וקסיגריפ לילדים

ישראל - עברית - Ministry of Health

קנה את זה

עלון מידע עלון מידע (PIL)

27-11-2020

מרכיב פעיל:
A/CALIFORNIA/7/2009 (H1N1) 7.5 MCG/DOSE; A/VICTORIA/361/2011 (H3N2) 7.5 MCG/DOSE
זמין מ:
MEDICI LTD
קוד ATC:
J07BB01
טופס פרצבטיות:
SUSPENSION FOR INJECTION
מסלול נתינה (של תרופות):
I.M, DEEP S.C.
תוצרת:
SANOFI PASTEUR S.A., FRANCE
קבוצה תרפויטית:
INFLUENZA, INACTIVATED, WHOLE VIRUS
סממני תרפויטית:
For the prevention of influenza, particularly in children aged from 6 to 35 months who run an increased risk of associated complications.
מספר אישור:
126513052200
תאריך אישור:
2012-09-01

מסמכים בשפות אחרות

עלון מידע עלון מידע - אנגלית

27-11-2020

מאפייני מוצר מאפייני מוצר - אנגלית

27-11-2020

עלון מידע עלון מידע - ערבית

27-11-2020

ÆÌÈ¢†˙ÂÓ˜ӷ†Ì˜È¯Ê‰Ï†˘È†ÆÌȯÁ‡†ÌÈÂÒÈÁ†ÌÚ†˙ÈÓʆ·†ÌÈ„ÏÈφÙȯ‚ÈÒ˜Â

Æ̈Ú˙‰Ï†˙ÂÏÂÏچȇÂÂφ˙ÂÚÙÂ˙˘†·Ï†ÈØÌÈ˘

˙ÂÏÂÏÚ†‰·†˘ÂÓÈ˘‰†ÔÓÊ·†¨‰Ù¯˙‰†Ï˘†‰Èˆ¯‰†˙ÂÏÈÚÙφÛÒÂ· †∫ȇÂÂφ˙ÂÚÙÂ˙

¨ÌÂÁ†¨ÌȘ¯Ù†·‡Î†¨Ìȯȯ˘†·‡Î†¨‰Úʉ†¨˘‡¯†·‡Î†∫Ô‚Ά¨È‡ÂÂφ˙ÂÚÙ˘‰†ÚÈÙ‰Ï

