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.

معلومات أخرى

الحالة

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

معلومات المرضى النشرة

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

„ÚÂÈÓ† ¯È˘Î˙‰† ÆÈ˘‰† ¯Â„Ó·† ‰˜·‡‰† ˙ÒӉφ ÒÓÓ† „Á‡

Æ„·Ï·†ÔÈÙ¯ËÂ‚†ËÚ·†˘ÂÓÈ˘†˙ÂÚˆÓ‡·†˙ȯÂÚ≠˙˙†‰˜¯Ê‰Ï

ËÚ·†˙ȯ„Ó≠„‰†˙ÈÒÁÓ·†ÈÓÚÙ≠·¯†˘ÂÓÈ˘†˘Ó˙˘‰Ï†Ô˙È

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Ùφ ÔÈÙ¯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¯·† ıÚÂÂȉφ ÈÏ·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‡† Â‰˘ÏΆ ÔÂÊÓφ ‰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‰‰† ÔÓÊφ ÌÈ˘† 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·† ¨˙ÂÏډφ ÏÂÏÚ† ‰ÏÈ„‚† ÔÂӯ‰

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

ÛË¢† ·˜ÚÓ† Æ˙¯ȉʆ ÈÚˆÓ‡† ˙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‰

·ÎÚφ ÏÂÏÚ† ˙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·‰

ÏΆ‡†‰ÚÈψ†˙ÂÁ˙Ù˙‰Ï†Ìȯچ˙ÂȉφÌȯ‰‰Â†‡Ù¯‰†ÏÚ

Æͯ··†Â‡†Í¯È·†·‡Î†ÏÚ†‰ÂÏ˙

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

ƉÈȇ¯·†˙ÂÚ¯Ù‰†Â‡†˙‡˜‰†¨‰ÏÈÁ·

∫˙ÂÈ˙Ù¯˙≠ÔÈ·†˙·‚˙

ÏÂÙȈ‰˙Ú†‰Ê†˙¯Ó‚†Ì‡†Â‡†¨˙ÙÒÂ†‰Ù¯˙†˙ØÏËÂ†Íȉ†Ì‡

ÈÙÒÂ˙Â†Ì˘¯Ó†‡Ïφ˙¯ÎÓ‰†˙ÂÙ¯˙†ÏÏÂΆ¨˙¯Á‡†‰Ù¯˙·

‡† ÌÈÂÎÈÒ† ÚÂÓφ È„Ά ÏÙËÓ‰† ‡Ù¯φ Á„φ ÍÈÏÚ† ¨‰ÂÊ˙

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

¨ÌȄȇ¯ËÒ˜È˯˜†¨ÔÈÓ†ÈÂӯ‰†∫˙‡·‰†˙ˆ·˜‰Ó†˙ÂÙ¯˙

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

ÆÒȯ˙‰†˙ËÂÏ·†„˜Ù˙·†‰Ú¯Ù‰·†ÏÂÙÈËφ˙ÂÙ¯˙Â

∫ȇÂÂφ˙ÂÚÙÂ˙

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

¨ËÁÓ‰† ˙¯È˜„† ¯Âʇ·† ˙·‚˙† ∫Ô‚Ά ¨È‡ÂÂφ ˙ÂÚÙÂ˙† ÚÈÙ‰Ï

˙˘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·˜ÈȆ ÔÂ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‡

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

PATIENT PACKAGE INSERT IN ACCORDANCE WITH

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 reconstitution injection 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 a Genotropin Pen only.

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

by non-secretion or inadequate secretion of pituitary growth

hormone.

• Growth problems in girls with Turner’s syndrome.

• Delayed growth in children with renal insufficiency.

• Prader-Willi's syndrome.

• Children born small for gestational age (SGA).

Adults: For adults who have suffered from growth hormone

deficiency since childhood, and for adults who have acquired

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 of Genotropin.

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 kidney disease, treatment with

Genotropin  should be discontinued prior to kidney

transplantation. Do not use if you have had a kidney

transplant.

Do not use this preparation in patients with Prader-Willi

syndrome who are severely obese or have severe

respiratory impairment.

Do not use this preparation without consulting a

doctor before starting treatment:

If you are pregnant or breastfeeding.

