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SPC, UK: Desferal Vials, 500mg or 2g (2010)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Novartis Pharmaceuticals UK Ltd
Διεύθυνση :
Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR
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Name of the medicinal product

Desferal Vials, 500mg or 2g.

Qualitative and quantitative composition

Each vial contains desferrioxamine mesilate 500mg or 2g.

Pharmaceutical form

A sterile, lyophilised powder available in vials containing 500mg or 2g 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

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 of chelated iron ...

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

Desferal has caused teratogenic effects in animals when given during pregnancy, particularly in the first trimester. In rabbits, desferrioxamine caused skeletal malformations. However, these teratogenic ...

Ικανότητα οδήγησης και χειρισμός μηχανημάτων

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

Chelating agent (ATC code: V03AC01). Desferal is a chelating agent for trivalent iron and aluminium ions; the resulting chelates (ferrioxamine and aluminoxamine) are stable and non-toxic. Neither chelate ...

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

48 months.

Special precautions for storage

Vial: Store below 25°C. Reconstituted solution: Single use only. From a microbiological point of view, the product should be used immediately after reconstitution (commencement of treatment within 3 hours). ...

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) or 1 (2 g).

Special precautions for disposal and other handling

None stated.

Marketing authorization holder

Novartis Pharmaceuticals UK Limited Trading as: Ciba Laboratories Frimley Business Park Frimley Camberley Surrey GU16 7SR

Marketing authorization number(s)

PL 00101/0523

Date of first authorization / renewal of the authorization

31 October 1997 / 12 December 2000

Date of revision of the text

26 April 2010