Æ˙ÂÙÈÈÚ†¨„Ú¯†¨ÈÏÂÁ†˙˘‚¯‰

·È·Ò†˙¢˜˙‰†¨È¯ÂÚ≠˙˙†Ì„≠Ûˢ†¨·‡Î†¨˙ÂÁÈÙ†¨˙ÂÈÓÂÓ„‡†≠†˙ÂÈÓ˜ӆ˙ÂÚÙÂ˙

ÆÔÂÒÈÁ‰†˜¯Ê‰†Â·†Ì˜Ӊ

ÆÏÂÙȈ‡ÏφÌÈÓȆ±≠≤†ÍÂ˙†ÏÏΆͯ„·†˙ÂÙÏÂÁ†‰Ï‡†˙ÂÚÙÂ˙

∫˙„ÁÂÈÓ†˙ÂÒÁÈÈ˙‰†˙·ÈÈÁÓ‰†˙ÂÚÙÂ˙

˙ÂȯÂÚ†˙·‚˙†∫˙‡·‰†˙ÂÚÙÂ˙‰Ó†¯˙ÂȆ‡†˙Á‡†‰ÚÈÙÂӆ̇†‡Ù¯φÈ؉Ù

Âί‡φ·‡Î†Æ‰Áȯن¨®‰È¯˜È˯‡†¨„¯‚©†ıˆ˜Ú†ÏÏÂΆÛ‚‰†ÏÎÏ†Ë˘Ù˙‰Ï†˙ÂÏÂÏÚ˘

¨ÌÂÁ·†˙ÂÂÏÓ†˙Â˙ÈÂÂÚ†¨®ÏÂÓÈ©†¯Â˜Â†ÌÂÁ†¨·‡Î†¨Ú‚Ó†˙˘ÂÁ˙·†‰Ú¯Ù‰†¨·ˆÚ†Ï˘

·‡Î†¨‰˘ÂÁ˙†¯ÒÂÁ†¨Ï·Ϸ†¨¯‡Âˆ·†˙¢˜Âφ̯‚φ˙ÂÏÂÏÚ˘†˙ÂÈ·ˆÚ†˙ÂÚ¯Ù‰

ÏΆ‡†˜ÏÁ†Ï˘†˜Â˙È˘†¨ÌÈÒ˜ÏÙ¯†Ô„·Â‡†¨Ï˜˘Ó†ÈÂÂÈ˘†Ô„·Â‡†¨ÌÈÈÙ‚‰†Ï˘†‰˘ÏÂÁÂ

Æ®‰¯·†Ô‡ÈÏÈ‚†˙ÂÓÒ˙†·ˆÚ‰†˙˜Ï„†¨‰¯„˘‰†ËÂÁ†ÁÂÓ‰†˙˜Ï„©†Û‚‰

˙ÚȈÙφ̯‚φÏÂÏچ̄†˙ÂÈÒË†Ï˘†Ô˘†¯ÙÒÓ†ÆÌ„‰†˙ÂÈÒˆ¯ÙÒÓ·†˙ÈÓʆ‰„ȯÈ

Æ‰Ú˘Ùӆ‡†ÈÁ˘‰†˙È·†¨¯‡Âˆ‰†˙ÂËÂÏ·†Ï˘†˙ÈÓʆ˙ÂÁÈÙ†¨¯˙ȆÌÂÓÈ„†Â‡†¯˙È

∫˙ÂÈ‚¯Ï‡†˙·‚˙

†≠ Ì„†Ï˘†‰¯È„Ò†‰˜Ù҇φ̄‰†˙ίÚÓ†Ï˘Î†Ï˘†È‡ÂÙ¯†Ì¯Á†·ˆÓφ˙ÂÏÈ·ÂÓ‰

ÆÌȯȄ†„‡ӆÌȯ˜Ó·†®Ìω©†ÌÈ¢‰†Ìȯ·‡Ï

†≠ ÏΆ‡†Ô¯‚†¨ÔÂ˘Ï†¨ÌÈÈ˙Ù˘†¨ÌÈÙ†ÏÏÂΆ¨¯‡Âˆ·Â†˘‡¯·†¯˜ÈÚ·†˙ȇ¯‰†˙ÂÁÈÙ

Ư˙ÂÈ·†ÌȯȄ†Ìȯ˜Ó·†Û‚·†¯Á‡†¯·‡

‰ÈÏΆ˙ÂÈڷφÌȯȄ†„‡ӆÌȯ˜Ó·Â†¯ÂÚ·†‰ÁȯÙφ̯‚φ‰ÏÂÎÈ˘†Ì„‰†ÈÏΆ˙˜Ï„

ÔÂÏÚ·†ÂȈ†‡Ï˘†È‡ÂÂφ˙ÂÚÙÂ˙†‰Ø˘È‚¯Ó†Í˙„ÏÈØÍ„ÏȆ·˘†‰¯˜Ó†Ïη†Æ˙ÂÙÏÂÁ

