Country: Australia
Bahasa: Inggeris
Sumber: Department of Health (Therapeutic Goods Administration)
Paracetamol
Fresenius Kabi Australia Pty Limited
Medicine Registered
CMI for Paracetamol Kabi July 2013 Filename: CMI paracetamol 210613 clean Page 1 of 3 PARACETAMOL KABI Paracetamol for Injection CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Paracetamol Kabi. 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 taking Paracetamol Kabi against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. Keep this leaflet. You may need to read it again. WHAT PARACETAMOL KABI IS USED FOR Paracetamol Kabi contains paracetamol an analgesic medicine which relieves pain and reduces fever. Paracetamol Kabi is a solution of paracetamol which is given by intravenous infusion (IV) directly into a vein, and is used to relieve pain or reduce fever following surgery. This medicine is available only with a doctor's prescription. BEFORE YOU ARE GIVEN PARACETAMOL KABI _WHEN YOU MUST NOT TAKE IT _ YOU MUST NOT BE GIVEN PARACETAMOL KABI IF YOU HAVE AN ALLERGY TO PARACETAMOL OR TO ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Symptoms of an allergic reaction to Paracetamol Kabi 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 MUST NOT BE GIVEN PARACETAMOL KABI IF YOU HAVE LIVER FAILURE Baca dokumen lengkap
Filename: ParPI020913 - clean Page 1 of 20 PRODUCT INFORMATION PARACETAMOL KABI SOLUTION FOR INFUSION 10MG/ML NAME OF MEDICINE Paracetamol Chemical Name: N-(4 –hydroxypenyl)acetamide Chemical Structure: CAS Registry Number: 103-90-9 Molecular weight: 151.2 DESCRIPTION Paracetamol solution for infusion 10mg/mL is a clear to slightly yellowish solution. Paracetamol is a white crystalline solid or powder chemically described as 4 – acetamidophenol. It is soluble in water (1 in 70), soluble in alcohol (1 in 7), acetone (1 in 13), glycerol (1 in 40), propylene glycol (1 in 9) and also soluble in solutions of the alkali hydroxides. Paracetamol Kabi solution for infusion contains 10 mg/mL of paracetamol (50 mL vial contains 500 mg of paracetamol, 100 mL vial contains 1 g of paracetamol). Paracetamol Kabi solution for infusion contains the excipients mannitol, cysteine hydrochloride, nitrogen (as protective gas), water for injections. PHARMACOLOGY PHARMACODYNAMICS The precise mechanism of the analgesic and antipyretic properties of paracetamol has yet to be established; it may involve central and peripheral actions. Paracetamol solution for infusion provides onset of pain relief within 5 to 10 minutes after the start of administration. The peak analgesic effect is obtained in 1 hour and the duration of this effect is usually 4 to 6 hours. Paracetamol 10 mg/mL solution for infusion reduces fever within 30 minutes after the start of administration with a duration of the antipyretic effect of at least 6 hours. PHARMACOKINETICS Absorption Filename: ParPI020913 - clean Baca dokumen lengkap