Χώρα: Αυστραλία
Γλώσσα: Αγγλικά
Πηγή: Department of Health (Therapeutic Goods Administration)
naloxone hydrochloride dihydrate, Quantity: 440 microgram/mL (Equivalent: naloxone hydrochloride?, Qty 400 microgram/mL)
Juno Pharmaceuticals Pty Ltd
naloxone hydrochloride dihydrate
Injection, solution
Excipient Ingredients: water for injections; hydrochloric acid
Intravenous, Subcutaneous, Intramuscular
1, 10, 5
(S4) Prescription Only Medicine
Naloxone hydrochloride injection is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by opioids including natural and synthetic opioids, propoxyphene, methadone and the narcotic-antagonist analgesics: nalbuphine, pentazocine and butorphanol. Naloxone hydrochloride injection is also indicated for the diagnosis of suspected acute opioid overdosage.
Visual Identification: Clear, colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2016-03-10
_ _ _Page 1 of 3_ NALOXONE JUNO NALOXONE JUNO NEONATAL _Naloxone Hydrochloride Dihydrate Solution for Injection _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about NALOXONE JUNO and NALOXONE JUNO NEONATAL (referred to as Naloxone. It does not contain all the available information and 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 treated with this medicine against the benefits it is expected to have for you. Please read this leaflet carefully and follow the instructions given to you by your doctor and the advice contained in this leaflet. IF YOU HAVE ANY CONCERNS ABOUT BEING TREATED WITH THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT NALOXONE JUNO AND NALOXONE JUNO NEONATAL IS USED FOR Naloxone hydrochloride dihydrate belongs to a group of medicines called opioid antagonists. Naloxone hydrochloride dihydrate works by reversing the effects of opium-like substances such as morphine, heroin and codeine. Your doctor may have prescribed this medicine for another reason. Ask your doctor if you have any questions about why this medicine has been prescribed for you. This medicine is available only with a doctor’s prescription. BEFORE YOU ARE GIVEN NALOXONE JUNO OR NALOXONE JUNO NEONATAL _WHEN NALOXONE JUNO AND _ _NALOXONE JUNO _ _NEONATAL MUST NOT BE _ _GIVEN_ YOU SHOULD NOT BE GIVEN THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • Any medicine containing naloxone hydrochloride dihydrate • Any of the ingredients listed at the end of this leaflet Some of the symptoms of an allergic reaction may include: • Shortness of breath • Wheezing or difficulty breathing • Swelling of the face, lips, tongue or other parts of the body • Rash, itching or hives on the skin. YOU SHOULD NOT BE GIVEN THIS MEDICINE IF THE SOLUTION IS DISCOLOURED OR CLOUDY, TURBID OR A PRECIPITATE IS PRESENT. The injection is normally a cle Διαβάστε το πλήρες έγγραφο
Australian Product Information PI v 3.0 Page | 1 AUSTRALIAN PRODUCT INFORMATION NALOXONE JUNO NALOXONE JUNO NEONATAL _ _ _ _ _ _ _(NALOXONE HYDROCHLORIDE (AS DIHYDRATE) INJECTION) _ 1 NAME OF THE MEDICINE The name of this medicine is naloxone hydrochloride dihydrate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION NALOXONE JUNO and NALOXONE JUNO NEONATAL are available as sterile solutions for intravenous, intramuscular and subcutaneous administration at a concentration of 400 micrograms of naloxone hydrochloride (as dihydrate) in 1 mL of water for injections, and 40 micrograms of naloxone hydrochloride (as dihydrate) in 2 mL water for injections. The pH is adjusted to 3.0 – 3.3 with hydrochloric acid. NALOXONE JUNO and NALOXONE JUNO NEONATAL, opioid antagonists, are synthetic congeners of oxymorphone. In structure they differ from oxymorphone in that the methyl group on the nitrogen atom is replaced by an allyl group. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM Solution for injection. NALOXONE JUNO and NALOXONE JUNO NEONATAL are clear, colourless solutions. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Naloxone hydrochloride dihydrate injection is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by opioids including natural and synthetic opioids, propoxyphene, methadone and the narcotic-antagonist analgesics: nalbuphine, pentazocine and butorphanol. Naloxone hydrochloride dihydrate injection is also indicated for the diagnosis of suspected acute opioid overdosage. 4.2 DOSE AND METHOD OF ADMINISTRATION NALOXONE JUNO and NALOXONE JUNO NEONATAL may be administered intravenously, intramuscularly, or subcutaneously. The most rapid onset of action is achieved by intravenous administration and it is recommended in emergency situations. Since the duration of action of some opioids may exceed that of naloxone hydrochloride dihydrate the patient should be kept under continued surveillance, and repeated doses of n Διαβάστε το πλήρες έγγραφο