چينوتروپين ١٢

المعلومات الرئيسية

  • اسم تجاري:
  • چينوتروپين ١٢
  • الشكل الصيدلاني:
  • LYOPHILIZED POWDER FOR INJECTION
  • طريقة التعاطي:
  • S.C
  • يسخدم من اجل:
  • البشر
  • نوع الدواء:
  • المخدرات الوباتشيك
  • المصنعة من قبل:
  • PFIZER MANUFACTURING BELGIUM NV/SA

المستندات

الأقلمة

  • متاح في:
  • چينوتروپين ١٢
    إسرائيل
  • اللغة:
  • العربية

معلومات العلاجية

  • المجموعة العلاجية:
  • SOMATROPIN
  • الخصائص العلاجية:
  • 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.

الحالة

  • المصدر:
  • Ministry of Health - State of Israel
  • تخويل:
  • 121352754022
  • تاريخ الترخيص:
  • 01-02-2011
  • اخر تحديث:
  • 09-08-2016

معلومات المرضى النشرة: نشرة المعلومات, خصائص المنتج

ÌÈÁ˜Â¯‰†˙Â˜˙†ÈÙφÔίˆÏ†ÔÂÏÚ

±π∏∂†≠†Â¢Ó˘˙‰†®ÌÈ¯È˘Î˙©

‡Ù¯†Ì˘¯Ó·†·ÈÈÁ†‰Ê†¯È˘Î˙

¯È˘Î˙·†ÈØ˘Ó˙˘˙†Ì¯Ë·†ÂÙÂÒ†„Ú†ÔÂÏÚ‰†˙‡†ÔÂÈÚ·†È؇¯˜

˙‡ȯ·‰†„¯˘Ó†È¢Ú†Ú·˜†‰Ê†ÔÂÏÚ†ËÓ¯ÂÙ

¯˘Â‡Â†˜„·†ÂÎÂ˙Â

ÔÈÙ¯ËÂ‚ ÔÈÙ¯ËÂ‚

‚¢Ó †μÆ≥ ‚¢Ó †±≤

˙ȯÂÚ≠˙˙†‰˜¯Ê‰Ï†‰˜·‡ ˙ȯÂÚ≠˙˙†‰˜¯Ê‰Ï†‰˜·‡

‰ÒÓ‰†È¯Á‡ ‰ÒÓ‰†È¯Á‡

∫·Î¯‰

∫‰ÏÈÎÓ†‰˜·‡†˙ÈÒÁÓ†ÏÎ ∫‰ÏÈÎÓ†‰˜·‡†˙ÈÒÁÓ†ÏÎ

Somatropin 5.3 mg Somatropin 12 mg

Glycine, Sodium dihydrogen ††††††††††∫ÌÈÏÈÚÙ†È˙Ï·†ÌȯÓÂÁ

phosphate anhydrous, Disodium phosphate anhydrous,

Water for injections, m-Cresol, Mannitol.

∫‰Êȯ‡

¯Â„Ó·†‰˜¯Ê‰Ï†‰˜·‡†ÌÚ†˙ȯ„Ó≠„†˙ÈÒÁÓ†‰ÏÈÎÓ†‰Êȯ‡†ÏÎ

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Ɖ˜¯Ê‰‰

ƉÏÈ„‚†ÔÂӯ‰ ∫˙ÈËÈÂÙ¯˙†‰ˆÂ·˜

∫˙ȇÂÙ¯†˙ÂÏÈÚÙ

‰˘¯Ù‰≠ȇ†È„È≠ÏÚ†˙ÂÓ¯‚‰†ÌÈ„ÏÈ·†‰ÏÈ„‚†˙ÂÈÚ··†ÏÂÙȈ∫ÌÈ„ÏÈ·

˙¯˙ÂȆ˙ËÂÏ·Ó†‰ÏÈ„‚‰†ÔÂӯ‰†Ï˘†˙˜ÙÒÓ†‡Ï†‰˘¯Ù‰†Â‡

ÆÁÂÓ‰

Ư¯Ë†Ì¯„ÈÒ†ÌÚ†˙Â··†‰ÏÈ„‚†˙ÂÈÚ·

Æ˙È˙ÈÈÏΆ‰˜ÈÙ҆ȇ†·˜Ú†ÌÈ„ÏÈ·†‰ÏÈ„‚†·ÂÎÈÚ

Æ® Prader-Willi's syndrome ©†ÈÏÈÂÂ≠¯„‡¯Ù†˘¢Ú†Ì¯„ÈÒ

Æ® SGA ©†ÔÂȯ‰‰†ÔÓÊφÌÈ˘†Â„ÏÂ˘†ÌÈ„ÏÈ

ʇӆ‰ÏÈ„‚†ÔÂӯ‰·†¯ÂÒÁÓÓ†ÂÏ·Ò˘†Ìȯ‚·Óφ∫Ìȯ‚·ӷ

·˜Ú†‰ÏÈ„‚†ÔÂӯ‰·†¯ÒÂÁÓ†ÌÈÏ·ÂÒ‰†Ìȯ‚·Óφ¨˙„Ïȉ

ÆÁÂÓ‰†˙¯˙ÂȆ˙ËÂÏ··†‰ÈÚ·

ø¯È˘Î˙·†˘Ó˙˘‰Ï†Ôȇ†È˙Ó

È·ÈίÓÓ†„Á‡Ï†˙Â˘È‚¯†‰Ú„Ȇ̇†¯È˘Î˙·†˘Ó˙˘‰Ï†Ôȇ

Æ¯È˘Î˙‰

Æ®ÔÏ‰Ï†È /‰‡¯©†Ï„Ȃφ˙„چÌÚ†ÌÈÏÂÁ·†¯È˘Î˙·†˘Ó˙˘‰Ï†Ôȇ

ÆÏÈÚÙ†È˙Ï‚Ï‚†ÍÂ˙†Ï„Ȃ†ÌÚ†ÌÈÏÂÁ·†¯È˘Î˙·†˘Ó˙˘‰Ï†Ôȇ

˙ÏÁ˙‰†Ì¯Ë†Â·†ÏÂÙÈˉ†˙‡†ÌÈÏ˘‰Ï†˘È†Ï„Ȃ†ÔÁ·Â‡†Ì‡

ÆÔÈÙ¯ËÂ‚·†˘ÂÓÈ˘‰

¯Á‡Ï†ÌÈÈËȯ˜†ÌÈηÈÒÓ†ÌÈÏ·ÂÒ‰†ÌÈÏÂÁ·†˘Ó˙˘‰Ï†Ôȇ

‰˜ÈÙÒ≠ȇ†¨˙È˙ίÚÓ≠·¯†‰Ó‡¯Ë†¨ÔË·†ÈÁÂ˙È†¨ÁÂ˙Ù†·Ï†ÁÂ˙È

ÆÌÈÓ„†ÌÈ·ˆÓ†‰ÓÈ˘‰†˙ίÚÓ†Ï˘

˙ÂÈÁÂφÌÚ†ÌÈ„ÏÈ·†‰ÏÈ„‚†„„ÈÚ†¯Â·Ú†¯È˘Î˙·†˘Ó˙˘‰Ï†Ôȇ

Æ˙¯‚҆®˙ÂÊÈÙÈÙ‡©†‰ÏÈ„‚

ÏÂÙÈˉ†˙‡†˜ÈÒىφ˘È†¨˙È¯Ά˙ÂÈÏΆ˙ÏÁÓ†ÌÚ†ÌÈ„ÏÈ·

Íȉ†Ì‡†˘Ó˙˘‰Ï†Ôȇ†Æ‰ÈÏΆ˙Ï˙˘‰†ÈÙφÔÈÙ¯ËÂ‚·

ƉÈÏΆ˙ØÏ˙˘ÂÓ

ÌÈÏ·ÂÒ‰†ÈÏÈÂÂ≠¯„‡¯Ù†˙ÂÓÒ˙†ÈÏÂÁ·†¯È˘Î˙·†˘Ó˙˘‰Ï†Ôȇ

