NEXIUM Powder for solution for injection / infusion (2017)
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Περιεχόμενα
Name of the medicinal product
Nexium I.V. 40 mg Powder for solution for injection/infusion.
Qualitative and quantitative composition
Each vial contains esomeprazole 40 mg (as sodium salt). Excipient(s) with known effect: This medicinal product contains <1 mmol sodium (23 mg) per 40 mg, i.e. essentially sodium free. For the full list ...
Pharmaceutical form
Powder for solution for injection/infusion. White to off-white porous cake or powder.
Therapeutic indications
Nexium for injection and infusion is indicated in adults for: Gastric antisecretory treatment when the oral route is not possible, such as:Gastroesophageal reflux disease (GERD) in patients with esophagitis ...
Posology and method of administration
Posology Adults Gastric antisecretory treatment when the oral route is not possible Patients who cannot take oral medication may be treated parenterally with 20–40 mg once daily. Patients with reflux 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 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 (uncommon) have been reported (see section 4.8). If affected ...
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 an oral dose of 280 mg were gastrointestinal symptoms and weakness. Single oral doses of 80 ...
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
Distribution The apparent volume of distribution at steady state in healthy subjects is approximately 0.22 l/kg body weight. Esomeprazole is 97% plasma protein bound. Biotransformation Esomeprazole is ...
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
Disodium edetate Sodium hydroxide (for pH adjustment)
Incompatibilities
This medicinal product must not be used with other medicinal products except those mentioned in section 6.6.
Shelf life
2 years in all climate zones. Shelf-life after reconstitution: Chemical and physical in-use stability has been demonstrated for 12 hours at 30°C. From a microbiological point of view, the product should ...
Special precautions for storage
Store in the original package, in order to protect from light. Vials can however, be stored exposed to normal indoor light outside the box for up to 24 hours. Do not store above 30°C.
Nature and contents of container
5ml vial made of colourless borosilicate glass, type I. Stopper made of bromobutyl latex-free rubber, cap made of aluminium and a plastic flip-off seal. Pack sizes: 1 vial, 10 vials. Not all pack sizes ...
Special precautions for disposal and other handling
The reconstituted solution should be inspected visually for particulate matter and discoloration prior to administration. Only clear solution should be used. For single use only. If the entire reconstituted ...
Marketing authorization holder
AstraZeneca UK Limited, 600 Capability Green, Luton, LU1 3LU, United Kingdom
Marketing authorization number(s)
PL 17901/0221
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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