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HSA Approval

NOREPINEPHRINE KALCEKS CONCENTRATE FOR SOLUTION FOR INFUSION 1MG/ML

SIN16733P

NOREPINEPHRINE KALCEKS CONCENTRATE FOR SOLUTION FOR INFUSION 1MG/ML

NOREPINEPHRINE KALCEKS CONCENTRATE FOR SOLUTION FOR INFUSION 1MG/ML

March 3, 2023

GOLDPLUS UNIVERSAL PTE LTD

GOLDPLUS UNIVERSAL PTE LTD

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

Noradrenaline tartrate eqv Noradrenaline

1.0mg/mL

Norepinephrine

Documents

Package Inserts

NOREPINEPHRINE KALCEKS CONCENTRATE FOR SOLUTION FOR INFUSION_PI.pdf

Approved: March 3, 2023

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