DEXSOL Oral solution (2022)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Contraindications
Hypersensitivity to dexamethasone or any of the excipients listed in section 6.1. Systemic infection unless specific anti*infective therapy is employed. Systemic fungal infections. Stomach ulcer or duodenal ...
Shelf life
2 years. Shelf life after first opening the container: 3 months.
Marketing authorization holder
Rosemont Pharmaceuticals Ltd., Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK
Overdose
Reports of acute toxicity and/or deaths following overdosage with glucocorticoids are rare. No antidote is available. Treatment is probably not indicated for reactions due to chronic poisoning unless the ...
Nature and contents of container
<u>Bottles:</u> 75ml and 150ml in Amber (Type III) glass. <u>Closures:</u> HDPE, EPE wadded, tamper evident, child resistant closure.
Effects on ability to drive and use machines
There are some side effects associated with this product that may affect some patients' ability to drive or operate machinery (see 4.8 Undesirable effects).
List of excipients
Benzoic acid (E420) Propylene glycol (E1520) Citric acid monohydrate Liquid maltitol (E965) Garden mint flavour (containing isopropanol and propylene glycol (E1520)) Liquid sorbitol (non-crystallising) ...
Incompatibilities
Not applicable.
Date of first authorization / renewal of the authorization
8<sup>th</sup> March 2005
Interaction with other medicinal products and other forms of interaction
Effects of other medicinal products on dexamethasone: Dexamethasone is metabolized via cytochrome P450 3A4 (CYP3A4). Concomitant administration of dexamethasone with inducers of CYP3A4, such as phenytoin, ...
Posology and method of administration
Posology Adults General considerations The dosage should be titrated to the individual response and the nature of the disease. In order to minimise side effects, the lowest effective possible dosage should ...
Qualitative and quantitative composition
Dexamethasone 2mg/5ml (as dexamethasone sodium phosphate). Excipients: Propylene glycol (E1520) – 450.6mg/5ml Liquid maltitol (E965) - 1375mg/5ml Sorbitol, liquid (non-crystallising) (E420) - 700mg/5ml ...
Pharmacokinetic properties
Dexamethasone is well absorbed when given by mouth; peak plasma levels are reached between 1 and 2 hours after ingestion and show wide interindividual variations. The mean plasma half life is 3.6 ± 0.9h. ...
Special precautions for disposal and other handling
No special requirement for disposal. Instructions for administration via nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes. Dexsol Oral Solution is suitable for use with the following ...
Undesirable effects
The incidence of predictable undesirable effects, including hypothalamic-pituitary-adrenal suppression correlates with the relative potency of the drug, dosage, timing of administration and the duration ...
Special precautions for storage
Do not store above 25°C. Do not refrigerate. The storage at temperatures higher than 25°C could allow precipitation inside the solution. Do not use the product if solid particles are observed inside the ...
Therapeutic indications
Dexamethasone is a corticosteroid. It is designed for use in certain endocrine and non-endocrine disorders, in certain cases of cerebral oedema and for diagnostic testing of adrenocortical hyperfunction. ...
Marketing authorization number(s)
PL 00427/0137
Pharmacodynamic properties
<b>Pharmacotherapeutic Group:</b> Corticosteroid <b>ATC Code:</b> H02AB02 Dexamethasone is a highly potent and long-acting glucocorticoid with negligible sodium retaining properties and is therefore, particularly ...
Date of revision of the text
18<sup>th</sup> January 2022
Preclinical safety data
In animal studies, cleft palate was observed in rats, mice, hamsters, rabbits, dogs and primates; not in horses and sheep. In some cases these divergences were combined with defects of the central nervous ...
Pharmaceutical form
Oral Solution. A colourless to faint yellow solution with odour of mint.
Pregnancy and lactation
Since adequate human reproduction studies have not been performed with corticosteroids, dexamethasone should not be used during pregnancy for maternal indications, unless it is clearly necessary. The lowest ...
Special warnings and precautions for use
<b>A patient information leaflet should be supplied with this product.</b> Patients should carry steroid treatment cards, which give clear guidance on the precautions to be taken to minimise risk, and ...
Name of the medicinal product
Dexsol 2mg/5ml Oral Solution.
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση: