digifab package insert

If cardiac arrest is imminent it can be given as a bolus injection. The dosage of DIGIFAB will vary according to the amount of digoxin to be neutralized.

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One 10 mL glass vial of DigiFab per pack.

. DIGIFAB is a digoxin immune fab ovine and is indicated for treatment of life-threatening or potentially life- threatening digoxin toxicity or overdose1 DOSAGE AND ADMINISTRATION For intravenous use only 2 Clinical Conditions Dosage Acute ingestion of unknown amounts of digoxin and toxicity in the absence of a serum digitalis concentration or. 1 PRESCRIBING INFORMATION 2 LANOXIN 3 digoxin 4. Production of antibodies specific for digoxin involves conjugation of digoxin as a hapten to human albumin.

FOR INTRAVENOUS ADMINISTRATION. Standard Dilutions Amount of drug Infusion volume Infusion rate Prescribed dose 50 ml 30 min Note. 7 LANOXIN digoxin is one of the cardiac or digitalis glycosides a closely related group of.

Insert the syringe needle into the vial through the center of the rubber stopper and direct the stream of Sterile Water for Injection USP to the glass wall of the vial. Free digoxin levels are decreased to zero within 1 min of Fab fragment administration but total serum digoxin levels are markedly increased. Relevant identified uses DigiFab is indicated for the treatment of patients with life-threatening or potentially life-threatening digoxin toxicity or overdose.

Avoid prolonged or vigorous agitation. DIPRIVAN 3 Propofol INJECTABLE EMULSION USP. Digibind Digoxin Immune Fab Ovine is a sterile lyophilized powder of antigen binding fragments Fab derived from specific antidigoxin antibodies raised in sheep.

Improvement in signs and symptoms usually begins in 30 minutes or less. NDC 50633-120-11 Store at 2 to 8C 36 to 46F. 4 In clinical trials 121 patients who received one n99 2 n21 or 3 n1 doses of VORAXAZE were evaluated for anti-glucarpidase antibodies.

5 WARNINGS AND PRECAUTIONS 51 General - Suicidal ingestion may result from more than one drug. Must use 022 micron filter. 4 CONTRAINDICATIONS There are no known contraindications to the use of DIGIFAB.

Forskningsrådet finansierte DigiFab-prosjektet i. Each vial of DigiFab which will bind approximately 05 mg digoxin contains 40 mg of digoxin immune Fab 75 mg approx of mannitol USP and 2 mg. 500 mcg 05 mg in 2 mL 250 mcg 025 mg per mL 6.

We also offer X-Rites profiling devices such as the i1 Pro i1 Pro 2 and i1 Pro 3. 47 971 79 073. Use within 4 hours after reconstitution.

DigiFab is supplied as a sterile purified lyophilized preparation containing 40 mg of digoxin immune Fab protein per vial. Digoxin-specific antibody fragment FAb Ovine DIGIFAB is administered by the intravenous route over 30 minutes. Alternatively for an acute ingested of an unknown amount where the serum concentration is not available it is recommended that 10 vials of DigiFab be administered empirically.

Storage And Handling DigiFab is supplied as a carton that contains 1 vial of product diluent not included. Add the reconstituted product to an appropriate volume of 09 sodium chloride for injectionVisually inspect reconstituted vials for particulate. 4 5 6.

In Australia any unused medicine or waste material should be disposed of by taking to your local. DigiFab is supplied in a single clear neutral glass vial closed with a butyl rubber stopper and fitted with aluminium flip top seal. Oppstart av DigiFabs kursvirksomhet i regi av Arendal Næringsforening.

7 Rx only. Although designed specifically to treat digoxin overdose a product very similar to DigiFab Digibind has been used successfully to treat life-threatening digitoxin overdose. For DigiFab no filtering required please see package insert pdf - FDA.

1 VIAL GLASS in 1 CARTON 1 INJECTION POWDER FOR. Give 5 vials initially if the patient is hemodynamically stable Give 10 vials initially if the patient is hemodynamically unstable Repeat doses of 5 ampoules should be given every 30 minutes until reversal of digoxin toxicity is achieved In cardiac arrest give 20 vials 760 mg or as many vials as are available if. If you already own a profiling software you can import profiles you created in software packages from companies such as X-Rite Monaco and Gretag McBeth now all under the name X-Rite.

The recommended dose for a given patient can be determined using the tables in the package insert or by contacting a regional poison center or toxicology consultant. Strict aseptic technique must always be maintained during handling. 66 Special Precautions for Disposal.

DIGIFAB is supplied as a sterile purified lyophilized preparation containing 40 mg of digoxin immune Fab protein per vial. Digifab with NDC 50633-120 is a a plasma derivative product labeled by. Consequences of multiple dosing with DIGIFAB have not been evaluated.

36 to 46F for up to 4 hours. Gently swirl the solution by rotating the vial to dissolve the lyophilized powder which has a cake-like appearance. This antidote is expensive 5000 per vial and not always readily available in.

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