Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
noradrenaline (norepinephrine) acid tartrate monohydrate, Quantity: 2 mg/mL (Equivalent: noradrenaline (norepinephrine), Qty 1 mg/mL)
Pfizer Australia Pty Ltd
noradrenaline (norepinephrine) acid tartrate monohydrate
Injection, concentrated
Excipient Ingredients: sodium metabisulfite; sodium chloride; water for injections
Intravenous
10 vials per pack
Medicine Registered
(S4) Prescription Only Medicine
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.
Visual Identification: Colourless or practically colourless liquid; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2012-11-29
LEVOPHED™ 1:1000 L E V O P H E D ™ 1 : 1 0 0 0 CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I BEING TREATED WITH LEVOPHED? LEVOPHED contains the active ingredient noradrenaline (norepinephrine). LEVOPHED is used by a doctor in an emergency to restore blood pressure back to normal. For more information, see Section 1. Why am I being treated with LEVOPHED? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE TREATMENT WITH LEVOPHED? Do not start treatment if you have ever had an allergic reaction to LEVOPHED or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before treatment with LEVOPHED? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with LEVOPHED and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW IS LEVOPHED GIVEN? Your doctor will decide what dose you will receive. This depends on your condition and how you respond to LEVOPHED. Often, the dose is adjusted according to how the medicine is affecting your blood pressure. More instructions can be found in Section 4. How is LEVOPHED given? in the full CMI. 5. WHAT SHOULD I KNOW DURING AND AFTER TREATMENT WITH LEVOPHED? THINGS YOU SHOULD DO • Remind any doctor, nurse, dentist or pharmacist who is treating you that you have been given or are being given LEVOPHED. DRIVING OR USING MACHINES • Do not drive or use any machines or tools until you know how LEVOPHED affects you. For more information, see Section 5. What should I know during and after treatment with LEVOPHED? in the full CMI. 6. ARE THERE ANY SIDE EFFECTS? Side effects include: skin and tissue damage close to the site of injection, anxiety, headac Прочетете целия документ
Version: pfplevoi10822 Supersedes Version: pfplevoi10920 AUSTRALIAN PRODUCT INFORMATION LEVOPHED™ 1:1000 (NORADRENALINE (NOREPINEPHRINE) AS ACID TARTRATE MONOHYDRATE) 1. NAME OF THE MEDICINE Noradrenaline (norepinephrine) 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: Sodium metabisulfite For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM LEVOPHED ™ 1:1000 is a sterile, clear colourless solution, concentrated solution for injection available in 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 LEVOPHED ™ 1:1000 is a concentrated solution for injection which must be diluted in glucose containing solutions prior to infusion. An infusion of LEVOPHED ™ 1:1000 should be given into a large vein (see Section 4.4 Special warnings and precautions for use) LEVOPHED ™ 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. This product contains no antimicrobial preservative, to reduce microbiological hazard, use as soon as practicable after preparation. If storage is necessary, hold at 2 to 8 °C for not more than 24 hours. Version: pfplevoi10822 Supersedes Version: pfplevoi10920 LEVOPHED ™ 1:1000 is for single use Прочетете целия документ