REMOTIV 500

国家: 以色列

语言: 英文

来源: Ministry of Health

有效成分:

HYPERICI HERBA EXTRACTUM SICCUM

可用日期:

RAFA LABORATORIES LTD

ATC代码:

N06AX

药物剂型:

FILM COATED TABLETS

组成:

HYPERICI HERBA EXTRACTUM SICCUM 500 MG

给药途径:

PER OS

处方类型:

Required

厂商:

MAX ZELLER SOHNE AG, SWITZERLAND

治疗组:

OTHER ANTIDEPRESSANTS

疗效迹象:

Symptoms of mild to moderate depression including: dejected mood, mood lability, inner restlessness, anxiety, states of tension and the difficulty in falling asleep and sleeping through the night which is associated with these conditions.Treatment is recommended for up to 24 weeks.

授权日期:

2014-07-31

资料单张

۱۹۸٦ – (ﺕﺍﺭﺿﺣﺗــﺳﻣ) ﺔﻟﺩﺎﻳﺻﻟﺍ
ﺔﻣﻅﻧﺃ ﺏﺟﻭﻣﺑ ﻙﻠﻬﺗــﺳﻣﻠﻟ
ﺔﻳﺑﻁ ﺓﺭـ
ـﺷﻧ
ﻂﻘﻓ ﺐﻴﺒﻁ ﺔﻔﺻﻭ ﺐﺟﻮﻤﺑ ءﺍﻭﺪﻟﺍ
ﻕ
ّ
ﻮﺴ
ُ
ﻳ
٥۰۰ ﺏﻳﺗﻭﻣﻳﺭ ۲٥۰ ﺏﻳﺗﻭﻣﻳﺭ
ﺔﻳﻠﻁﻣ ﺹﺍﺭﻗﺃ :ﺔﻟﺎ
ّ
ﻌﻔﻟﺍ ﺓﺩﺎﻤﻟﺍ
.(St. John's wort)
ﻡﻮﻜﻳﺮݒﻴﻬﻟﺍ ﺕﺎﺒﻧ ﻦﻣ ﺔﻓﺎﺟ
ﺓﺭﺎﺼﻋ ﻎﻠﻣ ۲٥۰ :ﻰﻠﻋ ﻱﻮﺘﺤﻳ
۲٥۰ ﺐﻴﺗﻮﻤﻳﺭ
ﻦﻣ ﺹﺮﻗ ﻞﻛ
.(St. John's wort)
ﻡﻮﻜﻳﺮݒﻴﻬﻟﺍ ﺕﺎﺒﻧ ﻦﻣ ﺔﻓﺎﺟ
ﺓﺭﺎﺼﻋ ﻎﻠﻣ ٥۰۰ :ﻰﻠﻋ ﻱﻮﺘﺤﻳ
٥۰۰ ﺐﻴﺗﻮﻤﻳﺭ
ﻦﻣ ﺹﺮﻗ ﻞﻛ
.ﻉﺍﺮﺘﺧﺍ ﺓءﺍﺮﺒﺑ ﺔﻴﻤﺤﻤﻟﺍ
ﺎﻬﻋﻮﻧ ﻦﻣ ﺓﺪﻳﺮﻓ ﺔﻘﻳﺮﻄﺑ ,
Ze117
ﻰﻋﺪﺗ ﻲﺘﻟﺍﻭ ,ﺔﺻﺎﺨﻟﺍ ﺓﺭﺎﺼﻌﻟﺍ
ﺝﺍﺮﺨﺘﺳﺍ ﻢﺘﻳ
.
ﻦﻴﺳﺮﭙﻳﺎﻫ ﻎﻠﻣ ۰.٥ ,
(
ﺕﺎﺒﻛﺮﻤﻟﺍ ﺔﻴﻘﺒﻟ ﺔﻓﺎﺿﻹﺎﺑ
)
ﻰﻠﻋ ۲٥۰ ﺐﻴﺗﻮﻤﻳﺭ ﺹﺮﻗ ﻲﻓ
ﺓﺭﺎﺼﻌﻟﺍ ﻱﻮﺘﺤﺗ
.ﻦﻴﺳﺮﭙﻳﺎﻫ ﻎﻠﻣ ۱ ,
(
ﺕﺎﺒﻛﺮﻤﻟﺍ ﺔﻴﻘﺒﻟ ﺔﻓﺎﺿﻹﺎﺑ
)
ﻰﻠﻋ ٥۰۰ ﺐﻴﺗﻮﻤﻳﺭ ﺹﺮﻗ ﻲﻓ
ﺓﺭﺎﺼﻌﻟﺍ ﻱﻮﺘﺤﺗ
.ﻦﻳﺭﻮﻓﺮﭙﻳﺎﻬﻟﺍ ﻦﻣ ﺓﺮﻴﻐﺻ
ﺔﻴﻤﻛ ﻰﻠﻋ ﻱﻮﺘﺤﺗ ﺪﻗ ﺓﺭﺎﺼﻌﻟﺍ
.۲ ﺪﻨﺒﻟﺍ ﻲﻓ 'ءﺍﻭﺪﻟﺍ ﺕﺎﺒﻛﺮﻣ
ﻦﻣ ءﺰﺟ ﻦﻋ ﺔﻤﻬﻣ ﺕﺎﻣﻮﻠﻌﻣ' ﺎ
ً
ﻀﻳﺃ ﺮﻈﻧﺃ .٦ ﺪﻨﺒﻟﺍ ﺮﻈﻧﺃ ﺔﻟﺎ
ّ
ﻌﻔﻟﺍ ﺮﻴﻏ ﺩﺍﻮﻤﻟﺍ ﺔﻤﺋﺎﻘﻟ
.
ءﺍﻭﺪﻟﺍ ﻞﻤﻌﺘﺴﺗ ﻥﺃ ﻞﺒﻗ
ﺎﻬﺘﻳﺎﻬﻧ ﻰﺘﺣ ﻥﺎﻌﻣﺈﺑ ﺓﺮﺸﻨﻟﺍ
ﺃﺮﻗﺇ
ﺐـ
ـﻴﺒﻄﻟﺍ ﻰــﻟﺇ ﻪــﺟﻮﺗ
,ﺔــﻴﻓﺎﺿﺇ ﺔﻠﺌــﺳﺃ ﻚـ

