if you take Zofran tablets

with a medicine called cisplatin, otherwise this side effect is

uncommon)

Uncommon (may occur in up to 1 in 100 people)

hiccups

low blood pressure, which can make you feel faint or dizzy

uneven heartbeat

chest pain

fits

unusual body movements or shaking

Rare (may occur in up to 1 in 1,000 people)

feeling dizzy or lightheaded

blurred vision

disturbance in heart rhythm (sometimes causing a sudden loss

of consciousness)

Very rare (may occur in up to 1 in 10,000 people)

poor vision or temporary loss of eyesight, which usually comes

back within 20 minutes

If you get any side effect, if any of the side effects get

worse, or when you suffer from side effect not mentioned

in the leaflet, you should consult the physician.

Reporting side effects

Side effects can be reported to the Ministry of Health by clicking

on the link “Report Side Effects of Drug Treatment” found on the

Ministry of Health homepage (www.health.gov.il) that directs you

to the online form for reporting side effects,

or by entering the link:

https://sideeffects.health.gov.il/

5. HOW TO STORE THE MEDICINE?

Avoid poisoning! This medicine and any other medicine should

be kept in a closed place out of the reach and sight of children

and/or infants in order to avoid poisoning. Do not induce

vomiting without an explicit instruction from the physician.

Do not use the medicine after the expiry date (exp. date)

appearing on the package. The expiry date refers to the last

day of that month.

Store below 30°C.

Do not dispose of medicines in the wastewater or household

waste bin. Consult the pharmacist about where to dispose of

medicines that are not in use. These measures will help protect

the environment.

6. ADDITIONAL INFORMATION

In addition to the active ingredient the medicine also contains

Lactose (anhydrous), microcrystalline cellulose, pre-gelatinised

maize starch, methylhydroxypropylcellulose, magnesium

stearate, titanium dioxide (E171) and iron oxide yellow

(E172).

What does the medicine look like and what is the content of

the package

Zofran tablets are yellow, oval, film-coated tablets marketed

in two strengths.

The 4 mg tablets contain 4 mg of the active ingredient

ondansetron and are marked with “GXET3” on one face and

plain on the other.

The 8 mg tablets contain 8 mg of the active ingredient

ondansetron and are marked with “GXET5” on one face and

plain on the other.

Zofran tablets are marketed in:

blister packs of 10 tablets.

Registration Holder: Novartis Israel Ltd., P.O.B 7126, Tel Aviv.

Manufacturer: Aspen Bad Oldesloe GmbH., Bad Oldesloe,

Germany.

Revised on June 2020.

Registration number of the medicine in the National Drug

Registry of the Ministry of Health:

Zofran Tablets 4 mg 049 96 26549

Zofran Tablets 8 mg 049 95 26560

PATIENT LEAFLET IN ACCORDANCE WITH THE

PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986

The medicine is dispensed according to

a physician’s prescription only

Zofran

®

Tablets 4 mg

Ondansetron (as hydrochloride dihydrate) 4 mg per tablet.

Zofran

®

Tablets 8 mg

Ondansetron (as hydrochloride dihydrate) 8 mg per tablet.

List of the additional ingredients detailed in section 6.

See also “Important information about some ingredients of the

medicine” in section 2.

Read the entire leaflet carefully before using the medicine.

This leaflet contains concise information about the medicine.

If you have any other questions, refer to the physician or the

pharmacist.

This medicine has been prescribed for you. Do not pass it on

to others. It may harm them even if it seems to you that their

medical condition is similar.

1. WHAT IS THE MEDICINE INTENDED FOR?

Zofran tablets are used for:

treating nausea and vomiting caused by chemotherapy (in

adults and children) or radiotherapy (adults only).

preventing and treating nausea and vomiting after surgery

(adults only).

Therapeutic group

Serotonin receptor antagonist (5HT

Zofran tablets contain an active ingredient called ondansetron.

Zofran belongs to a group of medicines called anti-emetics.

2. BEFORE USING THE MEDICINE

X

Do not use the medicine if:

you are taking apomorphine (used to treat Parkinson’s

disease).

you are sensitive (allergic) to ondansetron or to any of the

other ingredients contained in the medicine (listed in Section

If you are not sure, talk to your physician or pharmacist before

taking Zofran tablets.

Special warnings regarding the use of the medicine

!

Before the treatment with Zofran, tell the physician

if:

you have ever had heart problems (e.g., congestive heart failure

which causes shortness of breath and swollen ankles)

you have irregular heartbeat (arrhythmias)

you have congenital long QT syndrome in ECG. The medicine

should be administered with caution to patients who may

develop prolongation of QT, in particular patients with

electrolyte abnormalities, heart failure, bradyarrhythmias or

patients taking other medical supplements that may lead to

QT prolongation or electrolyte abnormalities

you are allergic to medicines similar to ondansetron, such as

granisetron or palonosetron

you have liver problems

you have a blockage in your gut

you are going to undergo adenotonsillar surgery, as the

medicine may mask occult bleeding

you have problems with the levels of salts in your blood,

such as potassium, sodium and magnesium

If you are not sure if any of the above apply to you, talk to your

physician or pharmacist before taking Zofran tablets.

!

