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نشرة الممارس الصحي نشرة معلومات المريض بالعربية نشرة معلومات المريض بالانجليزية صور الدواء بيانات الدواء
  SFDA PIL (Patient Information Leaflet (PIL) are under review by Saudi Food and Drug Authority)

SmofKabiven extra Nitrogen is an emulsion for infusion given into your blood by a drip (intravenous infusion). The product contains amino acids (components used to build proteins), glucose (carbohydrates), lipids (fat) and salts (electrolytes) in a plastic bag and can be given to adults and children aged 2 years and above.

 

A healthcare professional will give you SmofKabiven extra Nitrogen when other forms of feeding are not good enough or have not worked.


 

Do not use SmofKabiven extra Nitrogen

-        if you are allergic (hypersensitive) to active substances or any of the other ingredients of this medicine (listed in section 6)

-        if you are allergic to fish or egg

-        if you are allergic to peanuts or soya you should not use this product. SmofKabiven extra Nitrogen contains soya-bean oil

-        if you have too much lipids in the blood (hyperlipidemia)

-        if you have serious liver disorder

-        if you have blood clotting problems (coagulation disorder)

-        if your body has problems using amino acids

-        if you have serious kidney disease without access to dialysis

-        if you are in acute shock

-        if you have too much sugar in your blood (hyperglycaemia) which is uncontrolled

-        if you have high blood (serum) levels of the salts (electrolytes) included in SmofKabiven extra Nitrogen

-        if you have fluid in the lungs (acute pulmonary oedema)

-        if you have too much body fluid (hyperhydrated)

-        if you have heart failure that is not treated

-        if you have a defect in your blood clotting system (hemophagocytotic syndrome)

-        if you are in an unstable condition, such as after serious trauma, uncontrolled diabetes, acute heart attack, stroke, blood clot, metabolic acidosis (a disturbance resulting in too much acid in the blood), serious infection (severe sepsis), coma and if you don’t have enough body fluid (hypotonic dehydration)

-        in newborn babies or children under 2 years of age

 

Warnings and precautions

Talk to your doctor before using SmofKabiven extra Nitrogen if you have:

-            kidney problems

-            diabetes mellitus

-            pancreatitis (inflammation of the pancreas)

-            liver problems

-            hypothyrodism (thyroid problems)

-            sepsis (serious infection)

 

If you during the infusion get fever, rash, swelling, difficulty in breathing, chills, sweating, nausea or vomiting, tell the healthcare professional immediately because these symptoms might be caused by an allergic reaction or that you have been given too much of the medicine.

 

Your doctor may regularly need to check your blood for liver function tests and other values.

 

Children and adolescents

SmofKabiven extra Nitrogen is not meant for newborn babies or children younger than 2 years of age. SmofKabiven extra Nitrogen can be given to children and adolescents from 2 to 16/18 years old.

 

Other medicines and SmofKabiven extra Nitrogen

Tell your doctor if you are taking, have recently taken or might take any other medicines, even without prescription.

 

Pregnancy and breast-feeding

Data from using SmofKabiven extra Nitrogen during pregnancy or breast-feeding is lacking. SmofKabiven extra Nitrogen should therefore be given to pregnant or breast-feeding women only if the doctor find it necessary. The use of SmofKabiven extra Nitrogen may be considered during pregnancy and breastfeeding, as advised by your doctor.

 

Driving and using machines

Not relevant as the medicine is given at the hospital.

 


Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Your doctor will decide on the dose for you individually depending on your body weight and function. SmofKabiven extra Nitrogen will be given to you by a healthcare professional.

 

If you use more SmofKabiven extra Nitrogen than you should

It is unlikely that you will receive too much medicine as SmofKabiven extra Nitrogen is given to you by a healthcare professional.


Like all medicines, this medicine can cause side effects, although not everybody gets them.

 

Common (may affect up to 1 in 10 people): a slightly raised body temperature.

 

Uncommon (may affect up to 1 in 100 people): high blood (plasma) levels of compounds from the liver, lack of appetite, nausea, vomiting, chills, dizziness and headache.

 

Rare (may affect up to 1 in 1,000 people): low or high blood pressure, difficulty in breathing, fast heart beat (tachycardia). Hypersensitivity reactions (that can give symptoms like swelling, fever, fall in blood pressure, skin rashes, wheals (raised red areas), flushing, headache). Sensations of hot and cold. Paleness. Light blue coloured lips and skin (because of too less oxygen in the blood). Pain in the neck, back, bones, chest and loins.

 

Reporting of side effects

 

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via (see details below).
*By reporting side effects you can help provide more information on the safety of this medicine.
 

To report any side effect(s):

 

Saudi Arabia:

·        The National Pharmacovigilance Centre (NPC):

·        SFDA Call Center: 19999

·        E-mail: npc.drug@sfda.gov.sa

Website: https://ade.sfda.gov.sa/

 

  • UAE:
  • -     Pharmacovigilance & Medical Device section:

    ·         P.O.Box: 1853

    ·         Tel: 80011111

    ·         E-mail: pv@mohap.gov.ae

    Drug Department

    Ministry of Health & Prevention – Dubai- UAE

 

Other GCC states

Please contact the relevant competent authority

 

 


Keep this medicine out of the sight and reach of children.

 

Store in overpouch. Do not store above 25°C. Do not freeze.

 

Do not use this medicine after the expiry date which is stated on the label on the bag and box. The expiry date refers to the last day of that month.


What SmofKabiven extra Nitrogen contains

 

The active substances are

g per 1000 ml

 

Alanine

 

9.2

Arginine

7.9

Glycine

7.2

Histidine

2.0

Isoleucine

3.3

Leucine

4.8

Lysine (as acetate)

4.3

Methionine

2.8

Phenylalanine

3.3

Proline

7.3

Serine

4.3

Taurine

0.65

Threonine

2.9

Tryptophan

1.3

Tyrosine

0.26

Valine

4.1

Calcium chloride (as dihydrate)

0.28

Sodium glycerophosphate (as hydrate)

2.3

Magnesium sulphate (as heptahydrate)

0.61

Potassium chloride

2.3

Sodium acetate (as trihydrate)

1.6

Zinc sulphate (as heptahydrate)

Glucose (as monohydrate)

Soya-bean oil, refined

Medium-chain triglycerides

Olive oil, refined

Fish oil, rich in omega-3 fatty acids

 

0.0066

85

8.7

8.7

7.2

4.3

The other ingredients are glycerol, purified egg phospholipids, all-rac-a-tocopherol, sodium hydroxide (pH-adjustment), sodium oleate, acetic acid (pH-adjustment), hydrochloric acid (pH-adjustment) and water for injections.


