Երկիր: Ավստրալիա
Լեզու: անգլերեն
Աղբյուրը: Department of Health (Therapeutic Goods Administration)
bupivacaine hydrochloride, Quantity: 1.25 mg/mL (Equivalent: bupivacaine hydrochloride monohydrate, Qty 1.32 mg/mL); fentanyl citrate, Quantity: 7.9 microgram/mL (Equivalent: fentanyl, Qty 5 microgram/mL)
Aspen Pharmacare Australia Pty Ltd
bupivacaine hydrochloride,Fentanyl citrate
Injection, solution
Excipient Ingredients: sodium chloride; water for injections; hydrochloric acid; sodium hydroxide
Epidural
20mL x 5
(S8) Controlled Drug
Marcain 0.125% with fentanyl is intended for post-operative or obstetric epidural analgesia.
Visual Identification: Clear, colourless solution; Container Type: Ampoule; Container Material: PP; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2006-03-15
MARCAIN WITH FENTANYL 1 MARCAIN WITH FENTANYL _Bupivacaine hydrochloride with fentanyl citrate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about MARCAIN with FENTANYL. It does not contain all the information that is known about MARCAIN with FENTANYL. 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 being given MARCAIN with FENTANYL against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT MARCAIN WITH FENTANYL IS FOR MARCAIN with FENTANYL is used after surgery to treat post- operative pain. It can also be used to make childbirth less painful. MARCAIN 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. FENTANYL belongs to a group of medicines called narcotic analgesics. It is a powerful drug used to relieve pain. MARCAIN with FENTANYL is a combination of the two drugs and produces anaesthesia (loss of feeling) and analgesia (pain relief). Your doctor will have explained why you are being treated with MARCAIN with FENTANYL 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 another use. Ask your doctor if you want more information. As it contains fentanyl, MARCAIN with FENTANYL can be addictive, but when it is used only to relieve or prevent pain it is unlikely to become habit forming. BEFORE YOU ARE GIVEN MARCAIN WITH FENTANYL _WHEN YOU MUST NOT HAVE IT _ ASK YOUR DOCTOR ABOUT THE RISKS AND BENEFITS OF BEING GIVEN MARCAIN WITH FENTANYL WHILE YOU ARE PREGNANT OR BREASTFEEDING. We do not know if it is safe for you to be Կարդացեք ամբողջական փաստաթուղթը
1 AUSTRALIAN PRODUCT INFORMATION MARCAIN 0.125% WITH FENTANYL 100MCG/20ML INJECTION AMPOULE MARCAIN 0.125% WITH FENTANYL 100MCG/20ML INJECTION VIAL MARCAIN 0.125% WITH FENTANYL 1000MCG/200ML INJECTION BAG BUPIVACAINE HYDROCHLORIDE 1.25MG/ML (AS MONOHYDRATE) WITH FENTANYL 5 MICROGRAM/ML (AS CITRATE) NOT FOR INTRAVENOUS INFUSION UNDER ANY CIRCUMSTANCES 1 NAME OF THE MEDICINE Bupivacaine hydrochloride with fentanyl (as citrate). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Marcain 0.125% with fentanyl 5 microgram/mL is a sterile, isotonic aqueous solution containing bupivacaine hydrochloride (as monohydrate) 1.25mg/mL and fentanyl (as citrate) 5 microgram/mL as the active ingredients. They also contain sodium chloride and water for injections with nominal osmolality of 298mOsmol/kg. The pH of the solution is adjusted with sodium hydroxide or hydrochloric acid to remain between 4.0- 6.5 during the approved shelf-life. 3 PHARMACEUTICAL FORM A clear, colourless solution for injection or infusion. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Marcain 0.125% with fentanyl 5 microgram/mL is intended for post-operative or obstetric epidural analgesia. 4.2 D OSE AND METHOD OF ADMINISTRATION The lowest dosage that results in effective analgesia should be used and should be based on the status of the patient and the analgesia required. 2 RECOMMENDED DOSAGES FOR MARCAIN 0.125% WITH FENTANYL 5 microgram/mL FOR INFUSION FOR ANALGESIA IN THE AVERAGE HEALTHY 70KG ADULT PATIENT. PROCEDURE VOLUME DOSE bupivacaine fentanyl OBSTETRICS/GYNAECOLOGY EPIDURAL/CAUDAL (vaginal delivery, vacuum extraction, first, second stage) Bolus dose, 6 - 10 mL 7.5 - 12.5 mg 30 - 50 if required microgram followed by EPIDURAL INFUSION 4 - 10 ML/HR 5 - 12.5 MG/HR 20 - 50 MICROGRAM/HR POSTOPERATIVE ANALGESIA EPIDURAL Bolus dose, 6 - 10 mL 7.5 - 12.5 mg 30 - 50 if required microgram followed by EPIDURAL INFUSION* 4 - 10 ML/HR 5 - 12.5 MG/HR 20 - 50 MICROGRAM/HR MAXIMUM HOURLY DOSE (INFUSION + BOLUS) 10 mL 12.5 mg 50 microgram * for up to 48 h Կարդացեք ամբողջական փաստաթուղթը