Country: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
bupivacaine hydrochloride monohydrate, Quantity: 2.64 mg/mL (Equivalent: bupivacaine hydrochloride, Qty 2.5 mg/mL); adrenaline (epinephrine) acid tartrate, Quantity: 4.5 microgram/mL (Equivalent: adrenaline (epinephrine), Qty 2.5 microgram/mL)
Pfizer Australia Pty Ltd
Injection, solution
Excipient Ingredients: sodium citrate; citric acid; sodium metabisulfite; water for injections; sodium chloride
Subcutaneous, Epidural, Infiltration, Intramuscular
5
(S4) Prescription Only Medicine
Pfizer Bupivacaine with adrenaline 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.
Visual Identification: Clear, colourless or almost colourless solution, practically free from visible particles; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2018-10-19
PFIZER BUPIVACAINE WITH ADRENALINE INJECTION 1 PFIZER BUPIVACAINE WITH ADRENALINE _Bupivacaine hydrochloride monohydrate and adrenaline (epinephrine) acid tartrate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about Pfizer Bupivacaine with adrenaline. It does not contain all the information that is known about Pfizer Bupivacaine with adrenaline. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor will have weighed the risks of you using Pfizer Bupivacaine with adrenaline against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT PFIZER BUPIVACAINE WITH ADRENALINE IS USED FOR Pfizer Bupivacaine with adrenaline is used to prevent or relieve pain, but it will not put you to sleep. Pfizer Bupivacaine with adrenaline is also used after surgery to relieve pain. It can also be used to make childbirth less painful. Pfizer Bupivacaine with adrenaline belongs to a group of medicines called local anaesthetics. When injected, it makes the nerves nearby unable to pass messages to the brain and will therefore prevent or relieve pain. Depending on the amount used, Pfizer Bupivacaine with adrenaline will either totally stop pain or will cause a partial loss of feeling. Bupivacaine is combined with adrenaline (epinephrine) to make it last longer. Adrenaline (epinephrine) makes the blood vessels at the site of injection narrower, which keeps the Bupivacaine where it is needed for a longer time. Your doctor will have explained why you are being treated with Pfizer Bupivacaine with adrenaline 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. Your doctor may prescribe this medicine for uses other than those listed above. Ask your doct Прочитајте комплетан документ
Page 1 of 19 AUSTRALIAN PRODUCT INFORMATION – PFIZER BUPIVACAINE WITH ADRENALINE (BUPIVACAINE HYDROCHLORIDE (AS MONOHYDRATE) AND ADRENALINE (EPINEPHRINE) ACID TARTRATE) NOT FOR INTRAVENOUS ADMINISTRATION UNDER ANY CIRCUMSTANCES 1. NAME OF THE MEDICINE bupivacaine hydrochloride (as monohydrate) adrenaline (epinephrine) acid tartrate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Pfizer Bupivacaine with Adrenaline, Bupivacaine 0.25% w/v with adrenaline (epinephrine) 1:400,000 injection vial contains bupivacaine hydrochloride 2.5 mg/mL with adrenaline (epinephrine) 2.5 microgram/mL). Pfizer Bupivacaine with Adrenaline, Bupivacaine 0.5% w/v with adrenaline (epinephrine) 1:200,000 injection vial contains bupivacaine hydrochloride 5 mg/mL with adrenaline (epinephrine) 5 microgram/mL). Bupivacaine hydrochloride is a white or almost white, crystalline powder or colourless crystal that is soluble in water and freely soluble in ethanol (96%). Bupivacaine has a pKa of 8.1 and is more lipid soluble than lignocaine. Adrenaline (epinephrine) acid tartrate appears as a white or greyish-white, crystalline powder that is freely soluble in water and slightly soluble in ethanol (96%). Pfizer Bupivacaine with Adrenaline solution for injection is a sterile, isotonic aqueous solution of bupivacaine hydrochloride, adrenaline (epinephrine) and sodium chloride in Water for Injections BP. The pH of the solution is adjusted with citric acid and sodium citrate to remain between 3.3 - 5.0. Pfizer Bupivacaine with Adrenaline contain sodium metabisulfite as an antioxidant. EXCIPIENT(S) WITH KNOWN EFFECT Sodium metabisulfite For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Pfizer Bupivacaine with Adrenaline is a sterile solution for injection. The solutions are practically free from visible particles. Page 2 of 19 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pfizer Bupivacaine with Adrenaline is indicated for the production of local or regional anaesthesia and analgesia in individuals as follows: Прочитајте комплетан документ