Æ„ÈÓ†‡Ù¯‰†ÌÚ†ıÚÈÈ˙‰Ï†ÍÈÏÚ†˙ÈÏÏΉ†‰ØÂ˙˘‚¯‰·†ÈÂÈ˘†ÏÁ†Ì‡†Â‡†¨‰Ê

Æ„·Ï·†‡Ù¯‰†˙‡¯Â‰†ÈÙφÔÂÈÓ †∫ÔÂÈÓ

∫‡Ù¯ӆ˙¯Á‡†‰‡¯Â‰†¯„Ú‰·†Ï·Â˜Ó†ÔÂÈÓ

ƮϢӆ∞Æ≤쩆‰Ó†±†≠†ÌÈ˘„ÂÁ†≥μ†„Ú†ÌÈ˘„ÂÁ†∂†ÏÈ‚Ó†ÌÈ„ÏÈ

¨Ì‰ÈÈÁ·†‰¢‡¯‰†ÌÚÙ·†˙ÚÙ˘†„‚†ÌÈÒÁ˙Ó†¯˘‡†ÌÈ˘†π†ÏȂφ˙Á˙Ó†ÌÈ„ÏÈÏ

Ɖ¢‡¯‰†‰Ó‰Ó†˙ÂÁÙφ˙ÂÚ·˘†¥†Ï˘†ÔÓʆÁ¯ӷ†‰ÈÈ˘†‰Ó†˙˙φıÏÓÂÓ

ÆÌÈ˘„ÂÁ†∂†ÏȂφ˙Á˙Ó†˙˜ÂÈ˙φ˙„ÚÂÈÓ†‰ȇ†Âʆ‰Ù¯˙

Ɖ˜ÂÓÚ†˙ȯÂÚ†˙˙†Â‡†˙ȯȯ˘†ÍÂ˙†‰˜¯Ê‰Ï†∫˘ÂÓÈ˘‰†ÔÙ‡

ÆȯϘ҆‰¯Ëȇ†Ô˙Ó·†ÔÙ‡†Ì¢·†‰Ê†ÔÂÒÈÁ†˜È¯Ê‰Ï†Ôȇ

Æ˘ÂÓÈ˘‰†ÈÙφ¯„Á‰†˙¯Â˯ÙÓËφÔÂÒÈÁ‰†˙‡†‡È·‰Ï†˘È†Æ˘ÂÓÈ˘‰†ÈÙφ¯ÚÏ

‚˘È‰Ï†ıÂÁÓ†¯Â‚̘҆ӷ†¯ÂÓ˘Ï†˘È†˙¯Á‡†‰Ù¯˙†ÏΆÂʆ‰Ù¯˙† °‰ÏÚ¯‰†ÈØÚÓ

ƉÏÚ¯‰†ÈØÚÓ˙†ÍΆȄÈ≠ÏÚ†˙˜ÂÈ˙†Â‡Ø†ÌÈ„ÏÈ†Ï˘†Ì„È

ÔÂÈÓ†¯„Áφ„ÈÓ†È؉Ù†¨‰Ù¯˙‰†ÔÓ†‰Ø„ÏȆÚÏ·†˙ÂÚË·†Ì‡†Â‡†¯˙Ȇ˙Ó†˙ÏË†Ì‡

‰‡¯Â‰†‡Ïφ‰‡˜‰Ï†Ì¯‚φÔȇ†ÆÍ˙ȇ†‰Ù¯˙‰†˙Êȯ‡†È؇·‰Â†ÌÈÏÂÁ†˙È·†Ï˘

‰ÏÂÏÚ†‡È‰†˙دÁ‡†‰ÏÂÁ·†¨Í˙„ÏÈØÍ„ÏÈφ‰Ó˘¯†Âʆ‰Ù¯˙†°‡Ù¯ӆ˙˘¯ÂÙÓ

ÆÍȯÎӆ‡†¨ÍÈ΢†¨Íȷ¯˜Ï†Âʆ‰Ù¯˙†ÈØÔ˙˙†Ï‡†Æ˜ÈʉÏ

Í˙„ÏÈØÍ„ÏÈ˘†ÌÚÙ†Ï熉Ӊ†˙ÈÂÂ˙‰†˜Â„·Ï†˘È†°Í˘ÂÁ·†˙ÂÙ¯˙†ÏÂËÈφÔȇ

Æ̉φ‰Ø˜Â˜Ê†Íȉ†Ì‡†ÌÈÈÙ˜˘Ó†·Èί‰Ï†˘È†Æ‰Ù¯˙†˙ØÏËÂ

ƇÈÙ˜‰Ï†‡Ï†Æ¯Â‡Ó†Ô‚ÂÓ† (2 o C-8 o C) †¯¯˜Ó·† ∫‰ÒÁ‡

