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NOREPINEPHRINE KALCEKS CONCENTRATE FOR SOLUTION FOR INFUSION 1MG/ML [SIN16733P]
Active ingredients: NOREPINEPHRINE KALCEKS CONCENTRATE FOR SOLUTION FOR INFUSION 1MG/ML
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Product Info
NOREPINEPHRINE KALCEKS CONCENTRATE FOR SOLUTION FOR INFUSION 1MG/ML
[SIN16733P]
Product information
Active Ingredient and Strength | NORADRENALINE TARTRATE EQV NORADRENALINE - 1 MG/ML |
Dosage Form | INFUSION, SOLUTION CONCENTRATE |
Manufacturer and Country | HBM PHARMA S.R.O. - SLOVAK REPUBLIC |
Registration Number | SIN16733P |
Licence Holder | GOLDPLUS UNIVERSAL PTE LTD |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | C01CA03 |
4.1 Therapeutic indications
NOREPINEPHRINE KALCEKS is indicated to raise blood pressure in adult patients with severe, acute hypotension.
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.
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).
