NEXIUM Gastro-resistant granules (2017)
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Περιεχόμενα
Name of the medicinal product
Nexium 10 mg gastro-resistant granules for oral suspension, sachet.
Qualitative and quantitative composition
Each sachet contains: 10 mg esomeprazole (as magnesium trihydrate). Excipients with known effect: Each sachet contains 6.8 mg sucrose and 2.8 g glucose. For the full list of excipients, see section 6.1. ...
Pharmaceutical form
Gastro-resistant granules for oral suspension, sachet. Pale yellow fine granules. Brownish granules may be visible.
Therapeutic indications
Nexium oral suspension is primarily indicated for: Paediatric population Children 1-11 years old Gastroesophageal Reflux Disease (GERD): Treatment of endoscopically proven erosive reflux esophagitis. ...
Posology and method of administration
Posology Paediatric population Children 1–11 years with a bodyweight of ≥10 kg Gastroesophageal Reflux Disease (GERD): Treatment of endoscopically proven erosive reflux esophagitis:Weight ≥10 - <20 kg: ...
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 medicinal products Protease inhibitors Omeprazole has been reported to interact with some protease inhibitors. The clinical importance and the mechanisms ...
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 inhibitor 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
Esomeprazole granules: Glycerol monostearate 40-55 Hydroxypropyl cellulose Hypromellose Magnesium stearate Methacrylic acid–ethyl acrylate copolymer (1:1) dispersion 30% Polysorbate 80 Sugar spheres (sucrose ...
Incompatibilities
Not applicable.
Shelf life
3 years. To be used within 30 minutes after reconstitution.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Carton containing 28 or 30 sachets. Not all pack sizes may be marketed. Sachets (containing granules): Laminate consisting of three layers: polyethylene terephthalate (PET), aluminium, low density polyethylene ...
Special precautions for disposal and other handling
No special requirements for disposal. For patients who have a nasogastric or gastric tube in place For a 10 mg dose, add the contents of a 10 mg sachet into 15 ml of water. For a 20 mg dose add the contents ...
Marketing authorization holder
AstraZeneca UK Limited, Horizon Place, 600 Capability Green, Luton, Bedfordshire, LU1 3LU, United Kingdom
Marketing authorization number(s)
PL 17901/0253
Date of first authorization / renewal of the authorization
Date of first authorisation: 28 July 2008 Date of latest renewal: 10 March 2010
Date of revision of the text
29<sup>th</sup> May 2017
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