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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)

Parenteral energy supply, rehydration, basic solution.
Check ionogram '


Caution when supplying carbohydrate in the presence of
lactic acidosis.


Recommended flow rate :
3 ml/kg BW/h i.e.
70 drops/minute I 70 kg Bw


Caution when supplying carbohydrate in the presence of
lactic acidosis.


Do not store above 25°C.


Dextrose monohydrate 55g
~Anhydrous Dextrose 50g
Water for injection to 1000 ml
Theor. Osmolarity : 277 mOsm/1
Caloric Value : BOO KJ/L (190 Kcai/LJ


Bottle- type Bottle - Size Hospital - Size pack Plastic bottle 250 ml 10 X 250 ml Plastic bottle 500 ml 10 X 500 ml Plastic bottle 1000 ml 6 X 1000 ml

Pharmaceutical Solutions Industry
P.O.Box 17476 Jeddah 21484
Kingdom of Saudi Arabia

To report any side effect(s):
• Saudi Arabia:
National Pharmacovigilance and drug safety Center (NPC)
Fax: +966-11-2057662
Toll free: 8002490000 
Tel: +966-11-2038222 Ext. 2317-2334-2340 –2353 –2354- 2356 
E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc


Other GCC States:
Please contact the relevant competent authority


07/2010
  نشرة الدواء تحت مراجعة الهيئة العامة للغذاء والدواء (اقرأ هذه النشرة بعناية قبل البدء في استخدام هذا المنتج لأنه يحتوي على معلومات مهمة لك)

محلول بالحقن التسريبي في الوريد ف.ب.

مزود وريدي للطاقة- معالجة الجفاف -محلول اساس.

يجب توخي الحذر عند إمداد الجسم بالمواد الكربوهيدراتية

في حالة وجود زيادة في حموضة الدم ناشئة عن حمض الاكتيك

https://localhost:44358/Dashboard

حقن وريدي

لايوجد

يخزن عند درجة حرارة لا تتعدى 25 درجة مئوية

يحتوي اللتر الواحد على: دكستروز مائي                   55 جم

                                      يكافئ دكستروز لامائي       50جم

                                      ماء معد للحقن                  1000 مل 

                                      الضغط الأسموزي النظري =    277   م.اسمول /لتر

                                      السعرات الحرارية 800 ك جول /لتر (190 ك. كالوري /لتر)

لا يوجد

إنتاج مصنع المحاليل الطبية 

ص.ب 17476 جدة21484-المملكة العربية السعودية

 

للإبلاغ عن أي أعراض جانبیة:
محلول معقم یؤخذ عن طریق الفم .
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

 

07/2010
 Read this leaflet carefully before you start using this product as it contains important information for you

5% W/V Dextrose Intravenous Infusion BP

Each 1000 ml contains: Dextrose Monohydrate: 55 g equivalent to Anhydrous Dextrose 50 g. Water for injection to: 1000 ml. Theoretical Osmolarity: 277 mOsm/L. Caloric Value: 800KJ/L (190 Kcal/L).

Intravenous infusion. A clear colorless solution.

Parenteral Nutrition
Used as a parenteral source of calories and for parenteral nutrition.
Hypertonic dextrose injections (concentration >5%) are used to provide adequate calories in a minimal volume of water.
May be admixed with amino acids injections or other compatible IV fluids to provide parenteral nutrition.

Hypoglycemia
10 – 25% dextrose injections used in neonates and infants to restore blood glucose concentrations in the treatment of acute symptomatic hypoglycemia.
50% dextrose injections used in adults and children to restore blood glucose concentrations in the treatment of hypoglycemia resulting from insulin excess or other causes.
Used orally for the management of hypoglycemia in conscious diabetics.

Acute alcohol intoxication
For reduction of cerebrospinal pressure and/or cerebral edema due to delirium tremens or acute alcohol intoxication.