Glucose- and amino acid solutions are clear, colourless or slightly yellow and free from particles. The lipid emulsion is white and homogenous. Pack sizes: 1 x 506 ml, 6 x 506 ml 1 x 1012 ml, 4 x 1012 ml 1 x 1518 ml, 4 x 1518 ml 1 x 2025 ml, 4 x 2025 ml 1 x 2531 ml, 3 x 2531 ml

Manufacturer:

Fresenius Kabi AB

SE-751 74 Uppsala

Sweden

 

Marketing authorisation holder:

Fresenius Kabi Deutschland GmbH

D-61346 Bad Homburg v.d.H.

Germany


Jan 2021
  نشرة الدواء تحت مراجعة الهيئة العامة للغذاء والدواء (اقرأ هذه النشرة بعناية قبل البدء في استخدام هذا المنتج لأنه يحتوي على معلومات مهمة لك)

سموفكابيفين إكسترا نيتروجين هو مُستحلب للتسريب الوريدي، يُعطى عن طريق التنقيط في الوريد داخل الدم (التسريب الوريدي). ويحتوي هذا المُنتَج على كل من: أحماض أمينيَّة (مكونات تُستخدَم لبناء البروتينات)، والغلوكوز (الكربوهيدرات)، والمواد الدهنيَّة (دهون)؛ وذلك في كيس بلاستيكي. ويمكن أن يُعطى هذا الدواء لكل من البالغين والأطفال من عُمر عامين فما فوق.

وسوف يصف لك أخصائي الرعاية الصحيَّة دواء "سموفكابيفين إكسترا نيتروجين " عندما لا تعمل الأشكال الأخرى من التغذية أو حينما لا تكون جيدة بما فيه الكفاية.

لا تستخدم دواء "سموفكابيفين إكسترا نيتروجين " مع أي من الحالات الآتية:

-        إذا كنت تعاني من الحساسية (التحسس الشديد) تجاه المواد الفعَّالة أو أي من المكونات الأخرى لهذا الدواء (المُدرجة لاحقاً في القسم 6).

-        إذا كنت تعاني من الحساسية تجاه السمك أو البيض.

-        إذا كانت لديك حساسية من الفول السوداني أو الصويا، فلا يجب استخدام هذا المنتج، حيث يحتوي دواء "سموفكابيفين إكسترا نيتروجين  " على زيت فول الصويا.

-        إذا كنت تعاني من ارتفاع مستوى الدهون في الدم (فرط شحميات الدم).

-        إذا كان لديك اضطراب خطير في الكبد.

-        إذا كان لديك مشاكل في تخثر الدم (اضطراب التخثر).

-        إذا كان جسدك يعاني من مشكلات عند استخدام الأحماض الأمينيَّة.

-        إذا كان لديك مرض كُلوي خطير دون إجراء غسيل كُلوي.

-        إذا كنت تعاني من صدمة حادة.

-        إذا كنت تعاني من ارتفاع نسبة سكر الدم (فرط الغلوكوز في الدم) دون ضبط تلك النسبة.

-        إذا كان لديك ارتفاع في الدم (المصل) لمستويات الأملاح (الإلكتروليتات) المدرجة في سموفكابيفين إكسترا نيتروجين.

-        إذا كنت تعاني من وجود سوائل في الرئتين (وذمة رئوية حادة).

-        إذا كان لديك الكثير من السوائل في الجسم (فرط السوائل).

-        إذا كنت تعاني من قصور في القلب ولم يُعَالَج.

-        إذا كنت تعاني من خلل في نظام تخثُّر الدم (متلازمة البلعمة).

-        إذا كنت في حالة غير مستقرة، على سبيل المثال، بعد الإصابة بالصدمات الخطيرة، أو داء السكري غير المُتحكَّم به، أو النوبات القلبية الحادة، أو السكتة الدماغيَّة، أو جلطة الدم، أو الحُماض الاستقلابي (اضطراب يؤدي إلى إنتاج الكثير من الأحماض في الدم)، أو العدوى الخطيرة (التسمم الدموي الشديد)، أو الغيبوبة، أو إذا لم يكن لديك ما يكفي من سوائل الجسم (الجفاف ناقص التوتر).

-        مع الأطفال حديثي الولادة أو الأطفال دون عُمر السنتين.

 

الاحتياطات والمحاذير

لابد من استشارة الطبيب قبل استخدام دواء "سموفكابيفين إكسترا نيتروجين "، في حالة إذا كنت تعاني من أي مما يلي:

-        مشكلات في الكليتين.

-        داء السكري.

-        التهاب البنكرياس.

-        مشكلات في الكبد.

-        قصور الغدة الدرقيَّة (مشكلات في الغدة الدرقيَّة).

-        تسمم الدم (عدوى خطيرة).

وأثناء عملية التسريب الوريدي، في حالة الإصابة بالحمى أو الطفح الجلدي أو التورُّم أو صعوبة في التنفس أو القشعريرة أو التعرُّق أو الغثيان أو القيء، فلابد من استشارة أخصائي الرعاية الصحية على الفور، نظراً لأن تلك الأعراض قد تكون ناجمة عن رد فعل تحسسي، أو أنك قد تناولت جرعة زائدة من الدواء.

وقد يطلب منك الطبيب إجراء فحص للدم بشكل منتظم من أجل فحص اختبارات وظائف الكبد وغيرها من قيم الوظائف الحيوية الأخرى.

