NEXIUM Gastro-resistant tablet (2017)
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Περιεχόμενα
Name of the medicinal product
Nexium 20 mg gastro-resistant tablets.
Qualitative and quantitative composition
Each gastro-resistant tablet contains 22.3 mg esomeprazole magnesium trihydrate equivalent to 20 mg esomeprazole. Excipient(s) with known effect: Each gastro-resistant tablet contains 28 mg sucrose. For ...
Pharmaceutical form
Gastro-resistant tablet. A light-pink, oblong, biconvex, film-coated tablet engraved 20 mg on one side and A / EH on the other side.
Therapeutic indications
Nexium tablets are indicated in adults for: Gastroesophageal Reflux Disease (GERD): Treatment of erosive reflux esophagitis. Long-term management of patients with healed esophagitis to prevent relapse. ...
Posology and method of administration
Posology Adults Gastroesophageal Reflux Disease (GERD): Treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks. An additional 4 weeks treatment is recommended for patients in whom esophagitis ...
Contraindications
Hypersensitivity to the active substance, to substituted benzimidazoles or to any of the excipients listed in section 6.1. Esomeprazole should not be used concomitantly with nelfinavir (see section 4.5). ...
Special warnings and precautions for use
In the presence of any alarm symptom (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melaena) and when gastric ulcer is suspected or present, malignancy should ...
Interaction with other medicinal products and other forms of interaction
Effects of esomeprazole on the pharmacokinetics of other drugs Protease inhibitors Omeprazole has been reported to interact with some protease inhibitors. The clinical importance and the mechanisms behind ...
Fertility, pregnancy and lactation
Pregnancy Clinical data on exposed pregnancies with Nexium are insufficient. With the racemic mixture omeprazole data on a larger number of exposed pregnancies from epidemiological studies indicate no ...
Effects on ability to drive and use machines
Esomeprazole has minor influence on the ability to drive and use machines. Adverse reactions such as dizziness (uncommon) and blurred vision (rare) has been reported (see section 4.8). If affected patients ...
Undesirable effects
Summary of the safety profile Headache, abdominal pain, diarrhoea and nausea are among those adverse reactions that have been most commonly reported in clinical trials (and also from post-marketing use). ...
Overdose
There is very limited experience to date with deliberate overdose. The symptoms described in connection with 280 mg were gastrointestinal symptoms and weakness. Single doses of 80 mg esomeprazole were ...
Pharmacodynamic properties
Pharmacotherapeutic group: Drugs for acid-related disorders proton pump inhibitors ATC code: A02BC05 Esomeprazole is the S-isomer of omeprazole and reduces gastric acid secretion through a specific targeted ...
Pharmacokinetic properties
Absorption Esomeprazole is acid labile and is administered orally as enteric-coated granules. In vivo conversion to the R-isomer is negligible. Absorption of esomeprazole is rapid, with peak plasma levels ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development. ...
List of excipients
Glycerol monostearate 40-55 Hyprolose Hypromellose Iron oxide (reddish-brown and yellow) (E172) Magnesium stearate Methacrylic acid ethyl acrylate copolymer (1:1) dispersion 30 per cent Cellulose microcrystalline ...
Incompatibilities
Not applicable.
Shelf life
3 years. Climate zones III-IV: 18 months.
Special precautions for storage
Do not store above 30°C. Keep the container tightly closed (bottle) in order to protect from moisture. Store in the original package (blister) in order to protect from moisture.
Nature and contents of container
Polyethylene bottle with a tamper-proof, polypropylene screw cap equipped with a desiccant capsule. Aluminium blister package.Bottles of 2, 5, 7, 14, 15, 28, 30, 56, 60, 100, 140(5x28) tablets. Blister ...
Special precautions for disposal and other handling
No special requirements for disposal. Administration through gastric tube Put the tablet into an appropriate syringe and fill the syringe with approximately 25 ml water and approximately 5 ml air. For ...
Marketing authorization holder
AstraZeneca UK Limited, 600 Capability Green, Luton, LU1 3LU, UK
Marketing authorization number(s)
PL 17901/0068
Date of first authorization / renewal of the authorization
Date of first authorisation: 10 March 2005 Date of latest renewal: 10 March 2010
Date of revision of the text
29<sup>th</sup> May 2017
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