Pajjiż: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
ropivacaine hydrochloride
Pfizer Australia Pty Ltd
Ropivacaine hydrochloride
Registered
ROPIVACAINE PFIZER ® _Ropivacaine hydrochloride_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ROPIVACAINE PFIZER. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using Ropivacaine Pfizer against the benefits it is expected to 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 ROPIVACAINE PFIZER IS USED FOR ROPIVACAINE PFIZER 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, ROPIVACAINE PFIZER will either totally stop pain or will cause a partial loss of feeling. ROPIVACAINE PFIZER is used as an anaesthetic to stop the pain of surgery and/or to make childbirth less painful. ROPIVACAINE PFIZER is also used after surgery to treat post- operative pain. Your doctor will have explained why you are being treated with ROPIVACAINE PFIZER 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. ROPIVACAINE PFIZER is not addictive. BEFORE YOU ARE GIVEN ROPIVACAINE PFIZER _WHEN YOU MUST NOT USE IT_ ROPIVACAINE PFIZER 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 • prob Aqra d-dokument sħiħ
Version: pfpropvi10514 Supersedes: pfpropii10913 Page 1 of 22 PRODUCT INFORMATION ROPIVACAINE PFIZER ROPIVACAINE HYDROCHLORIDE NOT FOR INTRAVENOUS ADMINISTRATION UNDER ANY CIRCUMSTANCES NAME OF THE MEDICINE The active ingredient in ROPIVACAINE PFIZER ® is ropivacaine hydrochloride. The CAS number for the free base is 84057-95-4. The molecular formula of Ropivacaine hydrochloride is C 17 H 26 N 2 O·HCl. The chemical name for ropivacaine hydrochloride is (_S_)-(-)-propyl-piperidine-2-carboxylic acid (2,6-dimethyl-phenyl)-amide hydrochloride. The chemical structure of ropivacaine hydrochloride is: DESCRIPTION Ropivacaine hydrochloride monohydrate is a white crystalline powder and has a water solubility of about 50 mg/mL. Ropivacaine hydrochloride was developed as the pure S-(-)- isomer and has an enantiomeric purity of > 99%. It has a pKa of 8.1 (at 25 °C) and a molecular weight of 328.89. The pH of a saturated solution of ropivacaine hydrochloride is 4.5 and that of a 1% (w/v) aqueous solution is 5.0. ROPIVACAINE PFIZER solution for injection is a sterile, isotonic, isobaric, aqueous solution of ropivacaine HCl in Water for Injections BP. The pH of the solution is adjusted with sodium hydroxide or hydrochloric acid to remain between 4.0 - 6.0 during the approved shelf-life. The nominal osmolality of ROPIVACAINE PFIZER 0.2% (2 mg/mL) is 288 mosmol/kg. The solution is preservative free. Version: pfpropvi10514 Supersedes: pfpropii10913 Page 2 of 22 Product is for single use in one patient only. Any solution remaining from an opened container should be discarded. PHARMACOLOGY Ropivacaine has both anaesthetic and analgesic effects. At higher doses it produces surgical anaesthesia with motor block, while at lower doses it produces a sensory block including analgesia with little motor block. The duration and intensity of ropivacaine sensory block is not improved by the addition of adrenaline. Ropivacaine, like other local anaesthetics, causes reversible blockade of impulse propagation along nerve fibres by preventi Aqra d-dokument sħiħ