الأطفال والمُراهقون

دواء "سموفكابيفين إكسترا نيتروجين " هو دواء غير مُخصص للاستخدام كع الأطفال حديثي الولادة أو الأطفال ممن تقل أعمارهم عن عامين؛ ويمكن إعطاء دواء "سموفكابيفين إكسترا نيتروجين " للأطفال والمراهقين بداية من عُمر عامين (2) وحتى عُمر (16/18) عام.

 

استخدام دواء "سموفكابيفين إكسترا نيتروجين" مع الأدوية الأخرى

لابد من استشارة الطبيب، إذا كنت تأخذ حالياً أو قد أخذت مؤخرًا أو ربما تأخذ قريباً أي أدوية أخرى، حتى وإن كانت دون وصفة طبيَّة.

 

الحمل والرضاعة الطبيعيَّة

لا تتوافر حالياً أي بيانات حول استخدام دواء "سموفكابيفين إكسترا نيتروجين" خلال فترة الحمل أو الرضاعة الطبيعية. ولذلك، لا ينبغي إعطاء دواء "سموفكابيفين إكسترا نيتروجين  " للسيدات الحوامل أو اللواتي ترضعن رضاعة طبيعيَّة، إلا إذا وجد الطبيب المعالج الأمر ضروريًّا. ومن ثَم، يُؤخذ في عين الاعتبار استخدام دواء "سموفكابيفين إكسترا نيتروجين" وفقاً لما ينصحك به طبيبك.

 

القيادة واستخدام الآلات

من غير مناسب تعاطي الدواء أثناء القيادة أو استخدام الآلات، نظراً لأن الدواء يُعطى في المستشفى.

https://localhost:44358/Dashboard

لابد من تناول هذا الدواء دائمًا وأبدًا وفقاً لما يحدده لك الطبيب حرفيًّا، ولابد من مراجعة الأمر مع الطبيب إذا كنت مرتابًا في شيء ما. وسوف يقرر طبيبك الجرعة الملائمة لك بشكل فرديَّ حسب وزن جسمك ووظائفه. ويتم تعاطي دواء "سموفكابيفين إكسترا نيتروجين" بمعرفة أخصائي الرعاية الصحية.

في حالة تعاطي جرعة زائدة من دواء "سموفكابيفين إكسترا نيتروجين"، لابد من اتباع ما يلي:

من غير المحتمل أن تتلقى جرعات زائدة من الدواء حيث أن أخصائي الرعاية الصحيَّة هو من يقوم بإعطائك دواء "سموفكابيفين إكسترا نيتروجين".

 

من الممكن أن يتسبب هذا الدواء في إحداث بعض الآثار الجانبيَّة مثله مثل جميع الأدوية الأخرى، وإن لم تكن هذه الأعراض تصيب جميع المرضى.

- آثار جانبية شائعة (قد تؤثر على 1 من كل 10 أشخاص): ارتفاع طفيف في درجة حرارة الجسم.

- آثار جانبية غير شائعة (قد تؤثر على 1 من كل 100 شخص): ارتفاع مستويات (بلازما) الدم من المكونات الناتجة من الكبد، وقلة الشهية، والغثيان، والقيء، والقشعريرة، والدوار، والصداع.

- آثار جانبية نادرة (قد تؤثر على 1 من كل 1000 شخص): انخفاض ضغط الدم أو ارتفاعه، وصعوبة التنفس، وسرعة ضربات القلب (خفقان القلب)، وتفاعلات فرط الحساسية (والتي من الممكن أن تؤدي إلى بعض الأعراض مثل: التورم، والحمى، وانخفاض ضغط الدم، والطفح الجلدي، والبثور (مناطق حمراء مرتفعة)، والصداع، واحمرار الوجه)، والإحساس بالبرودة أو السخونة، وشحوب الوجه، وتلون الشفتين والجلد بلون أزرق فاتح (بسبب نقص الأكسجين في الدم)، والإصابة بآلام في الرقبة والظهر والعظام والصدر والخصر.

الإبلاغ عن الآثار الجانبيَّة

في حالة الإصابة بأي آثار جانبيَّة، فلابد من استشارة الطبيب أو الممرضة أو الصيدلي. ويشمل ذلك أي آثار جانبيَّة مُحتملَة غير مُدرَجَة في هذه النشرة. كما يمكنك أيضًا الإبلاغ عن الآثار الجانبيَّة مباشرة (انظر التفاصيل الواردة أدناه)، حيث يمكنك المُساعدة في توفير مزيد من المعلومات حول سلامة هذا الدواء من خلال الإبلاغ عن هذه الآثار الجانبيَّة.

 

للإبلاغ عن أي أثر (آثار) جانبية:

·         Text Box: المركز الوطني للتيقظ الدوائي: 
o	مركز الاتصال الموحد: 19999
o	البريد الالكتروني:  npc.drug@sfda.gov.sa
o	الموقع الالكتروني:  https://ade.sfda.gov.sa


المملكة العربية السعودية:

·         Text Box: قسم التيقظ للمستحضرات الصيدلانية والأجهزة الطبية:
صندوق بريد: 1853
هاتف: 80011111
البريد الإلكتروني :  pv@mohap.gov.ae 
 قسم الدواء – وزارة الصحة و وقاية المجتمع – دبي – الإمارات العربية المتحدة

الإمارات العربية المتحدة:

·         Text Box: يرجى التواصل مع الجهات المختصة ذات الصلة.دول مجلس التعاون الخليجي الأخرى:

- يُحفظ هذا الدواء بعيدًا عن متناول أيدي الأطفال ومرمى بصرهم.

- يُحفظ هذا الدواء في جراب التخزين الخاص به، ولا يجوز حفظه في درجة حرارة أعلى من 25 درجة مئويَّة، ولا يُجمَّد.

- لا تستخدم هذا الدواء بعد تاريخ انتهاء الصلاحية المدوَّن على الملصق الموجود على الكيس والعلبة الكرتون، ويشير تاريخ انتهاء الصلاحية إلى آخر يوم في ذلك الشهر المذكور.

