- Approval Id
- da7a840da9318f6b
- Drug Name
- NORADRENALINE AGUETTANT 1MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
- Product Name
- NORADRENALINE AGUETTANT 1MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
- Approval Number
- SIN15593P
- Approval Date
- 2018-12-04
- Registrant
- INTEGA PTE LTD
- Licence Holder
- INTEGA PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INFUSION, SOLUTION CONCENTRATE
- Dosage
- <p><strong>2 DOSAGE AND ADMINISTRATION</strong></p>
<p><strong>2.1 Important Dosage and Administration Instructions</strong></p>
<p><u>Correct Hypovolemia</u></p>
<p>Address hypovolemia before initiation of NORADRENALINE AGUETTANT therapy. If the patient does not respond to therapy, suspect occult hypovolemia <em>[see Warnings and Precautions (5.1)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</p>
<p><u>Administration</u></p>
<p>Dilute NORADRENALINE AGUETTANT prior to use <em>[see Dosage and Administration (2.3)]</em>.</p>
<p>Infuse NORADRENALINE AGUETTANT into a large vein. Avoid infusions into the veins of the leg in the elderly or in patients with occlusive vascular disease of the legs <em>[see Warnings and Precautions (5.1)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>. Avoid using a catheter-tie-in technique.</p>
<p><u>Discontinuation</u></p>
<p>When discontinuing the infusion, reduce the flow rate gradually. Avoid abrupt withdrawal.</p>
<p><strong>2.2 Dosage</strong></p>
<p>After an initial dosage of 8 to 12 mcg per minute via intravenous infusion, assess patient response and adjust dosage to maintain desired hemodynamic effect. Monitor blood pressure every two minutes until the desired hemodynamic effect is achieved, and then monitor blood pressure every five minutes for the duration of the infusion.</p>
<p>Typical maintenance intravenous dosage is 2 to 4 mcg per minute.</p>
<p><strong>2.3 Preparation of Diluted Solution</strong></p>
<p>Visually inspect NORADRENALINE AGUETTANT for particulate matter and discoloration prior to administration (the solution is colorless to slightly yellow). Do not use the solution if its color is pinkish or darker than slightly yellow or if it contains a precipitate.</p>
<p>Add the content of one NORADRENALINE AGUETTANT ampule (4 mg in 4 mL) to 1,000 mL of 5% Dextrose, 0.9% sodium chloride or isotonic dextrose saline to produce a 4 mcg per mL dilution. Dextrose reduces loss of potency due to oxidation.</p>
<p>Use higher concentration solutions in patients requiring fluid restriction.</p>
<p><strong>2.4 Drug Incompatibilities</strong></p>
<p>Avoid contact with iron salts, alkalis, or oxidizing agents.</p>
<p>Whole blood or plasma, if indicated to increase blood volume, should be administered separately.</p>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>1 INDICATIONS AND USAGE</strong></p>
<p>NORADRENALINE AGUETTANT is indicated to raise blood pressure in adult patients with severe, acute hypotension.</p>
- Contraindications
- <p><strong>4 CONTRAINDICATIONS</strong></p>
<p>None.</p>
- Atc Code
- C01CA03
- Atc Item Name
- norepinephrine
- Pharma Manufacturer Name
- AGUETTANT ASIA PACIFIC PTE. LTD.