If you suffer, or have suffered 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 heart surgery, 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 airway obstruction or sleep

apnea before initiation of treatment with Genotropin; 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, Genotropin should 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 on prolonged treatment in 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 above a certain dosage may

inhibit growth. Patients suffering from co-existing ACTH

deficiency should have their corticosteroid replacement

dose carefully adjusted to avoid its inhibitory effect on growth.

Make sure that thyroid function is balanced before starting

treatment with Genotropin. 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 airway obstruction 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 by the doctor only! This should

be done after 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

by the doctor. Even if there is an improvement in your

health, do not discontinue use of this medicine before

consulting your doctor.

Avoid poisoning!

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 have taken 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. Do not induce vomiting

unless explicitly instructed to do so by a 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.  Do not take medicines in the dark! Check

the label and the dose each time you take your medicine.

Wear glasses if you need them.

Storage:

Storage before reconstitution:

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

Do not freeze!

Storage after reconstitution:

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

for no more than 28 days . 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

To inject Genotropin use only the Genotropin Pen

device which is intended for mixing and injecting

Genotropin  doses according to the dosage

determined by the doctor.

What will you need?

• Genotropin Pen that is suitable for the cartridge

that has been prescribed for you.

• A cartridge of Genotropin 5.3 mg or 12 mg

(according to the doctor's instructions).

• Alcohol swab.

• An 8 mm needle (30G).

• A disposal container for used needles.

Components of the Genotropin Pen

Before you start

In order to prevent infection always wash your

hands with soap and water before preparing and

using the Genotropin Pen.

1. Attach the needle

• Remove the front cap of the Genotropin Pen.

• Unscrew the filling cartridge chamber.

• Take a new needle and remove the paper

covering.

• Screw the needle gently onto the filling cartridge

chamber by gently 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.

• Turn the black injection knob

counterclockwise as far as it will go.

• 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 move the Genotropin Pen 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 inject it. Instead contact the

Pfizer representative.

• Remove the outer needle cap and save it for

later.

• Remove and discard the inner needle cap.

Be careful not to touch the exposed needle.

• Remove any trapped air from the solution as

detailed below:

a. Turn the 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 the Genotropin Pen 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 grey mark 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.

• The Genotropin Pen contains a battery for the

dose display. To save the 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

by your healthcare provider.

• Pinch a fold of skin at the injection site firmly,

and push the Genotropin Pen 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

the Genotropin Pen.

8. Discard the needle and store the Genotropin

Pen

• Remove and store the needle guard, if you

used one.

• Carefully replace the outer protective needle

cap on the needle, as instructed by your

healthcare provider.

• Unscrew the needle and discard it in a proper

disposal container. Never reuse a needle.

• Replace the front cap, then put the Genotropin

Pen back in its protective case. Store it in the

refrigerator until your next injection.

Your next injection

If you already have a drug cartridge in your

Genotropin  Pen, prepare the pen and your dose

as follows:

• Remove the front cap of the Genotropin Pen.

• Remove the paper covering from the back of a

new needle.

• Screw the needle onto the filling cartridge chamber

by turning it clockwise.

• Remove the outer and inner protective needle caps.

• Follow the instructions above, starting with  step 6.

To replace the filling cartridge

• Press the white release button to reset the

Genotropin  Pen.

• Turn the black injection knob counterclockwise

as far as it will go.

• Unscrew the filling cartridge chamber and remove

the empty cartridge.

• Discard the empty cartridge as instructed by your

healthcare provider.

• To insert a new cartridge and prepare the

Genotropin  Pen for use, follow the instructions

detailed above.

Storage

Between uses, store your Genotropin Pen  in the

refrigerator in its protective case. Always remove

the needle  before storing.

Discard the cartridge in your Genotropin Pen 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 away from

home, keep your Genotropin Pen 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. To clean 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. To clean 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 the Genotropin Pen 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 very low 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

needle cap ÔÂÈÓ†ÌÏÂÒ

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ÈÓÈÙ ËÁÓ†Ô‚Ó

ÈˆÈÁ ÈÓ„˜†‰ÒÎÓ ÔÂÈÓ‰†‚ˆ

ÔÂÏÁ ËÁÓ†Ô‚Ó

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¯Â¯Á˘†¯Â˙ÙÎ ËÚ ˙ÈÒÁÓ†˙È·

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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

24-9-2018

FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

FDA has awarded 12 new clinical trial research grants to enhance the development of medical products for patients with rare diseases

FDA - U.S. Food and Drug Administration

13-9-2018

Review of the existing maximum residue levels for fluquinconazole according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for fluquinconazole according to Article 12 of Regulation (EC) No 396/2005

Published on: Wed, 12 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fluquinconazole. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for fluquinconazole within the European Union. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue ...

