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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)

5% Dextrose w/v in Compound Sodium Lactate Solution for Infusion is used: as a source
of carbohydrate (sugar) in the following situations:
- To treat a loss of body water and chemicals (e.g. by heavy sweating, kidney disorders) to
treat you, if the volume of blood in your blood vessels is low (hypovolaemia) or if you have
low blood pressure (hypotension).
- In metabolic acidosis (when the blood becomes too acidic).


Do not receive 5% Dextrose w/v in Compound Sodium Lactate Solution for Infusion if you
are suffering from any of the following conditions
- If you’re a newborn (less than 28 days old) receiving ceftriaxone (an antibiotic).
- If you’re allergic to sodium lactate or any of the other substances in Compound Sodium
Lactate/Dextrose Infusion
- When there is too much fluid in the spaces around the cells of the body (extracellular hyperhydration)
- When there is a larger volume of blood in the blood vessels than there should be (hypervolaemia)
- Severe kidney failure (when your kidneys do not work well and you require dialysis)
- Uncompensated heart failure. This is heart failure that is not adequately treated and
causes symptoms such as:
- Shortness of breath
- swelling of the ankles.
- Higher levels of potassium in the blood than normal (hyperkalaemia)
- Higher levels of calcium in the blood than normal (hypercalcaemia)
- A disorder in which the blood becomes too alkaline (metabolic alkalosis)
- Liver disease that causes fluid to build up within the abdomen (ascitic cirrhosis)
- Your blood is too acidic which is life-threatening (severe metabolic acidosis) - a particular
type of metabolic acidosis (lactic acidosis)
- Severe liver disease (when the liver does notfunction properly and requires very intensive treatment)
- Poor lactate metabolism (this occurs in severe liver disease, as lactate is removed by the liver)
- If you are taking cardiac glycosides (cardiotonics) used to treat heart failure, such as
digitalis or digoxin (See also “Taking other medicines”)
- Diabetes that is not adequately treated, allowing your blood sugar levels to rise above
normal (uncompensated diabetes) - states of Dextrose intolerance, for example: -
metabolic stress (when the body’s metabolism does not function correctly, e.g. due to
severe illness) - hyperosmolar coma (unconsciousness). This is a type of coma that can
occur if you have diabetes and do not receive enough medicine. - a higher amount of sugar
in the blood than normal (hyperglycaemia) – a higher amount of lactate in the blood than
normal (hyperlactataemia)
Warning and precautions
5% Dextrose w/v in Compound Sodium Lactate Solution for Infusion is a hypertonic
(concentrated) solution. Your doctor will take this into account when calculating how much
solution to give you.
Talk to your doctor or nurse before receiving 5% Dextrose w/v in Compound Sodium
Lactate Solution for Infusion if you have or have had any of the following medical
conditions.
- If you’re receiving ceftriaxone (an antibiotic).(See also “Other medicines and 5% Dextrose
w/v in Compound Sodium Lactate Solution for Infusion”)
- Heart failure
- Respiratory failure (lung disease) (special monitoring may be required in the above
conditions)
- Poor kidney function - higher levels of chloride in the blood than normal (hyperchloraemia)
- high blood pressure (hypertension)
- Buildup of fluid under the skin, affecting all parts of the body (general oedema)
- Buildup of fluid under the skin, particularly around the ankles (peripheral oedema)
- Buildup of fluid in the lungs (pulmonary oedema)
- High blood pressure during pregnancy (pre-eclampsia)
- a disease that causes high levels of a hormone called aldosterone (aldosteronism) -
higher levels of sodium in the blood than normal (hypernatraemia) or any other condition
associated with sodium retention (when the body retains too much sodium), such as
treatment with steroids (See also below, “Taking other medicines”).
- Diabetes (your blood sugar levels will be monitored closely and your insulin treatment
may need to be modified)
- Heart disease of any type
- Any condition that means that you are more likely to have high blood levels of potassium
(hyperkalaemia), such as:
- Kidney failure
- Adrenocortical insufficiency (this disease of the adrenal gland affects hormones that
control the concentration of chemicals in the body)
- Acute dehydration (a loss of water from the body, e.g. due to vomiting or diarrhoea)
- Extensive tissue damage (as can occur in severe burns) close monitoring of your blood
potassium levels is required.
- Diseases associated with high levels of vitamin D (e.g. sarcoidosis, a disease affecting
the skin and internal organs)
- Kidney stones
- Poor liver function

- A high pressure within the skull (intracranial hypertension)
- A stroke due to a clot in a blood vessel in the brain (ischaemic stroke)
- If you had a head injury less than a day ago.
When you are given this infusion, your doctor will take blood and urine samples to monitor:
- The amount of chemicals such as sodium and potassium in your blood (your plasma electrolytes)
- The amount of sugar (Dextrose)
- The acidity of your blood and urine (your acid-base balance).
Although Compound Sodium Lactate/Dextrose Infusion contains potassium, it does not contain
enough to treat very low blood plasma levels of potassium (severe potassium deficiency).
Calcium chloride can be harmful if injected into the body tissues. Therefore, the 5%
Dextrose w/v in Compound Sodium Lactate Solution for Infusion must not be given by
injecting it into a muscle (intramuscular injection). Also, your doctor will make every effort to
avoid the escape of the solution into the tissues surrounding the vein.
5% Dextrose w/v in Compound Sodium Lactate Solution for Infusion must not be given
through the same needle as a blood transfusion. This can damage the red blood cells or
cause them to clump together.
As 5% Dextrose w/v in Compound Sodium Lactate Solution for Infusion contains lactate (a
substance found in the body), it can make your blood too alkaline (metabolic alkalosis).
As 5% Dextrose w/v in Compound Sodium Lactate Solution for Infusion contains sugar
(Dextrose), it can cause a high level of sugar in the blood (hyperglycaemia). If this occurs,
your doctor may:
- adjust the speed of infusion
- give you insulin to reduce the blood sugar levels
This is particularly important if you are diabetic.
Children
5% Dextrose w/v in Compound Sodium Lactate Solution for Infusion should be given with
special care in children. Newborns, especially those born premature and with low birth
weight, are at increased risk of developing low or high levels of sugar in the blood (hypo-or
hyperglycemia), which may lead to complications.
Your doctor will take into account if you are receiving parenteral nutrition (nutrition given by
infusion into a vein). If you are given Compound Sodium Lactate/Dextrose Infusion for a
long time, you will be given an extra source of nutrients
Other medicines and 5% Dextrose w/v in Compound Sodium Lactate Solution for Infusion
Please tell your doctor or nurse if you are taking, have recently taken or might have taken
any other medicines.
It is particularly important that you inform your doctor if you are taking:
- Ceftriaxone (an antibiotic), this should not be given through the same infusion line, unless
thoroughly flushed.
- Cardiac glycosides (cardiotonics) such as digitalis or digoxin, used to treat heart failure,
must not be used with 5% Dextrose w/v in Compound Sodium Lactate Solution for Infusion
(see also section “You must NOT receive 5% Dextrose w/v in Compound Sodium Lactate
Solution for Infusion if you are suffering from …”). The effects of these drugs can be
increased by calcium. This can lead to life threatening changes to the heart rhythm
- Corticosteroids (anti-inflammatory medicines)
These medicines can cause the body to accumulate sodium and water, leading to:
- Tissue swelling due to fluid collection under the skin (oedema) - high blood pressure (hypertension).
The following medicines can increase the concentration of potassium in the blood. This
effect can be life threatening.
A rise in the blood potassium levels is more likely to occur if you have kidney disease.
- Potassium-sparing diuretics (certain water tablets, e.g. amiloride, spironolactone,
triamterene) (Note that these medicines may be included in combination medicinal products)
- Angiotensin converting enzyme (ACE) inhibitors (used to treat high blood pressure)
- Angiotensin II receptor antagonists (used to treat high blood pressure)
- Tacrolimus (used to prevent rejection of a transplant and to treat some skin diseases)
- Cyclosporin (used to prevent rejection of a transplant)
Other medicines that can affect or be affected by 5% Dextrose w/v in Compound Sodium
Lactate Solution for Infusion include:
- Thiazide diuretics such as hydrochlorothiazide or chlortalidone

- Vitamin D.
- Bisphosphonates (to treat bone diseases such as osteoporosis)
- fluoride (for the teeth and bones)
- Fluoroquinolones (a type of antibiotic, including ciprofloxacin, norfloxacin, ofloxacin)
- Tetracyclines (a type of antibiotic, including tetracycline)
- Acidic medicines, including:
- Salicylates used to treat inflammation (aspririn)
- Barbiturates (sleeping tablets)
- Lithium (used to treat psychiatric illness)
- Alkaline (basic) medicines including:
- Sympathomimetics (stimulant medicines such as ephedrine and pseudoephedrine, used
in cough and cold preparations).
- Other stimulants (e.g. dexamphetamine, phenfluramine).
5% Dextrose w/v in Compound Sodium Lactate Solution for Infusion with food and drink
You should ask your doctor or nurse about what you can eat or drink.
Pregnancy and breast-feeding
If you are pregnant of breast feeding, think you may be pregnant or are planning to have a
baby ask your doctor or nurse for advice before taking this medicine. 5% Dextrose w/v in
Compound Sodium Lactate Solution for Infusion can be used safely during pregnancy or
breast-feeding.
Your doctor will monitor the levels of chemicals in your blood and the amount of fluid in
your body.
Calcium can reach your unborn baby through the placenta and, after birth, through the
breast milk.
However, if another medicine is to be added to your solution for infusion during pregnancy
or breast-feeding you should:
- consult your doctor or nurse.
- read the Package Leaflet of the medicine that is to be added.
Driving and using machines
Ask your doctor or pharmacist for advice before driving or using machines.


