Država: Australija
Jezik: engleski
Izvor: Department of Health (Therapeutic Goods Administration)
bupivacaine hydrochloride monohydrate, Quantity: 5.28 mg/mL (Equivalent: bupivacaine hydrochloride, Qty 5 mg/mL)
Boucher & Muir Pty Ltd
Injection, solution
Excipient Ingredients: glucose; water for injections; sodium hydroxide
Intrathecal
10 x 4 mL
(S4) Prescription Only Medicine
Bupivacaine spinal heavy BNM is indicated for the production of spinal anaesthesia.,Bupivacaine spinal heavy BNM is suitable for abdominal surgery lasting 45 - 60 minutes and urological and lower limb surgery lasting 2 - 3 hours.
Visual Identification: Clear, colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2019-05-20
BUPIVACAINE SPINAL HEAVY BNM _SOLUTION FOR INTRATHECAL INJECTION_ _Bupivacaine hydrochloride 20 mg/4 mL (0.5%)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you are given Bupivacaine spinal heavy BNM. This leaflet answers some common questions about Bupivacaine spinal heavy BNM. It does not contain all the available information. The most up-to-date Consumer Medicine Information can be downloaded from www.ebs.tga.gov.au. 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 associated with giving you Bupivacaine spinal heavy 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, PHARMACIST OR NURSE. KEEP THIS LEAFLET WITH THE MEDICINE. You may want to read it again. WHAT BUPIVACAINE SPINAL HEAVY BNM IS USED FOR Bupivacaine spinal heavy BNM contains bupivacaine hydrochloride monohydrate. Bupivacaine spinal heavy BNM is used to prevent or relieve pain before surgery of the lower abdomen and lower limbs. They will not put you to sleep. Bupivacaine spinal heavy BNM can also be used to make childbirth less painful. Bupivacaine spinal heavy BNM belongs to a group of medicines called spinal local anaesthetics. They are injected into the spinal fluid where they make the nerves unable to pass messages to the brain. Depending on the amount used, Bupivacaine spinal heavy BNM will either totally stop pain or will cause a partial loss of feeling. Your doctor will have explained why you are being treated with Bupivacaine spinal heavy BNM and told you what dose you will be given. FOLLOW ALL DIRECTIONS 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 IT HAS BEEN PRESCRIBED FOR YOU. Bupivacaine spinal heavy BNM is only available with a doctor's prescription. Bupivacaine spinal heavy BNM Pročitajte cijeli dokument
BUPIVACAINE SPINAL HEAVY BNM 1 AUSTRALIAN PRODUCT INFORMATION BUPIVACAINE SPINAL HEAVY BNM BUPIVACAINE HYDROCHLORIDE MONOHYDRATE (Injection solution for the production of spinal anaesthesia) NOT FOR INTRAVENOUS ADMINISTRATION UNDER ANY CIRCUMSTANCES 1 NAME OF THE MEDICINE Bupivacaine hydrochloride monohydrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Bupivacaine spinal heavy BNM solution for injection is a sterile, hyperbaric, isotonic aqueous solution containing bupivacaine hydrochloride monohydrate equivalent to bupivacaine hydrochloride 5 mg/mL (0.5%w/v) in water for injections. It also contains glucose monohydrate equivalent to glucose 80 mg per mL of solution (8% w/v). It has a specific gravity of 1.03 g/mL at 20°C. The pH of the solution is adjusted with sodium hydroxide to remain between 4.0 and 6.0 during the approved shelf-life. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Clear and colourless solution for injection. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Bupivacaine spinal heavy BNM is indicated for the production of spinal anaesthesia. Bupivacaine spinal heavy BNM is suitable for abdominal surgery lasting 45 - 60 minutes and urological and lower limb surgery lasting 2 - 3 hours. 4.2 DOSE AND METHOD OF ADMINISTRATION 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. BUPIVACAINE SPINAL HEAVY BNM 2 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. Bupivacaine spinal heavy BNM is for use in one patient on one occasion only. Any solution remaining from an opened container should be discarded. The following dosage recommendatio Pročitajte cijeli dokument