Europe - EFSA - European Food Safety Authority Publications

12-9-2018

Enforcement Report for the Week of September 12, 2018

Enforcement Report for the Week of September 12, 2018

Recently Updated Records for the Week of September 12, 2018 Last Modified Date: Friday, September 07, 2018

FDA - U.S. Food and Drug Administration

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

7-9-2018

Orphan designation:  Recombinant human beta-glucuronidase (vestronidase alfa),  for the: Treatment of mucopolysaccharidosis type VII (Sly syndrome)

Orphan designation: Recombinant human beta-glucuronidase (vestronidase alfa), for the: Treatment of mucopolysaccharidosis type VII (Sly syndrome)

On 21 March 2012, orphan designation (EU/3/12/973) was granted by the European Commission to NDA Regulatory Science Ltd, United Kingdom, for recombinant human beta-glucuronidase for the treatment of mucopolysaccharidosis type VII (Sly syndrome).

Europe - EMA - European Medicines Agency

1-9-2018

Acknowledgement:EFSA  wishes  to  thank  the  rapporteur  Member  State  Denmark  for  thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

Acknowledgement:EFSA wishes to thank the rapporteur Member State Denmark for thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

Published on: Fri, 31 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance napropamide. To assess the occurrence of napropamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Review of the existing MRLs for fenbuconazole

Review of the existing MRLs for fenbuconazole

Published on: Fri, 31 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fenbuconazole. To assess the occurrence of fenbuconazole residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well...

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Denmark and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Denmark and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 During the project seven standard operating procedures (SOP) were developed for the four data domains (zoonoses, chemical contaminant, pesticide residues and veterinary medical products residues). The SOPs describe 1) How the national governance of risk assessment data is organised, 2) how data are collected and validated before delivering to EFSA covering all four domains, 3) How data is transferred to EFSA, 4) how to respond to EFSA request for clarificati...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Product Quest Manufacturing LLC Recalls All Nasal Products and Baby Oral Gels Manufactured at Florida Facility Due to Possible Microbial Contamination

Product Quest Manufacturing LLC Recalls All Nasal Products and Baby Oral Gels Manufactured at Florida Facility Due to Possible Microbial Contamination

Product Quest Manufacturing (“Product Quest”) announced its voluntary recall of Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist due to a finding of microbial contamination identified as Pseudomonas aeruginosa.

FDA - U.S. Food and Drug Administration

29-8-2018

Review of the existing maximum residue levels for sintofen according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for sintofen according to Article 12 of Regulation (EC) No 396/2005

Published on: Tue, 28 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance sintofen. To assess the occurrence of sintofen residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, as well as the European authorisations reported by Member ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Review of the existing maximum residue levels for prochloraz according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for prochloraz according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 27 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance prochloraz. To assess the occurrence of prochloraz residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as th...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Review of the existing maximum residue levels for napropamide according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for napropamide according to Article 12 of Regulation (EC) No 396/2005

Published on: Fri, 24 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance napropamide. To assess the occurrence of napropamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Review of the existing maximum residue levels for myclobutanil according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for myclobutanil according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 13 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance myclobutanil. To assess the occurrence of myclobutanil residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, the MRLs established by the Codex Alimentarius Com...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Outcome of the public consultation on a draft protocol for the Scientific Opinion on dietary sugars

Outcome of the public consultation on a draft protocol for the Scientific Opinion on dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on a draft protocol for the Scientific Opinion on free sugars from all dietary sources, prepared by the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel), supported by the ad‐hoc Working Group on Sugars. The draft protocol was endorsed by the Panel for public consultation at its plenary meeti...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 In June 2016, EFSA received a mandate from the national food competent authorities of five European countries (Denmark, Finland, Iceland, Norway and Sweden) to provide a dietary reference value (DRV) for sugars, with particular attention to added sugars. A draft protocol was developed with the aim of defining as much as possible beforehand the strategy that will be applied for collecting data, appraising the relevant evidence, and analysing and integrating t...