يحتوي دواء "سموفكابيفين إكسترا نيتروجين" على كل مما يلي:

المواد الفعالة

جرام لكل 1000 ملل

ألانين

9.2

أرجنين

7.9

جلايسين

7.2

هيستيدين

2.0

أيزوليوسين

3.3

ليوسن

4.8

لايسين (مثل: الأسيتات)

4.3

ميثيونين

2.8

فينيل ألانين

3.3

برولين

7.3

سيرين

4.3

تورين

0.65

ثريونين

2.9

تريبتوفان

1.3

تايروسين

0.26

فالين

كلوريد الكالسيوم (ثنائي الهيدرات)

جلسرين فوسفات الصوديوم (هيدرات)

كبريتات المغنيسيوم (سباعي الهيدرات)

كلوريد البوتاسيوم

أسيتات الصوديوم (ثلاثي هيدرات)

كبريتات الزنك (سباعي الهيدرات)

4.1

0.28

2.3

0.61

2.3

1.6

0.0066

الجلوكوز (مثل: أحادي الهيدرات)

زيت فول الصويا، مُصفَّى

دهون ثلاثية متوسِّطَة السلسلة

زيت زيتون، مُصفَّى

زيت السمك الغني بأحماض أوميغا 3 الدهنية

85

8.7

8.7

7.2

4.3

 

وتشتمل المكونات الأخرى على كل من: الجلسرين، وفسفوليبيدات البيض المُنقَّاة، وجميع أنواع راك-ألفا-توكوفيرول، وهيدروكسيد الصوديوم (لضبط الأس الهيدروجيني)، وأوليات الصوديوم، وحمض الأسيتيك (لضبط الأس الهيدروجيني)، وحمض الهيدروكلوريك (لضبط الأس الهيدروجيني)، وماء للحقن.

محاليل الأحماض الأمينية والجلوكوز هي محاليل رائقة وعديمة اللون أو صفراء قليلًا وخالية من الجزيئات، والمستحلب الدهني أبيض ومتجانس.

أحجام العبوات:

·         1 × 506 ملل، 6 × 506 ملل.

·         1 × 1012 ملل، 4 × 1012 ملل.

·         1 × 1518 ملل، 4 × 1518 ملل.

·         1 × 2025 ملل، 4 × 2025 ملل.

·         1 × 2531 ملل، 3 × 2531 ملل.

الشركة المُصنعة:

شركة فريسنيوس كابي ايه بي

 SE-751 74 أوبسالا

 السويد.

 

الشركة صاحبة رخصة التسويق:

فريزنيوس كابي دويتشلاند جي إم بي إتش

D-61346 باد همبورغ في دي إتش

ألمانيا

 

يناير 2021م
 Read this leaflet carefully before you start using this product as it contains important information for you

SmofKabiven extra Nitrogen, emulsion for infusion

SmofKabiven extra Nitrogen consists of a three chamber bag system. Each bag contains the following partial volumes depending on the five pack sizes. 506 ml 1012 ml 1518 ml 2025 ml 2531 ml Per 1000 ml Amino acid solution 10% with electrolytes 331 ml 662 ml 993 ml 1325 ml 1656 ml 654 ml Glucose 42% 102 ml 204 ml 306 ml 408 ml 510 ml 202 ml Lipid emulsion 20% 73 ml 146 ml 219 ml 292 ml 365 ml 144 ml This corresponds to the following total compositions: Active ingredients 506 ml 1012 ml 1518ml 2025 ml 2531 ml Per 1000 ml Alanine 4.6 g 9.3 g 14 g 19 g 23 g 9.2 g Arginine 4.0 g 7.9 g 12 g 16 g 20 g 7.9 g Glycine 3.6 g 7.3 g 11 g 15 g 18 g 7.2 g Histidine 1.0 g 2.0 g 3.0 g 4.0 g 5.0 g 2.0 g Isoleucine 1.7 g 3.3 g 5.0 g 6.6 g 8.3 g 3.3 g Leucine 2.4 g 4.9 g 7.3 g 9.8 g 12 g 4.8 g Lysine (as acetate) 2.2 g 4.4 g 6.6 g 8.7 g 11 g 4.3 g Methionine 1.4 g 2.8 g 4.3 g 5.7 g 7.1 g 2.8 g Phenylalanine 1.7 g 3.4 g 5.1 g 6.8 g 8.4 g 3.3 g Proline 3.7 g 7.4 g 11 g 15 g 19 g 7.3 g Serine 2.2 g 4.3 g 6.5 g 8.6 g 11 g 4.3 g Taurine 0.33 g 0.66 g 1.0 g 1.3 g 1.7 g 0.65 g Threonine 1.5 g 2.9 g 4.4 g 5.8 g 7.3 g 2.9 g Tryptophan 0.66 g 1.3 g 2.0 g 2.7 g 3.3 g 1.3 g Tyrosine 0.13 g 0.26 g 0.40 g 0.53 g 0.66 g 0.26 g Valine 2.1 g 4.1 g 6.2 g 8.2 g 10 g 4.1 g Calcium chloride dihydrate corresponding to Calcium chloride 0.14 g 0.29 g 0.43 g 0.58 g 0.72 g 0.28 g Sodium glycerophosphate (hydrate) corresponding to Sodium glycerophosphate 1.2 g 2.3 g 3.5 g 4.6 g 5.8 g 2.3 g Magnesium sulphate heptahydrate corresponding to Magnesium sulphate 0.31 g 0.62 g 0.92 g 1.2 g 1.5 g 0.61 g Potassium chloride 1.2 g 2.3 g 3.5 g 4.6 g 5.8 g 2.3 g Sodium acetate trihydrate corresponding to Sodium acetate 0.82 g 1.6 g 2.5 g 3.3 g 4.1 g 1.6 g Zinc sulphate heptahydrate corresponding to Zinc sulphate 0.0033 g 0.0066 g 0.010 g 0.013 g 0.017 g 0.0066 g Glucose monohydrate corresponding to Glucose 43 g 86 g 129 g 171 g 214 g 85 g Soya-bean oil, refined 4.4 g 8.8 g 13 g 18 g 22 g 8.7 g Medium-chain triglycerides 4.4 g 8.8 g 13 g 18 g 22 g 8.7 g Olive oil, refined 3.7 g 7.3 g 11 g 15 g 18 g 7.2 g Fish oil, rich in omega-3-acids 2.2 g 4.4 g 6.6 g 8.8 g 11 g 4.3 g Corresponding to 506 ml 1012 ml 1518ml 2025 ml 2531 ml Per 1000 ml • Amino acids 33.1 g 66.3 g 99.4 g 133 g 166 g 65.5 g • Nitrogen 5.3 g 10.6 g 15.9 g 21.2 g 26.5 g 10.5 g • Electrolytes - sodium 20.6 mmol 41.3 mmol 61.9 mmol 82.6 mmol 103 mmol 40.8 mmol - potassium 15.5 mmol 30.9 mmol 46.4 mmol 61.9 mmol 77.3 mmol 30.5 mmol - magnesium 2.6 mmol 5.2 mmol 7.7 mmol 10.3 mmol 12.9 mmol 5.1 mmol - calcium 1.3 mmol 2.6 mmol 3.9 mmol 5.2 mmol 6.5 mmol 2.6 mmol - phosphate1 6.4 mmol 12.9 mmol 19.3 mmol 25.8 mmol 32.2 mmol 12.7 mmol - zinc 0.02 mmol 0.04 mmol 0.06 mmol 0.08 mmol 0.10 mmol 0.04 mmol - sulphate 2.6 mmol 5.2 mmol 7.8 mmol 10.4 mmol 13.0 mmol 5.1 mmol - chloride 18.0 mmol 36.1 mmol 54.1 mmol 72.2 mmol 90.2 mmol 35.6 mmol - acetate 63.1 mmol 126 mmol 189 mmol 253 mmol 316 mmol 125 mmol • Carbohydrates - Glucose (anhydrous) 42.8 g 85.7 g 129 g 171 g 214 g 84.7 g • Lipids 14.6 g 2 9.2 g 43.8 g 58.4 g 73.0 g 28.9 g • Energy content - total (approx.) 450 kcal 1.9MJ 900 kcal 3.8MJ 1350 kcal 5.6MJ 1800 kcal 7.5MJ 2250 kcal 9.4MJ 889 kcal 3.7 MJ - non protein (approx.) 317 kcal 1.3 MJ 635 kcal 2.7 MJ 952 kcal 4.0 MJ 1270 kcal 5.3 MJ 1590 kcal 6.6 MJ 627 kcal 2.6 MJ 1 Contribution from both the lipid emulsion and the amino acid solution. For the full list of excipients, see section 6.1.

