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</head>

<body lang=3DRU link=3D"#2577D9" vlink=3Dpurple style=3D'tab-interval:36.0p=
t'>

<div class=3DWordSection1>

<h1><b style=3D'mso-bidi-font-weight:normal'><span lang=3DUK style=3D'font-=
size:12.0pt'>Інструкція<o:p></o:p></span></b></h1>

<p class=3DMsoNormal align=3Dcenter style=3D'text-align:center'><b style=3D=
'mso-bidi-font-weight:
normal'><span lang=3DUK style=3D'font-size:12.0pt;mso-ansi-language:UK'>для
медичного застосування лікарського засобу<o:p></o:p></span></b></p>

<p class=3DMsoNormal align=3Dcenter style=3D'text-align:center'><b style=3D=
'mso-bidi-font-weight:
normal'><span lang=3DUK style=3D'font-size:12.0pt;mso-ansi-language:UK'><o:=
p>&nbsp;</o:p></span></b></p>

<h3 align=3Dcenter style=3D'text-align:center'><b style=3D'mso-bidi-font-we=
ight:normal'><span
lang=3DUK style=3D'font-size:12.0pt;text-decoration:none;text-underline:non=
e'>ФОРТРАНС</span></b><b
style=3D'mso-bidi-font-weight:normal'><sup><span lang=3DUK style=3D'mso-bid=
i-font-size:
14.0pt;text-decoration:none;text-underline:none'>®</span></sup></b><b
style=3D'mso-bidi-font-weight:normal'><span lang=3DUK style=3D'font-size:12=
.0pt;
text-decoration:none;text-underline:none'><o:p></o:p></span></b></h3>

<h3 align=3Dcenter style=3D'text-align:center'><b style=3D'mso-bidi-font-we=
ight:normal'><span
lang=3DUK style=3D'font-size:12.0pt;text-decoration:none;text-underline:non=
e'>(</span></b><b
style=3D'mso-bidi-font-weight:normal'><span lang=3DEN-US style=3D'font-size=
:12.0pt;
mso-ansi-language:EN-US;text-decoration:none;text-underline:none'>FORTRANS<=
/span></b><b
style=3D'mso-bidi-font-weight:normal'><sup><span lang=3DUK style=3D'mso-bid=
i-font-size:
14.0pt;text-decoration:none;text-underline:none'>®</span></sup></b><b
style=3D'mso-bidi-font-weight:normal'><span lang=3DUK style=3D'font-size:12=
.0pt;
text-decoration:none;text-underline:none'>)<o:p></o:p></span></b></h3>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><b
style=3D'mso-bidi-font-weight:normal'><i style=3D'mso-bidi-font-style:norma=
l'><span
lang=3DUK>Склад:<o:p></o:p></span></i></b></p>

<p class=3DMsoBodyText><i style=3D'mso-bidi-font-style:normal'><span lang=
=3DUK
style=3D'font-size:12.0pt'>діючі речовини:</span></i><span lang=3DUK
style=3D'font-size:12.0pt;mso-ansi-language:RU'> </span><span lang=3DUK
style=3D'font-size:12.0pt'>1 пакетик містить: макрогол 4000<span
style=3D'mso-spacerun:yes'>     </span></span><span style=3D'font-size:12.0=
pt;
mso-ansi-language:RU'><span style=3D'mso-spacerun:yes'>  </span><span
style=3D'mso-spacerun:yes'> </span></span><span lang=3DUK style=3D'font-siz=
e:12.0pt'>64,00
г;</span><span style=3D'font-size:12.0pt;mso-ansi-language:RU'><o:p></o:p><=
/span></p>

<p class=3DMsoBodyText><span lang=3DUK style=3D'font-size:12.0pt'>натрію су=
льфат
безводний</span><span style=3D'font-size:12.0pt;mso-ansi-language:RU'><span
style=3D'mso-spacerun:yes'>                                               
</span></span><span lang=3DUK style=3D'font-size:12.0pt'>5,70 г</span><span
style=3D'font-size:12.0pt;mso-ansi-language:RU'>;<o:p></o:p></span></p>

<p class=3DMsoBodyText><span lang=3DUK style=3D'font-size:12.0pt'>натрію бі=
карбонат </span><span
style=3D'font-size:12.0pt;mso-ansi-language:RU'><span
style=3D'mso-spacerun:yes'>                                                =
           </span><span
style=3D'mso-spacerun:yes'>  </span></span><span lang=3DUK style=3D'font-si=
ze:12.0pt'>1,68
г</span><span style=3D'font-size:12.0pt;mso-ansi-language:RU'>;<o:p></o:p><=
/span></p>

<p class=3DMsoBodyText><span lang=3DUK style=3D'font-size:12.0pt'>натрію хл=
орид<span
style=3D'mso-tab-count:2'>                        </span></span><span
style=3D'font-size:12.0pt;mso-ansi-language:RU'><span
style=3D'mso-spacerun:yes'>               </span></span><span lang=3DUK
style=3D'font-size:12.0pt'><span style=3D'mso-tab-count:1'>         </span>=
<span
style=3D'mso-spacerun:yes'>                  </span></span><span
style=3D'font-size:12.0pt;mso-ansi-language:RU'><span
style=3D'mso-spacerun:yes'>  </span></span><span lang=3DUK style=3D'font-si=
ze:12.0pt'><span
style=3D'mso-spacerun:yes'> </span>1,46 г</span><span style=3D'font-size:12=
.0pt;
mso-ansi-language:RU'>;<o:p></o:p></span></p>