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market.

FDA - U.S. Food and Drug Administration

22-8-2018

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food, Inc. of Portland, OR is expanding its voluntary recall to include an additional quantity of Rad Cat Raw Diet across all varieties with Best By dates of 10/19/18 through 12/3/19 because it has the potential to be contaminated with Listeria monocytogenes. Radagast Pet Food is conducting this voluntary recall out of an abundance of caution because of its strong commitment to food safety and quality.

FDA - U.S. Food and Drug Administration

8-8-2018

Product Quest Manufacturing LLC Issues Voluntary Nationwide Recall of CVS Health 12 Hour Sinus Relief Nasal Mist Due to Microbiological Contamination

Product Quest Manufacturing LLC Issues Voluntary Nationwide Recall of CVS Health 12 Hour Sinus Relief Nasal Mist Due to Microbiological Contamination

Holly Hill, FL, Product Quest Manufacturing (“Product Quest”) is voluntarily recalling Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist, a clear, colorless liquid, to the consumer level. The product was found to have had microbiological contamination identified as Pseudomonas aeruginosa.

FDA - U.S. Food and Drug Administration

31-7-2018

ADM Animal Nutrition Recalls Mintrate® 36-15 Breed Right Cattle Tub - A specific lot of product may contain elevated levels of non-protein nitrogen, could harm cattle

ADM Animal Nutrition Recalls Mintrate® 36-15 Breed Right Cattle Tub - A specific lot of product may contain elevated levels of non-protein nitrogen, could harm cattle

ADM Animal Nutrition, a division of Archer Daniels Midland Company (NYSE: ADM), is recalling 200-pound tubs of Mintrate® 36-15 Breed Right Tub cattle feed, product number 54549AAA6H, because the product may contain elevated levels of non-protein nitrogen, which could be harmful to cattle. Excessive levels of non-protein nitrogen can be toxic to cattle and can cause muscle tremors (especially of face and ears), abdominal pain, bloat, frothy salivation, excessive urination, teeth grinding, incoordination, ...

FDA - U.S. Food and Drug Administration

19-9-2018

Reminder: #FDA site visit proposal solicitation period for the 2018  Experiential Learning Program is currently OPEN through Wednesday,  9/26/18 @ 12 pm EST. Click the link to find more about the  program & to submit your application  https://go.usa.gov/x

Reminder: #FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, 9/26/18 @ 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/x

Reminder: #FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, 9/26/18 @ 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/xPrum  #MedicalDevice pic.twitter.com/FN1mNN65dD

FDA - U.S. Food and Drug Administration

14-9-2018

Agenda:  Agenda - CAT agenda of the 12-14 September 2018 meeting

Agenda: Agenda - CAT agenda of the 12-14 September 2018 meeting

Europe - EMA - European Medicines Agency

12-9-2018

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application  https://go.usa.gov/x

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/x

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/xPrum  #FDA #MedicalDevice pic.twitter.com/Kyo5z44Os4

FDA - U.S. Food and Drug Administration

11-9-2018

 Focus group meeting  on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

Focus group meeting on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

This meeting will allow a direct exchange of views between the Agency’s working party and stakeholders on its draft reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation (EMA/CVMP/849775/2017). It complements the public consultation on this reflection paper ending on 31 January 2019. The reflection paper follows considerations in the report on a pilot project that aimed to develop and test non-experimental appr...

Europe - EMA - European Medicines Agency

5-9-2018

The FDA's site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 at 12 pm EST. Click the link to find more about the program and to submit your application:  https://go.u

The FDA's site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 at 12 pm EST. Click the link to find more about the program and to submit your application: https://go.u

The FDA's site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 at 12 pm EST. Click the link to find more about the program and to submit your application: https://go.usa.gov/xPcpn  #MedicalDevice

FDA - U.S. Food and Drug Administration

28-8-2018

EU/3/18/2067 (Omeros London Limited)

EU/3/18/2067 (Omeros London Limited)

EU/3/18/2067 (Active substance: Recombinant human monoclonal antibody against mannan-binding lectin-associated serine protease-2) - Orphan designation - Commission Decision (2018)5737 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/044/18

