- Approval Id
- cf074cf800801f1c
- Drug Name
- NOREPINEPHRINE KALCEKS CONCENTRATE FOR SOLUTION FOR INFUSION 1MG/ML
- Product Name
- NOREPINEPHRINE KALCEKS CONCENTRATE FOR SOLUTION FOR INFUSION 1MG/ML
- Approval Number
- SIN16733P
- Approval Date
- 2023-03-03
- Registrant
- GOLDPLUS UNIVERSAL PTE LTD
- Licence Holder
- GOLDPLUS UNIVERSAL PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INFUSION, SOLUTION CONCENTRATE
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p>Address hypovolemia before initiation of norepinephrine therapy. If the patient does not respond to therapy, suspect occult hypovolemia (see section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><u>Posology</u></p>
<p><em>Adults</em><br>
After an initial dosage of 8 to 12 micrograms 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.<br>
Typical maintenance intravenous dosage is 2 to 4 micrograms per minute.</p>
<p><em>Discontinuation of therapy</em><br>
When discontinuing the infusion, reduce the flow rate gradually. Avoid abrupt withdrawal.</p>
<p><u>Method of administration</u></p>
<p>Intravenous use after dilution.</p>
<p>Dilute prior to use.<br>
For instructions on dilution of the medicinal product before administration, see section 6.7 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
<p>Infuse norepinephrine into a large vein. Avoid infusions in the veins of the leg in the elderly or in patients with occlusive vascular disease of the legs (see section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).<br>
A drip counter or other suitable metering device is essential to permit an accurate estimation of the rate of flow in drops per minute. Avoid using a catheter-tie-in technique.</p>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>NOREPINEPHRINE KALCEKS is indicated to raise blood pressure in adult patients with severe, acute hypotension.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.<br>
Hypotension due to blood volume deficit (hypovolaemia).</p>
- Atc Code
- C01CA03
- Atc Item Name
- norepinephrine
- Pharma Manufacturer Name
- GOLDPLUS UNIVERSAL PTE LTD