<p class=3DMsoBodyText><span lang=3DUK style=3D'font-size:12.0pt'>калію хло=
рид<span
style=3D'mso-tab-count:4'>                                      </span><span
style=3D'mso-spacerun:yes'>                   </span></span><span
style=3D'font-size:12.0pt;mso-ansi-language:RU'><span
style=3D'mso-spacerun:yes'>            </span></span><span lang=3DUK
style=3D'font-size:12.0pt'><span style=3D'mso-spacerun:yes'>  </span>0,75 г=
</span><span
style=3D'font-size:12.0pt;mso-ansi-language:RU'>;<o:p></o:p></span></p>

<p class=3DMsoBodyText><i style=3D'mso-bidi-font-style:normal'><span lang=
=3DUK
style=3D'font-size:12.0pt'>допоміжні речовини</span></i><span lang=3DUK
style=3D'font-size:12.0pt'>: натрію сахарин</span><span style=3D'font-size:=
12.0pt;
mso-ansi-language:RU'>.<o:p></o:p></span></p>

<p class=3DMsoBodyText><span style=3D'font-size:12.0pt;mso-ansi-language:RU=
'><o:p>&nbsp;</o:p></span></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><b
style=3D'mso-bidi-font-weight:normal'><span lang=3DUK>Лікарська форма. </sp=
an></b><span
lang=3DUK>Порошок для орального розчину.<b style=3D'mso-bidi-font-weight:no=
rmal'><o:p></o:p></b></span></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><i
style=3D'mso-bidi-font-style:normal'><span lang=3DUK>Основні фізико-хімічні
властивості. <o:p></o:p></span></i></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><span lang=
=3DUK>Порошок
білого кольору, який легко розчиняється у воді.</span></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><span lang=
=3DUK><o:p>&nbsp;</o:p></span></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><b
style=3D'mso-bidi-font-weight:normal'><span lang=3DUK>Фармакотерапевтична г=
рупа.<o:p></o:p></span></b></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><span lang=
=3DUK>Осмотичні
проносні засоби. Код АТХ А06А D65.</span></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><span lang=
=3DUK><o:p>&nbsp;</o:p></span></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><b
style=3D'mso-bidi-font-weight:normal'><i><span lang=3DUK>Фармакологічні вла=
стивості</span></i><span
lang=3DUK>.<o:p></o:p></span></b></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><i
style=3D'mso-bidi-font-style:normal'><span lang=3DUK>Фармакодинаміка.<o:p><=
/o:p></span></i></p>

<p class=3D1 style=3D'margin-top:0cm;margin-right:0cm;margin-bottom:0cm;mar=
gin-left:
2.0pt;margin-bottom:.0001pt;line-height:normal;background:transparent'><span
lang=3DUK style=3D'font-size:12.0pt;font-family:"Times New Roman","serif"'>=
За
рахунок утворення водневих зв’язків з молекулами води Фортранс<b
style=3D'mso-bidi-font-weight:normal'><sup>®</sup></b> утримує її в кишечни=
ку.
Вода оводнює і збільшує вміст кишечнику по всій його довжині.<span
style=3D'mso-spacerun:yes'>  </span>Після цього препарат повністю евакуюєть=
ся з кишечника
разом з його вмістом.<o:p></o:p></span></p>

<p class=3D1 style=3D'margin-top:0cm;margin-right:0cm;margin-bottom:0cm;mar=
gin-left:
2.0pt;margin-bottom:.0001pt;line-height:normal;background:transparent'><span
class=3D3><span lang=3DUK style=3D'font-size:12.0pt;font-family:"Times New =
Roman","serif";
color:windowtext'>Об’єм неабсорбованої рідини у кишечнику відповідає за
проносну дію розчину лікарського засобу.<o:p></o:p></span></span></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><i
style=3D'mso-bidi-font-style:normal'><span lang=3DUK>Фармакокінетика.<o:p><=
/o:p></span></i></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><span lang=
=3DUK>Лікарський
засіб не всмоктується і не метаболізується.<b style=3D'mso-bidi-font-weight=
:normal'>
</b>Виводиться з організму<b style=3D'mso-bidi-font-weight:normal'> </b>у<b
style=3D'mso-bidi-font-weight:normal'> </b>незмінному стані.</span></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><span lang=
=3DUK><o:p>&nbsp;</o:p></span></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><b
style=3D'mso-bidi-font-weight:normal'><span lang=3DUK>Клінічні характеристи=
ки.<o:p></o:p></span></b></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><b
style=3D'mso-bidi-font-weight:normal'><i><span lang=3DUK>Показання.<o:p></o=
:p></span></i></b></p>

<p class=3DMsoNormal style=3D'text-align:justify'><span lang=3DUK style=3D'=
font-size:
12.0pt;mso-ansi-language:UK'>Очищення товстого кишечнику для підготовки
пацієнтів до проведення:<o:p></o:p></span></p>

<p class=3DMsoNormal style=3D'margin-left:18.0pt;text-align:justify;text-in=
dent:
-18.0pt;mso-list:l0 level1 lfo1;tab-stops:list 18.0pt'><![if !supportLists]=
><span
style=3D'font-size:12.0pt'><span style=3D'mso-list:Ignore'>-<span style=3D'=
font:7.0pt "Times New Roman"'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nb=
sp;
</span></span></span><![endif]><span style=3D'font-size:12.0pt'>ендоскопічн=
их або
рентгенологічних досліджень </span><span lang=3DUK style=3D'font-size:12.0p=
t;
mso-ansi-language:UK'>на товстому кишечнику</span><span style=3D'font-size:=
12.0pt'>;<o:p></o:p></span></p>