ÆÌȯʆÌȘȘÏÁ†Ï˘†˙ÂÁÎÂ†Â‡†Ú·ˆ†˙ÚÙ‰†Ï˘†‰¯˜Ó·†ÔÂÒÈÁ·†˘Ó˙˘‰Ï†¯ÂÒ‡

‰ÒÁ‡‰Ø‰Êȯ‡‰†È‡˙†ÈÙφ̂†Æ˜¯ÊÓ†Â˙‡·†˙¯Á‡†˙ÂÙ¯˙†ÌÚ†‰Ê†ÔÂÒÈÁ†··¯ÚφÔȇ

‰‚ÂÙ˙‰†Íȯ‡˙φ·Ï†ÌÈ˘Ï†‡†Æ„·Ï·†˙Ï·‚ÂÓ†‰Ù˜˙φ˙Â¯Ó˘†˙ÂÙ¯˙†¨ÌȈÏÓÂÓ‰

ƉÙ¯˙‰†˙‡†Íφ˜ÙÈÒ˘†Á˜Â¯·†ıÚÂÂȉφÍÈÏÚ†¨˜ÙÒ†Ï˘†‰¯˜Ó†Ïη†°¯È˘Î˙‰†Ï˘

ƉÊȯ‡†‰˙‡·†˙Â¢†˙ÂÙ¯˙†ÔÒÁ‡Ï†Ôȇ

±≤∂†μ±†≥∞μ≤≤†∞∞ †∫‰Ù¯˙‰†ÌÂ˘È¯†ßÒÓ

Æ˙Ù¯ˆ†¨ÔÂÈφ¨¯ËÒÙ†ÈÙÂÒ† ∫Ô¯ˆÈ

±π∏∂†≠†Â¢Ó˘˙‰†®ÌÈ¯È˘Î˙©†ÌÈÁ˜Â¯‰†˙Â˜˙†ÈÙφÔίˆÏ†ÔÂÏÚ

‡Ù¯†Ì˘¯Ó·†˙·ÈÈÁ†Âʆ‰Ù¯˙

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

„ȆÏÚ†¯˘Â‡Â†˜„·†ÂÎÂ˙†˙‡ȯ·‰†„¯˘Ó†È¢Ú†Ú·˜†‰Ê†ÔÂÏÚ†ËÓ¯ÂÙ

ÌÈ„ÏÈφÙȯ‚ÈÒ˜Â

Ï¢Ó†∞Æ≤μ†Ï˘†˘ÂÓÈ˘Ï†ÔÎÂÓ†˜¯ÊÓ·†‰˜¯Ê‰Ï†ÛÈÁ¯˙

≤∞∞∏≠≤∞∞π†Û¯ÂÁ†¨˙ÚÙ˘†˙ÚÈÓφÔÂÒÈÁ

ÌÈËÏÂȘ‡†ÌÈ‚ÈË‡†ÏÈÎÓ‰†¨˙ÓÂÓ†¨ÏˆÂÙÓ†¨ *˙ÚÙ˘‰†ÛÈ‚†‡Â‰†ÏÈÚÙ‰†¯ÓÂÁ‰†∫·Î¯‰

∫Ìȇ·‰†ÌÈÊÏ

ÆÏ¢Ó†∞Æ≤μ†Ï˘†‰Ó·

˙ËÏÁ‰Â † (northern hemisphere)† ÈÓÏÂÚ‰†˙‡ȯ·‰†Ô‚¯È‡†˙ˆÏÓ‰†˙‡†Ì‡Â˙†ÔÂÒÈÁ‰

Æ≤∞∞∏≠≤∞∞π†˙ÂÚφÈÙ¯ȇ‰†„ÂÁȇ‰

∫ÌÈÏÈÚÙ†È˙Ï·†ÌÈ·ÈίÓ

Buffer solution containing sodium chloride, disodium phosphate dihydrate, potassium

dihydrogen phosphate, potassium chloride and water for injections.

