Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
bupivacaine hydrochloride monohydrate, Quantity: 52.7 mg
Pfizer Australia Pty Ltd
Injection, solution
Excipient Ingredients: water for injections; sodium chloride; sodium hydroxide; hydrochloric acid
Epidural, Infiltration
10mL x 50
Medicine Registered
(S4) Prescription Only Medicine
Bupivacaine Injection is indicated for the production of local or regional anaesthesia and analgesia in individuals as follows: Surgical anaesthesia - Epidural block for surgery - Field block (minor and major nerve blocks and infiltration). Analgesia - Continuous epidural infusion or intermittent bolus epidural administration for analgesia in post operative pain or labour pain. - Field block (minor nerve block amd infiltration). The choice of 2 strengths, 0.25% and 0.5%, makes it possible to vary the degree of motor blockade.
Visual Identification: Clear, colourless solution, free from visible particles; Container Type: Ampoule; Container Material: LDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1991-08-13
BUPIVACAINE INJECTION BP _Bupivacaine hydrochloride monohydrate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Bupivacaine Injection BP. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking Bupivacaine Injection BP against the benefits this medicine is expected to have for you. This medicine is likely to be used while you are at the clinic or in hospital. If possible, please read this leaflet carefully before this medicine is given to you. In some cases this leaflet may be given to you after the medicine has been used. IF YOU HAVE ANY CONCERNS ABOUT RECEIVING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT BUPIVACAINE INJECTION BP IS USED FOR Bupivacaine is used to prevent or relieve pain, but it will not put you to sleep. Bupivacaine Injection BP is used during or after surgery to relieve pain. It can also be used to make childbirth less painful. Bupivacaine Injection BP belongs to a group of medicines known as local anaesthetics. It is injected into the body where it will either totally stop pain or will cause partial loss of feeling (numbness), depending on the amount used. Your doctor will have explained why you are being treated with Bupivacaine Injection BP and what dose you will be given. FOLLOW ALL THE DIRECTIONS AND ADVICE GIVEN TO YOU BY YOUR DOCTOR CAREFULLY. They may differ from the information contained in this leaflet. 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 product is available only on a doctor's prescription. BEFORE YOU ARE GIVEN BUPIVACAINE INJECTION BP _WHEN YOU MUST NOT BE GIVEN_ _IT:_ DO NOT USE BUPIVACAINE INJECTION BP IF YOU HAVE AN ALLERGY TO: • any medicine containing bupivacaine or other local anaesthetics e.g. lido Прочетете целия документ
Version: pfpbupii11120 Supersedes: pfpbupii10720 Page 1 of 15 AUSTRALIAN PRODUCT INFORMATION – BUPIVACAINE INJECTION BP (BUPIVACAINE HYDROCHLORIDE MONOHYDRATE) NOT FOR INTRAVENOUS ADMINISTRATION UNDER ANY CIRCUMSTANCES 1. NAME OF THE MEDICINE Bupivacaine hydrochloride monohydrate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of Bupivacaine Injection contains bupivacaine hydrochloride (as monohydrate) 50 mg or 100 mg. Each ampoule of Bupivacaine Injection contains bupivacaine hydrochloride (as monohydrate) 50 mg. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Solution for injection. Bupivacaine Injection BP is a sterile, isotonic, preservative-free solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Bupivacaine Injection is indicated for the production of local or regional anaesthesia and analgesia in individuals as follows: SURGICAL ANAESTHESIA • Epidural block for surgery • Field block (minor and major nerve blocks and infiltration). ANALGESIA • Continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain. • Field block (minor nerve block and infiltration). The choice of 2 strengths, 0.25% and 0.5%, makes it possible to vary the degree of motor blockade. Version: pfpbupii11120 Supersedes: pfpbupii10720 Page 2 of 15 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE As with all local anaesthetics, the dosage varies and depends upon the area to be anaesthetised, the vascularity of the tissues, the number of neuronal segments to be blocked, the depth of anaesthesia and degree of muscle relaxation required, individual tolerance, the technique of anaesthesia, and the physical condition of the patient. The lowest dosage that results in effective anaesthesia should be used. In general, surgical anaesthesia requires the use of higher concentrations and doses than those required for analgesia. The volume of the drug used will affect the extent of spread of anaesthesia. The presentations of B Прочетете целия документ