Æ˙¯ÂÓÁ†‰ÓÈ˘†˙Âگى†¨‰¯ÂÓÁ†‰Ó˘‰Ó

ÈÙφ‡Ù¯·†ıÚÂÂȉφÈÏ·Ó†¯È˘Î˙·†˘Ó˙˘‰Ï†Ôȇ

∫ÏÂÙÈˉ†˙ÏÁ˙‰

Ɖ˜ÈÈӆ‡†ÔÂȯ‰·†Íȉ†Ì‡

¨‰ÈÏΉ†„˜Ù˙·†È˜ÈÏÓ†¯·Ú·†˙Ϸ҆‡†˙ØÏ·ÂÒ†Íȉ†Ì‡

∫˙¯‰Ê‡

ÍÈÏÚ†¨È‰˘ÏΆ‰Ù¯˙φ‡†Â‰˘ÏΆÔÂÊÓφ‰Ø˘È‚¯†Íȉ†Ì‡

Æ¯È˘Î˙·†˘ÂÓÈ˘‰†ÈÙφ‡Ù¯φÍÎ≠ÏÚ†ÚȄ‰Ï

·Ï†ÈÁÂ˙È†Ô‚Ω†˙ÎÂÒÓ†‰ÏÁÓ·†ÌÈÏÂÁ†ÏÂÙÈˉ†Íωӷ†Ì‡

˘È†®ßÂΆ˙È˙ίÚÓ†·¯†‰Ó‡¯Ë†¨˙È˙ÓÈ˘†‰˜ÈÙ҆ȇ†¨ÔË·Â

ƇÙ¯φÍÎ≠ÏÚ†ÚȄ‰Ï

˙¯Á‡†˙ÂȇÂÙ¯†˙·ÈÒ†ÏÂÏ˘Ï†˘È†ÌÈÎÂÓ†Â„ÏÂ˘†ÌÈ„ÏÈ·

Æ¯È˘Î˙·†ÏÂÙÈˉ†˙ÏÈÁ˙†ÈÙφ‰ÏÈ„‚†˙ÂÚ¯Ù‰Ï

Úˆ·Ï†˘È†®ÔÂȯ‰‰†ÔÓÊφÌÈ˘†Â„ÏÂ˘†ÌÈ„ÏÈ©† SGA †ÈÏÂÁ·

ÏÂÙÈˉ†˙ÏÈÁ˙†ÈÙφ̈·†Ì„·†ÔÈÏÂÒȇ†Ê˜ÂÏ‚†˙Âӯφ˙˜Ȅ·

ÈÂÓ„†‰ÏÈ„‚†¯Â˘ن˙˜È„·†ÔΆ¨ÔÎÓ†¯Á‡Ï†‰˘†ÏΆ¯È˘Î˙·

ÆÏÂÙÈˉ†Íωӷ†‰˘·†ÌÈÈÓÚÙ†ÏÂÙÈˉ†ÈÙφ ( IGF-I )†±†ÔÈÏÂÒȇ

‰ÓÈÒÁ†˙ÂÁÎÂφ¯Â¯È·†Úˆ·Ï†˘È†ÈÏÈÂÂ≠¯„‡¯Ù†˙ÂÓÒ˙·†ÌÈÏÂÁ·

̯ˆ‰È˘·†‰ÓÈ˘†˙˜Òىφ˙ÂÂÈÏÚ‰†‰ÓÈ˘‰†Èί„·

¯È˘Î˙·†ÏÂÙÈˉ†Âχ†ÌÈÏÂÁ·†ªÔÈÙ¯ËÂ‚·†ÏÂÙȈ˙ÏÁ˙‰

ƉÓȇ˙Ó†‰Ë‡È„†ÌÚ†·Ï¢ӆ˙ÂȉφÍȯˆ

ÌÈÓÈÒ†¯Á‡†·˜ÚÓ†Úˆ·Ï†˘È†ÈÏÈÂÂ≠¯„‡¯Ù†˙ÂÓÒ˙·†ÌÈÏÂÁ·

¨˙¯ÈÁ·†‰¯ÓÁ‰†Â‡†‰ÏÁ˙‰†Ô‚Ά¨‰ÓÈ˘‰†Èί„·†Ì‰ÈÊÏ

ÆÌÈ„ÏÈ·†˙Ó˜ÚÂ

˙È˙ÁÙ˘Ó†‰È¯ÂËÒȉ†∫‡Ó‚„ϩ†˙¯ÎÂÒφÔÂÎÈÒ†ÌÚ†ÌÈÏÂÁ·

‰Ș˙†‡Ï†‰ÈˆËÓ‚ÈÙ†¨ÔÈÏÂÒȇφ˙„‚˙†¨‰Ó˘‰†¨˙¯ÎÂÒ†Ï˘

ÆʘÂςφ˙ÂÏÈ·Ò†˙˜È„·†Úˆ·Ï†˘È†®¯ÂÚ‰†Ï˘

˙Ó¯†˙‡†¨ÌÈÓÈÂÒÓ†ÌÈ·ˆÓ·†¨˙ÂÏډφÏÂÏÚ†‰ÏÈ„‚†ÔÂӯ‰

ÌÈÏ·ÂÒ‰†ÌÈÏÂÁ·†ÔÈÙ¯ËÂ‚·†˘ÂÓÈ˘‰†ÔÎφ¨Ì„·†¯ÎÂÒ‰

