PREDNISOLONE Suspension for injection (2017)
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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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