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 Φάρμακα Α - Ζ  Συγχορήγηση  Μητρότητα

PREDNISOLONE Suspension for injection (2017)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Deltastab 25 mg/ml Suspension for Injection. Prednisolone acetate 25mg/ml Suspension for Injection.

Qualitative and quantitative composition

Each ampoule contains 25 mg Prednisolone Acetate. Excipient(s) with known effect: Sodium chloride (9 mg/ml) Sodium carboxymethylcellulose (Blanose 7 M8SF) (5 mg/ml) Sodium hydroxide (q.s.) Benzyl alcohol ...

Pharmaceutical form

Suspension for Injection. A white or almost white suspension.

Therapeutic indications

This medicine is indicated in adults for the local treatment, by intra-articular or periarticular injection, of the following conditions: rheumatoid arthritis; osteoarthritis; synovitis not associated ...

Posology and method of administration

Posology Undesirable effects may be minimised by using the lowest effective dose for the minimum period and by administering the daily requirement as a single morning dose or whenever possible, as a single ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Systemic infections, unless specific anti-infective therapy is employed. Vaccination with live vaccines (see ...

Special warnings and precautions for use

A patient information leaflet should be supplied with this product. Patients should carry steroid treatment cards which give clear guidance on the precautions to be taken to minimise risk and provide details ...

Interaction with other medicinal products and other forms of interaction

Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the ...

Pregnancy and lactation

Pregnancy The ability of corticosteroids to cross the placenta varies between individual drugs. However, 88% of prednisolone is inactivated as it crosses the placenta. Administration of corticosteroids ...

Effects on ability to drive and use machines

This medicine has no or negligible influence on the ability to drive and use machines.

Undesirable effects

The incidence of predictable undesirable effects, including hypothalamo-pituitary-adrenal (HPA) suppression, correlates with the relative potency of the drug, dosage, timing of administration and the duration ...

Overdose

Management Overdosage is unlikely with this medicine but there is no specific antidote available. Treatment should be symptomatic.

Pharmacodynamic properties

Pharmacotherapeutic group: Glucocorticoids ATC code: H02AB Prednisolone is a glucocorticoid which has anti-inflammatory activity.

Pharmacokinetic properties

Absorption Absorption following intramuscular injection is relatively slow. Systemic absorption occurs slowly after local, intra-articular injection. Distribution Prednisolone is extensively bound to plasma ...

Preclinical safety data

There is no pre-clinical data of relevance to a prescriber which is additional to that already included in other sections of the SmPC.

List of excipients

Water for injections Sodium chloride for injections Benzyl alcohol Sodium carboxymethylcellulose (Blanose 7M8SF) Polysorbate 80 (Tween 80) With sodium hydroxide and/or sterile sodium hydroxide and/or hydrochloric ...

Incompatibilities

Not applicable.

Shelf life

3 years.

Special precautions for storage

Store at 15°C-25°C and protect from light.

Nature and contents of container

1ml flint neutral glass ampoules. 10 ampoules are packed in a polystyrene pack within a cardboard sleeve.

Special precautions for disposal and other handling

Shake the ampoule well before use. 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, United Kingdom

Marketing authorization number(s)

PL 20072/0222

Date of first authorization / renewal of the authorization

01/04/1993

Date of revision of the text

20/10/2017

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