ÛË¢†·˜ÚÓ†Æ˙¯ȉʆÈÚˆÓ‡†˙ËȘ†ÍÂ˙†‰˘ÚÈȆ˙¯ÎÂÒÓ

ƉχΆÌȯ˜Ó·†ÌÈÈÁ¯Î‰†‰„ÂÓˆ†‰Á‚˘‰Â†¯ÎÂÒ‰†˙Ó¯†¯Á‡

ÏÂÙÈ˷†∂∞†ÏÈ‚†ÏÚÓ†ÌÈÏÂÁ·†ÏÂÙÈˉ†˙„‡†Ï·‚ÂÓ†Ú„ÈÓ†ÌÈȘ

ÆÈÏÈÂÂ≠¯„‡¯Ù†˘¢Ú†Ì¯„ÈÒ†ÈÏÂÁ·Â†Ìȯ‚·ӷ†Í˘ÂÓÓ

ÈÂÏȂφ˙ÂÙÂÎ˙†˙˜Ȅ·†¯Â·Úφ˘È†¨Ï„Ȃ†ÌÚ†¯·Ú·†˙Á·Â‡†Ì‡

ÆÏ„Ȃ‰†˙Â˘È‰

·ÎÚφÏÂÏÚ†˙ÓÈÂÒÓ†‰Ó†ÏÚÓ†ÌȄȇ¯ËÒ˜È˯˜·†ÏÂÙÈË

Ìȇ˙‰Ï†˘È†¨ ACTH †¯ÒÂÁÓ†ÏÈ·˜Ó·†ÌÈÏ·ÂÒ‰†ÌÈÏÂÁ·†Æ‰ÏÈ„‚

ÚÂÓφȄΆȄȇ¯ËÒ˜È˯˜‰†ÛÈÏÁ˙‰†Ï˘†ÔÂÈÓ‰†˙‡†‰„ÈÙ˜·

ƉÏÈ„‚‰†ÏÚ†ÂÏ˘†˙·ÎÚÓ‰†‰ÚÙ˘‰‰†˙‡

ÏÂÙÈˉ†˙ÏÁ˙‰†ÈÙφÔʇӆÒȯ˙‰†˙ËÂÏ·†„˜Ù˙˘†‡„ÂÂφ˘È

„˜Ù˙†¯Á‡†È˙Ù˜˙†·˜ÚÓ†Úˆ·Ï†˘È†¨ÔΆÂÓΆÆÔÈÙ¯ËÂ‚·

ÆÏÂÙÈˉ†ÔÓÊ·†¨‰ËÂÏ·‰

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¨ÌÈ˘†˘‡¯†È·‡Î†Ï˘†‰¯˜Ó·†ÌÈÈÈÚ†˙˜Ȅ·†Í¯ÚφıÏÓÂÓ

ƉÈȇ¯·†˙ÂÚ¯Ù‰†Â‡†˙‡˜‰†¨‰ÏÈÁ·

∫˙ÂÈ˙Ù¯˙≠ÔÈ·†˙·‚˙

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È·‚φ„ÁÂÈÓ·†¨˙ÂÈ˙Ù¯˙≠ÔÈ·†˙·‚˙Ó†ÌÈÚ·Â‰†˙ÂÏÈÚÈ≠ȇ

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˙¯ÎÂÒ·†ÏÂÙÈËφ˙ÂÙ¯˙†¨ÔȯÂÙÒÂϘȈ†¨‰ÈÒÙÏÈهφ˙ÂÙ¯˙

ÆÒȯ˙‰†˙ËÂÏ·†„˜Ù˙·†‰Ú¯Ù‰·†ÏÂÙÈËφ˙ÂÙ¯˙Â

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˙ÂÏÂÏچ·†˘ÂÓÈ˘‰†ÔÓÊ·†¨¯È˘Î˙‰†Ï˘†‰Èˆ¯‰†˙ÂÏÈÚÙφÛÒÂ·

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˙˘ÂÁ˙†¨ÌȘ¯Ù†·‡Î†¨„Ï˘‰†È¯È¯˘·†ÔÂÈ˘È˜†¨˙ȯÙȯن˙ÂÁÈÙ