Emulsion for infusion. Glucose and amino acid solutions are clear and colourless to slightly yellow and free from particles. The lipid emulsion is white and homogenous. Osmolality: approx. 1600 mosmol/kg water Osmolarity: approx. 1300 mosmol/l pH (after mixing): approx. 5.6

Parenteral nutrition for adults and children aged 2 years and above when oral or enteral nutrition is impossible, insufficient or contraindicated


Posology

The appearance of the product after mixing the 3 chambers is a white emulsion.

 

The patient’s ability to eliminate lipids and metabolise nitrogen and glucose, and the nutritional requirements should govern the dosage and infusion rate, see section 4.4.

 

The dose should be individualised to the patient’s clinical condition, body weight (bw), nutritional and energy requirements, adjusting dosage based upon additional oral/enteral intake.

 

The nitrogen requirements for maintenance of body protein mass depend on the patient’s condition (e.g. nutritional state and degree of catabolic stress or anabolism).

 

Adults

 

The requirements are 0.10-0.15 g nitrogen/kg bw/day (0.6-0.9 g amino acids/kg bw/day) in the normal nutritional state or in conditions with mild catabolic stress. In patients with moderate to high metabolic stress with or without malnutrition, the requirements are in the range of 0.15-0.25 g nitrogen/kg bw/day (0.9-1.6 g amino acids/kg bw/day). In some very special conditions (e.g. burns or marked anabolism) the nitrogen need may be even higher.

 

Dosage:

The dosage range of 13-31 ml SmofKabiven extra Nitrogen/kg bw/day corresponds to 0.14-0.32 g nitrogen/kg bw/day (0.85-2.0 g amino acids/kg bw/day) and 12-28 kcal/kg bw/day of total energy (8-19 kcal/kg bw/day of non-protein energy). This covers the need of the majority of the patients. In obese patients the dose should be based on the estimated ideal weight.
 

Infusion rate:

The maximum infusion rate for glucose is 0.25 g/kg bw/h, for amino acid 0.1 g/kg bw/h, and for lipids 0.15 g/kg bw/h.

 

The infusion rate should not exceed 1.5 ml/kg bw/h (corresponding to 0.13 g glucose, 0.10 g amino acids, and 0.04 g lipids/kg bw/h). The recommended infusion period is 14-24 hours.

 

Maximum daily dose:

The maximum daily dose varies with the clinical condition of the patient and may even change from day to day. The recommended maximum daily dose is 31 ml/kg bw/day.

 

The recommended maximum daily dose of 31 ml/kg bw/day will provide 2.0 g amino acids/kg bw/day (corresponding to 0.32 g nitrogen/kg bw/day), 2.6 g glucose/kg bw/day, 0.9 g lipids/kg bw/day and a total energy content of 28 kcal/kg bw/day (corresponding to 19 kcal/kg bw/day of non-protein energy).

 

Paediatric population

 

Children (2-11 years)

 

Dosage:

The dose up to 31 ml/kg bw/day should be regularly adjusted to the requirements of the paediatric patient that varies more than in adult patients.

 

Infusion rate:

The recommended maximum infusion rate is 1.8 ml/kg bw/h (corresponding to 0.12 g amino acids/kg/h, 0.15 g/glucose/kg/h and 0.05 g lipids/kg/h). At the recommended maximum infusion rate, do not use an infusion period longer than 17 hours, except in exceptional cases and with careful monitoring.

 

The recommended infusion period is 12-24 hours.