<p class=3DMsoNormal style=3D'margin-left:18.0pt;text-align:justify;text-in=
dent:
-18.0pt;mso-list:l0 level1 lfo1;tab-stops:list 18.0pt'><![if !supportLists]=
><span
style=3D'font-size:12.0pt'><span style=3D'mso-list:Ignore'>-<span style=3D'=
font:7.0pt "Times New Roman"'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nb=
sp;
</span></span></span><![endif]><span style=3D'font-size:12.0pt'>хірургічних
втручань на </span><span lang=3DUK style=3D'font-size:12.0pt;mso-ansi-langu=
age:
UK'>товстому </span><span style=3D'font-size:12.0pt'>кишечнику.<o:p></o:p><=
/span></p>

<p class=3DMsoNormal style=3D'text-align:justify'><span style=3D'font-size:=
12.0pt'>Фортранс<sup>®</sup>
показаний до застосування доросли</span><span lang=3DUK style=3D'font-size:=
12.0pt;
mso-ansi-language:UK'>м</span><span style=3D'font-size:12.0pt'>.<o:p></o:p>=
</span></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><span
style=3D'mso-ansi-language:RU'><o:p>&nbsp;</o:p></span></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><b
style=3D'mso-bidi-font-weight:normal'><i><span lang=3DUK>Протипоказання.<o:=
p></o:p></span></i></b></p>

<p class=3DMsoBodyText style=3D'text-align:justify'><span style=3D'font-siz=
e:12.0pt;
mso-ansi-language:RU'>- </span><span lang=3DUK style=3D'font-size:12.0pt'>П=
ідвищена
чутливість до діючих або допоміжних речовин лікарського засобу. </span><span
style=3D'font-size:12.0pt;mso-ansi-language:RU'><o:p></o:p></span></p>

<p class=3DMsoBodyText style=3D'text-align:justify'><span style=3D'font-siz=
e:12.0pt;
mso-ansi-language:RU'>- </span><span lang=3DUK style=3D'font-size:12.0pt'>Т=
яжкі
порушення загального стану пацієнта, наприклад зневоднення організму або тя=
жка
серцева недостатність.</span><span style=3D'font-size:12.0pt;mso-ansi-langu=
age:
RU'><o:p></o:p></span></p>

<p class=3DMsoBodyText style=3D'text-align:justify'><span style=3D'font-siz=
e:12.0pt;
mso-ansi-language:RU'>- </span><span lang=3DUK style=3D'font-size:12.0pt'>П=
оширена
карцинома або будь-яке інше захворювання товстого кишечнику, що супроводжує=
ться
поширеним ушкодженням слизової оболонки кишечнику.<o:p></o:p></span></p>

<p class=3DMsoBodyText style=3D'text-align:justify'><span lang=3DUK style=
=3D'font-size:
12.0pt'>- Наявність або ризик виникнення кишкової непрохідності чи шлунково=
-кишкової
непрохідності.<o:p></o:p></span></p>

<p class=3DMsoBodyText style=3D'text-align:justify'><span lang=3DUK style=
=3D'font-size:
12.0pt'>- Перфорація або загроза перфорації шлунково-кишкового тракту.</spa=
n><span
style=3D'font-size:12.0pt;mso-ansi-language:RU'><o:p></o:p></span></p>

<p class=3DMsoBodyText style=3D'text-align:justify'><span style=3D'font-siz=
e:12.0pt;
mso-ansi-language:RU'>- </span><span lang=3DUK style=3D'font-size:12.0pt'>Б=
іль у
животі невизначеного походження. <o:p></o:p></span></p>

<p class=3DMsoBodyText style=3D'text-align:justify'><span lang=3DUK style=
=3D'font-size:
12.0pt'>- Розлади випорожнення шлунка (наприклад, гастропарез).<o:p></o:p><=
/span></p>

<p class=3DMsoBodyText style=3D'text-align:justify'><span lang=3DUK style=
=3D'font-size:
12.0pt'>- Токсичний коліт або токсичний мегаколон.<o:p></o:p></span></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><span lang=
=3DUK><o:p>&nbsp;</o:p></span></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><b
style=3D'mso-bidi-font-weight:normal'><i><span lang=3DUK>Взаємодія з іншими=
 лікарськими
засобами та інші види взаємодій.<o:p></o:p></span></i></b></p>

