MAXOLON Solution for injection (2019)
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Περιεχόμενα
Name of the medicinal product
Maxolon Injection.
Qualitative and quantitative composition
Each 2ml ampoule contains Metoclopramide Hydrochloride BP equivalent to 10mg of the anhydrous substance. Excipient(s) with known effect: Sodium Metabisulphite 1.48mg (0.148 % w/v). For the full list of ...
Pharmaceutical form
Clear colourless solution for intramuscular or intravenous administration.
Therapeutic indications
Adult population <u>Maxolon is indicated in adults for:</u> Prevention of post-operative nausea and vomiting (PONV). Symptomatic treatment of nausea and vomiting, including acute migraine induced nausea ...
Posology and method of administration
Posology Route of administration The solution can be administered intravenously or intramuscularly. Intravenous doses should be administered as a slow bolus (at least over 3 minutes). All indications (adult ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Gastrointestinal haemorrhage, mechanical obstruction or gastro-intestinal perforation for which the stimulation ...
Special warnings and precautions for use
Neurological Disorders Extrapyramidal disorders may occur, particularly in children and young adults, and/or when high doses are used. These reactions occur usually at the beginning of the treatment and ...
Interaction with other medicinal products and other forms of interaction
Contraindicated combination Levodopa or dopaminergic agonists and metoclopramide have a mutual antagonism (see section 4.3). Combination to be avoided Alcohol potentiates the sedative effect of metoclopramide. ...
Pregnancy and lactation
Pregnancy A large amount of data on pregnant women (more than 1000 exposed outcomes) indicates no malformative toxicity, nor foetotoxicity. Metoclopramide can be used during pregnancy if clinically needed. ...
Effects on ability to drive and use machines
Metoclopramide has moderate influence on the ability to drive and use machines. Metoclopramide may cause drowsiness, dizziness, dyskinesia and dystonias which could affect the vision and also interfere ...
Undesirable effects
Adverse reactions listed by System Organ Class. Frequencies are defined using the following convention: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), ...
Overdose
Symptoms Extrapyramidal disorders, drowsiness, decreased level of consciousness, confusion, hallucination, and cardio-respiratory arrest may occur. Management In case of extrapyramidal symptoms related ...
Pharmacodynamic properties
Pharmacotherapeutic group: Agents stimulating gastro-intestinal motility ATC code: A03FA01 The action of metoclopramide is closely associated with parasympathetic nervous control of the upper gastro-intestinal ...
Pharmacokinetic properties
Biotransformation Metoclopramide is metabolised in the liver and the predominant route of elimination of metoclopramide and its metabolites is via the kidney. Renal impairment The clearance of metoclopramide ...
Preclinical safety data
No additional data available.
List of excipients
Sodium chloride Sodium metabisulphite Water for injection
Incompatibilities
Not applicable.
Shelf life
60 months.
Special precautions for storage
Do not store above 25°C. If ampoules are removed from their carton, they should be stored away from light. If inadvertent exposure occurs, ampoules showing discolouration must be discarded.
Nature and contents of container
Clear glass 2ml ampoules (Ph. Eur. Type I neutral glass) in packs of 1 or 12 ampoules or 1 ampoule plus 12 tablets in an aluminium canister as a home visit pack. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Protect from light. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Amdipharm UK Limited, Capital House, 85 King William Street, London, EC4N 7BL, UK
Marketing authorization number(s)
PL 20072/0051
Date of first authorization / renewal of the authorization
16/06/1995
Date of revision of the text
January 2019
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