Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
bupivacaine hydrochloride monohydrate, Quantity: 105.54 mg (Equivalent: bupivacaine hydrochloride, Qty 100 mg); adrenaline (epinephrine) acid tartrate, Quantity: 182 microgram (Equivalent: adrenaline (epinephrine), Qty 100 microgram)
Phebra Pty Ltd
Injection, solution
Excipient Ingredients: sodium metabisulfite; hydrochloric acid; sodium chloride; water for injections
Intramuscular, Subcutaneous, Epidural, Infiltration
5 x 20 mL vials in sterile theatre pack
(S4) Prescription Only Medicine
Bupivacaine 0.5% with Adrenaline 1:200,000 Phebra 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 ? Intermittent bolus epidural administration for analgesia in postoperative pain or labour pain ? Field block (minor nerve block and infiltration)
Visual Identification: A colourless or almost colourless solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2022-10-07
Bupivacaine 0.5% with Adrenaline 1:200,000 Phebra Injection V.01 1 BUPIVACAINE 0.5% WITH ADRENALINE 1:200,000 PHEBRA INJECTION CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY IS BUPIVACAINE WITH ADRENALINE INJECTION BEING USED ? Bupivacaine with Adrenaline Injection contains the active ingredients bupivacaine hydrochloride and adrenaline (epinephrine) (as acid tartrate). Bupivacaine with Adrenaline Injection is used to prevent or relieve pain, but it will not put you to sleep. It is also used after surgery to relieve pain and to make childbirth less painful. For more information, see Section 1. Why is Bupivacaine with Adrenaline Injection being used ? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE BUPIVACAINE WITH ADRENALINE INJECTION IS USED? Do not use if you have ever had an allergic reaction to Bupivacaine with Adrenaline Injection or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before Bupivacaine with Adrenaline Injection is used? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Bupivacaine with Adrenaline Injection and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW IS BUPIVACAINE WITH ADRENALINE INJECTION USED? • Bupivacaine with Adrenaline Injection will be injected by your doctor into the skin, near a single nerve, or into an area that contains a large number of nerves. More instructions can be found in Section 4. How is Bupivacaine with Adrenaline Injection used ? in the full CMI. 5. WHAT SHOULD I KNOW WHILE BUPIVACAINE WITH ADRENALINE INJECTION IS BEING USED? DRIVING OR USING MACHINES • Be careful driving or operating machinery after you h Read the complete document
PRODUCT INFORMATION Australian Product Information Bupivacaine 0.5% with Adrenaline 1:200,000 Phebra Version 01 Page 1 of 18 BUPIVACAINE 0.5% WITH ADRENALINE 1:200,000 PHEBRA [BUPIVACAINE HYDROCHLORIDE AND ADRENALINE (EPINEPHRINE)] SOLUTION FOR INJECTION NOT FOR INTRAVENOUS ADMINISTRATION UNDER ANY CIRCUMSTANCES 1 NAME OF THE MEDICINE bupivacaine hydrochloride monohydrate adrenaline (epinephrine) acid tartrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Bupivacaine 0.5% with Adrenaline 1:200,000 Phebra solution for injection contains bupivacaine hydrochloride 100 mg/20 mL with adrenaline (epinephrine) (as acid tartrate) 100 micrograms/20 mL. The pH of the solution is between 3.0 - 5.5. Excipient with known effect: contains sulfites. For the full list of excipients, see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM Bupivacaine 0.5% with Adrenaline 1:200,000 Phebra is a sterile, clear, colourless, or almost colourless isotonic aqueous solution for injection or infusion. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Bupivacaine 0.5% with Adrenaline 1:200,000 Phebra 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 • Intermittent bolus epidural administration for analgesia in postoperative pain or labour pain • Field block (minor nerve block and infiltration) 4.2 D OSE AND METHOD OF ADMINISTRATION _Bupivacaine 0.25% with adrenaline (epinephrine) solution for injection, and bupivacaine 0.125%, 0.25%, 0.375% _ _and 0.5% solutions for injection, are unavailable in this brand however are available in other brands. _ _Where correct dosing requires a lower concentration of bupivacaine with adrenaline (epinephrine), or a bupivacaine _ _solution without adrenaline (epinephrine), products from other suppliers should be used. _ PRODUCT INFORMATION BUPIVACAINE 0.5% WITH ADRENALINE 1:200,000 PHEBRA Australian Product Information Bupi Read the complete document