Carpal tunnel syndrome ©†„ȉ†˘¯Â˘†˙ÏÚ˙†˙ÂÓÒ˙†¨ÏÂÓÈ

¨®¯È„©†¯·‚ÂÓ†È˙Ï‚Ï‚≠ÍÂ˙†ıÁφ¨®¯È„©†≤†‚ÂÒ†˙¯ÎÂÒ†¨®¯È„©

Ô‚Ω†Ì„·†ÌÈÂӯ‰‰†˙Ó¯·†ÌÈÈÂÈ˘†¨®„‡ӆ¯È„©†‰ÈÓ˜ÂÏ

Æ®¯È„©†·Ï·Ï·†˙˜Ï„†¨®ÏÂÊÈ˯˜†¨ÔÈÏÂÒȇ

∫˙„ÁÂÈÓ†˙ÂÒÁÈÈ˙‰†˙·ÈÈÁÓ‰†È‡ÂÂφ˙ÂÚÙÂ˙

˙‡†ÈؘÒÙ‰†≠†‰˜¯Ê‰‰†¯Âʇ·†‚ȯÁ†·‡Î†Â‡Ø†Ìȯȯ˘†·‡Î

ƇÙ¯φÈ؉Ù†ÏÂÙÈˉ

ÏÂÙÈˉ†˙‡†ÈؘÒÙ‰†≠†ÌÈÈÏ‚¯‰†˙Á‡·†‰ÚÈψ†‰ÚÈÙÂӆ̇

¨‰Èȇ¯·†˙ÂÚ¯Ù‰†¨ÌȯÊÂÁ†Â‡†ÌȯÂÓÁ†˘‡¯†È·‡Î†ÌÈÚÈÙÂӆ̇

ƇÙ¯φÈ؉Ù†ÏÂÙÈˉ†˙‡†ÈؘÒÙ‰†≠†‰‡˜‰†Â‡Ø†‰ÏÈÁ·

ÌÈÂÈÏÚ†‰ÓÈ˘†Èί„†˙ÓÈÒÁ†Ï˘†ÌÈÓÂËÙÓÈÒ†ÌÈÚÈÙÂӆ̇

È؉Ù†ÏÂÙÈˉ†˙‡†ÈؘÒÙ‰†≠†®˙¯ÈÁ·†‰¯ÓÁ‰†Â‡†‰ÏÁ˙‰©

ƇÙ¯Ï

ƇÙ¯φÈ؉Ù†ÏÂÙÈˉ†˙‡†ÈؘÒÙ‰†≠†‰˘˜†‰ÏÁÓ·†˙ÈÏÁ†Ì‡

ÌÈÏÂÏÚ‰†ÌÈÓÈÒ©†˙ÂÙÈÈÚ†¨Ô˙˘‰†˙ÂÓ熉ÈÈÏÚ†¨¯·‚ÂÓ†‡Óˆ

ÏÂÙÈË·†ÈØ͢Ӊ†≠†ÌÈÊÚ†ÔË·†È·‡Î†¨®≤†‚ÂÒÓ†˙¯ÎÂÒ†ÏÚ†„ÈÚ‰Ï

ƇÙ¯φÈ؉ÙÂ

ÂÈȈ†‡Ï˘†È‡ÂÂφ˙ÂÚÙÂ˙†‰Ø˘È‚¯Ó†Íȉ†Â·˘†‰¯˜Ó†Ïη

ıÚÈÈ˙‰Ï†ÍÈÏÚ†¨˙ÈÏÏΉ†Í˙˘‚¯‰·†ÈÂÈ˘†ÏÁ†Ì‡†Â‡†¨‰Ê†ÔÂÏÚ·

Æ„ÈÓ†‡Ù¯‰†ÌÚ

∫ÔÂÈÓ

˙˜¯Ê‰†¯Á‡Ï†¨˙‡Ê†°„·Ï·†‡Ù¯‰†È„È≠ÏÚ†Ú·˜ÈȆÔÂÈÓ‰

˙Ó‡˙‰Â†¨ÂÁ˜Èٷ†‡Ù¯‰†˙‡Ù¯Ó·†‰¢‡¯Ï†‰Ù¯˙‰

ÆÏÙÂËÓ†ÏÙÂËÓ†ÏÎφÈχ„ȷȄȇ†ÔÙ‡·†ÔÂÈÓ‰

Æ˙ˆÏÓÂÓ‰†‰Ó‰†ÏÚ†¯Â·ÚφÔȇ

∫˘ÂÓÈ˘‰†ÔÙ‡

Æ„·Ï·†‡Ù¯‰†˙‡¯Â‰†ÈÙÏ

Æ˙ȯÂÚ≠˙˙†‰˜¯Ê‰Ï†˙„ÚÂÈÓ†‰Ù¯˙‰

Ɖ˜È¯Êφ‰˜È¯ÊÓ†ÌÈ¢†‰˜¯Ê‰†È¯˙‡·†¯È˘Î˙‰†˙‡†˜È¯Ê‰Ï†˘È

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Æ¥∂∑≤μ†ÁÂ˙ÈÙ†‰Èψ¯‰†¨π†¯˜˘†ßÁ¯ GENO POWD PL SH 060912

PATIENT PACKAGE INSERT IN ACCORDANCEWITH

THE PHARMACISTS' REGULATIONS

(PREPARATIONS)-1986

The dispensing of this medicine

requires a doctor's prescription

Read this package insert carefully in its entirety

before using this medicine

The format of this leaflet was determined by

the Ministry of Health and

its content was checked and approved

GENOTROPIN GENOTROPIN

5.3 mg 12 mg

Powder for subcutaneous Powder for subcutaneous

injection after reconstitutioninjection after reconstitution

Composition:

Each powder cartridge Each powder cartridge

contains: contains:

Somatropin 5.3 mg Somatropin12 mg

Inactive ingredients: Glycine, Sodium dihydrogen

phosphate anhydrous, Disodium phosphate anhydrous,

Water for injections, m-Cresol, Mannitol.

Package:

Each package contains a two-chamber cartridge with

powder for injection in one chamber and a solvent for

reconstitution of the powder in the second chamber.

The preparation is intended for subcutaneous injection by

means of aGenotropinPenonly.

The two-chamber cartridge in the injector pen is suitable

for multiple use.

Therapeutic group:Growth hormone.

Therapeutic activity:

Children:Treatment of growth problems in children caused

bynon-secretion or inadequate secretion of pituitarygrowth

hormone.

Growth problems in girls withTurner’s syndrome.

Delayed growth in children with renal insufficiency.

Prader-Willi's syndrome.

Children born small for gestational age (SGA).

Adults:For adults who havesuffered from growth hormone

deficiency since childhood, and for adults who haveacquired

growth hormone deficiency due to a pituitary pathology.

When should the preparation not be used?

Do not use this preparation if there is a known sensitivity

to any of its ingredients.

Do not use this preparation in patients with evidence of

a tumor (see below).

Do not use the preparation in patients with an active

intracranial tumor.

