{"id":1241,"date":"2012-03-28T00:00:00","date_gmt":"2012-03-28T00:00:00","guid":{"rendered":"https:\/\/protherics2.aazzxx.com\/news\/digifab-40-mg-vial-digoxin-immune-fab\/"},"modified":"2022-09-08T09:54:17","modified_gmt":"2022-09-08T09:54:17","slug":"digifab-40-mg-vial-digoxin-immune-fab","status":"publish","type":"news","link":"https:\/\/serb.com\/nl\/news\/digifab-40-mg-vial-digoxin-immune-fab\/","title":{"rendered":"DigiFab\u00ae 40 mg\/vial digoxin immune Fab"},"content":{"rendered":"

Powder for solution for infusion Launched in the UK,<\/strong><\/em><\/p>\n

BTG, the specialist healthcare company today announces the launch of DigiFab\u00ae in the UK through Protherics Medicines Development Limited, a BTG International group company. DigiFab\u00ae is indicated for the treatment of patients with known (or strongly suspected) life-threatening digoxin toxicity associated with ventricular arrhythmias or bradyarrhythmias unresponsive to atropine where measures beyond withdrawal of digoxin and correction of serum electrolyte abnormalities are considered necessary.<\/p>\n

Digoxin and digoxin toxicity<\/strong><\/p>\n

Digoxin is indicated in the management of chronic cardiac failure where the dominant problem is systolic dysfunction and its therapeutic benefit is greatest in patients with ventricular dilatation. Digoxin is also indicated where cardiac failure is accompanied by atrial fibrillation and in the management of certain supraventricular arrhythmias, particularly chronic atrial flutter and fibrillation.<\/p>\n

Diagnosis of digoxin toxicity may be difficult due to variations in presentation, which may include nausea, vomiting and hypotension as well as additional non-specific symptoms. However, there are certain risk factors which are associated with heightened susceptibility including1,2:<\/p>\n

Advanced age (>80 years)
\nDecrease in renal clearance or loss of renal function due to chronic disease
\nHypokalemia
\nHypomagnesemia
\nHypothyroidism
\nMultiple concomitant prescription drugs
\nConcurrent use of macrolide antibiotics
\nConcurrent use of drugs that impair renal function
\nConcurrent use of drugs that cause hypokalemia
\nFurther information on the symptoms and diagnosis of digoxin toxicity is available for UK physicians in the UK Healthcare Professional area of BTG\u2019s website, accessible through the link at the bottom of this press release.<\/p>\n

In addition, as part of our on-going efforts to learn more about the use of DigiFab\u00ae in clinical practice, we have developed a DigiFab\u00ae UK registry, also accessible in the Healthcare Professionals area of our website. The information we will be gathering is non-personal demographic data, presentation and admission symptoms and signs, DigiFab\u00ae dosage regimens and the capture of any suspected adverse events that may occur. This information will allow BTG to continue to monitor the safety of DigiFab\u00ae, as well as to tailor future educational programs and communications to patients and healthcare professionals in order to maintain the safe and effective use of our products.<\/p>\n

DigiFab\u00ae: Important Safety Information3<\/strong><\/p>\n

As with any intravenous product, infusion-related reactions or hypersensitivity reactions are possible. It is recommended that patients are monitored for signs and symptoms of anaphylaxis and an acute allergic reaction. Medical support must be readily available when DigiFab\u00ae is administered. If an anaphylactic reaction occurs during an infusion then administration of DigiFab\u00ae must be stopped immediately.<\/p>\n

The likelihood of an allergic reaction may be higher in subjects who:<\/p>\n

Are allergic to sheep-derived proteins (as may be found in cheeses and meats). DigiFab\u00ae is produced from sheep protein.
\nAre allergic to papain, an extract of the papaya fruit. Papain is used to cleave the whole antibody into Fab and Fc fragments; traces of papain or inactivated papain residues may be present in DigiFab\u00ae. Papain shares allergenic structures with (i) chymopapain and other papaya extracts. (ii) bromelain found in pineapple. (iii) dust mite allergens and (iv) latex allergens.
\nExacerbation of low cardiac output states and congestive heart failure or a rapid ventricular response in patients with atrial fibrillation may occur owing to withdrawal of effect of digoxin.<\/p>\n

Adverse reactions may occur up to 14 days after the infusion has been administered.<\/p>\n

References:<\/p>\n

Wofford JL, Ettinger WH. Risk factors and manifestations of digoxin toxicity in the elderly. Am J Emerg Med. 1991;9(suppl 1):11-15
\nSchreiber D. Toxicity, digitalis. eMedicine from WebMD Web site. http:\/\/emedicine.medscape.com\/article\/814404-print. Updated December 2, 2009. Accessed June 11, 2010.
\nDigiFab\u00ae Summary of Product Characteristics. Protherics UK limited, Llandysul. 1 July 2011.
\nFor further information please contact:<\/p>\n

BTG<\/p>\n

Ashley Tapp, Communications Manager<\/p>\n

Tel +44 (0)20 7575 1513<\/p>\n","protected":false},"excerpt":{"rendered":"

Powder for solution for infusion Launched in the UK, BTG, the specialist healthcare company today announces the launch of DigiFab\u00ae in the UK through Protherics Medicines Development Limited, a BTG International group company. 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