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SPC, UK: HYDROCORTISONE 100mg/ml Solution for injection (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Efcortesol Injection. Hydrocortisone 100mg/ml solution for injection. Hydrocortisone 500mg/5ml solution for injection.

Qualitative and quantitative composition

Hydrocortisone Sodium Phosphate 13.39% w/v.

Pharmaceutical form

Solution for injection.

Therapeutic indications

This presentation permits rapid use in emergency situations involving the following conditions: Status asthmaticus and acute allergic reactions, including anaphylactic reaction to drugs. This medicine ...

Posology and method of administration

Undesirable effects may be minimised by using the lowest effective dose for the minimum period. Frequent patient review is required to titrate appropriately the dose against disease activity (see Section ...

Contraindications

Systemic infections, unless specific anti-infective therapy is employed. Live virus immunisation. Hypersensitivity to any component. This medicine should not be injected directly into tendons.

Special warnings and precautions for use

Corticosteroids should NOT be used in the treatment of cerebral oedema associated with acute head injury or cerebrovascular accident, as they are unlikely to be of benefit and may even be harmful. In patients ...

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, hydrocortisone readily crosses the placenta. Administration of corticosteroids to pregnant animals ...

Effects on ability to drive and use machines

None stated.

Undesirable effects

Side effects Paraesthesia may occur following intravenous administration and is probably related to the rate of injection. It is often localised to the genital area but in some cases may radiate over the ...

Overdose

None stated.

Pharmacodynamic properties

Hydrocortisone is a glucocorticoid with anti-inflammatory properties.

Pharmacokinetic properties

Hydrocortisone is readily absorbed from the gastrointestinal tract and peak blood concentrations are attained in about an hour. It is more than 90% bound to plasma proteins. Hydrocortisone is metabolised ...

Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to those in other sections of the SPC.

List of excipients

Disodium edetate Disodium hydrogen phosphate, anhydrous Sodium acid phosphate Sodium formaldehyde bisulphite monohydrate Phosphoric acid (10% solution) Water for injections

Incompatibilities

None known.

Shelf life

Shelf life: 24 months.

Special precautions for storage

Store below 25°C. Keep the ampoules in the outer carton.

Nature and contents of container

1ml and 5ml neutral glass ampoules.

Special precautions for disposal and other handling

No special instructions.

Marketing authorization holder

Amdipharm UK Limited, Capital House, 85 King William Street, London EC4N 7BL, UK

Marketing authorization number(s)

PL 20072/0229

Date of first authorization / renewal of the authorization

13/01/2009

Date of revision of the text

29/10/2018

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