<p class=3DMsoNormal style=3D'text-align:justify;background:white'><span la=
ng=3DUK
style=3D'font-size:12.0pt;mso-ansi-language:UK;mso-fareast-language:DE'>Мед=
ичний
працівник, що призначає лікування, має бути проінформований про будь-які ін=
ші
лікарські засоби, що їх одночасно приймає пацієнт перорально. У зв’язку з
випорожненням шлунка, яке викликає Фортранс<sup>®</sup>, інші лікарські зас=
оби для
перорального застосування можуть не абсорбуватися, тому їх слід приймати не
пізніше ніж за 2 години до прийняття розчину. Потрібно уникати прийому ліка=
рських
засобів для перорального застосування до та після прийому проносного засобу=
 до
завершення медичного огляду. Для лікарських засобів<span
style=3D'mso-spacerun:yes'>  </span>із вузьким терапевтичним діапазоном або=
 з
коротким періодом напіввиведення можливий особливий вплив на ефективність.<=
o:p></o:p></span></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><span lang=
=3DUK><o:p>&nbsp;</o:p></span></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><b
style=3D'mso-bidi-font-weight:normal'><i><span lang=3DUK>Особливості застос=
ування.<o:p></o:p></span></i></b></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><span lang=
=3DUK>Особам
літнього віку із послабленим здоров’ям рекомендується застосовувати лікарсь=
кий
засіб тільки під наглядом лікаря.</span></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><span lang=
=3DUK>Пронос,
викликаний застосуванням лікарського засобу Фортранс<sup>®</sup>, може зава=
жати
всмоктуванню лікарських засобів, прийнятих одночасно з лікарським засобом (=
див.
розділ «Взаємодія з іншими лікарськими засобами та інші види взаємодій»).</=
span></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><span lang=
=3DUK>Цей
лікарський засіб містить макрогол (поліетиленгліколь або ПЕГ).</span></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><span lang=
=3DUK>Алергічні
реакції, про які повідомлялося при застосуванні лікарських засобів на основі
макроголу: анафілактичний шок, висип, кропивниця, ангіоневротичний набряк (=
див.
розділ «Побічні реакції»).</span></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><span lang=
=3DUK>Лікарський
засіб не повинен викликати порушення електролітного балансу з огляду на
його<span style=3D'mso-spacerun:yes'>  </span>ізотонічний склад; однак, були
зафіксовані виняткові випадки водно-електролітних порушень серед пацієнтів
групи ризику. Пацієнтам із проявами зневоднення або пацієнтам із електроліт=
ними
аномаліями слід усунути їх перед застосуванням лікарського засобу для очище=
ння
кишечника. Цей лікарський засіб слід застосовувати з обережністю пацієнтам,=
 що
страждають на такі порушення, а також пацієнтам, що одночасно вживають
лікарські засоби, які підвищують ризик водно-електролітних порушень, включа=
ючи
гіпонатріємію та гіпокаліємію, або ж можуть підвищувати ризик потенційних
ускладнень (наприклад, пацієнтам із порушенням функції нирок, серцевою
недостатністю або при супутньому лікуванні сечогінними лікарськими засобами=
). У
цьому разі пацієнти потребують належного спостереження.</span></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><span lang=
=3DUK>Пацієнтам,
схильним до аспірації, прикутим до ліжка, або пацієнтам із неврологічними п=
орушеннями
та/або моторними розладами, через ризик розвитку аспіраційної пневмонії,
рекомендується застосовувати лікарський засіб з обережністю <span
style=3D'mso-spacerun:yes'> </span>та лише під наглядом лікаря. Таким паціє=
нтам
слід вводити лікарський засіб у сидячому положенні і через назогастральний
зонд.</span></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><span lang=
=3DUK>У
пацієнтів із серцевою або нирковою недостатністю може розвинутись гострий
набряк легень у зв’язку з надмірним надходженням води.</span></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><span lang=
=3DUK>Цей
лікарський засіб містить натрій. Лікарський засіб містить 1,967 г натрію на=
 1
пакетик. Це слід враховувати пацієнтам, що дотримуються дієти з обмеженням
вмісту солі.</span></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><span lang=
=3DUK><o:p>&nbsp;</o:p></span></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><i><span
lang=3DUK>Застосування у період вагітності або годування груддю.<o:p></o:p>=
</span></i></p>

<p class=3DMsoNormal><u><span lang=3DUK style=3D'font-size:12.0pt;mso-ansi-=
language:
UK'>Вагітність<o:p></o:p></span></u></p>

<p class=3DMsoNormal style=3D'text-align:justify;background:white'><span la=
ng=3DUK
style=3D'font-size:12.0pt;mso-ansi-language:UK;mso-fareast-language:DE'>Дан=
і щодо
застосування препарату Фортранс<sup>®</sup> вагітним жінкам відсутні або
обмежені. Дані доклінічних досліджень щодо репродуктивної токсичності недос=
татні.
<o:p></o:p></span></p>

<p class=3DMsoNormal style=3D'text-align:justify;background:white'><span la=
ng=3DUK
style=3D'font-size:12.0pt;mso-ansi-language:UK;mso-fareast-language:DE'>Фор=
транс<sup>®
</sup>можна застосовувати лише після ретельної оцінки співвідношення ризику=
 для
плода та користі для матері. <o:p></o:p></span></p>

<p class=3DMsoNormal style=3D'text-align:justify'><u><span lang=3DUK
style=3D'font-size:12.0pt;mso-ansi-language:UK'>Годування груддю<o:p></o:p>=
</span></u></p>

<p class=3DMsoNormal style=3D'text-align:justify;background:white'><span la=
ng=3DUK
style=3D'font-size:12.0pt;mso-ansi-language:UK;mso-fareast-language:DE'>Дан=
і щодо
застосування препарату Фортранс<sup>® </sup>в період годування груддю відсу=
тні
або обмежені. Невідомо, чи виділяється макрогол 4000 в грудне молоко. Не мо=
жна
виключити ризик для новонароджених/немовлят. <o:p></o:p></span></p>

<p class=3DMsoNormal style=3D'text-align:justify;background:white'><span la=
ng=3DUK
style=3D'font-size:12.0pt;mso-ansi-language:UK;mso-fareast-language:DE'>Фор=
транс<sup>®
</sup>можна застосовувати лише після ретельної оцінки співвідношення ризику=
 для
плода та користі для матері.<o:p></o:p></span></p>