Europe -DG Health and Food Safety

22-8-2018

CLYNAV (Elanco GmbH)

CLYNAV (Elanco GmbH)

CLYNAV (Active substance: Salmon pancreas disease vaccine (recombinant DNA plasmid)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5624 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2390/T/02

Europe -DG Health and Food Safety

15-8-2018

Scientific guideline:  Draft guideline on similar biological medicinal products containing recombinant granulocyte-colony stimulating factor (rG-CSF) - Revision 1, draft: consultation open

Scientific guideline: Draft guideline on similar biological medicinal products containing recombinant granulocyte-colony stimulating factor (rG-CSF) - Revision 1, draft: consultation open

The proposed guideline will replace annex to guideline on similar medicinal products containing biotechnology-derived proteins as active substance: Non-Clinical and Clinical Issues - Guidance on similar medicinal products containing recombinant granulocyte-colony stimulating factor, EMEA/CHMP/BMWP/31329/2005

Europe - EMA - European Medicines Agency

7-8-2018

EU/3/18/2049 (Inozyme Pharma Ireland Ltd)

EU/3/18/2049 (Inozyme Pharma Ireland Ltd)

EU/3/18/2049 (Active substance: Recombinant human ectonucleotide pyrophosphatase/phosphodiesterase 1 fused to the Fc fragment of IgG1) - Orphan designation - Commission Decision (2018)5281 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/053/18

Europe -DG Health and Food Safety

7-8-2018

LETIFEND (Laboratorios LETI, S.L.unipersonal)

LETIFEND (Laboratorios LETI, S.L.unipersonal)

LETIFEND (Active substance: Recombinant Protein Q from L. infantum MON-1) - Centralised - Yearly update - Commission Decision (2018)5415 of Tue, 07 Aug 2018

Europe -DG Health and Food Safety

7-8-2018

ACMD meeting statement, Meeting 40, 12 April 2018

ACMD meeting statement, Meeting 40, 12 April 2018

Advisory Committee on Medical Devices meeting statement

Therapeutic Goods Administration - Australia

2-8-2018

EU/3/14/1351 (Kyowa Kirin Holdings B.V.)

EU/3/14/1351 (Kyowa Kirin Holdings B.V.)

EU/3/14/1351 (Active substance: Recombinant human monoclonal IgG1 antibody for fibroblast growth factor 23) - Transfer of orphan designation - Commission Decision (2018)5289 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/133/14/T/02

Europe -DG Health and Food Safety

30-7-2018

Ceplene (Noventia Pharma Srl)

Ceplene (Noventia Pharma Srl)

Ceplene (Active substance: Histamine dihydrochloride) - Centralised - Renewal - Commission Decision (2018)5116 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/796/R/36

Europe -DG Health and Food Safety

27-7-2018

EU/3/14/1410 (Chiesi Farmaceutici S.p.A.)

EU/3/14/1410 (Chiesi Farmaceutici S.p.A.)

EU/3/14/1410 (Active substance: Recombinant human aspartylglucosaminidase) - Transfer of orphan designation - Commission Decision (2018)5051 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/172/14/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/11/911 (Chiesi Farmaceutici S.p.A.)

EU/3/11/911 (Chiesi Farmaceutici S.p.A.)

EU/3/11/911 (Active substance: Recombinant human galactocerebrosidase) - Transfer of orphan designation - Commission Decision (2018)5050 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/042/11/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/12/1097 (Celgene Europe B.V.)

EU/3/12/1097 (Celgene Europe B.V.)

EU/3/12/1097 (Active substance: Lenalidomide) - Transfer of orphan designation - Commission Decision (2018)5043 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/158/12/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/12/1091 (bluebird bio (Germany) GmbH)

EU/3/12/1091 (bluebird bio (Germany) GmbH)

EU/3/12/1091 (Active substance: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human betaA-T87Q-globin gene) - Transfer of orphan designation - Commission Decision (2018)5032 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/146/12/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/12/1003 (bluebird bio (Germany) GmbH)

EU/3/12/1003 (bluebird bio (Germany) GmbH)

EU/3/12/1003 (Active substance: Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA) - Transfer of orphan designation - Commission Decision (2018)5033 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/009/12/T/01

Europe -DG Health and Food Safety