Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
acetylcysteine, Quantity: 2 g
Link Medical Products Pty Ltd T/A Link Pharmaceuticals
acetylcysteine
Injection, concentrated
Excipient Ingredients: disodium edetate; water for injections; sodium hydroxide
Intravenous Infusion
10 x 10 mL ampoules
(S4) Prescription Only Medicine
Antidote for paracetamol poisoning. ,Acetylcysteine is indicated in the treatment of paracetamol overdose to protect against hepatotoxity.
Visual Identification: Clear colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2012-01-31
Acetylcysteine-Link CMI 1 ACETYLCYSTEINE-LINK _Acetylcysteine_ (AS-it-ile-SIS-teen) CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Acetylcysteine- Link. It does not contain all the available information. It does not take the place of talking to your doctor. All medicines have risks and benefits. Your doctor has weighed the risks of you being given Acetylcysteine-Link against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR. KEEP THIS LEAFLET WITH MEDICINE. You may need to read it again. WHAT ACETYLCYSTEINE- LINK IS USED FOR This medicine is used to treat paracetamol poisoning. It works by reacting with a toxic metabolite of paracetamol to prevent it damaging the liver. This medicine is most effective when started within 10 hours of exposure to paracetamol. 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. This medicine is not addictive. It is available only with a doctor’s prescription. BEFORE YOU ARE GIVEN ACETYLCYSTEINE-LINK _WHEN YOU MUST NOT BE _ _GIVEN IT _ _ _ DO NOT USE ACETYLCYSTEINE-LINK IF YOU HAVE AN ALLERGY TO: • Any medicine containing acetylcysteine • 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 IF YOU ARE NOT SURE WHETHER YOU SHOULD BE GIVEN THIS MEDICINE, TALK TO YOUR DOCTOR. _BEFORE YOU ARE GIVEN IT _ _ _ TELL YOUR DOCTOR IF YOU HAVE ALLERGIES TO ANY OTHER MEDICINES, FOODS, PRESERVATIVES OR DYES. TELL YOUR DOCTOR IF YOU HAVE OR HAVE HAD ANY OF THE FOLLOWING MEDICAL CONDITIONS; • Asthma or difficulty breathing • Stomach ulcers • Kidney problems • Liver problems TELL YOUR DOCTOR IF YOU WEIGH LESS THAN 40 KILOGRAMS. Your doctor may ha Lue koko asiakirja
_Page 1 of 10_ AUSTRALIAN PRODUCT INFORMATION - ACETYLCYSTEINE-LINK (ACETYLCYSTEINE) 1 NAME OF THE MEDICINE Acetylcysteine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Acetylcysteine 2 g in 10 mL For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Concentrated injection. Acetylcysteine-Link is a clear, colourless, sterile, pyrogen free, aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Antidote for paracetamol poisoning. Acetylcysteine is indicated in the treatment of paracetamol overdose to protect against hepatotoxity. 4.2 DOSE AND METHOD OF ADMINSTRATION To be most effective in protecting against liver damage, therapy with acetylcysteine should be started within ten hours of paracetamol ingestion. Although the role of acetylcysteine therapy in patients presenting later than 15 hours after paracetamol ingestion is not established, it may be considered as a clinical option in high risk patients. MANAGEMENT OF PARACETAMOL OVERDOSAGE It should be noted that, after an ingestion of a potentially fatal dose of paracetamol, the patient may appear relatively well initially and may even continue normal activities for a day or two before the onset of hepatic failure. Hepatic damage is more likely to occur with a lower dosage of paracetamol in patients who have a history of chronic alcohol or enzyme inducing drug ingestion (e.g. isoniazid, rifampicin, anticonvulsants including carbamazepine, phenytoin, phenobarbitone, primidone, sodium valproate). Patients are notoriously unreliable as to the amount ingested and the time of ingestion. Hepatic necrosis is preventable if treatment can be instituted within 10 to 12 hours of ingestion. NOTE: Liver damage may not be biochemically apparent for 24 to 48 hours after ingestion. Hepatic necrosis has been seen with 6 g of paracetamol, and death with 15 g. PATIENTS PRESENTING WITHIN 15 HOURS OF INGESTION Give activated charcoal (1 to 2 g/kg) if it is within one hour of paracetamol ingestion, and the patient's conscious state is Lue koko asiakirja