Regulatory Information
GOLDPLUS UNIVERSAL PTE LTD
GOLDPLUS UNIVERSAL PTE LTD
Therapeutic
Prescription Only
Formulation Information
INFUSION, SOLUTION CONCENTRATE
**4.2 Posology and method of administration** Address hypovolemia before initiation of norepinephrine therapy. If the patient does not respond to therapy, suspect occult hypovolemia (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Posology _Adults_ 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. Typical maintenance intravenous dosage is 2 to 4 micrograms per minute. _Discontinuation of therapy_ When discontinuing the infusion, reduce the flow rate gradually. Avoid abrupt withdrawal. Method of administration Intravenous use after dilution. Dilute prior to use. For instructions on dilution of the medicinal product before administration, see section 6.7 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. 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 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 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.
INTRAVENOUS
Medical Information
**4.1 Therapeutic indications** NOREPINEPHRINE KALCEKS is indicated to raise blood pressure in adult patients with severe, acute hypotension.
**4.3 Contraindications** Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. Hypotension due to blood volume deficit (hypovolaemia).
C01CA03
norepinephrine
Manufacturer Information
GOLDPLUS UNIVERSAL PTE LTD
HBM Pharma s.r.o.
Active Ingredients
Documents
Package Inserts
NOREPINEPHRINE KALCEKS CONCENTRATE FOR SOLUTION FOR INFUSION_PI.pdf
Approved: March 3, 2023