Glucose injection 50% w/v is strongly hypertonic and is used partly because of its dehydrating effects

 


Method of administration:
Intravenous infusion route.
Administer hypertonic dextrose solutions (e.g., >5%) slowly; rapid administration may produce substantial hyperglycemia and hyperosmolar syndrome.
It is preferable to administer hypertonic dextrose solutions via an IV catheter placed into a large central vein, and only after appropriate admixture or dilution.
Hypertonic dextrose solutions may be administered slowly via a large peripheral vein, preferably through a small bore needle.
If possible, alternate the injection site daily.
Ensure that the needle (or catheter) is within the vein lumen and avoid extravasation. (See Infusion Site Reactions under Cautions.)
Administer concentrated dextrose solutions (≥10%) only after appropriate dilution, except in the emergency treatment of severe hypoglycemia.

Posology:
Parenteral Nutrition and Hydration
Calculate dosage based on age, weight, clinical condition, fluid, electrolyte balance, laboratory results and acid-base balance of the patient.

Hypoglycemia
Neonates and infants: 250–500 mg/kg as a single dose (1–2 mL of 25% dextrose injection) in neonates. In severe cases or in older infants, higher or repeated single doses up to a maximum 10–12 mL of 25% dextrose injection may be required. Subsequently, if required, administer 10% dextrose injection by continuous IV infusion to stabilize blood glucose concentrations. Alternatively, 2 mL/kg of 10–25% dextrose injection in neonates and infants.

Children: 20 –50 mL of 50% dextrose injection administered slowly (e.g., 3 mL/minute). In severe cases, repeated doses and supportive therapy may required.

Adults: 20 – 50 mL of 50% dextrose injection administered slowly (e.g., 3 mL/minute). In severe cases, repeated doses and supportive therapy may be required.
When patients do not respond to or tolerate dextrose, consider the use of other drugs (e.g., glucagon, corticosteroids, and epinephrine).

Acute alcoholism: 50ml of glucose 50% w/v solution should be administered intravenously. Unmodified insulin (20 units) and thiamine hydrochloride (100mg) should be added to the infusion.

Prescribing Limits
Parenteral Nutrition and Hydration
Children: Maximum infusion rate without producing glycosuria: 0.5 g/kg per hour. Maximum infusion rate 0.8 g/kg per hour.
Adults: Maximum infusion rate without producing glycosuria: 0.5 g/kg per hour.

Maximum infusion rate 0.8 g/kg per hour.

Hypoglycemia
Neonates and infants: Maximum 10–12 mL of 25% dextrose injection in severe cases or in older infants.
Children: Maximum infusion rate without producing glycosuria: 0.5 g/kg per hour. Maximum infusion rate 0.8 g/kg per hour.
Adults: Maximum infusion rate without producing glycosuria: 0.5 g/kg per hour.
Maximum infusion rate 0.8 g/kg per hour.

 


• Simultaneous administration of dextrose solutions (without electrolytes) with blood through the same infusion set; risk of RBC cell pseudoagglutination. Hypertonic Dextrose Solutions • Hypersensitivity to corn products. • Anuria. • Hepatic or diabetic coma. • Intracranial or intraspinal hemorrhage. • Dehydrated patients with delirium tremens.

Warnings
Administer concentrated dextrose injections under supervision of a qualified clinician familiar with IV technique and possible complications.
Use with caution in patients with known subclinical or overt diabetes mellitus.
Use with caution in infants of diabetic mothers except when indicated in hypoglycemic neonates. Hypertonic solutions of glucose should be administered via a large central vein to minimise the damage at the site of injection

Hyperglycemia and Hyperosmolar Syndrome
Risk of hyperglycemia and/or hyperosmolar syndrome (e.g., dehydration, hypovolemia, mental confusion, loss of consciousness) with rapid administration, especially in patients with chronic uremia and known carbohydrate intolerance. Administer hypertonic dextrose solutions slowly. Monitor blood and urine glucose levels; administration of insulin may be required.

When infusions of concentrated dextrose are discontinued, consider a 5 or 10% dextrose substitute solution to prevent rebound hypoglycemia.

Fluid and/or Solute Overload
Possible fluid and/or solute overload resulting in dilution of serum electrolytes, overhydration, congested conditions, or pulmonary edema.
Risk of dilutional conditions is inversely proportional to the electrolyte concentration administered. Risk of solute overload and resultant congestive conditions with peripheral

and/or pulmonary edema is directly proportional to the electrolyte concentration administered.