<p class=3DMsoNormal style=3D'text-align:justify;background:white'><u><span
lang=3DUK style=3D'font-size:12.0pt;mso-ansi-language:UK;mso-fareast-langua=
ge:DE'>Фертильність<o:p></o:p></span></u></p>

<p class=3DMsoNormal style=3D'text-align:justify;background:white'><span la=
ng=3DUK
style=3D'font-size:12.0pt;mso-ansi-language:UK;mso-fareast-language:DE'>Дан=
і щодо
впливу препарату Фортранс<sup>® </sup><span style=3D'mso-spacerun:yes'> </s=
pan>на
фертильність відсутні.<o:p></o:p></span></p>

<p class=3DMsoNormal style=3D'text-align:justify;background:white'><span la=
ng=3DUK
style=3D'font-size:12.0pt;mso-ansi-language:UK;mso-fareast-language:DE'>Якщ=
о Ви
вагітні або годуєте груддю, або припускаєте, що можете бути вагітні, або
плануєте мати дитину, вам слід проконсультуватися зі своїм лікарем, перш ніж
застосовувати препарат Фортранс<sup>®</sup>. <o:p></o:p></span></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><b
style=3D'mso-bidi-font-weight:normal'><span lang=3DUK><o:p>&nbsp;</o:p></sp=
an></b></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><b
style=3D'mso-bidi-font-weight:normal'><i><span lang=3DUK>Здатність впливати=
 на
швидкість реакції при керуванні автотранспортом або іншими механізмами.<o:p=
></o:p></span></i></b></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><span lang=
=3DUK>Досліджень
впливу на здатність керувати автотранспортом і працювати з механізмами не
проводилося. </span></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><span lang=
=3DUK><o:p>&nbsp;</o:p></span></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><b
style=3D'mso-bidi-font-weight:normal'><i><span lang=3DUK>Спосіб застосуванн=
я та
дози.<o:p></o:p></span></i></b></p>

<p class=3DMsoNormal style=3D'text-align:justify'><span lang=3DUK style=3D'=
font-size:
12.0pt;mso-ansi-language:UK;mso-fareast-language:DE'>Фортранс<sup>® </sup>м=
ожна
застосовувати лише дорослим пацієнтам.<o:p></o:p></span></p>

<p class=3DMsoNormal style=3D'text-align:justify'><span lang=3DUK style=3D'=
font-size:
12.0pt;mso-ansi-language:UK'>Для перорального застосування.<o:p></o:p></spa=
n></p>

<p class=3DMsoNormal style=3D'text-align:justify;line-height:14.0pt;mso-lin=
e-height-rule:
exactly'><span style=3D'font-size:12.0pt'>Вміст </span><span lang=3DUK
style=3D'font-size:12.0pt;mso-ansi-language:UK'>одного </span><span
style=3D'font-size:12.0pt'>пакетика розчин</span><span lang=3DUK style=3D'f=
ont-size:
12.0pt;mso-ansi-language:UK'>ити</span><span style=3D'font-size:12.0pt'> в 1
літрі води</span><span lang=3DUK style=3D'font-size:12.0pt;mso-ansi-languag=
e:UK'>
до повного розчинення порошку</span><span style=3D'font-size:12.0pt'>. </sp=
an><span
lang=3DUK style=3D'font-size:12.0pt;mso-ansi-language:UK'><o:p></o:p></span=
></p>

<p class=3DMsoNormal style=3D'text-align:justify;line-height:14.0pt;mso-lin=
e-height-rule:
exactly'><span lang=3DUK style=3D'font-size:12.0pt;mso-ansi-language:UK'>До=
зування
встановлювати з розрахунку приблизно 1 літр розчину на 15–20 кг маси тіла. =
Доза
становить </span><span lang=3DUK style=3D'font-size:12.0pt;mso-bidi-font-si=
ze:10.0pt;
mso-ansi-language:UK'>3–4 літри розчину залежно від маси тіла пацієнта</spa=
n><span
lang=3DUK style=3D'font-size:12.0pt;mso-ansi-language:UK'>.</span><span lan=
g=3DUK
style=3D'font-size:12.0pt;mso-bidi-font-size:10.0pt;mso-ansi-language:UK'><=
o:p></o:p></span></p>

<p class=3DMsoNormal style=3D'text-align:justify;line-height:14.0pt;mso-lin=
e-height-rule:
exactly'><span lang=3DUK style=3D'font-size:12.0pt;mso-bidi-font-size:10.0p=
t;
mso-ansi-language:UK'>Препарат можна застосовувати одноетапно або у 2 етапи=
</span><span
lang=3DUK style=3D'font-size:12.0pt;mso-bidi-font-size:10.0pt'> </span><span
lang=3DUK style=3D'font-size:12.0pt;mso-bidi-font-size:10.0pt;mso-ansi-lang=
uage:
UK'>за умови, що приготований розчин вживається повністю (у середньому 3–4
літра розчину залежно від маси тіла пацієнта).<o:p></o:p></span></p>

<p class=3DMsoNormal style=3D'text-align:justify;line-height:14.0pt;mso-lin=
e-height-rule:
exactly'><u><span lang=3DUK style=3D'font-size:12.0pt;mso-bidi-font-size:10=
.0pt;
mso-ansi-language:UK'>Схема підготовки.<o:p></o:p></span></u></p>

<p class=3DMsoNormal style=3D'text-align:justify;line-height:14.0pt;mso-lin=
e-height-rule:
exactly'><span lang=3DUK style=3D'font-size:12.0pt;mso-bidi-font-size:10.0p=
t;
mso-ansi-language:UK'>Одноетапна підготовка: 3–4 літри ввечері перед
процедурою, можлива перерва на 1 годину після перших 2 літрів. <o:p></o:p><=
/span></p>

