Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
pantoprazole sodium, Quantity: 42.29 mg (Equivalent: pantoprazole, Qty 40 mg)
Sun Pharma ANZ Pty Ltd
Pantoprazole sodium
Injection, powder for
Excipient Ingredients:
Intravenous
One vial, Ten vials
(S4) Prescription Only Medicine
Short-term use where oral therapy is not appropriate for the following conditions. 1. Symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion, e.g. duodenal ulcer, gastric ulcer, reflux oesophagitis, gastrointestinal lesions refractory to H2 blockers, Zollinger-Ellison syndrome. 2. Maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis.,Note: Patients whose gastric or duodenal ulceration is not associated with ingestion of nonsteroidal anti-inflammatory drugs require treatment with antimicrobial agents in addition to anti-secretory drugs, whether on first presentation or recurrence.
Visual Identification: White to off-white coloured lyophilized cake in a colourless glass vial with a grey rubber stopper and sealed with a red aluminium flip-off cap; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2011-08-16
PANTOPRAZOLE SUN PI V3.0 1 of 5 PANTOPRAZOLE SUN _Pantoprazole (as Sodium) _ CON SUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET? This leafl et answers some common questions about PANTOPRAZOLE SUN. 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 taking PANTOPRAZOLE SUN against the benefits this medicine is expected to have for you. Use PANTOPRAZOLE SUN as directed and follow the advice given in the leaflet. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT PANTOPRAZOLE SUN IS USED FOR ULCER S PANTOPRAZOLE SUN is used to treat and help heal duodenal and gastric ulcers. Depending on the position of the ulcer it is called a gastric or duodenal ulcer. A gastric ulcer occurs in the stomach. A duodenal ulcer occurs in the duodenum which is the tube leading out of the stomach. These can be caused in part by too much acid being made in the stomach. REFLUX DISEASE PANTOPRAZOLE SUN is also used to treat reflux oesophagitis or reflux disease. This can be caused by 'washing back' (reflux) of food and acid from the stomach into the food pipe, also known as the oesophagus. Reflux can cause a burning sensation in the chest rising up to the throat, also known as heartburn. PANTOPRAZOLE SUN is also used to prevent reflux oesophagitis from coming back. ZOLLINGER-ELLISON SYNDROME PANTOPRAZOLE SUN is used to treat a rare condition called Zollinger- Ellison syndrome, where the stomach produces very large amounts of acid, much more than in ulcers and reflux disease. PANTOPRAZOLE SUN belongs to a group of medicines called proton pump inhibitors (PPIs). PANTOPRAZOLE SUN works by decreasing the amount of acid the stomach makes to give relief from the symptoms and allow healing to take place. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY PANTOPRAZOLE SUN HAS BEEN PRESCRIBED FO Les hele dokumentet
PANTOPRAZOLE SUN PI v5.0 1 AUSTRALIAN PRODUCT INFORMATION PANTOPRAZOLE SUN PANTOPRAZOLE (AS SODIUM) POWDER FOR INJECTION 1 NAME OF THE MEDICINE Pantoprazole (present as pantoprazole sodium) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Pantoprazole 40mg powder for injection contains 42.3mg pantoprazole sodium. Pantoprazole sodium is a white to off white amorphous hygroscopic powder. Solubility is low at neutral pH and increases with increasing pH. 3 PHARMACEUTICAL FORM Pantoprazole SUN 40mg powder for injection appears as a white to off white coloured lyophilized cake. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Short-term use where oral therapy is not appropriate for the following conditions. 1. Symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion, e.g. duodenal ulcer, gastric ulcer, reflux oesophagitis, gastrointestinal lesions refractory to H 2 blockers, Zollinger-Ellison syndrome. 2. Maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis. _Note: _ Patients whose gastric or duodenal ulceration is not associated with ingestion of nonsteroidal anti-inflammatory drugs require treatment with antimicrobial agents in addition to anti-secretory drugs, whether on first presentation or recurrence 4.2 D OSE AND METHOD OF ADMINISTRATION _DUODENAL ULCER, GASTRIC ULCER, GASTROINTESTINAL LESIONS REFRACTORY TO H_ _2_ _-BLOCKERS, _ _ZOLLINGER-ELLISON SYNDROME. _ 40 mg/day. _REFLUX OESOPHAGITIS. _ 20 to 40 mg/day. Intravenous Pantoprazole should be replaced with oral therapy as soon as practicable. RENAL IMPAIRMENT The usual daily dose of 20 or 40 mg can be given. HEPATIC IMPAIRMENT Pantoprazole is contraindicated in patients with cirrhosis or severe liver disease (see C ONTRAINDICATIONS ). With milder forms of liver disease, the initial dose should be reduced. PANTOPRAZOLE SUN PI v5.0 2 USE IN CHILDREN There are no data currently available on the use of pantoprazole in children. USE IN THE ELDERLY The usua Les hele dokumentet