- Approval Id
- d684696a57a76b33
- Drug Name
- 10 MEQ POTASSIUM CHLORIDE IN 5% DEXTROSE AND 0.33% SODIUM CHLORIDE INJECTION, USP
- Product Name
- 10 MEQ POTASSIUM CHLORIDE IN 5% DEXTROSE AND 0.33% SODIUM CHLORIDE INJECTION, USP
- Approval Number
- SIN13224P
- Approval Date
- 2006-11-28
- Registrant
- BAXTER HEALTHCARE (ASIA) PTE LTD
- Licence Holder
- BAXTER HEALTHCARE (ASIA) PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- GENERAL SALE LIST
- Dosage Form
- INJECTION
- Dosage
- <p><strong>2 DOSAGE AND ADMINISTRATION</strong></p>
<p><strong>2.1 Important Administration Instructions</strong></p>
<ul>
<li><p>Potassium Chloride in Dextrose and Sodium Chloride Injection is only for intravenous infusion <em>[see Warnings and Precautions (5.2) – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>].</em></p></li>
<li><p>The osmolarity of Potassium Chloride in Dextrose and Sodium Chloride Injection, ranges from 361 to 641 mOsmol/L (calc). Peripheral administration is generally acceptable; however, consider central vein administration if there is peripheral vein irritation, phlebitis, and/or associated pain especially with higher potassium concentrations.</p></li>
<li><p>Do not administer Potassium Chloride in Dextrose and Sodium Chloride Injection simultaneously with blood products through the same administration set because of the possibility of pseudoagglutination or hemolysis.</p></li>
<li><p>To prevent air embolism, use a non-vented infusion set or close the vent on a vented set, avoid multiple connections, do not connect flexible containers in series, fully evacuate residual gas in the container prior to administration, do not pressurize the flexible container to increase flow rates, and if administration is controlled by a pumping device, turn off pump before the container runs dry.</p></li>
<li><p>Prior to infusion, visually inspect the solution for particulate matter. The solution should be clear and there should be no precipitates. Do not administer unless solution is clear and container is undamaged.</p></li>
<li><p>Use of a final filter is recommended during administration of parenteral solutions, where possible.</p></li>
</ul>
<p><strong>2.2 Recommended Dosage</strong></p>
<p>The choice of the specific potassium chloride, sodium chloride, and dextrose concentrations, rate and volume depends on the age, weight, clinical and metabolic conditions of the patient and concomitant therapy. Electrolyte supplementation may be indicated according to the clinical needs of the patient.</p>
<p>The administration rate should be governed, especially for premature infants with low birth weight, during the first few days of therapy, by the patient’s tolerance to dextrose. Increase the infusion rate gradually as indicated by frequent monitoring of blood glucose concentrations <em>[see Warnings and Precautions (5.1), Use in Specific Populations (8.4) – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>].</em></p>
<p><strong>2.3 Instructions for Use</strong></p>
<p><u>To Open</u></p>
<ul>
<li><p>Do not remove container from overwrap until ready to use.</p></li>
<li><p>Tear overwrap down side at slit and remove solution container.</p></li>
<li><p>Visually inspect the container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.</p>
<p>Evaluate the following:</p>
<ul>
<li><p> If the outlet port protector is damaged, detached, or not present, discard container.</p></li>
<li><p>Check to ensure the solution is clear and there are no precipitates. Discard if there is a color change and/or the appearance of precipitates, insoluble complexes or crystals.</p></li>
<li><p>Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard container.</p></li>
</ul>
</li>
</ul>
<p><u>Preparation for Administration</u></p>
<ol>
<li><p>Suspend container from eyelet support.</p></li>
<li><p>Remove protector from outlet port at bottom of container.</p></li>
<li><p>Attach administration set. Refer to complete directions accompanying set.</p></li>
</ol>
<p><u>To Add Medication</u></p>
<ul>
<li><p>Additives may be incompatible. Complete information is not available. Do not use additives known or determined to be incompatible.</p></li>
<li><p>Consult with pharmacist, if available. If, in the informed judgment of the healthcare provider, it is deemed advisable to introduce additives, use aseptic technique.</p></li>
<li><p>When introducing additives, consult the instructions for use of the medication to be added and other relevant literature.</p></li>
<li><p>Before adding a substance or medication, verify that it is soluble and/or stable in Potassium Chloride in Dextrose and Sodium Chloride Injection and that the pH range of Potassium Chloride in Dextrose and Sodium Chloride Injection is appropriate.</p></li>
</ul>
<p><em>To Add Medication Before Solution Administration</em></p>
<ol>
<li><p>Prepare medication site.</p></li>
<li><p>Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.</p></li>
<li><p>Mix solution and medication thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly.</p></li>
<li><p>After addition, check to ensure the solution is clear and there are no precipitates. Discard if there is a color change and/or the appearance of precipitates, insoluble complexes or crystals.</p></li>
</ol>
<p><em>To Add Medication During Solution Administration</em></p>
<ol>
<li><p>Close clamp on the set.</p></li>
<li><p>Prepare medication site.</p></li>
<li><p>Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.</p></li>
<li><p>Remove container from IV pole and/or turn to an upright position.</p></li>
<li><p>Evacuate both ports by squeezing them while container is in the upright position.</p></li>
<li><p>Mix solution and medication thoroughly.</p></li>
<li><p>After addition, check to ensure the solution is clear and there are no precipitates. Discard if there is a color change and/or the appearance of precipitates, insoluble complexes or crystals, do not use.</p></li>
</ol>
<p><u>Storage</u></p>
<ul>
<li><p>Use promptly; do not store solutions containing additives.</p></li>
<li><p>Single-dose container.</p></li>
<li><p>Discard any unused portion.</p></li>
</ul>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>1 INDICATIONS AND USAGE</strong></p>
<p>Potassium Chloride in Dextrose and Sodium Chloride Injection is indicated as a source of water, electrolytes and calories.</p>
- Contraindications
- <p><strong>4 CONTRAINDICATIONS</strong></p>
<p>Potassium Chloride in Dextrose and Sodium Chloride Injection is contraindicated in patients with:</p>
<ul>
<li><p>known hypersensitivity to potassium chloride, dextrose and/or sodium chloride <em>[see Warnings and Precautions 5.1) – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>]</em></p></li>
<li><p>clinically significant hyperkalemia <em>[see Warnings and Precautions (5.2) – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>]</em></p></li>
<li><p>clinically significant hyperglycemia <em>[see Warnings and Precautions (5.3) – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>]</em></p></li>
</ul>
- Atc Code
- B05BB01
- Atc Item Name
- electrolytes
- Pharma Manufacturer Name
- BAXTER HEALTHCARE (ASIA) PTE LTD
- Company Detail Path
- /organization/baxter-healthcare-asia-pte-ltd