You will be given 5% Dextrose w/v in Compound Sodium Lactate Solution for Infusion by a
doctor or nurse.
Your doctor will decide on how much you need and when it is to be given. This will depend
on your age, weight, condition and the reason for treatment. The amount you are given
may also be affected by other treatments you are receiving.

You should NOT be given 5% Dextrose w/v in Compound Sodium Lactate Solution for
Infusion if there are particles floating in the solution or if the pack is damaged in any way.
5% Dextrose w/v in Compound Sodium Lactate Solution for Infusion will usually be given to
you through a plastic tube attached to a needle in a vein. Usually a vein in your arm is used to
give you the infusion. However, your doctor may use another method to give you the medicine.
Any unused solution should be thrown away. You should NOT be given an infusion of 5%
Dextrose w/v in Compound Sodium Lactate Solution for Infusion from a bag that has been
partly used.
If you receive more 5% Dextrose w/v in Compound Sodium Lactate Solution for Infusion
than you should
If you are given too much 5% Dextrose w/v in Compound Sodium Lactate Solution for
Infusion (over-infusion) or it is given too fast, this may lead to the following symptoms:
- Water and/or sodium (salt) overload with build-up of liquid in the tissues (oedema)
causing swelling
- Hyperkalaemia (higher levels of potassium in the blood than normal) especially in patients
with kidney failure, causing symptoms such as:
- Pins and needles in the arms and legs (paresthesia)
- Muscle weakness
- An inability to move (paralysis)
- An irregular heartbeat (cardiac arrhythmias)
- Heart block (a very slow heartbeat)
- Cardiac arrest (the heart stops beating; a life-threatening situation)
- Confusion
– Hypercalcaemia (higher levels of calcium in the blood than normal) causing symptoms such as:
- A decreased appetite (anorexia)
- Feeling sick (nausea)
- Vomiting
- Constipation
- Abdominal pain
- Mental disturbances such as irritability or depression
- Drinking lots of water (polydipsia)
- Producing more urine than normal (polyuria)
- Kidney disease due to buildup of calcium in the kidneys (nephrocalcinosis)
- Kidney stones
- Coma (unconsciousness)
- Chalky taste
- Redness (hot flushes)
- Dilatation of the blood vessels in the skin (peripheral vasodilatation).
- Hypokalaemia (lower levels of potassium in the blood than normal) and metabolic
alkalosis (when the blood becomes too basic) especially in patients with kidney failure,
causing symptoms such as:
- Mood changes
- Tiredness
- Shortness of breath
- Stiffness of the muscles
- Twitching of the muscles
- Contraction of muscles.
- The blood becomes too concentrated (hyperosmolarity)
- A loss of water from the body (dehydration)
- A high blood sugar level (hyperglycaemia)
- Sugar in the urine (hyperglycosuria)
- An increase in the amount of urine you produce (osmotic diuresis)
If you develop any of these symptoms you must inform your doctor immediately. Your
infusion will be stopped and you will be given treatment depending on the symptoms.
If a medicine has been added to your % Dextrose w/v in Compound Sodium Lactate
Solution for Infusion before over-infusion occurs, that medicine may also cause symptoms.
You should read the Package Leaflet of the added medicine for a list of possible symptoms
Stopping your % Dextrose w/v in Compound Sodium Lactate Solution for Infusion
Your doctor will decide when to stop giving you this infusion. If you have any further 

questions on the use of this product, ask your doctor or nurse.

 


Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you have any of the following symptoms you should tell your doctor or nurse immediately.
These may signs of a very severe or even fatal hypersensitivity (allergic) reaction called
anaphylactic shock:
- hives (urticaria) which may be localised to a part of the body or widespread
- skin rash
- redness of the skin (erythema)
- Itching (pruritus)
- Skin swelling (angioedema)
- Narrowing of the airways causing difficulty breathing (bronchospasm)
- Chest discomfort or pain
- Shortness of breath (dyspnea)
- Fever (pyrexia)
- Nausea
- Coughing
Some reactions may be due to the administration technique:
- Rash or itching (pruritus) of the infusion site
- Local pain or reaction (redness or swelling at the site of infusion)
- Infusion site anesthesia (numbness)
Other side effects noted with similar products (other sodium-lactate containing solutions)
include:
Other manifestations of hypersensitivity/infusion reactions: Laryngeal oedema (Quincke’s
edema), a slow heartbeat (bradycardia),a fast heartbeat (tachycardia), Blood pressure
decreased, Respiratory distress, Flushing, Throat irritation, Skin swelling, pins and needles
(paresthesias), reduced sense in the mouth (hypoesthesia oral), altered taste (dysgeusia);
• Anxiety
• Headache,
• Nasal congestion,
• Sneezing
• Changes in the concentrations of the chemicals in the blood (electrolyte disturbances)
• Higher levels of potassium in the blood than normal (hyperkalemia)
• A larger volume of blood in the blood vessels than there should be (hypervolemia)
• Panic Attack
• Other infusion site reactions: Infection at the site of injection, Phlebitis, Extravasation,
Infusion site inflammation, Infusion site swelling, Infusion site rash, Infusion site pain,
Infusion site burning

If a medicine has been added to the solution for infusion, the added medicine may also cause
side effects. These side effects will depend on the medicine that has been added. You should
read the Patient Information Leaflet of the added medicine for a list of possible symptoms.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly via the
national reporting system listed below. By reporting side effects you can help provide more
information on the safety of this medicine.


Keep this medicine out of the sight and reach of children. don’t store above 25 Co for 1000
ml plastic bottle. don’t store above 30 Co for 500 ml plastic bottles. You should NOT be given
this medicine after the expiry date which is stated on the bag (eg EXP: MM/YYYY). The expiry
date refers to the last day of that month. You should not be given this medicine, if there are
particles floating in the solution or if the unit is damaged in any way.


What 5% Dextrose w/v in Compound Sodium Lactate Solution for Infusion contains?
The active substances are: - sugar (Dextrose)
- Sodium chloride
- Potassium chloride
- Calcium chloride dehydrate.
- Sodium lactate
The only other ingredient is water for injections.


5% Dextrose w/v in Compound Sodium Lactate Solution for Infusion Solution for Infusion is a clear solution, free from visible particles. It is supplied in plastic bottles. The bottle sizes are: 500 ml, 1000 ml.

Pharmaceutical Solutions Industry Ltd.
Industrial Estate, Phase-2,
Road No. 208, Str. - 203
P O Box 17476
Jeddah 21484
Western Province
Saudi Arabia
Phone: +966-12-6361383
FAX: +966-12-6379460
Website: http://www.psiltd.com
 

To report any side effect(s):

For Saudi Arabia:

The National Pharmacovigilance and Drug Safety Centre (NPC)

* Fax: +966-11-205-7662

* Reporting hotline: 19999.

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

* Website: www.sfda.gov.sa/npc

Other GCC States:
Please contact the relevant competent authority


10/2021
  نشرة الدواء تحت مراجعة الهيئة العامة للغذاء والدواء (اقرأ هذه النشرة بعناية قبل البدء في استخدام هذا المنتج لأنه يحتوي على معلومات مهمة لك)

٥٪ وزن/حجم دكستروز في مركب الصوديوم لاكتیت يستخدم لعلاج فقدان میاه الجسم والمواد الكيمیائية (مثل التعرق
الشديد ، واضطرابات الكلى)
• لعلاجك إذا كان حجم الدم في الأوعية الدموية منخفضًا (نقص حجم الدم) أو إذا كان لدیك انخفاض في ضغط الدم (انخفاض ضغط الدم)
• في الحماض الاستقلابي (عندما يصبح الدم حمضيا جدًا).

