PREDNISOLONE Suppositories (2017)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
Name of the medicinal product
Prednisolone 5mg Suppositories.
Qualitative and quantitative composition
One suppository contains 5mg prednisolone as the sodium phosphate ester. For the full list of excipients, see section 6.1.
Pharmaceutical form
Suppository. Cream coloured, oval shaped waxy suppositories.
Therapeutic indications
Prednisolone is a glucocorticosteroid which is about four times as potent as hydrocortisone on a weight for weight basis. Prednisolone 5mg Suppositories are indicated for the treatment of haemorrhagic ...
Posology and method of administration
Posology Adults and paediatric population One suppository inserted at night and one in the morning after defaecation. When the response is good, treatment is usually continued for some months. If symptoms ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Systemic or local infection unless specific anti-infective therapy is employed.
Special warnings and precautions for use
Although Prednisolone 5mg Suppositories are applied locally, it should be borne in mind that there is likely to be substantial systemic absorption, especially when the bowel is inflamed. Undesirable effects ...
Interaction with other medicinal products and other forms of interaction
Systemic absorption of prednisolone should be borne in mind, especially when there is local inflammation. Thus the following interactions are possible: Co-treatment with CYP3A inhibitors, including cobicistat-containing ...
Pregnancy and lactation
Pregnancy There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
A wide range of psychiatric reactions including affective disorder (such as irritable, euphoric, depressed and labile mood and suicidal thoughts), psychotic reactions (including mania, delusions, hallucinations ...
Overdose
Treatment is unlikely to be needed in cases of acute overdosage.
Pharmacodynamic properties
ATC: A07EA01 Prednisolone sodium phosphate is an active corticosteroid with topical anti-inflammatory activity.
Pharmacokinetic properties
Biotransformation Corticosteroids are metabolised mainly in the liver but also in the kidney and are excreted in the urine. Synthetic corticosteroids such as prednisolone have increased potency when compared ...
Preclinical safety data
None stated.
List of excipients
Witepsol H15
Incompatibilities
None known.
Shelf life
2 years.
Special precautions for storage
Store below 25°C.
Nature and contents of container
Fin sealed plastic cavities moulded from 100 micron non-toxic PVC. Each cartoned plastic mould contains 10 suppositories (2 strips of 5 suppositories).
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
RPH Pharmaceuticals AB, Lagervägen 7, 136 50 Jordbro, Sweden
Marketing authorization number(s)
PL 36301/0055
Date of first authorization / renewal of the authorization
23/02/1993 / 19/05/2003
Date of revision of the text
31/10/2017
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