Drug interactions

If you are taking, or have recently taken, other medicines,

including non-prescription medicines, herbal medicines and food

supplements, tell the physician or the pharmacist. This is because

Zofran can affect the way some medicines work. Also, some other

medicines can affect the way Zofran works. Especially inform the

physician or the pharmacist if you are taking:

carbamazepine or phenytoin used to treat epilepsy

rifampicin used to treat infections such as tuberculosis (TB)

antibiotics such as erythromycin

antifungal medicines such as ketoconazole

anti-arrhythmic medicines used to treat irregular heartbeat

beta-blocker medicines used to treat certain heart or eye

problems, anxiety or to prevent migraines

tramadol and fentanyl, painkillers

medicines that affect the heart (such as haloperidol or

methadone)

cancer

medicines

(especially

anthracyclines

trastuzumab)

SSRIs (selective serotonin reuptake inhibitors) used to treat

depression and/or anxiety including fluoxetine, paroxetine,

sertraline, fluvoxamine, citalopram, escitalopram. There have

been reports about the development of serotonin syndrome

following the concomitant use of these drugs with Zofran.

SNRIs (serotonin noradrenaline reuptake inhibitors) used to treat

depression and/or anxiety including venlafaxine, duloxetine.

There have been reports about the development of serotonin

syndrome following the concomitant use of these drugs with

Zofran.

other medicines that can cause serotonin syndrome such

as mirtazapine for the treatment of depression, monoamine

oxidase inhibitor drugs for the treatment of Parkinson’s,

lithium for the treatment of psychiatric disorders or injectable

methylene blue.

If you are not sure if any of the above apply to you, talk to your

physician or pharmacist before taking Zofran tablets.

!

Pregnancy, breastfeeding and fertility

If you are pregnant, think you may be pregnant or are planning

to be pregnant, consult your physician or pharmacist before

taking Zofran, since Zofran may slightly increase the risk that

your baby will be born with a cleft palate (partial or complete

palate closure defect).

Do not breastfeed if you are taking Zofran. This is because small

amounts pass into the mother’s milk. Ask your physician for

advice.

!

Important information about some ingredients of the

medicine

This medicine contains lactose:

Each 4 mg Zofran tablet contains 81.875 mg lactose anhydrous

Each 8 mg Zofran tablet contains 163.75 mg lactose anhydrous

If you have been told by your physician that you have an

intolerance to some sugars, talk to your physician before taking

this medicine.

3. HOW SHOULD YOU USE THE MEDICINE?

Always use Zofran according to the physician’s instructions.

You should check with the physician or the pharmacist if you

are uncertain regarding the dosage and treatment regimen of

Zofran.

The dosage and treatment regimen will be determined by the

physician only. The dose you have been prescribed depends on

the treatment you are receiving.

To treat nausea and vomiting from chemotherapy or

radiotherapy (adults only)

On the day of chemotherapy or radiotherapy

the usual adult dose is 8 mg taken one to two hours before

treatment and another 8 mg taken 12 hours after the first

dose.

On the following days

the usual adult dose is 8 mg twice a day

the treatment may be given for up to 5 days.

Children:

To treat nausea and vomiting from chemotherapy

The physician will decide the dose depending on the child’s size

(body surface area).

SH ZOF TAB APL 22JUN20

SH ZOF TAB APL 22JUN20

ZOF TAB API 24MAR20 UK SmPC 03.2020

Page 1 of 13

Zofran

®

Tablets 4mg

Zofran

®

Tablets 8mg

1.

TRADE NAME OF THE MEDICINAL PRODUCT

Zofran Tablets 4mg

Zofran Tablets 8mg

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each Zofran Tablet 4mg contains ondansetron 4mg (as hydrochloride

dihydrate).

Each Zofran Tablet 8mg contains ondansetron 8mg (as hydrochloride

dihydrate).

Excipients with known effect:

Zofran Tablets 4 mg: Contains Lactose (anhydrous) 81.875 mg (see section 4.4).

Zofran Tablets 8 mg: Contains Lactose (anhydrous) 163.75 mg (see section 4.4).

For the full list of excipients see section 6.1.

3.

PHARMACEUTICAL FORM

Film coated tablet.

Zofran Tablet 4mg is a yellow, oval, biconvex tablet engraved "GXET3" on

one face and plain on the other.

Zofran Tablet 8mg is a yellow, oval, biconvex tablet engraved "GXET5" on

one face and plain on the other. Each tablet

4. CLINICAL PARTICULARS

4.1

Therapeutic Indications

Adults:

Zofran is indicated for the management of nausea and vomiting induced by

cytotoxic chemotherapy and radiotherapy.

Zofran is indicated for the prevention and treatment of post-operative nausea

and vomiting (PONV).

Paediatric Population:

Zofran is indicated for the management of nausea and vomiting induced by

cytotoxic chemotherapy.

4.2

Posology and Method of Administration

ZOF TAB API 24MAR20 UK SmPC 03.2020

Page 2 of 13

Chemotherapy and radiotherapy induced nausea and vomiting .

Adults:

The emetogenic potential of cancer treatment varies according to the doses and

combinations of chemotherapy and radiotherapy regimens used. The selection

of dose regimen should be determined by the severity of the emetogenic

challenge.

Emetogenic Chemotherapy and Radiotherapy

: Zofran can be given either by

oral (tablets), intravenous or intramuscular administration.

For oral administration: 8mg taken 1 to 2 hours before chemotherapy or

radiation treatment, followed by 8mg every 12 hours for a maximum of 5 days

to protect against delayed or prolonged emesis.

For highly emetogenic chemotherapy:

To protect against delayed or prolonged

emesis after the first 24 hours, oral treatment with Zofran may be continued

for up to 5 days after a course of treatment.

The recommended dose for oral administration is 8mg to be taken twice daily.

Paediatric Population:

Ondansetron may be administered as a single intravenous dose of 5mg/m

immediately before chemotherapy, followed by 4mg orally twelve hours later.

