digifab package insert
DigiFab package insert. Storage And Handling DigiFab is supplied as a carton that contains 1 vial of product diluent not included.
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2017 AHAACCHRS Guideline for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.
. Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information. Although designed specifically to treat digoxin overdose a product very similar to DigiFab Digibind has been used successfully to treat life-threatening digitoxin overdose. NDC 50633-120-11 Store at 2 to 8C 36 to 46F.
It is also indicated for poisoning from other cardioactive steroids. These fragments are obtained from the blood of healthy sheep immunized with a digoxin derivative digoxin-dicarboxymethoxylamine DDMA a digoxin analogue which contains the functionally essential. Relevant identified uses DigiFab is indicated for the treatment of patients with life-threatening or potentially life-threatening digoxin toxicity or overdose.
Improvement in signs and symptoms usually begins in 30 minutes or less. Handles a companys requirements for a complete package that will assist in planning any textile or graphic project. The dosing of DigiFab can vary depending on the amount ingested serum concentration andor suspected chronicity of toxicity.
Must use 022 micron filter. Digoxin immune Fab DigiFab Digibind is an effective antidote for acute acute on chronic and chronic digoxin toxicity. Free digoxin levels are decreased to zero within 1 min of Fab fragment administration but total serum digoxin levels are markedly increased.
Administer second vial if symptoms persist or recur. Standard Dilutions Amount of drug Infusion volume Infusion rate Prescribed dose 50 ml 30 min Note. The dosage of ELCYS should be individualized based on the patients clinical condition ability to adequately metabolize amino acids body weight and nutritionalfluid requirements as well as additional energy given.
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. Product Information Package Insert -. 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.
Poisoning with cardioactive steroid. However cardiac output may remain depressed. Al-Khatib SM Stevenson WG Ackerman MJ et al.
The contents of one 40-mg vial of DigiFab neutralizes approximately 05 mg of digoxin. Calculate DIGIFAB dose by multiplying the serum concentration by the patients weight and dividing by 100. Placebo Normal saline 30 minute IV infusion every 6 hours x 4 days.
Placebo Normal saline 30 minute IV infusion every 6 hours x 4 days. 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. Avoid prolonged or vigorous agitation.
Acute acute on chronic or chronic digoxin toxicity. Gently swirl the solution by rotating the vial to dissolve the lyophilized powder which has a cake-like appearance. The purpose of this web site is to familiarize potential customers with the company and.
Use within 4 hours after reconstitution. Dose 60 kg x 3 ngmL100 18 vials round up to 2 vials. DigiFabs background in the digital printing industry and the years of experience in the software development field make our products the perfect solution for all your graphic digital printing and textile design needs.
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. Use clinical judgment to. We are able to offer a turnkey printing solution that supports digital printing for both the graphic and textile markets.
Administer 12 the calculated dose 1 vial of and monitor the patient closely for persistent or DIGIFAB recurrent signs and symptoms of toxicity. For DigiFab no filtering required please see package insert pdf - FDA. A Report of the American College of CardiologyAmerican Heart Association Task Force on Clinical Practice.
DigiFab is supplied as a sterile purified lyophilized preparation containing 40 mg of digoxin immune Fab protein per vial. Comparative clinical studies have 2 shown that the hemodynamic effects of DIPRIVAN Injectable Emulsion during induction of. For the treatment of patients with life-threatening or potentially life-threatening digoxin toxicity or overdose.
2 nerve impulses presumably by increasing the threshold for electrical excitation in the nerve by slowing the propagation of the nerve impulse and by reducing the rate of rise. DIGIFAB Digoxin Immune Fab Ovine is a sterile lyophilized preparation of digoxin-immune ovine Fab monovalent immunoglobulin fragments. In our continuing effort to accommodate our design and production partners in the textile apparel and graphic industries DigiFab Systems strives to ensure CAD to CAM.
If toxicity not adequately reversed several hours after the dose or if toxicity recurs an additional dose may be necessary. 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. When to Use.
Usually given as a single dose.
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