Страна: Австралія
мова: англійська
Джерело: Department of Health (Therapeutic Goods Administration)
esomeprazole sodium, Quantity: 42.5 mg (Equivalent: esomeprazole, Qty 40 mg)
Juno Pharmaceuticals Pty Ltd
Esomeprazole sodium
Injection, powder for
Excipient Ingredients: sodium hydroxide; water for injections; disodium edetate
Intravenous
50 x 10mL, 10 x 10mL
(S4) Prescription Only Medicine
The short-term management of Gastro-Oesophageal Reflux Disease (GORD) in patients with oesophagitis and/or severe symptoms of reflux as an alternative when oral therapy is inappropriate.,Prevention of rebleeding in patients following therapeutic endoscopy for acute, bleeding gastric or duodenal ulcers.,Short-term management in patients requiring continued non-steroidal anti-inflammatory drug (NSAID) therapy when oral therapy is inappropriate:,? healing of gastric ulcers associated with NSAID therapy,? prevention of gastric and duodenal ulcers associated with NSAID therapy, in patients at risk,NOTE: Esomeprazole IV should be replaced with oral therapy as soon as practicable.
Visual Identification: Vial containing a white or almost white porous lyophilised powder.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2014-01-30
Esomeprazole AN CMI 1 ESOMEPRAZOLE AN _Esomeprazole sodium_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about Esomeprazole AN. It does not contain all the information that is known about Esomeprazole AN. 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 your being given Esomeprazole AN 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 ESOMEPRAZOLE AN IS USED FOR Esomeprazole AN will only be used if you are unable to take tablets. _REFLUX OESOPHAGITIS_ Esomeprazole AN is used to treat reflux oesophagitis or reflux disease in the short-term. This can be caused by "washing back" (reflux) of food and acid from the stomach into the food pipe (oesophagus). Reflux can cause a burning sensation in the chest rising up to the throat, also known as heartburn. _BLEEDING PEPTIC ULCERS_ Peptic ulcers are ulcers in the stomach or duodenum (tube leading out from the stomach). When these ulcers become severe enough, they start to bleed. Esomeprazole AN can be injected into your veins to treat these bleeding ulcers. Treatment with Esomeprazole AN should be followed with other therapy to reduce the amount of acid made by the stomach. This is to help your ulcer/s to heal. _UPPER GASTROINTESTINAL _ _SYMPTOMS ASSOCIATED _ _WITH NON-STEROIDAL ANTI- _ _INFLAMMATORY DRUGS _ _(NSAIDS) THERAPY_ If you are unable to eat or drink, Esomeprazole AN may be given to treat the symptoms of pain or discomfort in the stomach caused by NSAIDs (medicines used to treat pain or inflammation). Esomeprazole AN may also be used to help and prevent ulcers caused by NSAIDs. HOW ESOMEPRAZOLE AN WORKS Esomeprazole AN is a type of medicine called a proton-pump inhibitor. Esomeprazole AN works by decreasing the amount of acid made by the stomach, t Прочитайте повний документ
Australian Product Information Esomeprazole AN PI v7.0 Page | 1 AUSTRALIAN PRODUCT INFORMATION – ESOMEPRAZOLE AN (ESOMEPRAZOLE (AS SODIUM) 40MG) POWDER FOR INJECTION _ _ 1 NAME OF THE MEDICINE Esomeprazole AN contains esomeprazole sodium 2-3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL FORM Esomeprazole sodium is a white to yellowish white solid. Esomeprazole is a proton pump inhibitor and is a substituted benzimidazole. Esomeprazole is the S-isomer of omeprazole. It is optically stable _in vivo_, with negligible conversion to the R-isomer. ESOMEPRAZOLE AN is available as a white or almost white lyophilized powder for injection. Each vial contains esomeprazole sodium 42.5 mg, equivalent to 40 mg esomeprazole, disodium edetate 1.0 mg and sodium hydroxide q.s. for pH adjustment. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The short-term management of Gastro-Oesophageal Reflux Disease (GORD) in patients with oesophagitis and/or severe symptoms of reflux as an alternative when oral therapy is inappropriate. Prevention of rebleeding in patients following therapeutic endoscopy for acute, bleeding gastric or duodenal ulcers. Short-term management in patients requiring continued non-steroidal anti-inflammatory drug (NSAID) therapy when oral therapy is inappropriate: − healing of gastric ulcers associated with NSAID therapy − prevention of gastric and duodenal ulcers associated with NSAID therapy, in patients at risk NOTE: ESOMEPRAZOLE IV SHOULD BE REPLACED WITH ORAL THERAPY AS SOON AS PRACTICABLE. 4.2 DOSE AND METHOD OF ADMINISTRATION _DOSAGE _ Intravenous esomeprazole should only be used where oral medication is inappropriate e.g. in severely ill patients. Treatment with esomeprazole IV can be given for up to 10 days as part of a full treatment period for the specified indications. When oral therapy is possible or appropriate, intravenous therapy with esomeprazole should be discontinued and the therapy should be continued orally. ESOMEPRAZOLE AN powder for injection contains no antimicrobial Прочитайте повний документ