产品特点

Remotiv-SPC-November 2023
1. REMOTIV
® 250
REMOTIV
® 500
Film coated tablets
Herbal medicinal product
2. COMPOSITION
Composition
Active substance of Remotiv 250 mg: St. John's wort (Hypericum
perforatum), dry extract. One film-coated tablet contains 250mg of the
standardized dry extract (Ze 117), standardized to 0.5mg total
hypericin.
The unique patented extraction process (extraction solvent: ethanol
50%
w/w; drug-extract ratio: 4-7:1) guarantees a consistently high-quality
product, which has a very low hyperforin content (see below “Drug
interactions”).
Active
substance
of
Remotiv
500mg:
St.
John's
wort
(Hypericum
perforatum), dry extract. One film-coated tablet contains 500mg of the
standardized dry extract (Ze 117), standardized to 1mg total
hypericin.
The unique patented extraction process (extraction solvent: ethanol
50%
w/w; drug-extract ratio: 4-7:1) guarantees a consistently high-quality
product, which has a very low hyperforin content (see below “Drug
interactions”).
For list of excipients: see section 6.1
This medicine contains approx. 120 mg digestible carbohydrates per
single dose. The medicine is suitable for diabetics.
3. PHARMACEUTICAL FORM
GALENIC FORM AND ACTIVE SUBSTANCE PER UNIT
Film coated tablets.
Herbal medicinal product
Remotiv 250:
1 film coated tablet contains 250 mg of the quantified dry extract
from
St. John’s
wort
(corresponding
to
0.25 - 0.75 mg
total
hypericins
(calculated as hypericin) and maximum 0.5 mg hyperforin.
Remotiv 500:
1 film coated tablet contains 500 mg of the quantified dry extract
from
St. John’s
wort
(corresponding
to
0.5 - 1.5 mg
total
hypericins
(calculated as hypericin) and maximum 1 mg hyperforin.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
For the treatment of symptoms of mild to moderate depression
including dejected mood, mood lability, anxiety, inner restlessness,
states of tension, and difficulty in falling asleep and sleeping
through
the night which is associated with these conditions. Treatment is
recommended for up to 24 weeks.
4.2