 

Maximum daily dose:

The maximum daily dose varies with the clinical condition of the patient and may even change from day to day. The recommended maximum daily dose is 31 ml/kg bw/day.

 

The recommended maximum daily dose of 31 ml/kg bw/day will provide 2 g amino acids/kg bw/day (corresponding to 0.32 g nitrogen/kg bw/day), 2.6 g glucose/kg bw/day, 0.9 g lipids/kg bw/day and a total energy content of 28 kcal/kg bw/day (corresponding to 19 kcal/kg bw/day of non-protein energy).

 

Adolescents (12-16/18 years)

 

In adolescents, SmofKabiven extra Nitrogen can be used as in adults.

 

Method of administration

Intravenous use, infusion into a central vein.

 

The five different package sizes of SmofKabiven extra Nitrogen are intended for patients with high, moderately increased or basal nutritional requirements. To provide total parenteral nutrition, trace elements, vitamins and possibly electrolytes (taking into account the electrolytes already present in SmofKabiven) should be added to SmofKabiven extra Nitrogen according to the patients need.

 

For instructions on preparation of the medicinal product before administration, see section 6.6.


- Hypersensitivity to fish-, egg, soya- or peanut protein or to any of the active substances or excipients listed in section 6.1 - Severe hyperlipidemia - Severe liver insufficiency - Severe blood coagulation disorders - Congenital errors of amino acid metabolism - Severe renal insufficiency without access to hemofiltration or dialysis - Acute shock - Uncontrolled hyperglycaemia - Pathologically elevated serum levels of any of the included electrolytes - General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, and decompensated cardiac insufficiency - Hemophagocytotic syndrome - Unstable conditions (e.g. severe post-traumatic conditions, uncompensated diabetes mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis, severe sepsis, hypotonic dehydration and hyperosmolar coma) - Neonates and infants under 2 years of age

The capacity to eliminate lipids is individual and should therefore be monitored according to the routines of the clinician. This is in general done by checking the triglyceride levels. The concentration of triglycerides in serum should not exceed 4 mmol/l during infusion. An overdose may lead to fat overload syndrome, see section 4.8.

 

SmofKabiven extra Nitrogen should be given with caution in conditions of impaired lipid metabolism, which may occur in patients with renal failure, diabetes mellitus, pancreatitis, impaired liver function, hypothyroidism and sepsis.

 

This medicinal product contains soya-bean oil, fish oil and egg phospholipids, which may rarely cause allergic reactions. Cross allergic reaction has been observed between soya-bean and peanut.

 

To avoid risks associated with too rapid infusion rates, it is recommended to use a continuous and well-controlled infusion, if possible by using a volumetric pump.

 

Disturbances of the electrolyte and fluid balance (e.g. abnormally high or low serum levels of the electrolytes) should be corrected before starting the infusion.

 

SmofKabiven extra Nitrogen should be given with caution to patients with a tendency towards electrolyte retention. Special clinical monitoring is required at the beginning of any intravenous infusion. Should any abnormal sign occur, the infusion must be stopped.

 

Since an increased risk of infection is associated with the use of any central vein, strict aseptic precautions should be taken to avoid any contamination during catheter insertion and manipulation.

 

Serum glucose, electrolytes and osmolarity as well as fluid balance, acid-base status and liver enzyme tests should be monitored.

 

Blood cell count and coagulation should be monitored when lipids are given for a longer period.

 

In patients with renal insufficiency, the phosphate and potassium intake should be carefully controlled to prevent hyperphosphatemia and hyperkalaemia.

 

The amount of individual electrolytes to be added is governed by the clinical condition of the patient and by frequent monitoring of serum levels.

 

Parenteral nutrition should be given with caution in lactic acidosis, insufficient cellular oxygen supply and increased serum osmolarity.

 

Any sign or symptom of anaphylactic reaction (such as fever, shivering, rash or dyspnoea) should lead to immediate interruption of the infusion.

 

The lipid content of SmofKabiven extra Nitrogen may interfere with certain laboratory measurements (e.g. bilirubin, lactate dehydrogenase, oxygen saturation, hemoglobin) if blood is sampled before lipids have been adequately cleared from the bloodstream. Lipids are cleared after a lipid-free interval of 5‑6 hours in most patients.

 

Intravenous infusion of amino acids is accompanied by increased urinary excretion of the trace elements, in particular copper and zinc. This should be considered in the dosing of trace elements, especially during long-term intravenous nutrition. Amounts of zinc administered with SmofKabiven extra Nitrogen should be taken into account.

 

In malnourished patients, initiation of parenteral nutrition can precipitate fluid shifts resulting in pulmonary oedema and congestive heart failure as well as a decrease in the serum concentration of potassium, phosphorus, magnesium and water soluble vitamins. These changes can occur within 24 to 48 hours, therefore careful and slow initiation of parenteral nutrition is recommended in this patient group, together with close monitoring and appropriate adjustments of fluid, electrolytes, minerals and vitamins.

 

SmofKabiven extra Nitrogen should not be given simultaneously with blood in the same infusion set due to the risk of pseudoagglutination.

 

In patients with hyperglycaemia, administration of exogenous insulin might be necessary.

 

SmofKabiven extra Nitrogen is a preparation of complex composition. It is, therefore, strongly advisable not to add other solutions if compatibility is not proven (see section 6.2).

 

Paediatric population

Due to composition of the amino acid solution in SmofKabiven extra Nitrogen it is not suitable for the use in new-borns or infants below 2 years of age. There is no clinical experience of the use of SmofKabiven extra Nitrogen in children and adolescents (age 2  to 16/18 years).


Some medicinal products, like insulin, may interfere with the body’s lipase system. This kind of interaction seems, however, to be of limited clinical importance.

 

Heparin given in clinical doses causes a transient release of lipoprotein lipase into the circulation. This may result initially in increased plasma lipolysis followed by a transient decrease in triglyceride clearance.

 

Soya-bean oil has a natural content of vitamin K1. However, the concentration in SmofKabiven extra Nitrogen is so low that it is not expected to significantly influence the coagulation process in patients treated with coumarin derivatives.


