Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
noradrenaline (norepinephrine) acid tartrate monohydrate
Pfizer Australia Pty Ltd
noradrenaline (norepinephrine) acid tartrate monohydrate
Registered
Hospira ™ Noradrenaline CMI Page 1 HOSPIRA™ NORADRENALINE 1:1000 CONCENTRATE FOR INTRAVENOUS INJECTION _Noradrenaline (Norepinephrine) Acid Tartrate Monohydrate_ CONSUMER MEDICINE INFORMATION _Date of Dispensing_ _Consumer Name _ _ _ _Pharmacist Name _ _Consumer Address _ _ _ _Pharmacist Address _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Hospira Noradrenaline 1:1000. It does not contain all the available information. It 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 you being given Hospira Noradrenaline 1:1000 against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. Keep this leaflet in a safe place. You may need to read it again. WHAT HOSPIRA NORADRENALINE 1:1000 IS USED FOR Hospira Noradrenaline 1:1000 is only given by a doctor or nurse in an emergency situation, usually in hospital as a result of serious conditions which cause a dramatic drop in blood pressure. Such conditions could be: • a heart attack • infection in the blood • severe reaction to a drug • severe reaction to a blood transfusion • allergic reactions Hospira Noradrenaline 1:1000 is used to restore blood pressure back to normal. This medicine belongs to a group of medicines called sympathomimetic amines. It works by making the heart beat 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. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. There is no evidence that Hospira Noradrenaline 1:1000 is addictive_. _ This medicine is available only with a doctor’s prescription. BEFORE YOU ARE GIVEN HOSPIRA NORADRENALINE 1:1000 _WHEN YOU MUST NOT BE _ _GIVEN IT _ YOU SHOULD NOT BE GIVEN HOSPIRA NORADRENALINE 1:1000 IF YOU HAVE AN AL Læs hele dokumentet
Version: pfpnorhi11119 Supersedes: 2.0 Page 1 AUSTRALIAN PRODUCT INFORMATION HOSPIRA ™ NORADRENALINE 1:1000 CONCENTRATE FOR IV INJECTION (NORADRENALINE (NOREPINEPHRINE) AS ACID TARTRATE MONOHYDRATE) 1. NAME OF THE MEDICINE Noradrenaline (norepinephrine) (as acid tartrate monohydrate) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains noradrenaline (norepinephrine) 4 mg in 4 mL (1:1000), present as 8 mg of noradrenaline (norepinephrine) acid tartrate monohydrate in 4 mL. EXCIPIENT(S) WITH KNOWN EFFECT: Sulfites For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Hospira Noradrenaline (norepinephrine) 1:1000 is a sterile, colourless (or practically colourless), concentrated solution for injection available in single use vials. 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. 4.2 DOSE AND METHOD OF ADMINISTRATION Hospira Noradrenaline 1:1000 is a concentrated solution for injection which must be diluted in glucose containing solutions prior to infusion. An infusion of Hospira Noradrenaline 1:1000 should be given into a large vein (see Section 4.4 Special warnings and precautions for use) Hospira Noradrenaline 1:1000 must be administered in 5% glucose solution in distilled water or 5% glucose in saline solution, and must not be administered in saline solution alone. Whole blood or plasma, if indicated to increase blood volume, should be administered separately. Version: pfpnorhi11119 Supersedes: 2.0 Page 2 This product contains no antimicrobial preservative, to reduce microbiological hazard, use as soon as practicable after preparation. If storage is neces Læs hele dokumentet