If a tumor has been diagnosed anti-tumor therapy must

be completed before initiating use ofGenotropin.

Do not use in patients with critical complications following

open heart surgery,abdominal surgery,multi-system

trauma, respiratory failure or similar conditions.

Do not use the preparation for growth promotion in

children with closed epiphyses.

In children with chronic kidneydisease,treatment with

Genotropin should be discontinued prior to kidney

transplantation.Do not use if you havehad a kidney

transplant.

Do not use this preparation in patients with Prader-Willi

syndrome who are severely obese or havesevere

respiratory impairment.

Do not use this preparation without consulting a

doctor before starting treatment:

If you are pregnant or breastfeeding.

If you suffer, or havesuffered in the past, from impaired

Warnings:

If you are sensitive to any type of food or medicine, notify

your doctor before using this preparation.

Patients suffering from critical illness in the course of

treatment (such as heartsurgery,abdominal surgery,

respiratory failure, multiple organ trauma, etc.) should

inform the doctor about that.

In children who were born short, other medical reasons

for growth disturbances should be ruled out before

commencing treatment with this preparation.

In SGA patients (children born small for gestational age)

the following tests should be performed:measurement of

blood glucose and fasting insulin levels before starting

treatment with the preparation and every year after,as

well as insulin-like growth factor 1 (IGF-I) levels before

start of treatment and twice a year during treatment.

Patients with Prader-Willi syndrome should be evaluated

for the presence of upper airwayobstruction or sleep

apnea before initiation of treatment withGenotropin; in

these patients, treatment should always be in combination

with an appropriate diet.

Patients with Prader-Willi syndrome should be monitored

for signs of respiratory infection, such as onset of or

increased snoring, and signs of scoliosis in children.

In patients at risk for diabetes mellitus (for example, familial

history of diabetes, obesity, insulin resistance, abnormal

skin pigmentation) glucose tolerance testing should be

performed.

In certain cases, growth hormone may elevate the blood

sugar level;therefore,Genotropinshould be used with

caution in patients with diabetes mellitus.Regular monitoring

of blood sugar levels and close supervision are imperative

in such cases.

There is limited information on treatment of patients over

60 years of age and onprolonged treatmentin adults

and in patients with Prader-Willi syndrome.

If you were diagnosed with a tumor in the past, you must

undergo frequent tests to check for a recurrence of the

tumor.

Treatment with corticosteroids abovea certain dosage may

inhibit growth.Patients suffering from co-existing ACTH

deficiency should havetheir corticosteroid replacement

dose carefully adjusted to avoid its inhibitoryeffect on growth.

Make sure that thyroid function is balanced before starting

treatment withGenotropin.Thyroid function should also

be monitored periodically during treatment.

The doctor and parents should be alert to the development

of a limp or any complaint of pain in the hip or knee.

Eye examinations should be carried out in the event of

recurrent headaches, nausea, vomiting or vision

disturbances.

Drug interactions:

If you are taking another drug concomitantly or if you have

just finished treatment with another medicine, including

non-prescription medicines and food supplements, inform

the attending doctor, in order to prevent hazards or lack

of efficacy arising from drug interactions.This is especially

important for medicines belonging to the following groups:

sex hormones, corticosteroids, antiepileptics, cyclosporin,

medicines for treatment of diabetes, and medicines for

thyroid function disorders.

Side effects:

In addition to the desired effect of the medicine, adverse

reactions may occur during the course of taking this

medicine, such as:reactions in the area of injection,

peripheral edema, skeletal muscle stiffness, joint pain,

tingling sensation, carpal tunnel syndrome (rare), diabetes

mellitus type 2 (rare), intracranial hypertension (rare),

leukemia (very rare), changes in blood hormone levels

(such as insulin, cortisol), pancreatitis (rare).

Side effects requiring special attention:

Muscle pain and/or unusual pain in the area of injection -

If limping appears in one of the legs - stop treatment and

consult your doctor.

In case of severe or recurrent headaches, vision

disturbances,nausea and/or vomiting - stop treatment and

consult your doctor.

If symptoms of upper airwayobstruction appear (onset of

or increased snoring) - stop treatment and consult your

doctor.

If you become seriously ill - stop treatment and consult

your doctor.

Increased thirst, increased urine output, tiredness (signs

that may indicate diabetes mellitus type 2), intense

abdominal pain - continue treatment and consult your doctor.

In the event that you experience side effects not mentioned

in this leaflet, or if there is a change in your general health,

consult your doctor immediately.

Dosage:

Dosage will be determined bythe doctor only!This should

be doneafter the first injection of the medicine in the

doctor's clinic and with his supervision, and the dosage

should be adjusted individually for each patient .

Do not exceed the recommended dosage.

Directions for use:

According to the doctor's instructions only.

The medicine is intended for subcutaneous injection.Inject

the preparation at different injection sites for each injection.

You must be instructed by an authorized healthcare provider

on the method of preparing and injecting the medicine.

