البلد: أستراليا
اللغة: الإنجليزية
المصدر: Department of Health (Therapeutic Goods Administration)
paracetamol, Quantity: 10 mg/mL
Fresenius Kabi Australia Pty Ltd
Paracetamol
Injection, solution
Excipient Ingredients: cysteine hydrochloride monohydrate; nitrogen; mannitol; water for injections
Intravenous Infusion
50 x 100 mL bags, 60 x 100 mL bags, 20 x 100 mL vials
(S4) Prescription Only Medicine
Paracetamol 10 mg/mL, solution for infusion is indicated for the relief of mild to moderate pain and the reduction of fever where an intravenous route of administration is considered clinically necessary.
Visual Identification: Colourless to almost colourless solution; Container Type: Bag; Container Material: Plastic; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2014-07-03
1 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 is used to relieve pain and reduce fever following surgery. This medicine belongs to a group of medicines called analgesics. ASK YOUR DOCTOR IF YOU HAVE ANY CONCERNS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor's prescription. BEFORE YOU ARE GIVEN PARACETAMOL KABI _WHEN YOU MUST NOT BE GIVEN 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 THE FOLLOWING MEDICAL CONDITIONS. liver failure severe liver disease. IF YOU ARE NOT SURE WHETHER YOU SHOULD BE GIVEN PARACETAMOL KABI, TALK TO YOUR DOCTOR OR PHARMACIST. _BEFORE YOU START TO TAKE IT _ TELL YOUR DOCTOR IF YOU HAVE ALLERGIES TO ANY OTHER MEDICINES, FOODS, PRESERVATIVES OR DYES. TELL YOUR DOCTOR OR PHARMACIST IF YOU HAVE OR HAVE HAD ANY MEDICAL CONDITIONS: liver disease (including Gilbert’s syndrome) kidney disease alcoholism dehydration eating disorders (anorexia, bulimia) a wasting syndrome including unexplained weight loss, fatigue, اقرأ الوثيقة كاملة
AUSTRALIAN PRODUCT INFORMATION- PARACETAMOL KABI (PARACETAMOL) 1. NAME OF MEDICINE Paracetamol 2. QUALITATIVE AND QUANTATIVE COMPOSITION Paracetamol Kabi solution for infusion contains 10 mg/mL of paracetamol (50 mL vial/ bag contains 500 mg of paracetamol, 100 mL vial/bag contains 1 g of paracetamol). Paracetamol Kabi solution for infusion contains the excipients mannitol, cysteine hydrochloride, nitrogen (as protective gas), water for injections. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Paracetamol solution for infusion 10 mg/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. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Paracetamol 10 mg/mL solution for infusion is indicated for the relief of mild to moderate pain and the reduction of fever where an intravenous route of administration is considered clinically necessary. 4.2 DOSE AND METHOD OF ADMINISTRATION THE PRESCRIBED DOSE MUST BE BASED ON THE PATIENT’S WEIGHT. UNINTENTIONAL OVERDOSE CAN LEAD TO SERIOUS LIVER DAMAGE AND DEATH (SEE SECTION 4.9 OVERDOSE). Healthcare providers are reminded that it is essential to follow both the weight-related dose recommendations and to consider individual patient risk factors for hepatotoxicity including hepatocellular insufficiency, chronic alcoholism, chronic malnutrition (low reserves of hepatic glutathione), and dehydration (see section 4.2 DOSE METHOD AND ADMINISTRATION – HEPATIC IMPAIRMENT). It is recommended that suitable oral analgesic treatment be substituted for Paracetamol solution for infusion as soon as the patient can be treated by the oral route (see section 4.3 CONTRAINDICATIONS). INTRAVENOUS ROUTE Paracetamol solution for infusion 10 mg/mL should not be mixed with other medic اقرأ الوثيقة كاملة