4mg orally twice daily can be continued for up to 5 days after a course of

treatment.

Elderly:

Zofran is well tolerated by patients over 65 years. No alteration of oral dose or

frequency of administration is required.

Patients with Renal Impairment:

No alteration of daily dosage or frequency of dosing, or route of

administration are required.

Patients with Hepatic Impairment:

Clearance of Zofran is significantly reduced and serum half-life significantly

prolonged in subjects with moderate or severe impairment of hepatic function.

In such patients a total daily dose of 8mg should not be exceeded.

Patients with Poor Sparteine/Debrisoquine Metabolism:

The elimination half-life of ondansetron is not altered in subjects classified as

poor metabolisers of sparteine and debrisoquine. Consequently in such

patients repeat dosing will give drug exposure levels no different from those of

ZOF TAB API 24MAR20 UK SmPC 03.2020

Page 3 of 13

the general population. No alteration of daily dosage or frequency of dosing is

required.

Post operative nausea and vomiting (PONV):

Adults:

For the prevention of PONV:

Zofran can be administered orally or by

intravenous or intramuscular injection.

For oral administration: 16mg taken one hour prior to anaesthesia.

For the treatment of established PONV:

Intravenous or intramuscular

administration is recommended.

Children and Adolescents aged 2 years and over

No studies have been conducted on the use of orally administered ondansetron

in the prevention or treatment of post operative nausea and vomiting; slow i.v.

injection is recommended for this purpose.

Elderly:

There is limited experience in the use of Zofran in the prevention and

treatment of post-operative nausea and vomiting in the elderly,

however

Zofran is well tolerated in patients over 65 years receiving chemotherapy

.

Patients with Renal impairment:

No alteration of daily dosage or frequency of dosing, or route of

administration are required.

Patients with Hepatic impairment:

Clearance of Zofran is significantly reduced and serum half life significantly

prolonged in subjects with moderate or severe impairment of hepatic function.

In such patients a total daily dose of 8mg should not be exceeded.

Patients with poor Sparteine/Debrisoquine Metabolism:

The elimination half-life of ondansetron is not altered in subjects classified as

poor metabolisers of sparteine and debrisoquine. Consequently in such

patients repeat dosing will give drug exposure levels no different from those of

the general population. No alteration of daily dosage or frequency of dosing is

required.

4.3

Contraindications

Concomitant use with apomorphine (see section 4.5)

Hypersensitivity to the active substance or to any of the excipients listed in section

6.1.

ZOF TAB API 24MAR20 UK SmPC 03.2020

Page 4 of 13

4.4

Special warnings and precautions for use

Hypersensitivity reactions have been reported in patients who have exhibited

hypersensitivity

other

selective

receptor

antagonists.

Respiratory

events should be treated symptomatically and clinicians should pay particular

attention to them as precursors of hypersensitivity reactions.

Ondansetron prolongs the QT interval in a dose-dependent manner (see

section 5.1). In addition, post-marketing cases of Torsade de Pointes have

been reported in patients using ondansetron. Avoid ondansetron in patients

with congenital long QT syndrome. Ondansetron should be administered with

caution to patients who have or may develop prolongation of QTc, including

patients with electrolyte abnormalities, congestive heart failure,

bradyarrhythmias or patients taking other medicinal products that lead to QT

prolongation or electrolyte abnormalities.

Hypokalaemia and hypomagnesaemia should be corrected prior to

ondansetron administration.

The development of serotonin syndrome has been reported with 5-HT3

receptor antagonists. Most reports have been associated with concomitant use

of serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs),

serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase

inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene

blue). Some of the reported cases were fatal. Serotonin syndrome occurring

with overdose of Zofran alone has also been reported. The majority of reports

of serotonin syndrome related to 5-HT

receptor antagonist use occurred in a

post-anesthesia care unit or an infusion center.

Symptoms associated with serotonin syndrome may include the following

combination of signs and symptoms: mental status changes (e.g., agitation,

hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia,

labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia),

neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia,

incoordination), seizures, with or without gastrointestinal symptoms (e.g.,

nausea, vomiting, diarrhea). Patients should be monitored for the emergence of

serotonin syndrome, especially with concomitant use of Zofran and other

serotonergic drugs. If symptoms of serotonin syndrome occur, discontinue

Zofran and initiate supportive treatment. Patients should be informed of the

increased risk of serotonin syndrome, especially if Zofran is used

concomitantly with other serotonergic drugs (see sections 4.5 and 4.9).

As ondansetron is known to increase large bowel transit time, patients with

signs of subacute intestinal obstruction should be monitored following

administration.

In patients with adenotonsillar surgery prevention of nausea and vomiting with

ondansetron may mask occult bleeding. Therefore, such patients should be

followed carefully after ondansetron.

ZOF TAB API 24MAR20 UK SmPC 03.2020

Page 5 of 13

Patients with rare hereditary problems of galactose intolerance, Lapp lactase

deficiency or glucose-galactose malabsorption should not take this medicine.

Paediatric Population:

Paediatric patients receiving ondansetron with hepatotoxic chemotherapeutic

agents should be monitored closely for impaired hepatic function.

4.5

Interaction with other medicinal products and other forms of Interaction

There is no evidence that ondansetron either induces or inhibits the

metabolism of other drugs commonly coadministered with it. Specific studies

have shown that there are no interactions when ondansetron is administered

with alcohol, temazepam, furosemide, alfentanil, tramadol, morphine,

lidocaine, thiopental, or propofol.