Instructions for use:

See detailed instructions for use below.

How can you contribute to the success of the

treatment?

Complete the full course of treatment as recommended

bythe doctor.Even if there is an improvement in your

health, do not discontinue use of this medicine before

consulting your doctor.

Avoidpoisoning!

This preparation, and all other medicines, must be stored

in a safe place out of the reach of children and/or infants,

to avoid poisoning.If you havetaken an overdose, or if a

child has accidentally swallowed the medicine, proceed

immediately to a hospital emergency room and bring the

package of the medicine with you.Donotinducevomiting

unless explicitly instructed to do so bya doctor!This

preparation has been prescribed for the treatment of your

ailment;in another patient it may cause harm.Do not give

this preparation to your relatives, neighbours or

acquaintances. Donottakemedicinesinthedark! Check

the label and the doseeachtime you take your medicine.

Wear glasses if you need them.

Storage:

Storagebeforereconstitution:

Store in the refrigerator (2°C-8°C) and protect from light.

Do not freeze!

Storageafterreconstitution:

Store in the refrigerator (2°C-8°C) and protect from light

fornomorethan28days .Do not freeze!

Even if kept in their original container and stored as

recommended, medicines may be kept for a limited period

only.Please note the expiry date of the preparation! In

case of doubt, consult the pharmacist who dispensed the

preparation to you.Do not store different medications in

the same package.

License numbers:

Genotropin 5.3 mg: 111.08.26780.00, 111.08.26780.22

Genotropin 12 mg: 121.35.27540.22

Manufacturer:Pfizer, Manufacturing Belgium NV/SA.

License holder:Pfizer Pharmaceuticals Israel,

9 Shenkar St., Herzliya Pituach 46725.

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INSTRUCTIONS FOR USE

ToinjectGenotropinuse only theGenotropinPen

device which is intended for mixing and injecting

Genotropin doses according to the dosage

determined bythe doctor.

What will you need?

GenotropinPen that is suitable for the cartridge

that has been prescribed for you.

Acartridge ofGenotropin5.3 mg or 12 mg

(according to the doctor's instructions).

Alcohol swab.

An 8 mm needle (30G).

Adisposal container for used needles.

Components of the Genotropin Pen

Before you start

In order to prevent infectionalwayswash your

hands with soap and water before preparing and

using theGenotropinPen.

1.Attach the needle

Removethe front cap of theGenotropinPen.

Unscrew the filling cartridge chamber.

Take a new needle and removethe paper

covering.

Screw the needle gently onto the filling cartridge

chamber bygently turning it clockwise.

2.Insert the filling cartridge into the Genotropin Pen

Use only the 5.3 mg cartridge for the 5.3 mg

Pen or the 12 mg cartridge for the 12 mg Pen

(according to the doctor's instructions).

Wipe the metal/rubber tip of the cartridge with

an alcohol swab.

Insert the cartridge into the filling cartridge

chamber with the metal/rubber tip (the powder

side) facing inwards.

Push the cartridge firmly into place.

3.Prepare the body of the Pen

Press the release button (with the red end) to

release the black injection knob.

Turnthe black injection knob

counterclockwiseasfarasitwillgo.

Check that the plunger rod is not visible through

the window at the top of the plastic body of the

pen.After the rod is no longer visible through

the window,proceed to the next step.

4.Screw the Genotropin Pen parts together

Hold the filling cartridge chamber upright (facing

upward).

Gently screw the filling cartridge chamber and

plastic body back together.This action mixes

the diluent in the rear chamber of the cartridge

with the growth hormone powder in the front

chamber.

Gently movetheGenotropinPen from side to

side to help dissolve the powder completely.

Do not shake it as that might inactivate the

growth hormone.

5.Examine the solution and release trapped air

Look through the cartridge window in the filling

cartridge chamber and make sure the solution

is clear.If you see particles or if the solution is

discolored,do not injectit.Instead contact the

Pfizer representative.

Removethe outer needle cap and saveit for

later.

Removeand discard the inner needle cap.

Be careful not to touch the exposed needle.

Removeany trapped air from the solution as

detailed below:

a.Turnthe black injection knob clockwise.

This will line up the white mark on the black

injection knob with the gray mark on the

body of the pen.

b.Hold theGenotropinPen with the needle

pointing upward and gently tap the filling

cartridge chamber with your finger to move

any air bubbles to the top.

c.Push the black injection knob all the way in.

You will see a drop of liquid appear at the

needle point.

This action will release any trapped air.

d.If no liquid squirts out, press the white release

button and turn the black injection knob

clockwise (to the right) until the white mark

lines up with the greymark again.Repeat

the detailed instructions in steps b and c.

If necessary,reattach the needle guard - push

it back to its place until a click is heard.Again,

be careful not to touch the exposed needle.To

avoid an accidental needle prick, grip the sides

of the needle guard;never push on the end.

6.Dial your prescribed dose

Press the red release button to reset the device.