There are no data available on exposure of SmofKabiven extra Nitrogen in pregnant or breast-feeding women. There are no studies available on reproductive toxicity in animals. Parenteral nutrition may become necessary during pregnancy and lactation. SmofKabiven extra Nitrogen, should only be given to pregnant and breast-feeding women after careful consideration.


Not relevant.


 

Common

≥ 1/100  to  < 1/10

Uncommon

≥ 1/1,000  to  < 1/100

Rare

≥ 1/10,000  to  < 1/1,000

Cardiac disorders

 

 

 

Tachycardia

Respiratory, thoracic and mediastinal disorders

 

 

Dyspnoea

Gastrointestinal disorders

 

Lack of appetite, nausea, vomiting

 

Metabolism and nutrition disorders

 

Elevated plasma levels of liver enzymes

 

Vascular disorders

 

 

Hypotension, hypertension

General disorders and administration site conditions

Slight increase in body temperature

Chills, dizziness, headache

Hypersensitivity-reactions (e.g. anaphylactic or anaphylactoid reactions, skin rash, urticaria, flush, headache), heat or cold sensation, paleness, cyanosis, pain in the neck, back, bones, chest and loins.

Should these side-effects occur the infusion of SmofKabiven extra Nitrogen should be stopped or, if necessary, continued at a reduced dosage.

 

Fat overload syndrome

Impaired capacity to eliminate triglycerides can lead to “Fat overload syndrome” which may be caused by overdose. Possible signs of metabolic overload must be observed. The cause may be genetic (individually different metabolism) or the lipid metabolism may be affected by ongoing or previous illnesses. This syndrome may also appear during severe hypertriglyceridemia, even at the recommended infusion rate, and in association with a sudden change in the patient’s clinical condition, such as renal function impairment or infection. The fat overload syndrome is characterised by hyperlipemia, fever, lipid infiltration, hepatomegaly with or without icterus, splenomegaly, anemia, leukopenia, thrombocytopenia, coagulation disorder, hemolysis and reticulocytosis, abnormal liver function tests and coma. The symptoms are usually reversible if the infusion of the lipid emulsion is discontinued.

 

Excess of amino acid infusion

As with other amino acid solutions, the amino acid content in SmofKabiven extra Nitrogen may cause undesirable effects when the recommended infusion rate is exceeded. These effects are nausea, vomiting, shivering and sweating. Amino acid infusion may also cause a rise in body temperature. With an impaired renal function, increased levels of nitrogen containing metabolites (e.g. creatinine, urea) may occur.

 

Excess of glucose infusion

If the glucose clearance capacity of the patient is exceeded, hyperglycaemia will develop.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system

 

- To reports any side effect(s):

 

· Saudi Arabia:

· The National Pharmacovigilance Centre (NPC):

- SFDA Call Center: 19999

- E-mail: npc.drug@sfda.gov.sa

- Website: https://ade.sfda.gov.sa/

       

Other GCC States:

Please contact the relevant competent authority.

·

 


See section 4.8 “Fat overload syndrome”, “Excess of amino acid infusion” and “Excess of glucose infusion”.

 

If symptoms of overdose of lipids or amino acids occur, the infusion should be slowed down or discontinued. There is no specific antidote for overdose. Emergency procedures should be general supportive measures, with particular attention to respiratory and cardiovascular systems. Close biochemical monitoring would be essential and specific abnormalities treated appropriately.

 

If hyperglycaemia occurs, it should be treated according to the clinical situation either by appropriate insulin administration and/or adjustment of the infusion rate.

 

Additionally, overdose might cause fluid overload, electrolyte imbalances and hyperosmolality.

 

In some rare serious cases, haemodialysis, haemofiltration or haemodiafiltration may be considered.


Pharmacotherapeutic group: Solutions for parenteral nutrition.

ATC code: B05BA10

 

Lipid emulsion

The lipid emulsion of SmofKabiven extra Nitrogen is composed of Smoflipid and has a particle size and biological properties similar to those of endogenous chylomicrons. The constituents of Smoflipid (soya-bean oil, medium-chain triglycerides, olive oil and fish oil) have except for their energy contents their own pharmacodynamic properties.

 

Soya-bean oil has a high content of essential fatty acids. The omega-6 fatty acid linoleic acid is the most abundant (approx. 55-60 %). Alpha-linolenic acid, an omega-3 fatty acid, constitutes about 8 %. This part of SmofKabiven extra Nitrogen provides the necessary amount of essential fatty acids.

 

Medium-chain fatty acids are rapidly oxidised and provide the body with a form of immediately available energy.

 

Olive oil mainly provides energy in the form of mono-unsaturated fatty acids, which are much less prone to peroxidation than the corresponding amount of poly-unsaturated fatty acids.

 

Fish oil is characterised by a high content of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). DHA is an important structural component of cell membranes, whereas EPA is a precursor of eicosanoids as prostaglandines, thromboxanes and leukotrienes.

 

Two studies providing home parenteral nutrition in patients in need of long-term nutrition support have been performed. The primary objective in both studies was to show safety. Efficacy was the secondary objective in one of the studies, which was done in paediatric patients. This study was stratified by age groups (1 month - <2 years, and 2-11 years respectively). Both studies showed that Smoflipid has the same safety profile as the comparator (Intralipid 20 %). Efficacy in the paediatric study was measured by weight gain, height, body mass index, pre-albumin, retinol binding protein and fatty acid profile. There was no difference between the groups in any of the parameters except the fatty acid profile after 4 weeks treatment. The fatty acid profile in the Smoflipid patients revealed an increase in omega-3 fatty acids in plasma lipoproteins and red blood cells phospholipids and hence reflects the composition of the infused lipid emulsion.

 

Amino acids and electrolytes

The amino acids, constituents of protein in ordinary food, are utilised for tissue protein synthesis and any surplus is channelled to a number of metabolic pathways. Studies have shown a thermogenic effect of amino acid infusion.

 

Glucose

Glucose should have no pharmacodynamic effects apart from contributing to maintain or replete the normal nutritional status.