Ondansetron is metabolised by multiple hepatic cytochrome P-450 enzymes:

CYP3A4, CYP2D6 and CYP1A2. Due to the multiplicity of metabolic

enzymes capable of metabolising ondansetron, enzyme inhibition or reduced

activity

enzyme

(e.g.

CYP2D6

genetic

deficiency)

normally

compensated by other enzymes and should result in little or no significant

change in overall ondansetron clearance or dose requirement.

Caution should be exercised when ondansetron is coadministered with drugs

that prolong the QT interval and/or cause electrolyte abnormalities (see section

4.4).

Use of ondansetron with QT prolonging drugs may result in additional QT

prolongation. Concomitant use of ondansetron with cardiotoxic drugs (e.g.

anthracyclines (such as doxorubicin, daunorubicin) or trastuzumab),

antibiotics (such as erythromycin), antifungals (such as ketoconazole,

antiarrhythmics (such as amiodarone) and beta blockers (such as atenolol or

timolol) may increase the risk of arrhythmias. (see section 4.4).

Serotonergic Drugs:

Serotonin syndrome (including altered mental status,

autonomic instability, and neuromuscular symptoms) has been described

following the concomitant use of 5-HT

receptor antagonists and other

serotonergic drugs, including selective serotonin reuptake inhibitors (SSRIs)

and serotonin and noradrenaline reuptake inhibitors (SNRIs) (see section 4.4).

Apomorphine:

Based

reports

profound

hypotension

loss

consciousness

when

ondansetron

administered

with

apomorphine

hydrochloride, concomitant use with apomorphine is contraindicated.

Phenytoin, Carbamazepine and Rifampicin:

In patients treated with potent

inducers of CYP3A4 (i.e. phenytoin, carbamazepine, and rifampicin), the oral

clearance of ondansetron was increased and ondansetron blood concentrations

were decreased.

ZOF TAB API 24MAR20 UK SmPC 03.2020

Page 6 of 13

Tramadol:

Data from small studies indicate that ondansetron may reduce the

analgesic effect of tramadol.

4.6

Fertility, pregnancy and lactation

Pregnancy

Based

human

experience

epidemiological

studies,

ondansetron

suspected to cause orofacial malformations when administered during first

trimester of pregnancy.

cohort

study

including

million

pregnancies,

first

trimester

ondansetron

associated

with

increased

risk

oral

clefts

additional cases per 10,000 women treated; adjusted relative risk, 1.24 (95%

CI 1.03 to 1.48).

available

epidemiological

studies

cardiac

malformations

show

conflicting results. Animal studies do not indicate direct or indirect harmful

effects with respect to reproductive toxicity.

The use of ondansetron in pregnancy is not recommended.

Breast-feeding

Tests have shown that ondansetron passes into the milk of lactating animals. It

is therefore recommended that mothers receiving Zofran should not breast-

feed their babies.

Fertility

There is no information on the effects of ondansetron on human fertility.

4.7

Effects on ability to drive and use machines

In psychomotor testing ondansetron does not impair performance nor cause

sedation. No detrimental effects on such activities are predicted from the

pharmacology of ondansetron

4.8

Undesirable effects

Adverse events are listed below by system organ class and frequency.

Frequencies are defined as: very common (

1/10), common (

1/100 to

<

1/10),

uncommon (

1/1000 to

<

1/100), rare (

1/10,000 to

<

1/1000) and very rare

<

1/10,000). Very common, common and uncommon events were generally

determined from clinical trial data. The incidence in placebo was taken into

account. Rare and very rare events were generally determined from post-

marketing spontaneous data.

The following frequencies are estimated at the standard recommended doses

of ondansetron. The adverse event profiles in children and adolescents were

comparable to that seen in adults.

Immune system disorders

ZOF TAB API 24MAR20 UK SmPC 03.2020

Page 7 of 13

Rare:

Immediate hypersensitivity reactions sometimes severe,

including anaphylaxis.

Nervous system disorders

Very common: Headache.

Uncommon:

Seizures, movement disorders (including extrapyramidal

reactions such as dystonic reactions, oculogyric crisis and

dyskinesia)

Rare:

Dizziness predominantly during rapid IV administration.

Eye disorders

Rare:

Transient visual disturbances (eg. blurred vision)

predominantly during IV administration.

Very rare:

Transient blindness predominantly during IV administration.

Cardiac disorders

Uncommon:

Arrhythmias, chest pain with or without ST segment

depression, bradycardia.

Rare:

QTc prolongation (including Torsade de Pointes)

Vascular disorders

Common:

Sensation of warmth or flushing.

Uncommon:

Hypotension.

Respiratory, thoracic and mediastinal disorders

Uncommon:

Hiccups.

Gastrointestinal disorders

Common:

Constipation.

Hepatobiliary disorders

Uncommon:

Asymptomatic increases in liver function tests.

1. Observed without definitive evidence of persistent clinical sequelae.

2. The majority of the blindness cases reported resolved within

20 minutes

Most patients had received chemotherapeutic agents, which included

cisplatin. Some cases of transient blindness were reported as cortical in

origin.

3. These events were observed commonly in patients receiving chemotherapy

with cisplatin.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal

product is important. It allows continued monitoring of the benefit/risk balance

of the medicinal product. Any suspected adverse events should be reported to

the Ministry of Health according to the National Regulation by using an online

form

https://sideeffects.health.gov.il

ZOF TAB API 24MAR20 UK SmPC 03.2020

Page 8 of 13

4.9

Overdose

Symptoms and Signs

There is limited experience of ondansetron overdose. In the majority of cases,

symptoms were similar to those already reported in patients receiving

recommended doses (see section 4.8). Manifestations that have been reported

include visual disturbances, severe constipation, hypotension and a vasovagal

episode with transient second-degree AV block.

Ondansetron prolongs the QT interval in a dose-dependent fashion. ECG

monitoring is recommended in cases of overdose.

Paediatric cases consistent with serotonin syndrome have been reported after

inadvertent oral overdoses of ondansetron (exceeding estimated ingestion of 5

mg/kg) in young children. Reported symptoms included somnolence,

agitation, tachycardia, tachypnea, hypertension, flushing, mydriasis,

diaphoresis, myoclonic movements, horizontal nystagmus, hyperreflexia, and

seizure. Patients required supportive care, including intubation in some cases,

with complete recovery without sequelae within 1 to 2 days.

Treatment

There is no specific antidote for ondansetron, therefore in all cases of

suspected overdose, symptomatic and supportive therapy should be given as

appropriate.

Further management should be as clinically indicated or as recommended by the

poisons centre, where available.

The use of ipecacuanha to treat overdose with ondansetron is not

recommended, as patients are unlikely to respond due to the anti-emetic action

of ondansetron itself.

5. PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Mechanism of Action

Ondansetron is a potent, highly selective 5HT3 receptor-antagonist. Its

precise mode of action in the control of nausea and vomiting is not known.

Chemotherapeutic agents and radiotherapy may cause release of 5HT in the

small intestine initiating a vomiting reflex by activating vagal afferents via

5HT3 receptors. Ondansetron blocks the initiation of this reflex. Activation

of vagal afferents may also cause a release of 5HT in the area postrema,

located on the floor of the fourth ventricle, and this may also promote emesis

through a central mechanism. Thus, the effect of ondansetron in the

management of the nausea and vomiting induced by cytotoxic chemotherapy

and radiotherapy is probably due to antagonism of 5HT3 receptors on neurons

located both in the peripheral and central nervous system. The mechanisms of

action in post-operative nausea and vomiting are not known but there may be

common pathways with cytotoxic induced nausea and vomiting.

ZOF TAB API 24MAR20 UK SmPC 03.2020

Page 9 of 13

Ondansetron does not alter plasma prolactin concentrations.

The role of ondansetron in opiate-induced emesis is not yet established.

QT Prolongation

The effect of ondansetron on the QTc interval was evaluated in a double blind,

randomized, placebo and positive (moxifloxacin) controlled, crossover study

in 58 healthy adult men and women. Ondansetron doses included 8 mg and

32 mg infused intravenously over 15 minutes. At the highest tested dose of

32 mg, the maximum mean (upper limit of 90% CI) difference in QTcF from

placebo after baseline-correction was 19.6 (21.5) msec. At the lower tested

dose of 8 mg, the maximum mean (upper limit of 90% CI) difference in QTcF

from placebo after baseline-correction was 5.8 (7.8) msec. In this study, there

were no QTcF measurements greater than 480 msec and no QTcF

prolongation was greater than 60 msec.

Paediatric population:

Chemotherapy-induced nausea and vomiting (CINV)

The efficacy of ondansetron in the control of emesis and nausea induced by

cancer chemotherapy was assessed in a double-blind randomised trial in

415 patients aged 1 to 18 years (S3AB3006). On the days of chemotherapy,

patients received either ondansetron 5 mg/m

intravenous and ondansetron 4

mg orally after 8 to 12 hours or ondansetron 0.45 mg/kg intravenous and

placebo orally after 8 to 12 hours. Post-chemotherapy both groups received

4 mg ondansetron syrup twice daily for 3 days. Complete control of emesis on

worst day of chemotherapy was 49% (5 mg/m

intravenous and ondansetron

4 mg orally) and 41% (0.45 mg/kg intravenous and placebo orally). Post-

chemotherapy both groups received 4 mg ondansetron syrup twice daily for 3

days. There was no difference in the overall incidence or nature of adverse

events between the two treatment groups.

double-blind

randomised

placebo-controlled

trial

(S3AB4003)

438 patients aged 1 to 17 years demonstrated complete control of emesis on

worst day of chemotherapy in:

73% of patients when ondansetron was administered intravenously at a

dose of 5 mg/m

intravenous together with 2 to 4 mg dexamethasone orally

71% of patients when ondansetron was administered as syrup at a dose of

8 mg together with 2 to 4 mg dexamethasone orally on the days of

chemotherapy.

Post-chemotherapy both groups received 4 mg ondansetron syrup twice daily

for 2 days. There was no difference in the overall incidence or nature of

adverse events between the two treatment groups.

efficacy

ondansetron

75 children

aged

48 months

investigated in an open-label, non-comparative, single-arm study (S3A40320).

All children received three 0.15 mg/kg doses of intravenous ondansetron,

administered 30 minutes before the start of chemotherapy and then at 4 and 8

ZOF TAB API 24MAR20 UK SmPC 03.2020

Page 10 of 13

hours after the first dose. Complete control of emesis was achieved in 56% of

patients.

Another open-label, non-comparative, single-arm study (S3A239) investigated

the efficacy of one intravenous dose of 0.15 mg/kg ondansetron followed by

two oral ondansetron doses of 4 mg for children aged < 12 years and 8 mg for

children aged ≥ 12 years (total no. of children n= 28). Complete control of

emesis was achieved in 42% of patients.

5.2

Pharmacokinetic properties

Following oral administration, ondansetron is passively and completely

absorbed from the gastrointestinal tract and undergoes first pass metabolism.

Peak plasma concentrations of about 30ng/mL are attained approximately 1.5

hours after an 8mg dose. For doses above 8mg the increase in ondansetron

systemic exposure with dose is greater than proportional; this may reflect some

reduction in first pass metabolism at higher oral doses. Mean bioavailability in

healthy male subjects, following the oral administration of a single 8 mg

tablet, is approximately 55 to 60%. Bioavailability, following oral

administration, is slightly enhanced by the presence of food but unaffected by

antacids.

The disposition of ondansetron following oral, intramuscular(IM) and

intravenous(IV) dosing is similar with a terminal half life of about 3 hours and

steady state volume of distribution of about 140L. Equivalent systemic

exposure is achieved after IM and IV administration of ondansetron.

A 4mg intravenous infusion of ondansetron given over 5 minutes results in

peak plasma concentrations of about 65ng/mL. Following intramuscular

administration of ondansetron, peak plasma concentrations of about 25ng/mL

are attained within 10 minutes of injection.

Following administration of ondansetron suppository, plasma ondansetron

concentrations become detectable between 15 and 60 minutes after dosing.

Concentrations rise in an essentially linear fashion, until peak concentrations

of 20-30 ng/mL are attained, typically 6 hours after dosing. Plasma

concentrations then fall, but at a slower rate than observed following oral

dosing due to continued absorption of ondansetron. The absolute

bioavailability of ondansetron from the suppository is approximately 60% and

is not affected by gender. The half life of the elimination phase following

suppository administration is determined by the rate of ondansetron

absorption, not systemic clearance and is approximately 6 hours. Females

show a small, clinically insignificant, increase in half-life in comparison with

males.

Ondansetron is not highly protein bound (70-76%). Ondansetron is cleared

from the systemic circulation predominantly by hepatic metabolism through

multiple enzymatic pathways. Less than 5% of the absorbed dose is excreted

unchanged in the urine. The absence of the enzyme CYP2D6 (the

debrisoquine polymorphism) has no effect on ondansetron's pharmacokinetics.

ZOF TAB API 24MAR20 UK SmPC 03.2020

Page 11 of 13

The pharmacokinetic properties of ondansetron are unchanged on repeat

dosing.

Special Patient Populations:

Gender

Gender

differences

were

shown

disposition

ondansetron,

with

females having a greater rate and extent of absorption following an oral dose

and reduced systemic clearance and volume of distribution (adjusted for

weight).

Children and Adolescents (aged 1 month to 17 years)

Population pharmacokinetic analysis was performed on 428 subjects (cancer

patients, surgery patients and healthy volunteers) aged 1 month to 44 years

following intravenous administration of ondansetron. Based on this analysis,

systemic exposure (AUC) of ondansetron following oral or IV dosing in children

and adolescents was comparable to adults, with the exception of infants aged 1

to 4 months. Volume was related to age and was lower in adults than in infants

and children. Clearance was related to weight but not to age with the exception

of infants aged 1 to 4 months. It is difficult to conclude whether there was an

additional reduction in clearance related to age in infants 1 to 4 months or

simply inherent variability due to the low number of subjects studied in this age

group. Since patients less than 6 months of age will only receive a single dose in

PONV a decreased clearance is not likely to be clinically relevant.

Elderly

Early Phase I studies in healthy elderly volunteers showed a slight age-related

decrease in clearance, and an increase in half-life of ondansetron. However,

wide inter-subject variability resulted in considerable overlap in

pharmacokinetic parameters between young (< 65 years of age) and elderly

subjects (≥ 65 years of age) and there were no overall differences in safety or

efficacy observed between young and elderly cancer patients enrolled in CINV

clinical trials to support a different dosing recommendation for the elderly.

Based on more recent ondansetron plasma concentrations and exposure-

response modelling, a greater effect on QTcF is predicted in patients ≥75 years

of age compared to young adults. Specific dosing information is provided for

patients over 65 years of age and over 75 years of age for intravenous dosing.

Renal impairment

In patients with renal impairment (creatinine clearance 15-60 mL/min), both

systemic clearance and volume of distribution are reduced following IV

administration of ondansetron, resulting in a slight, but clinically insignificant,

increase in elimination half-life (5.4 hours). A study in patients with severe

renal impairment who required regular haemodialysis (studied between

dialyses) showed ondansetron's pharmacokinetics to be essentially unchanged

following IV administration.

Hepatic impairment

ZOF TAB API 24MAR20 UK SmPC 03.2020

Page 12 of 13

Following oral, intravenous or intramuscular dosing in patients with severe

hepatic impairment, ondansetron's systemic clearance is markedly reduced

with prolonged elimination half-lives (15-32 hours) and an oral bioavailability

approaching 100% due to reduced pre-systemic metabolism. The

pharmacokinetics of ondansetron following administration as a suppository

have not been evaluated in patients with hepatic impairment.

5.3

Preclinical safety data

No additional data of relevance.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Lactose (anhydrous), microcrystalline cellulose, pregelatinised maize starch,

methylhydroxypropyl cellulose, magnesium stearate, titanium dioxide (E171),

iron oxide yellow (E172).

6.2

Incompatibilities

None reported.

6.3

Shelf life

The expiry date of the product is indicated on the packaging materials.

6.4

Special precautions for storage

Store below 30

6.5

Nature and contents of container

Blister packs of 10 tablets comprising blister film and foil lidding.

6.6

Special precautions for disposal and other handling

None stated.

ADMINISTRATIVE DATA

7.

Manufacturer

Aspen Bad Oldesloe GmbH, Bad Oldesloe, Germany

8.

Registration holder

ZOF TAB API 24MAR20 UK SmPC 03.2020

Page 13 of 13

Novartis Israel Ltd., POB 7126, Tel-Aviv

9.

License number

Zofran Tablets 4 mg 049-96-26549

Zofran Tablets 8 mg 049-95-26560

The content of this leaflet was approved by the Ministry of Health in May 2015 and updated

according to the guidelines of the Ministry of Health in March 2020

העדוה העדוה

לע לע

הרמחה הרמחה

(

(

עדימ עדימ

ןולעב )תוחיטב ןולעב )תוחיטב

ל

ל

אפור אפור

ןכדועמ( ןכדועמ(

05.2013

05.2013

ךיראת

07

/201

5

תילגנאב רישכת םש

Zofran Tablets 4 mg; Zofran Tablets 8 mg

םושירה רפסמ

049-95-26560

;

049-96-26549

םושירה לעב םש

GlaxoSmithKline (ISRAEL) Ltd

:

! דבלב תורמחהה טורפל דעוימ הז ספוט תושקובמה תורמחהה ןולעב קרפ יחכונ טסקט שדח טסקט

Special

Warnings and

Precautions

for Use

Hypersensitivity reactions have

been reported in patients who

have exhibited hypersensitivity to

other selective 5HT

receptor

antagonists. …

Hypersensitivity reactions have been reported in patients who have exhibited

hypersensitivity to other selective 5HT

receptor antagonists.Respiratory

events should be treated symptomatically and clinicians should pay particular

attention to them as precursors of hypersensitivity reactions.

There have been post-marketing reports describing patients with serotonin

syndrome (including altered mental status, autonomic instability and

neuromuscular abnormalities) following the concomitant use of ondansetron

and other serotonergic drugs (including selective serotonin reuptake

inhibitors (SSRI) and serotonin noradrenaline reuptake inhibitors (SNRIs)). If

concomitant treatment with ondansetron and other serotonergic drugs is

clinically warranted, appropriate observation of the patient is advised.

In patients with adenotonsillar surgery prevention of nausea and vomiting

with ondansetron may mask occult bleeding. Therefore, such patients should

followed carefully after ondansetron.

Paediatric Population:

Paediatric patients receiving ondansetron with hepatotoxic chemotherapeutic

agents should be monitored closely for impaired hepatic function.

Patients with rare hereditary problems of galactose intolerance, Lapp lactase

deficiency or glucose-galactose malabsorption should not take this medicine.

Undesirable

Effects

Additional data from post marketing experience

Cardiovascular

Arrhythmias (including ventricular and supraventricular tachycardia,

premature ventricular contractions, and atrial fibrillation), bradycardia,

electrocardiographic alterations (including second-degree heart block,

QT/QTc interval prolongation, and ST segment depression), palpitations, and

syncope.

General

Flushing. Rare cases of hypersensitivity reactions, sometimes severe (e.g.,

anaphylactic reactions, angioedema, bronchospasm, cardiopulmonary

arrest, hypotension, laryngeal edema, laryngospasm, shock, shortness of

breath, stridor) have also been reported. A positive lymphocyte

transformation test to ondansetron has been reported, which suggests

immunologic sensitivity to ondansetron.

Hepatobiliary

Liver enzyme abnormalities have been reported. Liver failure and death have

been reported in patients with cancer receiving concurrent medications

including potentially hepatotoxic cytotoxic chemotherapy and antibiotics.

Neurological

Oculogyric crisis, appearing alone, as well as with other dystonic reactions.

Skin

Urticaria , Stevens-Johnson syndrome Toxic skin eruption, including toxic

epidermal necrolysis

Overdose

Symptoms and Signs

There is limited experience of

ondansetron overdose. In the

majority of cases, symptoms were

similar to those already reported in

patients receiving recommended

doses (see Adverse Reactions).

Symptoms and Signs

There is limited experience of ondansetron overdose. In the majority of

cases, symptoms were similar to those already reported in patients receiving

recommended doses (see section 4.8). Manifestations that have been

reported include visual disturbances, severe constipation, hypotension and a

vasovagal episode with transient second-degree AV block.

תושקובמה תורמחהה תונמוסמ ובש ,ןולעה ב"צמ .בוהצ עקר לע

רדגב םניאש םייוניש עבצב (ןולעב) ונמוס תורמחה קורי

העדוה העדוה

לע לע

הרמחה הרמחה

(

(

עדימ עדימ

ןולעב )תוחיטב ןולעב )תוחיטב

ןכרצל ןכרצל ןכדועמ( ןכדועמ(

05.2013

05.2013

ךיראת

07

/201

5

תילגנאב רישכת םש

Zofran Tablets 4 mg; Zofran Tablets 8 mg

םושירה רפסמ

049-95-26560

;

049-96-26549

םושירה לעב םש

GlaxoSmithKline (ISRAEL) Ltd

:

! דבלב תורמחהה טורפל דעוימ הז ספוט תושקובמה תורמחהה ןולעב קרפ יחכונ טסקט שדח טסקט שומיש ינפל הפורתב ילבמ הפורתב שמתשהל ןיא תלחתה ינפל אפורב ץעוויהל לופיטה

וא ןוירה תננכתמ ,ןוירהב ךניה םא .הקינימ רבעב תלבס וא לבוס ךנה םא ,השק תוריצע/םייעמ תמיסחמ .רידס אל בל בצק ןוגכ בל תויעבמ רבעב תלבס וא לבוס ךנה םא .דבכה דוקפתב יוקילמ תורהזא