يجب ألا تتلقى ٥٪ وزن/حجم دكستروز في مركب الصوديوم لاكتيت إذا كنت تعاني من أي من الحالات التالية:
• إذا كنت مولودًا جديدًا (أقل من ۲۸ یومًا) تتلقى سیفترياكسون (مضاد حيوي)
( • إذا كنت تعاني من حساسية من لاكتات الصوديوم أو أي من المكونات الأخرى في مركب الصوديوم لاكتات (مدرج في القسم ٦
• عندما يكون هناك الكثير من السوائل في المساحات المحيطة بخلايا الجسم (فرط الجفاف خارج الخلية)
• عندما يزيد حجم الدم في الأوعية الدموية اكثر مما يجب
• الفشل الكلوي الحاد (عندما لا تعمل كليتك جيدًا وتحتاج إلى غسيل الكلى)
• قصور القلب غير المكافئ (فشل القلب الذي لا يتم علاجه بشكل كاف ويسبب أعراضًا مثل: - ضيق التنفس - تورم الكاحلين.)
• ارتفاع مستويات البوتاسيوم في الدم عن المعدل الطبيعي (فرط بوتاسيوم الدم)
• ارتفاع مستويات الكالسيوم في الدم عن المعدل الطبيعي (فرط كالسيوم الدم)
• اضطراب يصبح فيه الدم قلويا جدًا (قلاء استقلابي)
• مرض الكبد الذي يتسبب في تراكم السوائل داخل البطن (تليف الكبد الحاد).
• دمك شدید الحموضة وھو ما یھدد الحیاة (الحماض الأیضي الحاد)
•• نوع معين من الحماض الايضي (الحماض اللبني)
• مرض الكبد الحاد (عندما لا يعمل الكبد بشكل صحيح ويتطلب علاجًا مكثفًا للغاية)
• ضعف استقلاب اللاكتات (يحدث ھذا في مرض الكبد الحاد ، حيث تتم إزالة اللاكتات بواسطة الكبد)
• إذا كنت تتناول الجليكوسيدات المستخدمة لعلاج قصور القلب ، مثل الديجيتال أو الديجوكسين (انظر أيضًا "تناول أدوية أخرى").
• مرض السكري الذي لا يتم علاجه بشكل كافٍ ، مما يسمح بارتفاع مستويات السكر في الدم عن المعدل الطبيعي
(مرض السكري غير المكافئ)
- حالات عدم تحمل دكستروز ، على سبيل المثال: - الإجهاد الأيضي (عندما لايعمل التمثيل الغذائي في الجسم بشكل
صحيح ، على سبيل المثال بسبب مرض شديد) غيبوبة (فاقد الوعي). هذا نوع من الغيبوبة التي يمكن أن تحدث إذا
كنت مصابًا بمرض السكري ولا تتلقى ما يكفي من الأدوية.
- نسبة السكر في الدم أعلى من المعتاد (ارتفاع السكر في الدم)
- كمية اللاكتات في الدم أعلى من المعتاد (فرط سكر الدم في الدم)

المحاذير والإحتياطات
هو محلول مفرط التوتر (مركز). سيأخذ طبيبك هذا الأمر في الاعتبار عند حساب مقدار المحلول الذي يعطيه لك.
تحدث إلى طبيبك أو ممرضك قبل تلقي مركب كلوريد الصوديوم لاكتيت إذا كان لديك أو عانيت من أي من الحالات
الطبية التالية:
• إذا كنت تتلقى عقار السيفترياكسون (مضاد حيوي).
• فشل القلب.
• فشل الجهاز التنفسي (أمراض الرئة) (قد يلزم متابعة خاصة في الحالات المذكورة أعلاه).
• ضعف وظائف الكلى.
• ارتفاع مستويات الكلوريد في الدم عن المعدل الطبيعي (فرط كلور الدم).
• ارتفاع ضغط الدم (ارتفاع ضغط الدم).
• ترسب السوائل تحت الجلد ، مما يؤثر على جميع أجزاء الجسم (الوذمة).
• ترسب السوائل تحت الجلد ، خاصة حول الكاحلين (الوذمة المحيطية)
• ترسب السوائل في الرئتين (الوذمة الرئوية)
• ارتفاع ضغط الدم أثناء الحمل (مقدمات الارتعاج)
• مرض يسبب مستويات عالية من هرمون يسمى الألدوستيرون (الألدوستيرونية).
• ارتفاع مستويات الصوديوم في الدم عن المعدل الطبيعي (فرط صوديوم الدم) أو أي حالة أخرى مرتبطة بالاحتفاظ بالصوديوم
(عندما يحتفظ الجسم بالكثير من الصوديوم) ، مثل العلاج باستخدام المنشطات (انظر أيضًا أدناه ، "تناول أدوية أخرى")
• مرض السكري (ستتم مراقبة مستويات السكر في الدم عن كثب وقد يلزم تعديل علاج الأنسولين).
•• أمراض القلب من أي نوع
• أي حالة تعني زیيادة احتمال ارتفاع مستويات البوتاسيوم في الدم (فرط بوتاسيوم الدم) ، مثل
- فشل كلوي
- قصور في القشرة الكظرية (يؤثر مرض الغدة الكظرية على الهرمونات التي تتحكم في تركيز المواد الكيميائية في الجسم)
- الجفاف الحاد (فقدان الماء من الجسم ، على سبيل المثال بسبب القيء أو الإسهال).
- تلف الأنسجة واسعة النطاق (كما يمكن أن يحدث في الحروق الشديدة) مطلوب رصد دقيق لمستويات البوتاسيوم في الدم.
• الأمراض المرتبطة بمستويات عالية من فيتامين (د) مثل الساركويد ، وهو مرض يصيب الجلد والأعضاء الداخلية
• حصى الكلى
• ضعف وظائف الكبد
- ارتفاع الضغط داخل الجمجمة (ارتفاع ضغط الدم داخل الجمجمة)
- سكتة دماغية نتيجة لتجلط في الأوعية الدموية في الدماغ (السكتة الدماغية)
- إذا كان لدیيك إصابة في الرأس منذ أقل من يوم
عندمايتم إعطاء هذا الدواء سيأخذ طبيبك عينات من الدم والبول لمراقبة:
- كمیية المواد الكيمیيائية مثل الصوديوم والبوتاسیيوم في دمك.

- كمية السكر في دمك.

- حموضة دمك وبولك.
على الرغم من أن مركب كلوريد الصوديوم لاكتيت يحتوي على البوتاسيوم ، إلا أنھه لا یيحتوي على ما يكفي لعلاج
مستويات بلازما الدم منخفضة للغاية من البوتاسيوم (نقص البوتاسيوم الحاد).

كلوريد الكالسيوم يمكن أن يكون ضارا إذا حقن في أنسجة الجسم, لذلك لا يجب إعطاء مركب الصوديوم لاكتيت عن
طريق حقنه في العضلات (الحقن العضلي).
أيضًا ، سيبذل طبيبك كل جهد ممكن لتجنب هروب المحلول إلى الأنسجة المحيطة بالوريد.
لا يجب إعطاء مركب كلوريد الصوديوم لاكتيت من خلال نفس الإبرة التي يتم بھها نقل الدم. نظرًا لأن مركب
الصوديوم لاكتيت يمكن أن يتلف خلايا الدم الحمراء أو يتسبب في تجمعها معًا.
مركب الصوديوم لاكتيت يحتوي على اللاكتات (مادة موجودة في الجسم) ، فإنه يمكن أن يجعل دمك قلويا جدًا.
بما أن ٥٪ دكستروز في مركب الصوديوم لاكتيت للتسريب يحتوي على دكستروز (سكر العنب) ، فقد يتسبب ذلك في
ارتفاع نسبة السكر في الدم (ارتفاع السكر في الدم). في حالة حدوث ذلك ، سوف يفعل طبيبك التالي:
- ضبط سرعة التسريب
- أعطاء الأنسولين لخفض مستويات السكر في الدم
هذا مهم بشكل خاص إذا كنت مصابًا بمرض السكري.
الأطفال:
يجب إعطاء الأطفال عناية خاصة عند اعطاء ٥٪ دكستروز في مركب الصوديوم لاكتيت للتسريب. يتعرض المواليد
الجدد ، خاصةً المولودين قبل الأوان والذين يعانون من انخفاض الوزن عند الولادة ، لخطر متزايد للإصابة بمستويات
منخفضة أو عالية من السكر في الدم (نقص السكر في الدم أو ارتفاع السكر في الدم) ، مما قد يؤدي إلى مضاعفات.
سيأخذ طبيبك في الاعتبار إذا كنت تتلقى التغذية الوريدية (التغذیة المقدمة عن طريق الحقن في الوريد).
إذا تم إعطاؤك ٥٪ دكستروز في مركب الصوديوم لاكتيت للتسريب لفترة طويلة ، فسوف تحصل على مصدر إضافي
من العناصر الغذائية.

الأدوية الأخرى وهذا المنتج
أخبر طبيبك أو ممرضك إذا كنت تتناول ، أو قد اتخذت مؤخرا أو قد تأخذ أي أدوية أخرى. من المهم بشكل خاص أن
تخبر طبيبك إذا كنت تأخذ:
- سيفترياكسون (مضاد حيوي) ، لا ينبغي أن يعطى من خلال نفس خط التسريب ، ما لم يتم مسحه جيدًا.
- الجليكوسيدات القلبية (أمراض القلب) مثل الديجيتال أو الديجوكسين المستخدم لعلاج قصور القلب ، يجب ألا
تستخدمه مع ٥٪ دكستروز في مركب الصوديوم لاكتيت. (انظر أيضًا القسم "يجب ألا تتلقى ٥٪ دكستروز في مركب
الصوديوم لاكتيت للتسريب إذا كنت تعاني من ...").
يمكن تزيد آثار هذه الأدوية عن طريق الكالسيوم الذي يمكن أن يؤدي إلى تغييرات تهدد الحياة على إيقاع القلب.
- الستيرويدات (الأدوية المضادة للالتهابات)
يمكن أن تسبب هذه الأدوية في تراكم الجسم للصوديوم والماء ، مما يؤدي إلى:
- تورم الأنسجة بسبب تجمع السوائل تحت الجلد (وذمة)
- ارتفاع ضغط الدم (ارتفاع ضغط الدم).
الأدوية التالية يمكن أن تزيد من تركيز البوتاسيوم في الدم. هذا التأثير يمكن أن يهدد الحياة من المرجح أن يحدث
ارتفاع في مستويات البوتاسيوم في الدم إذا كان لديك مرض في الكلى:
- مدرات البول الموفرة للبوتاسيوم على سبيل المثال (الأميلوراید ، سبيرونولاكتون ، تريامتيرین) (لاحظ أن هذه
الأدوية يمكن ان تستخدم مع ادوية اخرى).
- مثبطات الإنزيم المحول للأنجيوتنسين (يستخدم لعلاج ارتفاع ضغط الدم).
- مضادات مستقبلات أنجيوتنسين (تستخدم لعلاج ارتفاع ضغط الدم).
يستخدم لمنع رفض عملية زرع ومعالجة بعض الأمراض الجلدية. ( Tacrolimus) - تاكروميلس
- السيكلوسبورين (يستخدم لمنع رفض عملية الزرع).
الأدوية الأخرى التي يمكن أن تؤثر أو تتأثر في ٥٪ دكستروز في مركب الصوديوم لاكتيت تتضمن:
- مدرات البول الثيازيدية مثل هيدروكلوروثيازید أو كلورتاليدون
- فيتامين د
- البايفوسفونيت (لعلاج أمراض العظام مثل هشاشة العظام)
- الفلوريد (للأسنان والعظام)
- الفلوروكينولونات (نوع من المضادات الحيوية ، بما في ذلك سيبروفلوكساسين ، نورفلوكساسين ، أوفلوكساسين)
- التتراسيكلين (نوع من المضادات الحيوية ، بما في ذلك التتراسيكلين)
- الأدوية الحمضية ، بما في ذلك:
- الساليسيلات المستخدمة لعلاج الالتهابات (الأسبرين)
- الباربيتورات (أقراص النوم)
- الليثيوم (يستخدم لعلاج الأمراض النفسية

- الأدوية القلوية (الأساسية) بما في ذلك:
- الأدوية المنشطة مثل الإيفيدرين والسودوإيفيدريين (المستخدمة في المستحضرات السعال والبرد)
- المنشطات الأخرى (مثل الديكسامفيتامین ، الفينفلورامين).
٥٪ دكستروز في مركب الصوديوم لاكتيت مع الطعام والشراب
يجب أن تسأل طبيبك أو الممرض عما يمكنك أن تأكله أو تشربه.
الحمل والرضاعة الطبيعية
إذا كنتِ حاملًا او تعتقدين أنك قد تكوني حاملًا أو تخططي لإنجاب طفل ، اطلبي من طبيبك أو ممرضك الحصول على
المشورة قبل تناول هذا الدواء. يمكن استخدا ٥٪ دكستروز في مركب الصوديوم لاكتيت بأمان أثناء الحمل أو
الرضاعة الطبيعية.
سيقوم طبيبك بمراقبة مستويات المواد الكيمیائية في دمك وكمية السائل في جسمك.
يمكن أن يصل الكالسيوم إلى طفلك الذي لم يولد بعد من خلال المشيمة ، وبعد الولادة أو من خلال حليب الثدي.
ومع ذلك ، إذا تم إضافة دواء آخر إلى محلولك للتسريب أثناء الحمل أو الرضاعة الطبيعية ، يجب عليك:
- استشر طبيبك أو الممرض.
- اقرأ نشرة الدواء المراد إضافته.

القيادة واستخدام الآلات
اسأل طبيبك أو الصيدلي للحصول على المشورة قبل القيادة أو استخدام الآلات.

 

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سيتم إعطاؤك ٥٪ دكستروز في مركب الصوديوم للتسريب من قبل الطبيب أو الممرضة
سيقرر طبيبك مقدار ما تحتاجه ومتى يتم إعطاؤه.
هذا يعتمد على عمرك والوزن والحالة وسبب العلاج. قد تتأثر الكمية الذي قدمت لك أيضًا بالمعالجات الأخرى التي تتلقاها.
يجب ألا يتم إعطاؤك ٥٪ دكستروز في مركب الصوديوم لاكتيت للتسريب إذا كانت هناك جزیيئات تطفو في لمحلول أو
في حالة تلف العبوة بأي طريقة.
٥٪ دكستروز في مركب الصوديوم لاكتيت للتسريب عادة ما يعطى لك من خلال أنبوب بلاستيكي متصل بإبرة في الوريد.
عادة ما يتم استخدام الوريد في ذراعك لإعطائك الحقن في الوريد. ومع ذلك قد يستخدم الطبيب طريقة أخرى لإعطائك الدواء.
يجب التخلص من أي محلول غير مستخدم. يجب أن لا تحصل على اي جرعة من ٥٪ دكستروز في مركب الصوديوم

لاكتيت من العبوة التي تم استخدامها جزئيا.
إذا كنت تتلقى ٥٪ دكستروز في مركب الصوديوم لاكتيت للتسريب أكثر من مما ينبغي
إذا تم إعطاؤك نسبة ٥٪ دكستروز في مركب الصوديوم لاكتيت من أجل التسريب (الإفراط في التسريب) أو إذا تم
إعطاؤها بسرعة كبيرة ، فقد يؤدي ذلك إلى الأعراض التالية:
- زيادة بالماء و / أو الصوديوم (الملح) مع تراكم السائل في الأنسجة (وذمة) مما تسبب تورم.
- فرط بوتاسيوم الدم (مستويات البوتاسيوم في الدم أعلى من المعتاد) وخاصة في المرضى الذين يعانون من الفشل
الكلوي ، مسببة أعراض مثل:
- دبابيس وإبر في الذراعين والساقين (تشوش الحس)
- ضعف العضلات
- عدم القدرة على الحركة (الشلل)
- عدم انتظام ضربات القلب (عدم انتظام ضربات القلب)
- كتلة القلب (نبضات بطيئة جدا)
- السكتة القلبية (توقف القلب عن الخفقان ؛ وضع يهدد الحياة)
- الارتباك
- فرط كالسيوم الدم (مستويات الكالسیيوم في الدم أعلى من المعتاد) مسببة أعراض مثل:
- انخفاض الشهية (فقدان الشهية)
- الشعور بالمرض (غثيان)
- القيء
- الإمساك
- وجع بطن
- الاضطرابات العقلية مثل التهيج أو الاكتئاب
(polydipsia) - شرب الكثير من الماء
- إنتاج كمية أكبر من البول عن المعتاد (بولوريا)
- مرض الكلى بسبب تراكم الكالسيوم في الكلى (الكلوية)
- حصى الكلى
- غيبوبة (فاقد الوعي)
- طعم طباشيري
- احمرار (الهبات الساخنة)
- توسع الأوعية الدموية في الجلد (توسع الأوعية المحيطية).
- نقص بوتاسيوم الدم (انخفاض مستويات البوتاسيوم في الدم عن المعدل الطبيعي) والقلويات الأیضية (عندما يصبح
الدم أساسيا جدًا) خاصة في المرضى الذين يعانون من قصور كلوي ، مما يسبب أعراضًا مثل:

- تغيرات في المزاج
- التعب
- ضيق في التنفس
- تصلب العضلات
- الوخز في العضلات
- تقلص العضلات.
- يصبح الدم مركّزًا جدًا (مفرط التناسلية)
- فقدان الماء من الجسم (الجفاف)
- ارتفاع مستوى السكر في الدم (ارتفاع السكر في الدم)
- السكر في البول (ارتفاع السكر في البول)
- زيادة في كمية البول التي تنتجها (إدرار البول الأسموزي)
إذا ظهرت عليك أي من هذه الأعراض ، فعليك إبلاغ طبيبك على الفور. سيتم إيقاف ضخك وسيتم إعطاؤك العلاج
وفقًا للأعراض.
إذا تمت إضافة دواء إلى ٥٪ دكستروز في مركب الصوديوم لاكتيت للتسريب فقد يتسبب هذا الدواء أيضًا في ظهور أعراض.
يجب عليك قراءة النشرة الطبية المضافة للحصول على قائمة بالأعراض المحتملة.
التوقف عن اعطاء ٥٪ دكستروز في مركب الصوديوم لاكتيت للتسريب
سيقرر طبيبك موعد التوقف عن إعطائك المحلول. إذا كانت لديك أي أسئلة أخرى حول استخدام هذا المنتج ، اسأل
طبيبك أو ممرضتك.

مثل جميع الأدوية ، يمكن أن يسبب هذا الدواء آثارًا جانبية ، على الرغم من عدم حصول الجميع عليها.
إذا كان لديك أي من الأعراض التالية ، يجب عليك إخبار طبيبك أو ممرضتك على الفور. قد تكون ھذه علامات على
تفاعل شديد الحساسية أو قاتل للغاية (الحساسیة) يسمى صدمة الحساسية:
- الشرى التي يمكن أن تتحول إلى جزء من الجسم أو على نطاق واسع
- الطفح الجلدي
- احمرار الجلد (حمامي)
- الحكة (الحكة)
- تورم الجلد (وذمة وعائية)
- ضيق الشعب الهوائية يسبب صعوبة في التنفس (تشنج قصبي)
- ألم في الصدر أو ألم
- ضيق التنفس (ضيق التنفس)
- الحمى (بيركسيا)
- غثيان
- السعال
قد تكون بعض ردود الفعل بسبب أسلوب اعطاء المحلول بالوريد:
- طفح أو حكة (حكة) من موقع التسريب
- ألم أو تفاعل موضعي (احمرار أو تورم في موضع التسريب)
- التخدير موقع التخدير (خدر)
الآثار الجانبية الأخرى التي لوحظت مع المنتجات المماثلة (المحاليل الأخرى التي تحتوي على لاكتات الصوديوم) تشمل:
المظاهر الأخرى لفرط الحساسية / تفاعلات التسريب:
وذمة الحنجرة (وذمة كوينك) ، ضربات القلب البطيئة (بطء القلب) ، ضربات القلب السريعة
(عدم انتظام دقات القلب) ، انخفاض ضغط الدم ، ضائقة التنفس ، الإحمرار ، تهيج الحلق ، تهيج الجلد ، الدبابيس
والإبر ، انخفاض الإحساس في الفم (نقص إفرازات الفم) ، تغيير الذوق (عسر الهضم)
•القلق
•صداع الراس،
•إحتقان بالأنف،
• العطس
• التغيرات في تركيزات المواد الكیميائية في الدم (اضطرابات بالاملاح)
• ارتفاع مستويات البوتاسيوم في الدم عن المعدل الطبيعي (فرط بوتاسيوم الدم)
• وجود كمية أكبر من الدم في الأوعية الدموية مما يجب أن يكون (فرط حجم الدم)
• نوبة الهلع
• تفاعلات موقع الحقن الأخرى: العدوى في موقع الحقن ، التهاب الوريد ، التسرب ، التهاب موضع الحقن ، تورم

موقع الحقن ، طفح موقع الحقن ، ألم في موقع الحقن ، حرق موقع الحقن.
إذا تمت إضافة دواء إلى محلول التسريب ، فقد يتسبب الدواء المضاف أيضًا في حدوث آثار جانبية. تعتمد هذه الآثار
الجانبية على الدواء الذي تمت إضافته  يجب عليك قراءة نشرة معلومات المريض الخاصة بالدواء المُضاف للحصول
على قائمة بالأعراض المحتملة

الحفاظ على هذا الدواء بعيدا عن متناول الأطفال.
يخزن عن درجة حرارة لا تتعدى ۲٥ درجة مئوية لحجم ۱۰۰۰ مل. يخزن عن درجة حرارة لا تتعدى ۳۰ درجة
EXP: : مئوية لحجم ٥۰۰ مل. يجب عدم إعطاؤك هذا الدواء بعد تاريخ انتهاء الصلاحية المذكور في الكيس (مثال
يشير تاريخ انتهاء الصلاحية إلى اليوم الأخير من ذلك الشهر. يجب عدم إعطائك هذا الدواء ، إذا .(MM / YYYY
كانت هناك جسيمات تطفو في المحلول أو إذا تعرضت الوحدة للتلف بأي طريقة.

المواد الفعالة هي: - سكر الدكستروز
- كلوريد الصوديوم
- كلوريد البوتاسيوم
- كلوريد الكالسيوم.
- اكتات الصوديوم
العنصر الوحيد الآخر هو الماء للحقن.

٥٪ دكستروز في مركب الصوديوم لاكتيت للتسريب هو محلول واضح ، خالي من الجزيئات المرئية
يتم توفيره في عبوات بلاستيكية.
الاحجام المتوفرة ھي: ٥۰۰ مل و ۱۰۰۰ مل

مصنع المحاليل الطبية.
العنوان:المنطقة الصناعية، المرحلة الثانية.
طريق رقم ۲۰۸ ، شارع ۲۰۳
. صندوق بريد ۱۷٤۷٦ جدة ۲۱٤۸٤
المنطقة الغربية
المملكة العربية السعودية
+۹٦٦-۱۲- الهاتف: ٦۳٦۱۳۸۳
+۹٦٦-۱۲- الفاكس: ٦۳۷۹٤٦۰
http://www.psiltd.com: الموقع الالكتروني
تمت الموافقة على هذه النشرة بتاريخ اكتوبر ۲۰۲۱

 


للإبلاغ عن أي أعراض جانبیة:


المملكة العربیة السعودیة
المركز الوطني للتیقظ والسلامة الدوائیة 
فاكس+۹٦٦۱۱۲۰٥۷٦٦۲: 
ھاتف مجاني: ۸۰۰۲٤۹۰۰۰۰
تلفون: ۰۰۹٦٦-۱۱-۲۰۳۸۲۲۲
تحویلة: ،۲۳٥۳ ،۲۳٥٦ ،۲۳۱۷ ،۲۳٥٤ ،۲۳۳٤ ۲۳٤۰
npc.drug@sfda.gov.sa : الألكتروني البرید
www.sfda.gov.sa/npc : الألكتروني الموقع

دول الخلیج الأخرى:
الرجاء الاتصال بالمؤسسات والھیئات الوطنیة في كل دولة

 

10/2021
 Read this leaflet carefully before you start using this product as it contains important information for you

5% Dextrose w/v with Compound Sodium Lactate Solution for Infusion. (Synonym: “Ringer Lactate & Dextrose 5% w/v solution for infusion”)

One liter contains: Dextrose Monohydrate……………….55 g Sodium Lactate………………………..3.20 g Sodium Chloride………………….…..6.00 g Potassium Chloride……………….…0.40 g Calcium Chloride 2H2O……..…… 0.27 g Water for injections……………… 1000 ml For the full list of excipients, see section 6.1.

Solution for infusion. Clear solution, free from visible particles.

5% Dextrose w/v with Compound Sodium Lactate (Ringer Lactate & Dextrose
5% w/v solution) is used in the following indications when a source of
carbohydrate is required: - Restoration of extracellular fluid and electrolyte balance
or replacement of extracellular fluid loss where isotonic concentrations of
electrolytes are sufficient
- Short term volume replacement (alone or in association with colloid) in case of
hypovolemia or hypotension. - Regulation or maintenance of metabolic acidosis
balance and/or treatment of mild to moderate metabolic acidosis (except lactic
acidosis)

 


Posology
Adults and the Elderly
Dosage, rate, and duration of administration are to be individualized and depend
upon the indication for use, the patient’s age, weight, clinical condition, and
concomitant treatment, and on the patient’s clinical and laboratory response to
treatment. It should be determined by a physician experienced in intravenous fluid
therapy.
Recommended dosage: The amount of 5% Dextrose w/v solution with Compound
Sodium Lactate needed to restore normal blood volume is 3 to 5 times the volume
of lost blood.
The recommended dosage is:
• for adults: 500 ml to 3Liters /24h

• for infants, toddlers and children :
• 0-10 kg body weight: 100 ml / kg / 24 h
• 10-20 kg body weight: 1000 ml + (50 ml/ kg over 10 kg) / 24h
• > 20 kg body weight: 1500 ml + (20 ml/ kg over 20 kg) / 24h.
Administration rate: The infusion rate is usually 40 mL/kg/24h in adults.
Paediatric patients The safety and efficacy of 5% Dextrose w/v solution with
Compound Sodium Lactate in children has not been established by adequate and
well-controlled trials; however, the use of electrolyte solutions in the paediatric
population is referenced in the medical literature.
The infusion rate and volume depends on the age, weight, clinical and metabolic
conditions of the patient, concomitant therapy and should be determined by the
consulting physician experienced in pediatric intravenous fluid therapy
Lactate-containing solutions should be administered with particular caution to

neonates and infants less than 6 months of age.
Pediatric infusion rate is 5 ml/kg/h in average but the value varies with age: •
infants: 6-8 mL/kg/h • toddlers: , 4-6 mL/kg/h,
• Children: 2-4 mL/kg/h.

In children with burns, the dose is on average 3.4 mL/kg/per cent burn at 24 h postburn
and 6.3 mL/kg/per cent burn at 48 h. In severely head-injured children the
dose is on average 2850 mL/m².
Infusion rate and total volume can be higher in surgery or in case of need.
The infusion rate of intravenous solutions containing Dextrose should be selected
with caution in children. It should not exceed the patient’s ability to utilize
Dextrose in order to avoid hyperglycaemia. Therefore the maximum acute
administration rate ranges from 5mg/kg/min for adults to 10-18 mg/kg/min for
babies and children, depending on the age and the total body mass. See also section
4.4, Paediatric population.
Note: - infants and toddlers: aged from 28 days to 23 months (a toddler is an infant
who can walk)
- Children: age from about 2 to 11 years

Use in geriatric patients
When selecting the type of infusion solution and the volume/rate of infusion for a
geriatric patient, consider that geriatric patients are generally more likely to have
cardiac, renal, hepatic, and other diseases or concomitant drug therapy.
Method of administration:
The solution is for intravenous administration through a sterile and non-pyrogenic
administration set using aseptic technique. The equipment should be primed with
the solution in order to prevent air entering the system.
The solution should be inspected visually for particulate matter and discoloration
prior to administration. Do not administer unless the solution is clear, free from
visible particles and the seal is intact. Do not remove unit from overwrap until
ready for use. The inner bag maintains the sterility of the solution. Administer
immediately following the insertion of infusion set.

Do not connect flexible plastic containers in series in order to avoid air embolism
due to possible residual air contained in the primary container. Pressurizing
intravenous solutions contained in flexible plastic containers to increase flow rates
can result in air embolism if the residual air in the container is not fully evacuated
prior to administration.

Use of a vented intravenous administration set with the vent in the open position
could result in air embolism. Vented intravenous administration sets with the vent
in the open position should not be used with flexible plastic containers.
This hypertonic solution should be administered via a large peripheral or
preferably a central vein. Rapid infusion in peripheral veins may be harmful.
Additives may be introduced before infusion or during infusion through the
injection site. When making additions to 5% Dextrose w/v solution with
Compound Sodium Lactate, aseptic technique must be used. Mix the solution
thoroughly when additives have been introduced. Do not store solutions containing
additives.

For information on incompatibilities and preparation of the product with additives,
please see sections 6.2 and 6.6.


As for other calcium-containing infusion solutions, concomitant administration of ceftriaxone and 5% Dextrose w/v solution with Compound Sodium Lactate is contraindicated in newborns (≤ 28 days of age), even if separate infusion lines are used (risk of fatal ceftriaxone-calcium salt precipitation in the neonate’s bloodstream). For patients over 28 days of age please see section 4.4. 5% Dextrose w/v solution with Compound Sodium Lactate is also contraindicated in patients with • A known hypersensitivity to sodium lactate. • Extracellular hyperhydration or hypervolemia • Severe renal insufficiency (with oliguria/anuria) • Uncompensated cardiac failure • Hyperkalemia • Hypercalcemia • Metabolic alkalosis • Ascitic cirrhosis • Severe metabolic acidosis • Conditions associated with increased lactate levels (hyperlactatemia) including lactic acidosis, or impaired lactate utilization, such as severe hepatic insufficiency. • Concomitant digitalis therapy (see section 4.5 Interactions with other medicinal products and other forms of interaction) The solution is also contraindicated in case of uncompensated diabetes, other. known Dextrose intolerances (such as metabolic stress situations), hyperosmolar. coma, hyperglycemia, hyperlactatemia

Hypersensitivity reactions
The infusion must be stopped immediately if any signs or symptoms of a suspected
hypersensitivity reaction develop. Appropriate therapeutic countermeasures must
be instituted as clinically indicated. Solutions containing Dextrose should be used
with caution in patients with known allergy to corn or corn products.
Incompatibilities
Ceftriaxone In patients older than 28 days (including adults), ceftriaxone must not
be administered simultaneously with intravenous calcium-containing solutions,
including Compound Sodium Lactate & Dextrose 5% solution, through the same
infusion line. If the same infusion line is used for sequential administration, the
line must be thoroughly flushed between infusions with a compatible fluid. . For
patients under 28 days, please see section 4.3.

Administration of citrate anticoagulated/preserved blood Due to the risk of
coagulation precipitated by its calcium content, 5% Dextrose w/v solution with
Compound Sodium Lactate must not be added to or administered simultaneously
through the same tubing with citrate anticoagulated/preserved blood.
Due to Dextrose presence, 5% Dextrose w/v solution with Compound Sodium
Lactate should not be infused concomitantly to massive blood transfusion (risk of
pseudo-agglutination) through the same infusion set.
Electrolyte balance
Hypernatraemia Compound Sodium Lactate solution should only be administered
to patients with hypernatraemia after careful consideration of the underlying cause
and alternative intravenous fluids. Monitoring of plasma sodium and volume status
during treatment is recommended. Compound Sodium Lactate solution should be

administered with particular caution in patients with conditions predisposing to
hypernatraemia (such as adrenocortical insufficiency, diabetes insipidus or
extensive tissue injury) and in patients with cardiac disease.”
Hyperchloraemia Compound Sodium Lactate solution should only be administered
to patients with hyperchloraemia after careful consideration of the underlying
cause and alternative intravenous fluids. Monitoring of plasma chloride and acidbase
balance during treatment is recommended. Compound Sodium Lactate
solution should be administered with particular caution to patients with conditions
predisposing to hyperchloraemia (such as renal failure and renal tubular acidosis,
diabetes insipidus), and patients with urinary diversion or patients taking certain
diuretics (carbonic anhydrase inhibitors e.g. acetazolamide) or steroids (androgens,
estrogens corticosteroids) and in patients with severe dehydration

Use in patients with potassium deficiency
Although 5% Dextrose w/v solution with Compound Sodium Lactate has a
potassium concentration similar to the concentration in plasma, it is insufficient to
produce a useful effect in case of severe potassium insufficiency and therefore it
should not be used for this purpose.
Use in patients at risk for hyperkalaemia
5% Dextrose w/v solution with Compound Sodium Lactate should be administered
with particular caution to patients with conditions predisposing to hyperkalaemia
(such as severe renal impairment or adrenocortical insufficiency, acute
dehydration, or extensive tissue injury or burns) and in patients with cardiac
disease.

The plasma potassium level of the patient must be particularly closely monitored in
patients at risk of hyperkalaemia.
Use in patients at risk for hypercalcaemia
Calcium chloride is irritant, therefore care should be taken to prevent extravasation
during intravenous injection and intramuscular injection must be avoided.
Solutions containing calcium salts should be used with caution in patients with
conditions predisposing to hypercalcaemia, such as patients with renal impairment
and granulomatous diseases associated with increased calcitriol synthesis such as
sarcoidosis, calcium renal calculi or a history of such calculi fluid balance/renal
function.

Use in patients with renal impairment
5% Dextrose w/v solution with Compound Sodium Lactate should be administered
with particular caution to patients with renal impairment. In such patients
administration of 5% Dextrose w/v solution with Compound Sodium Lactate may
result in sodium and/or potassium retention.
Risk of Fluid and/or Solute Overload and Electrolyte Disturbances
Depending on the volume and rate of infusion, intravenous administration of 5%
Dextrose w/v solution with Compound Sodium Lactate can cause
• Fluid and/or solute overload resulting in overhydration and, for example,
congested states, including pulmonary congestion and edema.
• Clinically relevant electrolyte disturbances and acid-base imbalance.
Clinical evaluation and periodic laboratory determinations may be necessary to
monitor changes in fluid balance, electrolyte and Dextrose concentrations and acidbase

balance during prolonged parenteral therapy or whenever the condition of the
patient or the rate of administration warrants such evaluation.
High volume infusion must be used under specific monitoring in patients with
cardiac or pulmonary failure.
Use in patients with hypervolemia, overhydration or conditions causing sodium
retention and edema 5% Dextrose w/v solution with Compound Sodium Lactate
should be administered with particular caution to hypervolemic or overhydrated
patients.

Due to the sodium chloride content 5% Dextrose w/v solution with Compound
Sodium Lactate should be administered with particular caution to patients with
conditions that may cause sodium retention, fluid overload and edema, such as
patients with primary hyperaldosteronism, secondary hyperaldosteronism
(associated with, e.g., hypertension, congestive heart failure, renal artery stenosis
or nephrosclerosis), or preeclampsia. (see also Section Error! Reference source not
found.)
Acid-base balance Use in patients at risk for alkalosis 5% Dextrose w/v solution
with Compound Sodium Lactate should be administered with particular caution to
patients at risk for alkalosis. Because lactate is metabolized to bicarbonate,

administration may result in, or worsen, metabolic alkalosis. Seizure may be
precipitated by the alkalosis induced by lactate but this is uncommon.
Dextrose metabolism Use in patients with or at risk for hyperglycemia Solutions
containing Dextrose should be used with caution in patients with impaired
Dextrose tolerance or diabetes mellitus. For newborns – especially those born
premature and with low birth weight, please see below “use in paediatric patients”.
Lactate is a substrate for gluconeogenesis. Therefore, Dextrose levels should be
carefully monitored in Type 2 diabetics receiving 5% Dextrose w/v solution with
Compound Sodium Lactate
Because 5% Dextrose w/v solution with Compound Sodium Lactate contains
Dextrose and lactate (which is metabolized to Dextrose ), administration of 5%
Dextrose w/v solution with Compound Sodium Lactate that exceeds the metabolic
capacity for Dextrose may lead to hyperglycaemia.
Hyperglycaemia has been implicated in increasing cerebral ischemic brain damage
and impairing recovery after acute ischemic strokes. Caution is recommended in

using Dextrose containing solutions in such patients.
Early hyperglycaemia has been associated with poor outcomes in patients with
severe traumatic brain injury. Infusion of Dextrose solution could be
contraindicated in the first 24 hours following head trauma and blood Dextrose
concentration should be closely monitored during intracranial hypertension
episodes.
If hyperglycaemia occurs, the rate of administration should be reduced and/or
insulin administered, or the insulin dose adjusted
Use in paediatric patients
Newborns – especially those born premature and with low birth weight - are at
increased risk of developing hypo- or hyperglycaemia and therefore need close
monitoring during treatment with intravenous Dextrose solutions to ensure
adequate glycaemic control in order to avoid potential long term adverse effects. •

Hypoglycaemia in the newborn can cause prolonged seizures, coma and brain
damage. • Hyperglycaemia has been associated with intraventricular haemorrhage,
late onset bacterial and fungal infection, retinopathy of prematurity, necrotizing
enterocolitis, bronchopulmonary dysplasia, prolonged length of hospital stay, and
death.

In order to avoid potentially fatal over infusion of intravenous fluids to the
neonate, special attention needs to be paid to the method of administration. When
using a syringe pump to administer intravenous fluids or medicines to neonates, a
bag of fluid should not be left connected to the syringe. When using an infusion
pump all clamps on the intravenous administration set must be closed before
removing the administration set from the pump, or switching the pump off. This is
required regardless of whether the administration set has an anti-free flow device.
The intravenous infusion device and administration equipment must be frequently
monitored.
Plasma electrolyte concentrations should be closely monitored in the paediatric
population as this population may have impaired ability to regulate fluids and
electrolytes.

Other warnings Osmolarity 5% Dextrose w/v solution with Compound Sodium
Lactate is a hypertonic solution, with an approximate osmolarity of 555 mOsm/l.
The normal physiologic serum osmolarity range is approximately 280 to 310
mOsmol/L.
Administration of substantially hypertonic solutions may cause venous irritation,
including phlebitis. Hyperosmolar solutions should be administered with caution, if
at all, to patients with hyperosmolar states.
Administration
Adding other medication or using an incorrect administration technique might
cause the appearance of fever reactions due to the possible introduction of
pyrogens. In such case the infusion must be stopped immediately.

For information on incompatibilities and preparation of the product with additives,
please see sections 6.2 and 6.6.


Ceftriaxone: See section 4.3 and 4.4 for more information.
Interaction related to the presence of sodium: Caution is advised when
administering 5% Dextrose w/v solution with Compound Sodium Lactate to
patients treated with drugs that may increase the risk of sodium and fluid retention
(with oedema and hypertension), such as corticosteroids.

Interaction related to the presence of potassium: Because of its potassium content,
5% Dextrose w/v solution with Compound Sodium Lactate should be administered
with caution in patients treated with agents or products that can cause
hyperkalaemia or increase the risk of hyperkalaemia, such as - Potassium-sparing
diuretics (amiloride, spironolactone, triamterene, alone or in association). -
Angiotensin converting enzyme inhibitors (ACEi) and angiotensin II receptor
antagonists - Tacrolimus, cyclosporin.
Administration of potassium in patients treated with such medications can produce
severe and potentially fatal hyperkalaemia, particularly in patients with severe
renal insufficiency.
Interaction related to the presence of calcium: Administration of calcium may
increase the effects of digitalis and lead to serious or fatal cardiac arrhythmia.
Therefore, larger volumes or a faster infusion rates should be used with caution in
patients treated with digitalis glycosides.

- Caution is advised when administering 5% Dextrose w/v solution with
Compound Sodium Lactate to patients treated with thiazide diuretics or vitamin D,
as these can increase the risk of hypercalcemia. - Bisphosphonates, fluoride, some
fluoroquinolones and tetracyclines which are less absorbed (lower availability)
when administered with calcium.
Interaction related to the presence of lactate (which is metabolized into
bicarbonate):
Caution is advised when administering 5% Dextrose w/v solution with Compound
Sodium Lactate to patients treated with drugs for which renal elimination is pH
dependent. Due to the alkalinizing action of lactate (formation of bicarbonate), 5%
Dextrose w/v solution with Compound Sodium Lactate may interfere with the
elimination of such drugs. - Renal clearance of acidic drugs such as salicylates,
barbiturates, and lithium may be increased because of the alkalinisation of urine by
the bicarbonate resulting from lactate metabolism. - Renal clearance of alkaline
drugs, such as sympathomimetics (e.g. ephedrine, pseudoephedrine) and stimulants

(e.g. dexamphetamine sulfate, phenfluramine hydrochloride) may be decreased

 


Pregnancy 5% Dextrose w/v solution with Compound Sodium Lactate can be used
safely during pregnancy and lactation as long as the electrolyte- and fluid balance
is controlled

Breast-feeding It is reminded that calcium crosses the placenta and is distributed
into breast milk.
Additions When a medication is added, the nature of the drug and its use during
pregnancy and lactation have to be considered separately.


No studies have been conducted on the influence of 5% Dextrose w/v solution with
Compound Sodium Lactate on the ability to operate an automobile or other heavy
machinery.


The following adverse reactions (listed by MedDRA System Organ Class) have
been reported spontaneously during the post-market experience. The frequency
cannot be estimated from the available data.

System Organ Class
(SOC)
Adverse reactions (Preferred
Term)
Frequency category
Immune System
Disorders
Hypersensitivity/infusion
reactions, including
Anaphylactic/Anaphylactoid
reactions, possibly
manifested by one or more
of the following symptoms:
Angioedema, Chest pain,
Chest discomfort,
Bronchospasm, Dyspnea,
Cough, Urticaria, Rash,
Pruritus, Erythema, Nausea,
Pyrexia,
Not known
General Disorders and
Administration Site
Conditions
Infusion site reactions
possibly manifested by one
or more of the following
symptoms: Infusion site
pruritus, Infusion site
erythema, Infusion site
anaesthesia(numbness)
Not known

 

The following adverse reactions have been reported spontaneously during the use
of other sodium-lactate containing solutions
• Other manifestations of hypersensitivity/infusion reactions: Laryngeal edema
(Quincke’s edema), Bradycardia, Tachycardia, Blood pressure decreased,
Respiratory distress, Flushing, Throat irritation, Skin swelling, Paraesthesia,
Hypoesthesia oral, Dysgeusia, Anxiety, Headache, Nasal congestion, Sneezing
• Electrolyte disturbances
• Hyperkalaemia
• Hypervolemia
• Panic Attack

Other infusion site reaction symptoms: Infection at the site of injection, Phlebitis,
Extravasation, Infusion site inflammation, Infusion site swelling, Infusion site rash,
Infusion site pain, Infusion site burning
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.
To report any side effect(s):
Saudi Arabia:
The National Pharmacovigilance and Drug Safety Centre (NPC)
Fax: +966-11-205-7662
Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.