Infusion Site Reactions
Infusion site and other reactions (e.g., fever, infection at the injection site, venous thrombosis, hypervolemia, extravasation, phlebitis extending from injection site) possible. May occur because of the solution (e.g., contamination) or administration technique.
Hypertonic dextrose injections may cause local pain or venous irritation or damage. (See IV Administration under Dosage and Administration.) If adverse effects occur, discontinue infusion; evaluate patient and institute appropriate therapeutic measures; save remainder of fluid for examination, if necessary.

General precautions for IV administration
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not administer unless solution is clear and seal is intact.

Do not connect flexible plastic containers of intravenous solution in series, i.e., do not piggyback connections. Such use could result in air embolism due to residual air being drawn from one container before administration of the fluid from a secondary container is completed.

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.


When dextrose is used in fixed combination with sodium chloride, consider the cautions, precautions, and contraindications associated with sodium chloride.
Electrolyte disturbances (i.e., hypokalemia) produced by large doses of dextrose may predispose digitalized patients to toxicity. So additional potassium may be required in fasting patients with normal renal function.
Consider the use of other drugs (e.g., glucagon, corticosteroids, and epinephrine) as they affect the blood glucose level.


Fertility
Not relevant

Pregnancy
Category C.
Lactation
Not known whether dextrose is excreted into milk. Use with caution in nursing women.


Not relevant.


Hypovolemia, hypervolemia, dehydration, oedema, fever, mental confusion, unconsciousness, hyperosmolar syndrome, hyperglycaemia, hypokalaemia, acidosis, hypophosphataemia, hypomagnesemia, polyuria, glycosuria, ketonuria, nausea, diarrhoea, polydipsia, vein irritation, tissue necrosis, pulmonary oedema, tachypnoea
Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection.
The physician should also be alert to the possibility of adverse reactions to drug additives.

Prescribing information for drug additives to be administered in this manner should be consulted.
If the patient is over 65 years of age or very young he may has an increased chance of getting side effects.


• Risk of hyperglycemia and/or hyperosmolar syndrome (e.g., dehydration, hypovolemia, mental confusion, loss of consciousness).
• Possible fluid and/or solute overload resulting in dilution of serum electrolytes, overhydration, congested conditions, or pulmonary edema.
• Risk of solute overload and resultant congestive conditions with peripheral and/or pulmonary edema is directly proportional to the electrolyte concentration administered.
• See undesirable effects section.

Emergency measures
In the event of a fluid or solute overload during parenteral therapy, revaluate the patient's condition and initiate appropriate corrective treatment.
Monitor blood and urine glucose levels; administration of insulin may be required.
 


•Increases blood glucose concentrations and provides calories and water.
•May aid in minimizing liver glycogen depletion, exert a protein-sparing action, anddecrease or prevent ketosis.
•Induces diuresis.
Pharmacotherapeutic group Code: V06DC01


Readily metabolized to carbon dioxide and water.


Not relevant


Water for injection


Knowledge of added drug compatibility is needed before mixing drugs.
If drugs mixed together, the mixture should be inspected for precipitations, turbidity or change in colour, however not all incompatibilities are visible.


5 Years for Plastic Bottle. From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

Do not store above 25°C.


500 ml plastic and Glass bottle.


Before administration, the product should be visually inspected for any particulate matter and discoloration.
For single use only.
Any unused solution should be discarded.


Pharmaceutical Solutions Industry Ltd. Industrial Estate, Phase-2, Road No. 208, Str. - 203 P O Box 17476 Jeddah 21484 Western Province Saudi Arabia Phone: +966-2-6361383 FAX: +966-2-6379460 Website: http://www.psiltd.com To report any side effect(s): •Saudi Arabia: National Pharmacovigilance Center (NPC) Fax: +966-11-2057662 Toll free: 800249000 E-mail: npc.drug@sfda.gov.sa Website: www.sfda.gov.sa/npc Other GCC States: Please contact the relevant competent authority.

27th July. 2015
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