וא והשלכ ןוזמל שיגר ךנה םא לע עידוהל ךילע ,יהשלכ הפורתל .הפורתה תליטנ ינפל אפורל ךכ תוקידב ינפל אפורל עידוהל ךילע וז הפורתש ןוויכ דבכ ידוקפתל םד תואצות לע עיפשהל הלולע .הקידבה .זוטקל הליכמ הפורתה הפורתב שומישל תועגונה תודחוימ תורהזא םא אפורל רפס ,ןרפוזב לופיטה ינפל

בל תויעב ךל ויה םעפ יא המישנ רצוקל תמרוג רשא בל תקיפס יא ןוגכ) (םיחופנ םיילוסרקו

(בצק תוערפה) רידס וניא ךלש בלה בצק

ןורטסינרג ןוגכ ,ןורטסנאדנואל תומודה תופורתל יגרלא התא

דבכב תויעב ךל שי

םייעמ תמיסח ךל שי

םויזנגמו ןרתנ ,ןגלשא ןוגכ ,ךמדב םיחלמה תומר םע תויעב ךל שי

וא ,תפסונ הפורת לטונ ךנה םא הפורתב לופיט התע הז תרמג םא םשרמ אלל תופורת ללוכ ,תרחא אפורל חוודל ךילע ,אפרמ יחמצו יא וא םינוכיס עונמל ידכ לפטמה ןיב תובוגתמ םיעבונה תוליעי דחוימב ,תויתפורת :תואבה תוצובקהמ תופורת יבגל ,ןיציפמאפיר ,ןיפזמברק ,ןיאוטינפ .לודמרט ןרפוזו תורחא תופורת אלל תופורת ללוכ תורחא תופורת ,הנורחאל תחקל םא וא ,חקול התא םא םושמ תאז .חקורל וא אפורל ךכ לע רפס ,הנוזת יפסותו אפרמ יחמצ ,םשרמ קלח ,ןכ ומכ .תופורתהמ קלח לש הלועפה ןפוא לע עיפשהל הלולע ןרפוזש שי דחוימב .ןרפוז לש הלועפה ןפוא לע עיפשהל תולולע תורחאה תופורתהמ :חקול התא םא חקורה וא אפורה תא עדייל

היספליפאב לופיטל תושמשמה ןיאוטינפ וא ןיפזאמאבראק

) תפחש ומכ םימוהיזב לופיטל תשמשמה ןיציפמאפיר

לוזאנוקוטק וא ןיצימורתירא ומכ הקיטויביטנא

רידס אל בל בצקב לופיטל תושמשמה תוימתיראיטנא תופורת

וא בלב תומייוסמ תויעבב לופיטל תושמשמה אטב תומסוח תופורת תונרגימ תעינמל וא הדרחב ,םייניעב

םיבאכ ךכשמ ,לודאמארט

(ןודתמ וא לודירפולה ,ןוגכ) בלה לע תועיפשמה תופורת

(באמוזוטסארטו םינילקיצרטנא דחוימב) ןטרסל תופורת

SSRIs

םישמשמה (ןינוטורס לש םיביטקלס תרזוח הגיפס יבכעמ) ,ןיטסקוראפ ,ןיטסקואולפ םיללוכה הדרחב וא/ו ןואכדב לופיטל םארפולאטיצסא ,םארפולאטיצ ,ןימאסקובולפ ,ןילארטרס

SNRIs

םישמשמה (ןילנרדארונ ןינוטורס לש תרזוח הגיפס יבכעמ) .ןיטסקולוד ,ןיסקאפאלנו םיללוכה הדרחב וא/ו ןואכדב לופיטל זוטקל הליכמ הפורתה הפורתה לש םיביכרהמ קלח לע בושח עדימ .זוטקל הליכמ וז הפורת תוליבס יא ךל שיש ךלש אפורה י"ע ךל רמאנ םא .וז הפורת תליטנ ינפל ךלש אפורה םע חחוש ,םימיוסמ םירכוסל תועפות יאוול תובייחמה יאוול תועפות תדחוימ תוסחייתה

רתי תושיגר תעפוה

רידס אל בל בצק תויגרלא תובוגת .דימ אפור הארו התוא תחקל קספה ,תיגרלא הבוגת ךל שי םא

:לולכל םייושע םינמיסה

...

תוטטומתה תופסונ יאוול תועפות

...

-מ תוחפב תועיפומ) תוחיכש ןניא

1

ךותמ

100

(םישנא

...

רידס אל בל בצק תוילע רופרפ :ללוכ -תוימתירא) בלה בצקב תוערפה[ עטקמ תכראה ,יטיא בל בצק ,(םירדח רופרפו

גקא תוקידבב ]תופלעתהו :הפורתה קוויש רחאל העודי אל תוחיכשב ופצנש יאוול תועפות

ידבכ לשכ לש םיבצמ וחווד ,ןכ ומכ . דבכ ימיזנא לש תומרב םייוניש לאיצנטופ תולעב תופסונ תופורת ליבקמב ולביקש ןטרס ילפוטמב תוומו .תוקיטויביטנאו תידבכ תוליערל

תוירוע יאוול תועפות ןכו , (הירקירטוא) תלרח :ןוגכ תוירוע יאוול תועפות ג ןביטס :ןוגכ םייח תונכסמ

ףוליקו תויחופלש םע תבחרנ החירפו ןוסנו קיסקוט-ינלער ילמרדיפא קמנ) ףוגה חטש ינפמ לודג קלח ינפ לע רוע (סיזילורקנ למרדיפא תושקובמה תורמחהה תונמוסמ ובש ,ןולעה ב"צמ .בוהצ עקר לע

רדגב םניאש םייוניש עבצב (ןולעב) ונמוס תורמחה קורי

Similar products

Search alerts related to this product

View documents history

Share this information