Negara: Selandia Baru
Bahasa: Inggris
Sumber: Medsafe (Medicines Safety Authority)
Pantoprazole sodium sesquihydrate 45.1mg equivalent to Pantoprazole 40 mg; ;
Viatris Limited
Pantoprazole sodium sesquihydrate 45.1 mg (equivalent to Pantoprazole 40 mg)
40 mg
Enteric coated tablet
Active: Pantoprazole sodium sesquihydrate 45.1mg equivalent to Pantoprazole 40 mg Excipient: Calcium stearate Crospovidone Mannitol Methacrylic acid copolymer Opadry yellow 02B520025 Povidone Purified water Sodium carbonate Triethyl citrate
Blister pack, Dessicant PE/aluminium, 30 tablets
Prescription
Prescription
Mylan Laboratories Limited
1. For the symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion: - Duodenal ulcer
Package - Contents - Shelf Life: Blister pack, Polyamide/PVC/aluminium or Dessicant PE/aluminium - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Polyamide/PVC/aluminium or Dessicant PE/aluminium - 100 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE with 2 in 1 desiccant - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE with 2 in 1 desiccant - 90 tablets - 36 months from date of manufacture stored at or below 25°C 100 days opened stored at or below 25°C - Bottle, plastic, HDPE with 2 in 1 desiccant - 100 tablets - 36 months from date of manufacture stored at or below 25°C 100 days opened stored at or below 25°C - Bottle, plastic, HDPE - 100 tablets - 36 months from date of manufacture stored at or below 25°C 100 days opened stored at or below 25°C
2010-01-14
Page 1 of 4 NEW ZEALAND CONSUMER MEDICINE INFORMATION PANZOP RELIEF _PANTOPRAZOLE ENTERIC-COATED TABLETS 20 MG & 40 MG_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Panzop Relief. 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 Panzop Relief 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 WITH THE MEDICINE. You may need to read it again. WHAT PANZOP RELIEF IS USED FOR Panzop Relief contains the active ingredient pantoprazole. It belongs to a group of medicines called Proton Pump Inhibitors or PPIs. ULCERS Panzop Relief is used to treat or help heal peptic ulcers of the stomach and duodenum. These can be caused in part by too much acid being made in the stomach. Panzop Relief is also used to help stop duodenal ulcers re-occurring. REFLUX OESOPHAGITIS Panzop Relief is used to treat reflux oesophagitis or reflux disease. This is 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. HELICOBACTER PYLORI Panzop Relief can also be used in combination with certain antibiotics to help eliminate _H. pylori _infections in certain people with ulcers or chronic gastritis. _H. pylori _is a bacteria which is associated with the development of ulcers. ZOLLINGER-ELLISON SYNDROME Panzop Relief is also used to treat a rare condition called Zollinger- Ellision syndrome, where the stomach produces large amounts of acid, much more than in ulcers or reflux disease. Panzop Relief 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 THIS MEDICINE HAS BEEN PRESCRIBED F Baca dokumen lengkapnya
Page 1 of 22 NEW ZEALAND DATA SHEET PANZOP RELIEF 1. PRODUCT NAME Panzop Relief, 20 mg and 40 mg, gastro-resistant tablet. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Panzop Relief 20 mg tablets contain pantoprazole sodium sesquihydrate 22.55 mg, equivalent to pantoprazole 20 mg. Panzop Relief 40 mg tablets contain pantoprazole sodium sesquihydrate 45.100 mg, equivalent to pantoprazole 40 mg. Excipient(s) with known effect: mannitol, povidone, sodium carbonate, triethyl citrate. Allergen declaration: sulfites and gluten from wheat. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Panzop Relief 20 mg tablets are dark yellow, oval, biconvex, enteric coated tablets, plain on both sides and approximately 4.3 mm x 8.4 mm. Panzop Relief 40 mg tablets are dark yellow, oval, biconvex, enteric coated tablets, plain on both sides and approximately 5.7 mm x 11.6 mm. 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS_ 1. For the symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion: • Duodenal ulcer • Gastric ulcer • Gastro-oesophageal reflux disease (GORD) • For the treatment of mild reflux disease and associated symptoms (e.g. heartburn, acid regurgitation, pain on swallowing) • Reflux oesophagitis • Zollinger-Ellison Syndrome 2. Eradication of Helicobacter pylori (hereinafter referred to as H. pylori) in combination with • clarithromycin and amoxycillin or • clarithromycin and metronidazole or • amoxycillin and metronidazole (see section 4.2) in cases of duodenal ulcer and gastric ulcer with the objective of reducing the recurrence of duodenal and gastric ulcers caused by this microorganism. Page 2 of 22 The NIH have recommended that regimens to eradicate H. pylori in patients with PUD should contain both anti-secretory agents and anti-microbial agents (to which H. pylori has been demonstrated to be sensitive _ in vivo_). A trial by Bardhan in patients with gastritis, florid duodenal ulcer or history of duodenal ulcer has Baca dokumen lengkapnya