Lipid emulsion

The individual triglycerides in Smoflipid have different clearance rate but Smoflipid as a mixture is eliminated faster than long chain triglycerides (LCT). Olive oil has the slowest clearance rate of the components (somewhat slower than LCT) and medium chain triglycerides (MCT) the fastest. Fish oil in a mixture with LCT has the same clearance rate as LCT alone.

 

Amino acids and electrolytes

The principal pharmacokinetic properties of the infused amino acids and electrolytes are essentially the same as for amino acids and electrolytes supplied by ordinary food. However, the amino acids of dietary protein first enter the portal vein and then the systemic circulation, while intravenously infused amino acids reach the systemic circulation directly.

 

Glucose

The pharmacokinetic properties of infused glucose are essentially the same as those of glucose supplied by ordinary food.


Preclinical safety studies with SmofKabiven extra Nitrogen have not been performed. However, preclinical data for Smoflipid as well as amino acid and glucose solutions of various concentrations and sodium glycerophosphate reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity. No teratogenic effects or other embryotoxic injuries could be observed in rabbits with amino acid solutions and are not to be expected from lipid emulsions and sodium glycerophosphate when giving at the recommended doses as substitution therapy. Nutritional products (amino acid solutions, lipid emulsions, and sodium glycerophosphate) used in replacement therapy at physiological levels are not expected to be embryotoxic, teratogenic, or to influence reproductive performance or fertility.

 

In a test on guinea pigs (maximisation test) fish oil emulsion showed moderate dermal sensitisation. A systemic antigenicity test gave no indication of evidence of anaphylactic potential of fish oil.

 

SmofKabiven intravenous infusion (the intended route of administration), as well as intraarterial, intramuscular, paravenous and subcutaneous injections did not reveal any drug substance-related changes in rabbits. SmofKabiven is a product with the same qualitative composition as SmofKabiven extra Nitrogen.


Glycerol

Purified egg phospholipids

all-rac-α-Tocopherol

Sodium hydroxide (pH adjuster)

Sodium oleate

Acetic acid, glacial (pH adjuster)

Hydrochloric acid (pH adjuster)

Water for injections


SmofKabiven extra Nitrogen may only be mixed with other medicinal products for which compatibility has been documented, see section 6.6.


Shelf life of the medicinal product as packaged for sale 2 years Shelf life after mixing Chemical and physical in-use stability of the mixed three chamber bag has been demonstrated for36 hours at 25C. From a microbiological point of view the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8C. Shelf life after mixing with additives From a microbiological point of view, the product should be used immediately when additions have been made. If not used immediately, the in-use storage time and conditions prior to use are the responsibility of the user and should normally not be longer than 24 hours at 2-8C.

Do not store above 25°C. Do not freeze. Store in overpouch.

 

Shelf life after mixing: See section 6.3.

Shelf life after mixing with additives: See section 6.3.


The container consists of a multichamber inner bag and an overpouch. The inner bag is separated into three chambers by peelable seals. An oxygen absorber is placed between the inner bag and the overpouch.  The inner bag is made of a multilayer polymer film, Biofine.

 

The Biofine inner bag film consists of poly(propylene-co-ethylene), synthetic rubber poly[styrene-block-(butylene-co-ethylene)] (SEBS) and synthetic rubber poly(styrene-block-isoprene) (SIS). The infusion and additive ports are made of polypropylene and synthetic rubber poly[styrene-block-(butylene-co-ethylene)] (SEBS) equipped with synthetic polyisoprene (latex-free) stoppers. The blind port, which is only used during manufacturing, is made of polypropylene equipped with a synthetic polyisoprene (latex-free) stopper.

 

Pack sizes:

1 x 506 ml, 6 x 506 ml

1 x 1012 ml, 4 x 1012 ml

1 x 1518 ml, 4 x 1518 ml

1 x 2025 ml, 4 x 2025 ml

1 x 2531 ml, 3 x 2531 ml

 

Not all pack sizes may be marketed.


Instructions for use

Do not use if package is damaged. Use only if the amino acid and glucose solutions are clear and colourless or slightly yellow and the lipid emulsion is white and homogenous. The contents of the three separate chambers have to be mixed before use, and before any additions are made via the additive port.

 

After separation of the peelable seals the bag should be inverted on a number of occasions to ensure a homogenous mixture, which does not show any evidence of phase separation.

 

Compatibility

Compatibility data are available with the named branded products Dipeptiven, Addaven, Vitalipid N Adult and Soluvit N (lyophilized) in defined amounts and generics of electrolytes in defined concentrations. When making electrolyte additions, the amounts already present in the bag should be taken into account to meet the clinical needs of the patient. Generated data supports additions to the activated bag according to the summary table below:

 

Maximal total contents

SmofKabiven extra Nitrogen bag size

1012 ml, 1518 ml, 2025 ml and 2531 ml

506 ml

Additive

Volume

Dipeptiven

0 - 300 ml

0 - 150 ml

Addaven

0 - 20 ml

0 - 10 ml

Soluvit N (lyophilized)

0 - 2 vials

0 - 1 vial

Vitalipid N Adult

0 - 20 ml

0 - 10 ml

 

Concentration

Sodium

0 - 150 mmol/l

0 - 150 mmol/l

Potassium

0 - 150 mmol/l

0 - 150 mmol/l

Calcium

0 - 5 mmol/l

0 - 5 mmol/l

Magnesium

0 - 5 mmol/l

0 - 5 mmol/l

Phosphate (Addiphos)  OR

Phosphate (Glycophos)

0 - 15 mmol/l

0 - 30 mmol/l

0 - 15 mmol/l

0 - 30 mmol/l

Zinc

0 - 0.2 mmol/l

0 - 0.2 mmol/l

Selenium

0 - 2 µmol/l

0 - 2 µmol/l

Note: This table is intended to indicate compatibility. It is not a dosing guideline.

 

Addition should be made aseptically.

 

For single use only. Any mixture remaining after infusion must be discarded.

 

Any unused medicinal product or waste material should be disposed in accordance with local requirement.

 


Fresenius Kabi Deutschland GmbH D-61346 Bad Homburg v.d.H. Germany

Jan 2021
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