País: Australia
Idioma: inglés
Fuente: Department of Health (Therapeutic Goods Administration)
paracetamol, Quantity: 10 mg/mL
Boucher & Muir Pty Ltd
Paracetamol
Injection, intravenous infusion
Excipient Ingredients: water for injections; mannitol; sodium hydroxide; dibasic sodium phosphate dihydrate; povidone
Intravenous
100mL bags in packs of 12
Medicine Registered
(S4) Prescription Only Medicine
Paracetamol BNM 1000mg/100mL, 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: A clear and particle free solution; Container Type: Bag; Container Material: Plastic; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2013-08-09
1 PARACETAMOL BNM Consumer Medicine Information PARACETAMOL BNM _PARACETAMOL _ _ _ 1000 mg/100 mL solution for infusion WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you are given Paracetamol BNM. This leaflet answers some common questions about Paracetamol BNM. It does not contain all the available information. Reading this leaflet 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 giving you Paracetamol BNM against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may want to read it again. WHAT PARACETAMOL BNM IS USED FOR Paracetamol BNM contains paracetamol, an analgesic medicine which relieves pain and reduces fever. Paracetamol BNM is a sterile solution for infusion which is given by intravenous infusion directly into a vein, and is used to relieve pain or reduce fever following surgery. Your doctor may have prescribed this medicine for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. Paracetamol BNM is available only with a doctor's prescription. Paracetamol BNM is not addictive. 2 PARACETAMOL BNM BEFORE YOU ARE GIVEN PARACETAMOL BNM _ _ Paracetamol BNM is not suitable for everyone. _WHEN YOU MUST NOT BE GIVEN IT _ _ _ YOU MUST NOT BE GIVEN PARACETAMOL BNM IF: ▪ you are allergic to any medicine containing paracetamol or any of the ingredients listed at the end of this leaflet ▪ you have liver failure or severe liver disease. 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. PARACETAMOL BNM MUST NOT BE USED AFTER THE EXPIRY DATE PRINTED ON THE PACK, OR IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. THE SOLUTION MUST BE CLEAR BEFORE USE. IF YOU ARE NOT SURE WHETHER Y Leer el documento completo
PARACETAMOL BNM 1 AUSTRALIAN PRODUCT INFORMATION PARACETAMOL BNM (PARACETAMOL) SOLUTION FOR INFUSION 1 NAME OF THE MEDICINE Paracetamol 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Paracetamol BNM (paracetamol) solution for infusion contains 1000mg/100mL of paracetamol. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Paracetamol BNM solution for infusion is clear to slightly brownish solution. The pH of the solution is adjusted to remain between 4.5 and 6.5 during the approved shelf life. The solution is isotonic and slightly hypobaric. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Paracetamol BNM 1000mg/100mL 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 and method of administration, hepatic impairment) PARACETAMOL BNM 2 It is recommended that a suitable oral analgesic treatment be substituted for Paracetamol BNM as soon as the patient can be treated by oral route (see Section 4.3 Contraindications). Intravenous route Paracetamol BNM 1000mg/100mL solution for infusion should not be mixed with other medicinal products. Use of the 100 mL bag is restricted to adults, adolescents and children weighing more than 33 kg. Dosage DOSING IS BASED ON PATIENT WEIGHT . Dosing recommendations are presented in the table below: TABLE 1 PATIENT WEIGHT PARACETAMOL DOSE (10 MG/ML) PER ADMINISTRATION MINIMUM INTERVAL BETWEEN EACH ADM Leer el documento completo