The black injection knob will pop out and

the dose display window will read 0.0.

With the dose display activated, turn the black

injection knob clockwise until your prescribed

dose is displayed.

If you go too far,just turn the knob back the

other way until the correct dose is displayed.

NOTE: If you turn the black injection knob backwards

beyond 0.0 after a cartridge has been inserted, the

dose display will show (--).Just turn the injection

knob clockwise until numbers reappear on the dose

display.

TheGenotropinPen contains a battery for the

dose display.Tosavethe battery’s energy, the

dose display is activated for two minutes and

then automatically disappears.

Although the display is no longer visible, the

dose remains available for delivery.

NOTE:

5.3 mg Pen - Each click of the black injection

knob equals a one-tenth-of-a milligram dose

(0.1 mg).One click - or 0.1 mg - is the minimum

possible dose per injection;20 clicks - or 2.0

mg - is the maximum possible dose per injection.

If you accidentally dial more than the maximum

2 mg dose, some liquid may emerge from the

tip.This is normal and will not affect your injection

- simply dial back to the correct dose.

12 mg Pen - Each click of the black injection

knob equals a two-tenths-of-a milligram dose

(0.2 mg).One click - or 0.2 mg - is the minimum

possible dose per injection;20 clicks - or 4.0

mg - is the maximum possible dose per injection.

If you accidentally dial more than the maximum

4 mg dose, some liquid may emerge from the

tip.This is normal and will not affect your injection

- simply dial back to the correct dose.

7.Inject your Genotropin dose

Select and prepare an injection site (such as

thigh, buttocks, arm or abdomen), as directed

byyour healthcare provider.

Pinch a fold of skin at the injection site firmly,

and push theGenotropinPen into the skin fold

at a 90°angle.

Push the pen down as far as possible.

Push the black injection knob until it clicks.

Wait at least 10 seconds and then withdraw

theGenotropinPen.

8.Discard the needle and store the Genotropin

Pen

Removeand store the needle guard, if you

used one.

Carefullyreplace the outer protective needle

cap on the needle, as instructed byyour

healthcare provider.

Unscrew the needle and discard it in a proper

disposal container.Never reuse a needle.

Replace the front cap, then put theGenotropin

Pen back in its protective case.Store it in the

refrigerator until your next injection.

Your next injection

If you already havea drug cartridge in your

Genotropin Pen, prepare the pen and your dose

as follows:

Removethe front cap of theGenotropinPen.

Removethe paper covering from the back of a

new needle.

Screw the needle onto the filling cartridge chamber

byturning it clockwise.

Removethe outer and inner protective needle caps.

Follow the instructions above, starting with step 6.

Toreplace the filling cartridge

Press the white release button to reset the

Genotropin Pen.

Turnthe black injection knob counterclockwise

asfarasitwillgo.

Unscrew the filling cartridge chamber and remove

the empty cartridge.

Discard the empty cartridge as instructed byyour

healthcare provider.

To insert a new cartridge and prepare the

Genotropin Pen for use, follow the instructions

detailed above.

Storage

Between uses, store yourGenotropinPen in the

refrigerator in its protective case.Always remove

the needle before storing.

Discard the cartridge in yourGenotropinPen within

28 days from reconstitution (from the moment the

growth hormone and the liquid were mixed) even if

the cartridge is not empty.When you are awayfrom

home, keep yourGenotropinPen in its protective

case and carry it in an insulated bag with an ice

pack to protect it from heat.Place a barrier between

the ice pack and the pen to prevent freezing.

Put it back in a refrigerator as soon as possible.

Caring for your Genotropin Pen

No special maintenance is required.Toclean the

Genotropin Pen, wipe the outside surface with a

damp cloth.Do not immerse in liquid.Do not use

alcohol or any other cleaning agents, as they may

damage the plastic body.Toclean the reusable needle

guard, wipe it with a damp cloth or alcohol swab.

COMMON QUESTIONS

How do I tell how much Genotropin is left in

the Genotropin Pen?

Look at the dose scale located along the side of

the window of the filling cartridge chamber.The

front edge of the gray rubber plunger lines up with

the number of milligrams remaining in the cartridge.

What happens when the battery runs low?

The battery in theGenotropinPen should run for

two years.When it begins to run low due to the end

of the battery’s life,you will see a flashing symbol

( ) in the dose display.This means the battery will

last about another month.When the battery is dead,

the dose display will show the symbol ( ) steadily.

A flashing "bt" in the dose display means the battery

is running verylow for some other reason and will

last for about another month.When the battery is

dead, the display will show a steady "bt".

Call the Pfizer representative for help.

If the battery suddenly dies, can the Genotropin

Pen still be used?

Yes.Call the Pfizer representative for instructions

on how to determine the dose without the electronic

Inner protective

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ËÁÓ Needle guard

Outer protective

needle cap Needle Front cap Filling cartridge

chamber

Cartridge window Window

Dose scale

Release button Black injection

knob Dose display