Toll free phone: 8002490000
E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc
Other GCC States:
Please contact the relevant competent authority.

 


An excessive volume or too high a rate of administration of 5% Dextrose w/v
solution with Compound Sodium Lactate may lead to fluid and sodium overload

with a risk of edema (peripheral and/or pulmonary), particularly when renal
sodium excretion is impaired. In this case extra renal dialysis may be necessary.
Excessive administration of potassium may lead to the development of
hyperkalemia, especially in patients with renal impairment. Symptoms include
paresthesia of the extremities, muscle weakness, paralysis, cardiac arrhythmias,
heart block, cardiac arrest, and mental confusion.
Excessive administration of calcium salts may lead to hypercalcemia. Symptoms of
hypercalcemia may include anorexia, nausea, vomiting, constipation, abdominal
pain, muscle weakness, mental disturbances, polydipsia, polyuria,
nephrocalcinosis, renal calculi, and, in severe cases, cardiac arrhythmias and coma.
Too rapid intravenous injection of calcium salts may also lead to many of the
symptoms of hypercalcemia as well as to chalky taste, hot flushes, and peripheral
vasodilatation. Mild asymptomatic hypercalcemia will usually resolve on stopping
administration of calcium and other contributory drugs such as vitamin D. If
hypercalcemia is severe, urgent treatment (such as loop diuretics, hemodialysis,

calcitonin, bisphosphonates, trisodium edetate) is required.
Excessive administration of lactate may lead to metabolic alkalosis. Metabolic
alkalosis may be accompanied by hypokalemia. Symptoms may include mood
changes, tiredness, shortness of breath, muscle weakness, and irregular heartbeat.
Muscle hypertonicity, twitching, and tetany may develop especially in
hypocalcemic patients. Treatment of metabolic alkalosis due to bicarbonate
overdose consists mainly of appropriate correction of fluid and electrolyte balance.
Replacement of calcium, chloride, and potassium may be of particular importance.
Excessive administration of a Dextrose -containing solution may lead to
hyperglycemia, hyperosmolarity, osmotic diuresis, and dehydration.

When overdose is related to medications added to the solution infused, the signs
and symptoms of over infusion will be related to the nature of the additive being
used. In the event of accidental over infusion, treatment should be discontinued
and the patient should be observed for the appropriate signs and symptoms related
to the drug administered. The relevant symptomatic and supportive measures
should be provided as necessary.


Pharmacotherapeutic group (ATC code): B05BB02 “Electrolytes with
Carbohydrates”.
5% Dextrose w/v solution with Compound Sodium Lactate (Ringer Lactate &
Dextrose 5% w/v solution) is an hypertonic solution of electrolytes and Dextrose .
The pharmacological properties of the 5% Dextrose w/v solution with Compound
Sodium Lactate (Ringer Lactate & Dextrose 5% w/v solution) are those of its
components (Dextrose, sodium, potassium, calcium, chloride and lactate).
Dextrose is the main source of energy, and this solution provides 200 kcal/L.
The main effect of 5% Dextrose w/v solution with Compound Sodium Lactate
(Ringer Lactate & Dextrose 5% w/v) is the expansion of the extracellular
compartment including both the interstitial fluid and the intravascular fluid.

The lactate is metabolised into bicarbonate, mainly in the liver, and produces an
alkalinising effect on the plasma.
In healthy volunteers receiving Compound Sodium Lactate (Ringer Lactate),
central venous pressure changes were associated with a secretion of atrial
natriuretic peptide.
There is no significant changes in glucagon, norepinephrine, epinephrine, blood
Dextrose and insulin levels in aortic surgery patients receiving Compound Sodium
Lactate & Dextrose 5% w/v (Ringer Lactate & Dextrose 5% w/v).
When medication is added to 5% Dextrose w/v solution with Compound Sodium
Lactate (Ringer Lactate & Dextrose 5% w/v), the overall pharmacodynamics of the
solution will depend on the nature of the drug used.

 


The pharmacokinetic properties of the 5% Dextrose w/v solution with Compound
Sodium Lactate (Ringer Lactate & Dextrose 5% w/v solution) are those of its
components (Dextrose, sodium, potassium, calcium, chloride and lactate).
Infusion of 5% Dextrose w/v solution with Compound Sodium Lactate (Ringer
Lactate & Dextrose 5% w/v) in normal hemodynamically stable adults does not
increase circulating lactate concentrations.
The pharmacokinetics of D-lactate and L-lactate are similar.

The lactate in Compound Sodium Lactate & Dextrose 5% w/v solution (Ringer
Lactate & Dextrose 5% w/v solution) is metabolized by both oxidation and
gluconeogenesis, predominantly in the liver, and bicarbonate is generated by both
processes over 1-2 h.
When medication is added to 5% Dextrose w/v solution with Compound Sodium
Lactate (Ringer Lactate & Dextrose 5% w/v), the overall pharmacokinetics of the
solution will depend on the nature of the drug used.


Preclinical safety data of 5% Dextrose w/v solution with Compound Sodium
Lactate (Ringer Lactate & Dextrose 5% w/v) solution in animals are not relevant
since its constituents are physiological components in animal and human plasma.
Toxic effects are not to be expected under the condition of clinical application.
The safety of potential additives should be considered separately.


Water for Injections


Ceftriaxone must not be mixed with calcium-containing solutions including 5%
Dextrose w/v solution with Compound Sodium Lactate. See also sections 4.3 and
4.4.
As with all parenteral solutions additives may be incompatible. Compatibility of
the additives with the Compound Sodium Lactate & Dextrose 5% solution and
Viaflo container must be assessed before addition. After addition of an additive,
check for a possible colour change and/or the appearance of precipitates, insoluble
complexes or crystals.
The Instructions for Use of the medication to be added and other relevant literature
must be consulted.

Before adding a substance or medication, verify that it is soluble and/or stable in
water and that the pH range of 5% Dextrose w/v solution with Compound Sodium
Lactate is appropriate.(pH 4.0 to 6.5)..

When making additions to 5% Dextrose w/v solution with Compound Sodium
Lactate, aseptic technique must be used. Mix the solution thoroughly when
additives have been introduced. Do not store solutions containing additives.
As guidance the following medications are incompatible with the 5% Dextrose w/v
solution with Compound Sodium Lactate (non-exhaustive listing):
Medications incompatible with 5% Dextrose w/v solution with Compound Sodium
Lactate Aminocaproic acid Amphotericin B Ceftriaxone Cortisone acetate
Diethylstilbestrol Etamivan Ethyl alcohol Phosphate and carbonate solutions
Oxytetracycline Thiopental sodium Versenate disodium

Medications with partial incompatibility with 5% Dextrose w/v solution with
Compound Sodium Lactate: Tetracycline stable for 12 hours Ampicillin sodium
concentration of 2%-3% stable for 4 hours concentration >3% must be given
within 1 hour Minocycline stable for 12 hours Doxycycline stable for 6 hours
Additives known or determined to be incompatible should not be used.


2 years for NPVC bags. 4 years for Plastic bottle.

Do not store above 30Co
for Non-PVC Bags and size: 500 ml polyethylene plastic
bottle.
Do not store above 25Co
for size: 1000 ml polyethylene plastic bottle.


The product is a clear, colorless solution in over wrapped Non-PVC Bag with two
SFC ports, poly ethylene plastic bottle.
NPVC Bag sizes: 500 ml, 1000ml.
Plastic bottles sizes: 500 ml, 1000 ml.


After opening the container, the contents should be used immediately and should
not be stored for a subsequent infusion.

Discard after single use. Discard any unused portion. Do not reconnect partially
used bags.
Return container to in use position, re-open the clamp and continue administration.


Pharmaceutical Solutions Industry Ltd. Industrial Estate, Phase-2, Road No. 208, Str. - 203 P O Box 17476 Jeddah 21484 Western Province Saudi Arabia Phone: +966-12-6361383 FAX: +966-12-6379460 Website: http://www.psiltd.com To report any side effect(s): For Saudi Arabia: The National Pharmacovigilance and Drug Safety Centre (NPC) * Fax: +966-11-205-7662 * Reporting hotline: 19999. * E-mail: npc.drug@sfda.gov.sa * Website: www.sfda.gov.sa/npc Other GCC States: Please contact the relevant competent authority

Aug 2020
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