∫˙ȇÂÙ¯†˙ÂÏÈÚÙ

≥μ†„Ú†ÌÈ˘„ÂÁ†∂†ÏÈ‚Ó†˙˜ÂÈ˙†ÌÈ„ÏÈ·†¯˜ÈÚ·†¨˙ÚÙ˘†˙ÚÈÓφ„ÚÂÈÓ†ÔÂÒÈÁ‰

Æ˙ÚÙ˘Ó†ÌÈηÈÒφ‰Â·‚†ÔÂÎÈÒ†ÌÚ†ÌÈ˘„ÂÁ

ÌÂÈÓ†˙ÂÚ·˘†≤≠≥†ÍÂ˙†ÏÏÎ≠ͯ„·†˙Ï·˜˙Ó†˙ÚÙ˘‰†ÈÙÈ‚†ÈÙÓ†˙ÈÂÒÈÁ†‰‚‰

ÆÌÈ˘„ÂÁ†∂≠±≤†ÏÏΆͯ„·†‡Â‰Â†‰˙˘Ó†‰‚‰‰†ÔÓÊ†Í˘Ó†Æ‰˜¯Ê‰‰

ø¯È˘Î˙·†˘Ó˙˘‰Ï†Ôȇ†È˙Ó

ƉÙ¯˙‰†È·ÈίÓÓ†„Á‡Ï†˙Â˘È‚¯†Í˙„ÏÈØÍ„ÏÈφ̇†˘Ó˙˘‰Ï†Ôȇ

¨„ȉ„ÏÓ¯ÂÙφ¨ÔȈÈÓ‡Èφ¨˙ÂÙÂÚ†È·ÏÁφ¨ÌȈȷφ˙Â˘È‚¯†‰Ú„Ȇ̇†˘Ó˙˘‰Ï†Ôȇ

Æπ†ÏÂÈÒ˜Â˘‡Ï

ƉÓφ‰ˆÈ·†Ô·ÏÁ†Ï˘†Ì¯‚¯˜ÈÓ†∞Æ∞≤μ†≠Ó†¯˙ÂȆÏÈÎÓ†Âȇ†ÌÈ„ÏÈφÙȯ‚ÈÒ˜Â

˙ίÚÓ·†‰ÙȯÁ†‰ÏÁÓÓ†˙ØÏ·ÂÒ†Í˙„ÏÈØÍ„ÏȆ̇†‰Ê†ÔÂÒÈÁ·†˘Ó˙˘‰Ï†Ôȇ

ÛÈ„Ú†‰ÊΆ‰¯˜Ó·©†ÌÂÁ·†‰ÂÂÏÓ‰†‰ÏÁÓӆ‡†¨¯Á‡†ÏÈÚن̉ÈÊӆ‡†¨‰ÓÈ˘‰

Æ®ÔÂÒÈÁ‰†˙‡†˙ÂÁ„Ï

∫ÏÂÙÈˉ†˙ÏÁ˙‰†ÈÙφ‡Ù¯·†ıÚÂÂȉφÈÏ·Ó†¯È˘Î˙·†˘Ó˙˘‰Ï†Ôȇ

Æ˙ÈÂÒÈÁ‰†˙ίÚÓ‰†„˜Ù˙·†È˜ÈÏÓ†¯·Ú·†‰ØϷ҆‡†˙ØÏ·ÂÒ†Í˙„ÏÈØÍ„ÏȆ̇

∫˙¯‰Ê‡

ÍÈÏÚ†¨ÔÂÒÈÁ‰†¯Á‡Ï˘†ÌÈÓÈ·†Ì„†˙˜È„·†‰Ø¯·Ú†Í˙„ÏÈØÍ„ÏȆȉ˘ÏΆ‰·ÈÒӆ̇

ÂÙˆ†¨Ì„†˙˜Ȅ·†Ï˘†˙ÂÈ‚˘†˙ÂÈ·ÂÈÁ†˙‡ˆÂ˙˘†¯Á‡Ó†˙‡Ê†ÆÏÙËÓ‰†‡Ù¯φÁ„Ï

ÆÂÒÂÁ†¯·ÎÓ†‰Ê˘†ÌÈÏÂÁ†¯ÙÒÓ·

∫˙ÂÈ˙Ù¯˙≠ÔÈ·†˙·‚˙

‰Ù¯˙·†ÏÂÙȈ‰˙Ú†‰Ê†‰Ø¯Ó‚†Ì‡†Â‡†¨˙ÙÒÂ†‰Ù¯˙†˙ØÏËÂ†Í˙„ÏÈØÍ„ÏȆ̇

˙·‚˙Ó†ÌÈÚ·Â‰†˙ÂÏÈÚÈ≠ȇ†Â‡†ÌÈÂÎÈÒ†ÚÂÓφȄΆÏÙËÓ‰†‡Ù¯φÁ„φÍÈÏÚ†¨˙¯Á‡

˙ίÚÓ‰†˙‡†ÌÈ˘ÈÏÁÓ‰†ÌÈÏÂÙȈ‡Ø†˙ÂÙ¯˙†È·‚φ„ÁÂÈÓ·†¨˙ÂÈ˙Ù¯˙≠ÔÈ·

˙ίÚӆȇ΄ӆÌÈÏÂÙÈË†Ï˘†Ìȯ˜Ó·†Ô¢φ‰ÏÂÏÚ†˙ÈÂÒÈÁ‰†‰·Â‚˙‰†Æ˙ÈÂÒÈÁ‰

˙˙φÔ˙È†Æ‰ȯ˜·†ÌÈÏÂÙȈ¨˙ÂÈÒ˜ÂËÂËȈ†˙ÂÙ¯˙†¨ÌȄȇ¯ËÒ˜È˯˜†ÂÓΆ˙ÈÂÒÈÁ

A/Brisbane/59/2007 (H1N1)-like strain IVR-148 derived

from A/Brisbane/59/2007 7.5 micrograms HA**

A/Brisbane/10/2007 (H3N2)-like strain NYMC X-175C derived

from A/Uruguay/716/2007 7.5 micrograms HA**

B/Florida/4/2006-like strain B/Florida/4/2006 7.5 micrograms HA**

*propagated in fertilised hens’eggs from healthy chicken flocks

**haemagglutinin

PATIENT PACKAGE INSERT IN ACCORDANCE WITH

THEPHARMACISTS'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

Vaxigrip Pediatric Use

Suspension for Injection in a prefilled syringe of 0.25 ml

InfluenzaVaccine (winter 2008-2009)

Composition:The active ingredient is Influenza virus*, split, inactivated, containing

antigens equivalent to the following strains:

A/Brisbane/59/2007 (H1N1)-like strain IVR-148 derived

from A/Brisbane/59/2007 7.5 micrograms HA**

A/Brisbane/10/2007 (H3N2)-like strain NYMC X-175C derived

from A/Uruguay/716/2007 7.5micrograms HA**

B/Florida/4/2006-like strain B/Florida/4/2006 7.5microgramsHA**

for one 0.25 ml dose.

*propagated in fertilised hens’eggs from healthy chicken flocks

**haemagglutinin

The vaccine complies with theW.H.O.recommendations (northern hemisphere)

and the E.U.decision for the 2008-2009 season.

Inactive ingredients: Buffer solution containing sodium chloride, disodium

phosphate dihydrate, potassium dihydrogen phosphate, potassium chloride and

water for injections.

Therapeutic activity:The vaccine is intended for prevention of influenza

particularly in children and infants from 6 to 35 months of age at high risk of

influenza-associated complications.Seroprotection against the influenza virus

is generally obtained within 2 to 3 weeks following the vaccination.The duration

of immunity varies, but usually lasts for 6-12 months.

When should the preparation not be used?

Do not use this medicine if your child is sensitive to any of its ingredients.

Do not use this medicine if your child is sensitive to eggs, chicken proteins,

neomycin, formaldehyde, or to octoxinol 9.

Vaxigrip Pediatric Usedoes not contain more than 0.025 microgram ovalbumin

per dose.

Do not use this vaccine if your child is suffering from an acute disease of the

respiratory system, or from another active infection, or from an illness

accompanied byfever (in this case it is preferable to postpone vaccination).

