- Approval Id
- 286530f5f6f8edcd
- Drug Name
- GLUCOSE INTRAVENOUS INFUSION BP 5%
- Product Name
- GLUCOSE INTRAVENOUS INFUSION BP 5%
- Approval Number
- SIN06311P
- Approval Date
- 1991-07-02
- Registrant
- B. BRAUN SINGAPORE PTE LTD
- Licence Holder
- B. BRAUN SINGAPORE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- GENERAL SALE LIST
- Dosage Form
- INJECTION
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><strong><u>Carbohydrate solution for intravenous liquid therapy</u></strong></p>
<p>The dosage depends on the age, weight, clinical and physiological (acid-base balance) conditions of the patient. The concomitant therapy should be determined by the consulting specialist.</p>
<p><strong><u>Vehicle solution for compatible medicinal products</u></strong></p>
<p>The volume to be chosen depends on the desired concentration of the medicinal product for which the solution is to be used as vehicle having regard to the maximum dose stated below.<br>
<u>Posology</u></p>
<p>Fluid balance, serum glucose, serum sodium, and other electrolytes may need to be monitored before and during administration, especially in patients with increased non-osmotic vasopressin release (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients co-medicated with vasopressin agonist drugs due to the risk of hyponatraemia.</p>
<p>Monitoring of serum sodium is particularly important for physiologically hypotonic fluids. Glucose Intravenous Infusion 5% solution for infusion may become hypotonic after administration due to glucose metabolisation in the body (see sections 4.4. 4.5 and 4.8 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>Of note, provision of the entire daily fluid supply with this solution alone is contraindicated. See sections 4.3 and 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
<p><em>Adults</em></p>
<p><u>Maximum daily intake</u><br>
The maximum daily dose for Glucose Intravenous Infusion 5% Solution for Infusion results from the maximum daily fluid demand and should not exceed 40 ml per kg body weight per day, corresponding to 2 g of glucose per kg body weight per day.</p>
<p><u>Maximum infusion rate</u><br>
Up to 5 ml per kg body weight per hour, corresponding to 0.25 g of glucose per kg body weight per hour.</p>
<p><em>Paediatric population</em></p>
<p>The recommended dosage for treatment fluid depletion is:</p>
<ul class="dash">
<li><p>0–10 kg body weight: 100 ml/kg/24 h</p></li>
<li>10–20 kg body weight: 1000 ml + 50 ml /kg for each kg > 10 kg/24 h</li>
<li>> 20 kg body weight: 1500 ml + 20 ml / kg for each kg > 20 kg/24 h</li>
</ul>
<p><u>Maximum infusion rate</u><br>
Up to 5 ml per kg body weight per hour, corresponding to 0.25 g of glucose per kg body weight per hour.</p>
<p>Dosing of this solution should be as restrictive as possible and must be accompanied by adequate electrolyte substitution. See sections 4.3 and 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
<p><u>Method of administration</u></p>
<p>Intravenous use.<br>
The possibility of peripheral venous infusion depends on the osmolarity of the prepared mixture.</p>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<ul>
<li>Carbohydrate solution for intravenous liquid therapy</li>
<li>Vehicle solution for compatible medicinal products</li>
<li>Hypertonic dehydration</li>
</ul>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<ul>
<li>Hypersensitivity to the active substance. See section 4.4 and 4.8 for corn allergies – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em></li>
<li>Hyperglycaemia, not responding to insulin doses of up to 6 units insulin/hour</li>
<li>Lactic acidosis</li>
</ul>
<p>If it is necessary to administer large volumes, further contraindications can arise on account of the fluid load:</p>
<ul>
<li>Hypotonic hyperhydration</li>
<li>Isotonic hyperhydration</li>
<li>Acute congestive heart failure</li>
<li>Pulmonary oedema</li>
</ul>
<p>This solution must not be used alone for fluid supply/rehydration because it does not contain electrolytes. See section <strong>4.4</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Atc Code
- B05CX01
- Atc Item Name
- glucose
- Pharma Manufacturer Name
- B. Braun Singapore Pte Ltd.
- Company Detail Path
- /organization/b-braun-singapore-pte-ltd