Šalis: Australija
kalba: anglų
Šaltinis: Department of Health (Therapeutic Goods Administration)
remifentanil hydrochloride, Quantity: 5.5 IU/mg (Equivalent: remifentanil, Qty 5 mg)
Sandoz Pty Ltd
Remifentanil hydrochloride
Injection, powder for
Excipient Ingredients: glycine; nitrogen; hydrochloric acid
Intravenous Infusion, Intravenous Bolus
5
(S8) Controlled Drug
-as an opioid adjunct for use during induction and/or maintenance of general anaesthesia during surgical procedures including cardiac surgery in adults.,-as an opioid adjunct for use during induction and/or maintenance of general anaesthesia during surgical but not cardiac procedures in children aged 1 to 12 years.,-for continuation as an analgesic into the immediate post-operative period under the close supervision of medically qualified persons trained in the use of anaesthetic drugs, during transition to longer acting analgesia following adult cardiac surgery -,when endotracheal intubation and controlled ventilation are anticipated.,-for provision of analgesia and sedation in mechanically ventilated intensive care patients.
Visual Identification: 10mL clear glass vial with a latex-free rubber stopper, containing a white to almost white powder.; 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
2013-03-25
Remifentanil Sandoz powder for injection 1 REMIFENTANIL SANDOZ _ _ REMIFENTANIL [AS HYDROCHLORIDE]_ _POWDER FOR INJECTION_ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Remifentanil Sandoz. 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 being given this medicine 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 REMIFENTANIL SANDOZ IS USED FOR This medicine is used as an anaesthetic with other anaesthetics to produce and/or maintain heavy sleep during your operation. If you are a cardiac patient, it may also be used to help relieve strong pain immediately following your operation. Remifentanil Sandoz may also be used for patients in the Intensive Care Unit to maintain sleep and relieve pain. It contains the active ingredient remifentanil. Remifentanil_ _belongs to a group of medicines called_ _ opioids. It differs from other medicines in this group by its very quick onset and very short duration of action. ASK YOUR DOCTOR OR ANAESTHETIST IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. As with other opioids, this medicine can be addictive. This is unlikely to happen when Remifentanil Sandoz is used during your operation. BEFORE YOU ARE GIVEN REMIFENTANIL SANDOZ _WHEN YOU MUST NOT BE GIVEN REMIFENTANIL SANDOZ _ DO NOT USE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: remifentanil or to any of the other ingredients listed at the end of this leaflet under Product Description. Some of the symptoms of an allergic reaction may include: shortness of breath wheezing or difficulty breathing Remifentanil Sandoz Powder for Injection 2 swelling of the face, lips, ton Perskaitykite visą dokumentą
_Product Information _ _ _ _Page _ _Remifentanil Sandoz 1mg, 2mg, 5mg Powder for Injection _ _02/2016 _ _Sandoz Pty Ltd _ _ _ _Version 04 _ _1_ _ _ PRODUCT INFORMATION REMIFENTANIL SANDOZ ® 1MG, 2MG, 5MG POWDER FOR INJECTION NAME OF THE MEDICINE _Active Ingredient:_ Remifentanil hydrochloride _Chemical Name_: 1-(2-Methoxycarbonyl-ethyl)-4-(phenylpropionyl-amino)- piperidine-4-carboxylic acid methyl ester hydrochloride. _Chemical structure: _ _CAS:_ 132539-07-2 _Empirical formula:_ C 20 H 28 N 2 O 5 .HCl _MW:_ 412.9 DESCRIPTION The log P n-octanol/water is 17.9. Remifentanil HCl possesses no chiral centres. Remifentanil Sandoz Powder for Injection is supplied as sterile, non-pyrogenic, preservative-free lyophilised powder for intravenous administration. The product requires reconstitution and dilution before use. Remifentanil Sandoz 1mg Powder for Injection contains 1mg remifentanil (as hydrochloride). Remifentanil Sandoz 2mg Powder for Injection contains 2mg remifentanil (as hydrochloride). Remifentanil Sandoz 5mg Powder for Injection contains 5mg remifentanil (as hydrochloride). Remifentanil Sandoz Powder for Injection also contains the following inactive ingredients: glycine, hydrochloric acid. PHARMACOLOGY _Product Information _ _ _ _Page _ _Remifentanil Sandoz 1mg, 2mg, 5mg Powder for Injection _ _02/2016 _ _Sandoz Pty Ltd _ _ _ _Version 04 _ _2_ _ _ Pharmacodynamics Remifentanil is a potent, selective, 4-anilidopiperidine μ-opioid agonist with pharmacological action typical of this class of compound. It is distinguished from other 4-anilidopiperidines (fentanyl analogues) by its rapid onset and very short duration of action. The μ-opioid activity of remifentanil is antagonised by naloxone. Remifentanil in humans has a rapid blood-brain equilibration half-time of 1 ± 1 minutes (mean ± SD) and a rapid onset of action. The pharmacodynamic effects of remifentanil closely follow the measured blood concentrations, allowing direct correlation between dose, blood levels and response. Blood concentration decreas Perskaitykite visą dokumentą