چينوتروپين ١٢
देश: इसराइल
भाषा: अरबी
स्रोत: Ministry of Health
सूचना पत्रक
(PIL)
12-10-2022
अनुरोध भेजा।
सक्रिय संघटक:
SOMATROPIN RECOMBINANT 36 IU/ML
थमां उपलब्ध:
PFIZER PHARMACEUTICALS ISRAEL LTD
ए.टी.सी कोड:
H01AC01
फार्मास्यूटिकल फॉर्म:
LYOPHILIZED POWDER FOR INJECTION
प्रशासन का मार्ग:
S.C
द्वारा बनाया गया:
PFIZER MANUFACTURING BELGIUM NV/SA
चिकित्सीय समूह:
SOMATROPIN
चिकित्सीय संकेत:
Children: Short stature due to inadequate or failed secretion of pituitary growth hormone or Turner`s syndrome. Short stature in children with renal insufficiency. Growth disturbance (height SDS<2.5 and parenteral adjusted height SDS < -1) in short children born SGA (SGA - small for gestational age i.e. born small in relation to the length of the fetus development) with a birth witght and/or length < 2 SD who failed to show catch up growth (HV SDS < 0 during the last year) by 4 years of age or later. Prader willi syndrome for improvement of growth and body composition. Adults: For adults who have suffered from growth-hormone deficiency since childhood. For adults who have aquired growth hormone deficiency due to a pituitary pathology causing hypopituitarism.
प्राधिकरण की तारीख:
2011-02-01
सूचना पत्रक
Genotropin GQ 5.3mg, Israel, PIL CC 04 July 2022_ _
2021-0068728
1 ﺔﻟدﺎﯾﺻﻟا ﺔﻣظﻧأ بﺟوﻣﺑ
كﻠﮭﺗﺳﻣﻠﻟ ةرﺷﻧ
)
تار
َ
ﺿﺣﺗﺳﻣ (
-
1986
طﻘﻓ بﯾﺑط ﺔﻔﺻو بﺟوﻣﺑ ءاودﻟا ق
ّ
وﺳ
ُ
ﯾ
نﯾﭘورﺗوﻧﯾﭼ
™
5.3
ﻎﻠﻣ
دﻠﺟﻟا تﺣﺗ نﻘﺣﻠﻟ لوﻠﺣﻣ رﯾﺿﺣﺗﻟ
بﯾذ
ُ
ﻣو قوﺣﺳﻣ .
نﯾﭘورﺗوﻧﯾﭼ ﺔﻧﻘﺣﻣ مﻠﻗ يوﺗﺣﯾ
5.3
ﻰﻠﻋ ﻎﻠﻣ : بوﺷﺄﻣ نﯾﭘورﺗﺎﻣوﺳ
5.3
ﻎﻠﻣ / لﻠﻣ
SOMATROPIN RECOMBINANT 5.3 MG/ML
دﻧﺑﻟا رظﻧا ،ﺔﯾﺳﺎﺳﺣﻟا تﺎﺑﺑﺳ
ُ
ﻣو ﺔﻟﺎ
ّ
ﻌﻔﻟا رﯾﻏ
ّ
داوﻣﻟا ﺔﻣﺋﺎﻘﻟ
6
"
ﺔ
ّ
ﯾﻓﺎﺿإ تﺎﻣوﻠﻌﻣ
."
ءاودﻟا لﺎﻣﻌﺗﺳﺎﺑ ءدﺑﻟا لﺑﻗ كﻟذو
ﺎﮭﺗﯾﺎﮭﻧ ﻰﺗﺣ ن
ّ
ﻌﻣﺗﺑ ةرﺷﻧﻟا أرﻗا
.
ءاو
ّ
دﻟا نﻋ ةزﺟوﻣ تﺎﻣوﻠﻌﻣ ﻰﻠﻋ
ةرﺷﻧﻟا هذھ يوﺗﺣﺗ
.
ﺔﻠﺋﺳأ كﯾدﻟ تﻧﺎﻛ اذإ
ﮫ
ّ
ﺟوﺗ ،ﺔﯾﻓﺎﺿإ
ّ
ﻲﻟدﯾﺻﻟا وأ بﯾﺑطﻟا ﻰﻟإ
.
كﺟﻼﻌﻟ ءاودﻟا اذھ ف
ِ
ﺻ
ُ
و
.
؛نﯾرﺧﻶﻟ ﮫ
ِ
طﻌﺗ ﻻ
مﮭﺗﻟﺎﺣو ﺔ
ّ
ﯾﺣﺻﻟا كﺗﻟﺎﺣ نﯾﺑ ﮫﺑﺎﺷﺗ كﻟ ادﺑ
وﻟ ﻰﺗﺣ ،مﮭﺑ
ّ
رﺿﯾ دﻗ ﮫ
ّ
ﻧﻷ
.
؟نﯾﭘورﺗوﻧﯾﭼ نﻋ ﮫﺗﻓرﻌﻣ
ّ
ﻲﻠﻋ اذﺎﻣ
•
نﻣ ﮫﻧﻘﺣو ءاودﻟا رﯾﺿﺣﺗ ﺔﻘﯾرط
لوﺣ دﺎﺷرإ زﺎﯾﺗﺟا كﯾﻠﻋ ءاودﻟا
لﺎﻣﻌﺗﺳا لﺑﻗ
لھؤﻣ ﻲﺑط مﻗﺎط لﺑﻗ
.
1
.
؟ءاوّ
دﻟا اذھ ّ
دﻋأ
َ
مﻟ
لﺎﻔطﻷا ىدﻟ
:
•
ﺔﯾﻣﺎﺧﻧﻟا ةدﻐﻟا نﻣ وﻣﻧﻟا
نوﻣرﮭﻟ فﺎﻛ رﯾﻏ زارﻓإ وأ زارﻓإ مدﻋ
نﻋ ﺔﺟﺗﺎﻧﻟا لﺎﻔطﻷ ىدﻟ وﻣﻧﻟا
لﻛﺎﺷﻣ جﻼﻌﻟ
.
•
رﻧرﯾﺗ ﺔﻣز
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