DEXAMETHASONE Solution for injection (2018)
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Περιεχόμενα
Name of the medicinal product
Dexamethasone 3.8 mg/ml solution for injection.
Qualitative and quantitative composition
Each one ml contains 3.8 mg dexamethasone (as sodium phosphate) which is equivalent to 5.0 mg dexamethasone sodium phosphate. Excipient with known effect: Sodium: <1 mmol sodium (23 mg) per dose. For the ...
Pharmaceutical form
Solution for injection. Colourless aqueous solution.
Therapeutic indications
Corticosteroid. For use in certain endocrine and non-endocrine disorders responsive to corticosteroid therapy. Systemic (intravenous or intramuscular) administration Dexamethasone solution for injection ...
Posology and method of administration
DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. In neonates, especially the premature infant, only preservative-free ...
Contraindications
Systemic infection unless specific anti-infective therapy is employed. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Local injection of a glucocorticoid is ...
Special warnings and precautions for use
A Patient Information Leaflet should be supplied with this product. Severe allergic reactions Rare instances of anaphylactoid/anaphylactic reactions with a possibility of shock have occurred in patients ...
Interaction with other medicinal products and other forms of interaction
Rifampicin, rifabutin, ephedrine, carbamazepine, phenylbutazone, phenobarbital, phenytoin, primidone, and aminoglutethimide enhance the metabolism of corticosteroids and its therapeutic effects may be ...
Pregnancy and lactation
Pregnancy The ability of corticosteroids to cross the placenta varies between individual drugs, however, dexamethasone readily crosses the placenta. Administration of corticosteroids to pregnant animals ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
Local adverse reactions include post-injection flare, and a painless destruction of the joint reminiscent of Charcots arthropathy especially with repeated intra-articular injection. The incidence of predictable ...
Overdose
It is difficult to define an excessive dose of a corticosteroid as the therapeutic dose will vary according to the indication and patient requirements. Massive IV corticosteroid doses given as a pulse ...
Pharmacodynamic properties
Pharmacotherapeutic group: Corticosteroids for systemic use, Glucocorticoids ATC code: H02AB02 Dexamethasone is a synthetic adrenocorticoid with approximately a 7 times higher anti-inflammatory potency ...
Pharmacokinetic properties
Absorption After administration of Dexamethasone solution for injection, dexamethasone sodium phosphate is rapidly hydrolysed to dexamethasone. After an IV dose of 20 mg dexamethasone plasma levels peak ...
Preclinical safety data
In animal studies, cleft palate was observed in rats, mice, hamsters, rabbits, dogs and primates; not in horses and sheep. In some cases these divergences were combined with defects of the central nervous ...
List of excipients
Glycerol (E422) Disodium edetate Water for injections Sodium hydroxide (E524) or Phosphoric acid (E338)
Incompatibilities
None known.
Shelf life
Shelf life As packaged for sale: 2 years. The product should be used immediately after first opening. Following dilution with infusion fluids (see section 6.6): Chemical and physical in-use stability of ...
Special precautions for storage
As packaged for sale: Store in a refrigerator (2°C-8°C). Do not freeze. Store in the original package. Following dilution with infusion fluids: See section 6.3.
Nature and contents of container
2 ml colourless glass vial containing 1 ml of solution. Available in cartons of 1 or 10 vials. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Dexamethasone solution for injection may be diluted with the following solutions for injection or infusion: Sodium Chloride 0.9% infusion Glucose 5% Infusion Compound Sodium Lactate Infusion Hartmanns ...
Marketing authorization holder
Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
Marketing authorization number(s)
PL 39699/0060
Date of first authorization / renewal of the authorization
Date of first authorisation: 31 March 1989 Date of latest renewal: 18 June 2010
Date of revision of the text
28/11/2018
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