<p class=3DMsoNormal style=3D'text-align:justify;line-height:14.0pt;mso-lin=
e-height-rule:
exactly'><span lang=3DUK style=3D'font-size:12.0pt;mso-bidi-font-size:10.0p=
t;
mso-ansi-language:UK'>Двоетапна підготовка: 2 літри ввечері перед процедуро=
ю і
1–2 літри вранці в день процедури, останню склянку приймати за 3–4 години п=
еред
процедурою; або 3 літри ввечері перед процедурою і 1 літр вранці в день
процедури, останню склянку приймати за 3–4 години перед процедурою.<o:p></o=
:p></span></p>

<p class=3DMsoNormal style=3D'text-align:justify;line-height:14.0pt;mso-lin=
e-height-rule:
exactly'><span lang=3DUK style=3D'font-size:12.0pt;mso-bidi-font-size:10.0p=
t;
mso-ansi-language:UK'>Рекомендована норма застосування препарату становить
1–1,5 літра на годину (тобто 250 мл кожні 10–15 хвилин).<o:p></o:p></span><=
/p>

<p class=3DMsoNormal style=3D'text-align:justify;line-height:14.0pt;mso-lin=
e-height-rule:
exactly'><span lang=3DUK style=3D'font-size:12.0pt;mso-bidi-font-size:10.0p=
t;
mso-ansi-language:UK'>Лікар може корегувати рекомендовану норму застосування
препарату відповідно до клінічного стану пацієнта і потенційних супутніх
захворювань.<o:p></o:p></span></p>

<p class=3DMsoNormal style=3D'text-align:justify;line-height:14.0pt;mso-lin=
e-height-rule:
exactly'><u><span lang=3DUK style=3D'font-size:12.0pt;mso-ansi-language:UK'=
>Пацієнти
з порушенням функції нирок.<o:p></o:p></span></u></p>

<p class=3DMsoNormal style=3D'text-align:justify;line-height:14.0pt;mso-lin=
e-height-rule:
exactly'><span lang=3DUK style=3D'font-size:12.0pt;mso-ansi-language:UK'>Що=
до цієї
категорії немає достатніх даних (див. розділ «Особливості застосування»).<o=
:p></o:p></span></p>

<p class=3DMsoNormal style=3D'text-align:justify;line-height:14.0pt;mso-lin=
e-height-rule:
exactly'><u><span lang=3DUK style=3D'font-size:12.0pt;mso-ansi-language:UK'=
>Діти.<o:p></o:p></span></u></p>

<p class=3DMsoNormal style=3D'text-align:justify;line-height:14.0pt;mso-lin=
e-height-rule:
exactly'><span lang=3DUK style=3D'font-size:12.0pt;mso-ansi-language:UK'>Бе=
зпеку та
ефективність препарату Фортранс<sup>®</sup> для дітей (віком до 18 років) не
встановлено.<o:p></o:p></span></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><span lang=
=3DUK><o:p>&nbsp;</o:p></span></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><i><span
lang=3DUK>Діти.<o:p></o:p></span></i></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><span lang=
=3DUK>Не
застосовують дітям.</span></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><span lang=
=3DUK><o:p>&nbsp;</o:p></span></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><b
style=3D'mso-bidi-font-weight:normal'><i><span lang=3DUK>Передозування.<o:p=
></o:p></span></i></b></p>

<p class=3DMsoNormal style=3D'text-align:justify'><span lang=3DUK style=3D'=
font-size:
12.0pt;mso-ansi-language:UK'>Повідомлень про передозування не було.<o:p></o=
:p></span></p>

<p class=3DMsoNormal style=3D'text-align:justify'><span lang=3DUK style=3D'=
font-size:
12.0pt;mso-ansi-language:UK;mso-fareast-language:DE'>Проте слід проводити
спостереження за водно-електролітним балансом та рівнем гідратації в пацієн=
та у
випадку передозування з тяжкою діареєю.<o:p></o:p></span></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><span lang=
=3DUK><o:p>&nbsp;</o:p></span></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><b
style=3D'mso-bidi-font-weight:normal'><i><span lang=3DUK>Побічні реакції.<o=
:p></o:p></span></i></b></p>

<p class=3DMsoNormal style=3D'text-align:justify;background:white'><span la=
ng=3DUK
style=3D'font-size:12.0pt;mso-ansi-language:UK;mso-fareast-language:DE'>Діа=
рея є
очікуваним наслідком застосування лікарського засобу Фортранс<sup>®</sup>.<=
o:p></o:p></span></p>

<p class=3DMsoNormal style=3D'text-align:justify;background:white'><span la=
ng=3DUK
style=3D'font-size:12.0pt;mso-ansi-language:UK;mso-fareast-language:DE'>На
початку прийому відзначалися напади нудоти та блювання, що зазвичай зникали=
 при
подальшому застосуванні.<o:p></o:p></span></p>

<p class=3DMsoNormal style=3D'text-align:justify;background:white'><span la=
ng=3DUK
style=3D'font-size:12.0pt;mso-ansi-language:UK;mso-fareast-language:DE'>Ниж=
че
перераховано небажані реакції згідно з даними клінічних випробувань і небаж=
ані
явища, про які повідомлялося в ході післяреєстраційних досліджень. Частота
визначається таким чином: дуже часто (&#8805;1/10), часто (&#8805;1/100 до
&lt;1/10), нечасто (&#8805;1/1000 до &lt;1/100), рідко (&#8805;1/10000
&gt;1/1000), дуже рідко (&lt;1/10000), невідомо (не може бути оцінено на
підставі наявних даних).<o:p></o:p></span></p>

