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SPC, UK: Dexsol 2mg/5ml Oral Solution (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Rosemont Pharmaceuticals Limited
Διεύθυνση :
Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, Yorkshire, LS11 9XE
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Name of the medicinal product

Dexsol 2mg/5ml Oral Solution.

Qualitative and quantitative composition

Dexamethasone 2mg/5ml (as dexamethasone sodium phosphate). Excipients: Propylene glycol 450mg/5ml Garden mint flavour (containing 0.61mg/5ml propylene glycol) Liquid maltitol 1375mg/5ml Liquid sorbitol ...

Pharmaceutical form

Oral Solution. A colourless to faint yellow solution with odour of mint.

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. ...

Posology and method of administration

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 be used ...

Contraindications

Hypersensitivity to dexamethasone or any of the excipients listed. Systemic infection unless specific anti-infective therapy is employed. Systemic fungal infections. Stomach ulcer or duodenal ulcer. Infection ...

Special warnings and precautions for use

Patients should carry steroid treatment cards, which give clear guidance on the precautions to be taken to minimise risk, and which provides details of prescriber, drug, dosage and the duration of treatment. ...

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, ...

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 ...

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).

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 ...

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 ...

Pharmacodynamic properties

Pharmacotherapeutic Group: Corticosteroid ATC Code: H02AB02 Dexamethasone is a highly potent and long-acting glucocorticoid with negligible sodium retaining properties and is therefore, particularly suitable ...

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. ...

Preclinical safety data

Toxicity: Cleft palate is observed in rats, mice, hamsters, rabbits, dogs and primates. It is not observed in horses and sheep. Sometime abnormalities were accompanied by defects from the central nervous ...

List of excipients

Benzoic acid Propylene glycol Citric acid monohydrate Liquid maltitol Garden mint flavour (containing isopropanol and propylene glycol) Liquid sorbitol non-crystallising Sodium citrate Purified water ...

Incompatibilities

Not applicable.

Shelf life

Shelf Life: 2 years. Shelf life after first opening the container: 3 months.

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 ...

Nature and contents of container

Bottles: 75ml and 150ml in Amber (Type III) glass. Closures: HDPE, EPE wadded, tamper evident, child resistant closure.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Rosemont Pharmaceuticals Ltd. Rosemont House Yorkdale Industrial Park Braithwaite Street Leeds LS11 9XE UK

Marketing authorization number(s)

PL 00427/0137

Date of first authorization / renewal of the authorization

Date of first authorisation: 08th March 2005

Date of revision of the text

06 September 2012
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