Țară: Australia
Limbă: engleză
Sursă: Department of Health (Therapeutic Goods Administration)
ropivacaine hydrochloride, Quantity: 2 mg/mL
Aspen Pharmacare Australia Pty Ltd
Injection, solution
Excipient Ingredients: sodium chloride; sodium hydroxide; water for injections; hydrochloric acid
Epidural, Infiltration, Intracutaneous, Intradermal, Intramuscular, Intraneural, Subcutaneous, Mucosal
5 x 20mL
(S4) Prescription Only Medicine
Surgical anaesthesia (Adults and children over 12 years of age) Epidural block for surgery including caesarean section. Intrathecal anaesthesia. Field block (minor nerve block and infiltration). Major nerve block. Analgesia (Adults and children over 12 years of age) Continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain. Field block (minor nerve block and infiltration). Continuous peripheral nerve block infusion or intermittent injections for post operative pain management. Analgesia (Children aged 0-12 years). Caudal epidural block in neonates (>37 weeks gestation and over 2500g weight), infants and children up to and including 12 years. Continuous epidural infusion in infants (>30 days and over 2500g weight) and children up to and including 12 years. Peripheral nerve block in children aged 1 up to and including 12 years. For peri- and postoperative pain management. There are no safety or efficacy data to support the use of ropivacaine for analgesia for longer than 72 hours. (Data for peripheral nerve block administered as a continuous peripheral infusion or intermittent injections support the use for up to 48 hours only).
Visual Identification: A clear, colourless solution.; Container Type: Ampoule; Container Material: PP; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
1996-01-30
NAROPIN ® 1 NAROPIN ® _Ropivacaine hydrochloride _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about NAROPIN ® . It does not contain all the information that is known about NAROPIN. 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 NAROPIN against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT NAROPIN IS FOR NAROPIN is a local anaesthetic (an- a-set-ik). It is injected into the body where it makes the nerves unable to pass messages to the brain. Depending on the amount used, NAROPIN will either totally stop pain or will cause a partial loss of feeling. NAROPIN is used as an anaesthetic to stop the pain of surgery and/or to make childbirth less painful. NAROPIN is also used after surgery to treat post-operative pain. Your doctor will have explained why you are being treated with NAROPIN 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. NAROPIN is not addictive. BEFORE YOU ARE GIVEN NAROPIN _WHEN YOU MUST NOT USE IT _ NAROPIN must not be used if: 1. YOU HAVE ANY ALLERGIES TO • any ingredient listed at the end of this leaflet • any other local anaesthetics 2. YOU HAVE PROBLEMS CONTROLLING YOUR LOW BLOOD PRESSURE 3. YOU HAVE INFLAMMATION AND/OR AN INFECTION AT THE SITE OF INJECTION _BEFORE YOU START TO USE IT _ • You must tell your doctor if: 1. YOU HAVE ANY ALLERGIES TO OTHER SUBSTANCES 2. YOU HAVE ANY OF THESE MEDICAL CONDITIONS • problems with your blood pressure or circulation • blood poisoning • problems with the clotting of your blood • acidosis, or too much acid i Citiți documentul complet
1 AUSTRALIAN PRODUCT INFORMATION NAROPIN (ROPIVACAINE HYDROCHLORIDE) (INJECTION SOLUTIONS FOR THE PRODUCTION OF LOCAL OR REGIONAL ANAESTHESIA) 1 NAME OF THE MEDICINE Ropivacaine hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredient in NAROPIN ® is ropivacaine hydrochloride. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Injection, solution A clear colourless solution. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS SURGICAL ANAESTHESIA (ADULTS AND CHILDREN OVER 12 YEARS OF AGE) − epidural block for surgery including caesarean section − intrathecal anaesthesia − field block (minor nerve block and infiltration) − major nerve block ANALGESIA (ADULTS AND CHILDREN OVER 12 YEARS OF AGE) − continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain − field block (minor nerve block and infiltration) − continuous peripheral nerve block infusion or intermittent injections for post- operative pain management − continuous wound infusion for postoperative pain management (adults only) ANALGESIA (CHILDREN AGED 0 - 12 YEARS) − Caudal epidural block in neonates (> 37 weeks gestation and over 2500 g weight), infants and children up to and including 12 years − Continuous epidural infusion in infants (> 30 days and over 2500 g weight) and children up to and including 12 years − Peripheral nerve block in children aged 1 up to and including 12 years For peri- and postoperative pain management. NOT FOR INTRAVENOUS ADMINISTRATION UNDER ANY CIRCUMSTANCES 2 There are no safety or efficacy data to support the use of NAROPIN for analgesia for longer than 72 hours. (Data for peripheral nerve block administered as a continuous peripheral infusion or intermittent injections and for continuous wound infusion support the use for up to 48 hours only). 4.2 D OSE AND METHOD OF ADMINISTRATION NAROPIN should only be used by or under the supervision of clinicians experienced in regional anae Citiți documentul complet