<p class=3DMsoNormal style=3D'text-align:justify;background:white'><i
style=3D'mso-bidi-font-style:normal'><span lang=3DUK style=3D'font-size:12.=
0pt;
mso-ansi-language:UK'>З боку травної системи</span></i><span lang=3DUK
style=3D'font-size:12.0pt;mso-ansi-language:UK'>: <o:p></o:p></span></p>

<p class=3DMsoNormal style=3D'text-align:justify;background:white'><span la=
ng=3DUK
style=3D'font-size:12.0pt;mso-ansi-language:UK;mso-fareast-language:DE'>Дуже
часто: нудота, біль у животі, здуття живота.<o:p></o:p></span></p>

<p class=3DMsoNormal style=3D'text-align:justify;background:white'><span la=
ng=3DUK
style=3D'font-size:12.0pt;mso-ansi-language:UK;mso-fareast-language:DE'>Час=
то:
блювання.<o:p></o:p></span></p>

<p class=3DMsoNormal style=3D'text-align:justify;background:white'><i
style=3D'mso-bidi-font-style:normal'><span lang=3DUK style=3D'font-size:12.=
0pt;
mso-ansi-language:UK;mso-fareast-language:DE'>З боку імунної системи:<o:p><=
/o:p></span></i></p>

<p class=3DMsoNormal style=3D'background:white'><span lang=3DUK style=3D'fo=
nt-size:
12.0pt;mso-ansi-language:UK;mso-fareast-language:DE'>Невідомо:</span><span
lang=3DUK style=3D'font-size:12.0pt;mso-ansi-language:UK'> реакції </span><=
span
lang=3DUK style=3D'font-size:12.0pt;mso-ansi-language:UK;mso-fareast-langua=
ge:DE'>гіперчутливості,
включаючи анафілактичний шок, ангіоневротичний набряк, кропивниця, висип,
свербіж.<o:p></o:p></span></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><span lang=
=3DUK><o:p>&nbsp;</o:p></span></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><b
style=3D'mso-bidi-font-weight:normal'><i style=3D'mso-bidi-font-style:norma=
l'><span
lang=3DUK>Термін придатності.<o:p></o:p></span></i></b></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><span lang=
=3DUK>36
місяців.</span></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><span lang=
=3DUK><o:p>&nbsp;</o:p></span></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><b
style=3D'mso-bidi-font-weight:normal'><span lang=3DUK>Умови зберігання.<o:p=
></o:p></span></b></p>

<p class=3DMsoBodyText style=3D'text-align:justify'><span lang=3DUK style=
=3D'font-size:
12.0pt'>Не потребує</span><span lang=3DUK> </span><span lang=3DUK style=3D'=
font-size:
12.0pt'>спеціальних умов зберігання. </span><span style=3D'font-size:12.0pt;
mso-ansi-language:RU'>Зберігати у недоступному для дітей місці.<o:p></o:p><=
/span></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><span
style=3D'mso-ansi-language:RU'><o:p>&nbsp;</o:p></span></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><b
style=3D'mso-bidi-font-weight:normal'><span lang=3DUK>Упаковка.<o:p></o:p><=
/span></b></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><span lang=
=3DUK>По
73,69 г порошку у пакетику; по 4 пакетики у картонній коробці.</span></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><span lang=
=3DUK><o:p>&nbsp;</o:p></span></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><b
style=3D'mso-bidi-font-weight:normal'><span lang=3DUK>Категорія відпуску.<o=
:p></o:p></span></b></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><span lang=
=3DUK>За
рецептом.</span></p>

<p style=3D'margin:0cm;margin-bottom:.0001pt;text-align:justify'><span lang=
=3DUK><o:p>&nbsp;</o:p></span></p>

<p class=3DMsoNormal style=3D'text-align:justify'><b><span lang=3DUK
style=3D'font-size:12.0pt;mso-ansi-language:UK;mso-fareast-language:RU'>Вир=
обник.<o:p></o:p></span></b></p>

<p class=3DMsoNormal style=3D'text-align:justify;mso-pagination:none;mso-la=
yout-grid-align:
none;punctuation-wrap:simple;text-autospace:none'><span lang=3DUK
style=3D'font-size:12.0pt;mso-ansi-language:UK;mso-fareast-language:RU'>БОФ=
УР
ІПСЕН ІНДУСТРІ/</span><span lang=3DEN-US style=3D'font-size:12.0pt;mso-ansi=
-language:
EN-US;mso-fareast-language:RU'>BEAUFOUR</span><span lang=3DEN-US
style=3D'font-size:12.0pt;mso-ansi-language:UK;mso-fareast-language:RU'> </=
span><span
lang=3DEN-US style=3D'font-size:12.0pt;mso-ansi-language:EN-US;mso-fareast-=
language:
RU'>IPSEN</span><span lang=3DEN-US style=3D'font-size:12.0pt;mso-ansi-langu=
age:
UK;mso-fareast-language:RU'> </span><span lang=3DEN-US style=3D'font-size:1=
2.0pt;
mso-ansi-language:EN-US;mso-fareast-language:RU'>INDUSTRIE</span><span lang=
=3DUK
style=3D'font-size:12.0pt;mso-ansi-language:UK;mso-fareast-language:RU'>.<o=
:p></o:p></span></p>

