Country: New Zealand
Bahasa: Inggeris
Sumber: Medsafe (Medicines Safety Authority)
Noradrenaline acid tartrate monohydrate 0.2 mg/mL equivalent to noradrenaline 0.1mg/mL; ;
Boucher & Muir (New Zealand) Limited t/a BNM Group
5 mg/50mL
Solution for infusion
Active: Noradrenaline acid tartrate monohydrate 0.2 mg/mL equivalent to noradrenaline 0.1mg/mL Excipient: Hydrochloric acid Sodium chloride Water for injection
Prescription
For the restoration of blood pressure in certain acute hypotensive states (e.g. phaeochromocytomectomy, sympathectomy, poliomyelitis, spinal anaesthesia, myocardial infarction, septicaemia, blood transfusion and drug reactions). As an adjunct in the treatment of cardiac arrest. To restore and maintain an adequate blood pressure after an effective heartbeat and ventilation have been established by other means.
Package - Contents - Shelf Life: Vial, glass, 50 mL type I with bromobutyl stopper and Al flip-off cap - 1 dose units - 18 months from date of manufacture stored at or below 25°C protect from light. Do not refrigerate. Do not freeze
2019-05-07
1 NORALIN NEW ZEALAND CONSUMER MEDICINE INFORMATION NORALIN _NORADRENALINE (NOREPINEPHRINE) (AS ACID TARTRATE MONOHYDRATE) _ Solution for intravenous infusion 3 mg/50 mL, 5 mg/50 mL, 6 mg/50 mL & 10 mg/50 mL WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you are given Noralin. This leaflet answers some common questions about Noralin. It does not contain all the available information. The most up-to-date Consumer Medicine Information can be downloaded from www.ebs.tga.gov.au. Reading this leaflet does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of giving you Noralin against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may want to read it again. WHAT NORALIN IS USED FOR Noralin contains noradrenaline (norepinephrine) acid tartrate monohydrate. It belongs to a group of medicines called sympathomimetic amines. It works by making the heartbeat more forcefully and constricting blood vessels. This results in a higher blood pressure and greater blood flow to the heart and other organs of the body. Noralin is given in emergency situations as a result of medical conditions which cause a dramatic drop in blood pressure . Such situations/conditions could be: ▪ associated with surgical procedures ▪ infections caused by poliovirus ▪ a heart attack ▪ infection in the blood ▪ severe reaction to a medicine ▪ severe reaction to a blood transfusion ▪ allergic reactions. 2 NORALIN Noralin is used to restore blood pressure back to normal. It is given only by a doctor or nurse, usually in hospital. Your doctor may have prescribed this medicine for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. Noralin is only available with a doctor's prescription. There is no evidence that Noralin is addictive. BEFORE YOU ARE GIVEN NORALIN Baca dokumen lengkap
1 NORALIN NORADRENALINE (NOREPINEPHRINE) SOLUTION FOR INTRAVENOUS INFUSION NEW ZEALAND DATA SHEET 1 PRODUCT NAME NORALIN 3 mg/50 mL, 5 mg/50 mL, 6 mg/50 mL and 10 mg/50 mL solution for intravenous infusion. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 3 mg/50 mL vial contains noradrenaline (norepinephrine) 0.06 mg in 1 mL, present as 0.12 mg of noradrenaline (norepinephrine) acid tartrate monohydrate in 1 mL. Each 5 mg/50 mL vial contains noradrenaline (norepinephrine) 0.1 mg in 1 mL, present as 0.2 mg of noradrenaline (norepinephrine) acid tartrate monohydrate in 1 mL. Each 6 mg/50 mL vial contains noradrenaline (norepinephrine) 0.12 mg in 1 mL, present as 0.24 mg of noradrenaline (norepinephrine) acid tartrate monohydrate in 1 mL. Each 10 mg/50 mL vial contains noradrenaline (norepinephrine) 0.2 mg in 1 mL, present as 0.4 mg of noradrenaline (norepinephrine) acid tartrate monohydrate in 1 mL. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Noralin is a sterile, clear colourless solution for intravenous infusion available in vials. The solution has a pH of 3.0 to 4.5. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the restoration of blood pressure in certain acute hypotensive states (e.g. phaeochromocytomectomy, sympathectomy, poliomyelitis, spinal anaesthesia, myocardial infarction, septicaemia, blood transfusion and drug reactions). As an adjunct in the treatment of cardiac arrest. To restore and maintain an adequate blood pressure after an effective heartbeat and ventilation have been established by other means. 2 NORALIN NORADRENALINE (NOREPINEPHRINE) SOLUTION FOR INTRAVENOUS INFUSION 4.2 DOSE AND METHOD OF ADMINISTRATION Noralin should only be administered by healthcare professionals familiar with its use. Noralin is a ready-to-use solution for intravenous infusion. THE SOLUTION SHOULD NOT BE DILUTED BEFORE USE . _Restoration of blood pressure in acute hypotensive states _ Blood volume depletion should always be corrected as fully as possible before any vasopressor is admi Baca dokumen lengkap