DESFERAL Sterile, lyophilised powder (2020)
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Περιεχόμενα
Name of the medicinal product
Desferal Vials, 500mg.
Qualitative and quantitative composition
Each vial contains desferrioxamine mesilate 500mg.
Pharmaceutical form
A sterile, lyophilised powder available in vials containing 500mg of desferrioxamine mesilate.
Therapeutic indications
Treatment for chronic iron overload, e.g. transfusional haemosiderosis in patients receiving regular transfusions e.g. thalassaemia major primary and secondary haemochromatosis in patients in whom concomitant ...
Posology and method of administration
Desferal may be administered parenterally. For parenteral administration The drug should preferably be employed in the form of a 10% solution, e.g. 500 mg: by dissolving the contents of one 500mg vial ...
Contraindications
Hypersensitivity to desferrioxamine mesilate unless the patients can be desensitised.
Special warnings and precautions for use
Renal impairment Desferal should be used with caution in patients with renal impairment since the metal complexes are excreted via the kidneys. In these patients, dialysis will increase the elimination ...
Interaction with other medicinal products and other forms of interaction
Oral administration of vitamin C (up to a maximum of 200 mg daily, given in divided doses) may serve to enhance excretion of the iron complex in response to Desferal; larger doses of vitamin C fail to ...
Pregnancy and lactation
Women of child-bearing potential In women of child-bearing potential, each case the benefits for the mother must be weighed against the risks for the child. Pregnancy There is a limited amount of data ...
Effects on ability to drive and use machines
Patients experiencing CNS effects such as dizziness or impaired vision or hearing should be warned against driving or operating machinery.
Undesirable effects
Adverse reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to ≤1/100); ...
Overdose
Desferal is usually administered parenterally and acute poisoning is unlikely to occur. Signs and symptoms Tachycardia, hypotension and gastro-intestinal symptoms have occasionally occurred in patients ...
Pharmacodynamic properties
<b>Chelating agent</b> <b>ATC code:</b> V03AC01 Desferal is a chelating agent for trivalent iron and aluminium ions; the resulting chelates (ferrioxamine and aluminoxamine) are stable and non-toxic. Neither ...
Pharmacokinetic properties
Absorption Desferrioxamine is rapidly absorbed after intramuscular bolus injection or slow subcutaneous infusion, but only poorly absorbed from the gastrointestinal tract in the presence of intact mucosa. ...
Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.
List of excipients
None present.
Incompatibilities
None known.
Shelf life
36 months.
Special precautions for storage
<u>Vial:</u> Do not store above 25°C. <u>Reconstituted solution:</u> Single use only. From a microbiological point of view, the product should be used immediately after reconstitution (commencement of ...
Nature and contents of container
Each vial contains a white to practically white lyophilisate supplied in a clear glass vial in a pack size of 10 (500 mg).
Special precautions for disposal and other handling
None stated.
Marketing authorization holder
Novartis Pharmaceuticals UK Limited, 2nd Floor, The WestWorks Building, White City Place, 195 Wood Lane, London, W12 7FQ, United Kingdom
Marketing authorization number(s)
PL00101/0523
Date of first authorization / renewal of the authorization
31 October 1997 / 12 December 2000
Date of revision of the text
23 July 2020
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