<p class=3DMsoNormal style=3D'text-align:justify'><b><span lang=3DUK
style=3D'font-size:12.0pt;mso-ansi-language:UK;mso-fareast-language:RU'><o:=
p>&nbsp;</o:p></span></b></p>

<p class=3DMsoNormal style=3D'text-align:justify'><b><span lang=3DUK
style=3D'font-size:12.0pt;mso-ansi-language:UK;mso-fareast-language:RU'>Міс=
цезнаходження
виробника та його адреса місця провадження діяльності.<o:p></o:p></span></b=
></p>

<p class=3DMsoNormal style=3D'text-align:justify;mso-pagination:none;mso-la=
yout-grid-align:
none;punctuation-wrap:simple;text-autospace:none'><span lang=3DUK
style=3D'font-size:12.0pt;mso-ansi-language:UK;mso-fareast-language:RU'>Рю =
Ете
Віртон 28100 ДРЬО, Франція/</span><span lang=3DEN-US style=3D'font-size:12.=
0pt;
mso-ansi-language:EN-US;mso-fareast-language:RU'>Rue</span><span lang=3DEN-=
US
style=3D'font-size:12.0pt;mso-ansi-language:UK;mso-fareast-language:RU'> </=
span><span
lang=3DEN-US style=3D'font-size:12.0pt;mso-ansi-language:EN-US;mso-fareast-=
language:
RU'>Ethe</span><span lang=3DEN-US style=3D'font-size:12.0pt;mso-ansi-langua=
ge:UK;
mso-fareast-language:RU'> </span><span lang=3DEN-US style=3D'font-size:12.0=
pt;
mso-ansi-language:EN-US;mso-fareast-language:RU'>Virton</span><span lang=3D=
UK
style=3D'font-size:12.0pt;mso-ansi-language:UK;mso-fareast-language:RU'> 28=
100 </span><span
lang=3DEN-US style=3D'font-size:12.0pt;mso-ansi-language:EN-US;mso-fareast-=
language:
RU'>DREUX</span><span lang=3DUK style=3D'font-size:12.0pt;mso-ansi-language=
:UK;
mso-fareast-language:RU'>, </span><span lang=3DEN-US style=3D'font-size:12.=
0pt;
mso-ansi-language:EN-US;mso-fareast-language:RU'>France</span><span lang=3D=
UK
style=3D'font-size:12.0pt;mso-ansi-language:UK;mso-fareast-language:RU'>.<o=
:p></o:p></span></p>

<p class=3DMsoNormal style=3D'text-align:justify'><span lang=3DUK style=3D'=
font-size:
12.0pt;mso-ansi-language:UK;mso-fareast-language:RU;mso-bidi-font-weight:bo=
ld'><o:p>&nbsp;</o:p></span></p>

<p class=3DMsoNormal style=3D'text-align:justify'><b style=3D'mso-bidi-font=
-weight:
normal'><span lang=3DUK style=3D'font-size:12.0pt;mso-ansi-language:UK'>Зая=
вник.<o:p></o:p></span></b></p>

<p class=3DMsoNormal style=3D'text-align:justify;mso-pagination:none;mso-la=
yout-grid-align:
none;punctuation-wrap:simple;text-autospace:none'><span lang=3DUK
style=3D'font-size:12.0pt;mso-ansi-language:UK'>ІПСЕН КОНСЬЮМЕР ХЕЛСКЕА
Акціонерне товариство спрощеного типу / </span><span style=3D'font-size:12.=
0pt'>IPSEN</span><span
style=3D'font-size:12.0pt;mso-ansi-language:UK'> </span><span style=3D'font=
-size:
12.0pt'>CONSUMER</span><span style=3D'font-size:12.0pt;mso-ansi-language:UK=
'> </span><span
style=3D'font-size:12.0pt'>HEALTHCARE</span><span style=3D'font-size:12.0pt;
mso-ansi-language:UK'> </span><span style=3D'font-size:12.0pt'>Simplified</=
span><span
style=3D'font-size:12.0pt;mso-ansi-language:UK'> </span><span style=3D'font=
-size:
12.0pt'>Joint</span><span style=3D'font-size:12.0pt;mso-ansi-language:UK'> =
</span><span
style=3D'font-size:12.0pt'>Stock</span><span style=3D'font-size:12.0pt;mso-=
ansi-language:
UK'> </span><span style=3D'font-size:12.0pt'>company</span><span lang=3DUK
style=3D'font-size:12.0pt;mso-ansi-language:UK'>.<o:p></o:p></span></p>

<p class=3DMsoNormal style=3D'text-align:justify'><b style=3D'mso-bidi-font=
-weight:
normal'><span lang=3DUK style=3D'font-size:12.0pt;mso-ansi-language:UK'><o:=
p>&nbsp;</o:p></span></b></p>

<p class=3DMsoNormal style=3D'text-align:justify'><b style=3D'mso-bidi-font=
-weight:
normal'><span style=3D'font-size:12.0pt'>Місцезнаходження заявника та/або
представника заявника.<o:p></o:p></span></b></p>

<p class=3DMsoNormal style=3D'text-align:justify'><span style=3D'font-size:=
12.0pt'>65
Набережна Жорж Горс 92100 Булонь-Бійанкур, Франція / 65 Quai Georges Gorse
92100 Boulogne-Billancourt, France.<o:p></o:p></span></p>

</div>

</body>

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