Do not take this medicine without consulting a doctor before starting

treatment:

If your child is suffering, or has suffered in the past, from impaired function of

the immune system.

Warnings:If, for any reason, your child has a blood test within a few days

following an influenza vaccination, please tell your doctor.This is because false

positive blood test results were observed in a few patients who had recently

been vaccinated.

Drug interactions:If your child is taking another drug or has just finished

treatment with another medicine, informthe attending doctor, in order to prevent

hazards or lack of efficacy arising from drug interactions.This is especially

important for medicines and/or treatments which weaken the immune system

such as immunosuppressant treatment (e.g.corticosteroids, cytotoxic drugs or

radiotherapy).Vaxigrip Pediatric Usecan be administered concomitantly with

other vaccines using different injection sites.It should be noted that the adverse

Side effects:In addition to the desired effect of the medicine, adverse reactions

may occur during the course of taking this medicine, for example:headache,

sweating, muscular pain (myalgia), joint pain (arthralgia), fever, malaise, shivering,

fatigue.

Localreactions:redness, swelling, pain, bruising (ecchymosis), hardness

(induration) around the area where the vaccine is injected.

These reactions usually disappear within 1-2 days without treatment.

Side effects that require special attention:

Refer to the doctor if you experience one or more of the following effects:

Skin reactions that may spread throughout the body including itchiness of the

skin (pruritus, urticaria), rash.

Pain situated on the nerveroute (neuralgia), anomalies in the perception of

touch, pain, heat and cold (paraesthesia), convulsions associated with fever,

neurological disorders that may result in stiff neck, confusion, numbness, pain

and weakness of the limbs, loss of balance, loss of reflexes,paralysis of part

or all the body (encephalomyelitis, neuritis, Guillain-Barré syndrome).

Temporaryreduction in the number of platelets;a low number of these can result

in excessive bruising or bleeding (transient thrombocytopenia), transient swelling

of the glands in the neck, armpit or groin (transient lymphadenopathy).

Allergic reactions:

-leading to medical emergency with a failure of the circulatory system to maintain

adequate blood flow to the different organs (shock) in rare cases.

-swelling most apparent in the head and neck, including the face, lips, tongue,

throat or any other part of the body (angioedema) in veryrare cases.

Vessel inflammation (vasculitis) which may result in skin rashes and in veryrare

cases in transient kidney problems.

In the event that your child experiences side effects not mentioned in this leaflet,

or if there is a change in his/her general health, consult a doctor immediately.

Dosage:Dosage is according to doctor's instructions only.

Recommended dosageunless otherwise prescribed byyour doctor:

Children from 6 to 35 months of age:one dose (0.25 ml).

For children below 9 years of age who havenot previously been vaccinated

against influenza, a second dose should be given after an interval of at least 4

weeks in between doses.This medicine is not intended for administration to

infants below 6 months of age.

Directions for use:For intramuscular or deep subcutaneous injection.

This vaccine should never be administered by the intravascular route.

Shake before use.

The vaccine should be brought to room temperature before use.

Avoidpoisoning!This medicine, 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 medicine has been prescribed for your child;

in another patient it may cause harm.

Do not give this medicine to your relatives, neighbours or acquaintances.

Donottakemedicinesinthedark! Check the label and the doseeachtime your

child is taking a medicine. Wear glasses if you need them.

Storage:Store in a refrigerator (2 o C-8 o C) and protected from light.

Do not freeze.This vaccine must not be used in the event of colouring or presence

of foreign particles.Do not mix this vaccine with other medicines in the same

syringe.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 medicine! In case of doubt, consult the pharmacist who dispensed the

medicine to you.Do not store different medications in the same package.

License number:126 51 30522 00

Manufacturer:sanofi pasteur, Lyon, France.

License holder:Medici Medical Ltd., 2 Hapnina St., Ra’anana.

מוצרים דומים

חיפוש התראות הקשורות למוצר זה

צפו בהיסטוריית המסמכים

שתף מידע זה