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PREDNISOLONE Suppositories (2017)

Αναφορές

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

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση: