digifab package insert

Product Information Package Insert -. Free digoxin levels are decreased to zero within 1 min of Fab fragment administration but total serum digoxin levels are markedly increased.

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1 See WARNINGS and DOSAGE AND ADMINISTRATION Handling.

. 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. Standard Dilutions Amount of drug Infusion volume Infusion rate Prescribed dose 50 ml 30 min Note. Chronic digoxin toxicity in the absence of a serum digitalis concentration.

DigiFab is supplied in a single clear neutral glass vial closed with a butyl rubber stopper and fitted with aluminium flip top seal. The contents of one 40-mg vial of DigiFab neutralizes approximately 05 mg of digoxin. The dosing of DigiFab can vary depending on the amount ingested serum concentration andor suspected chronicity of toxicity.

Digoxin immune Fab DigiFab Digibind is an effective antidote for acute acute on chronic and chronic digoxin toxicity. One 10 mL glass vial of DigiFab per pack. Digoxin-specific antibody fragment FAb Ovine DIGIFAB is administered by the intravenous route over 30 minutes.

Must use 022 micron filter. 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. DigiFab is supplied as a sterile purified lyophilized preparation containing 40 mg of digoxin immune Fab protein per vial.

Improvement in signs and symptoms usually begins in 30 minutes or less. The dosage of will vary DIGIFAB according to the amount of digoxin to be neutralized. The purpose of this web site is to familiarize potential customers with the company and.

When to Use. The evaluation of adverse reactions in patients treated with VORAXAZE is confounded by the population in which it was studied patients with toxic plasma methotrexate levels due to. Avoid prolonged or vigorous agitation.

Although designed specifically to treat digoxin overdose a product very similar to DigiFab Digibind has been used successfully to treat life-threatening digitoxin overdose. DigiFab is indicated for the treatment of patients with life-threatening or potentially life-threatening digoxin toxicity or overdose. Use within 4 hours after reconstitution.

If toxicity not adequately reversed several hours after the dose or if toxicity recurs an additional dose may be necessary. Acute Ingestion of Unknown Quantity Administer 20 vials Larger dose has faster onset but may cause febrile reaction. May give 10 vials initially then at.

Relevant identified uses DigiFab is indicated for the treatment of patients with life-threatening or potentially life-threatening digoxin toxicity or overdose. Administer 1 vial of DIGIFAB in Infants and Children 20 Kg. Storage And Handling DigiFab is supplied as a carton that contains 1 vial of product diluent not included.

We are able to offer a turnkey printing solution that supports digital printing for both the graphic and textile markets. Gently swirl the solution by rotating the vial to dissolve the lyophilized powder which has a cake-like appearance. Consequences of multiple dosing with DIGIFAB have not been evaluated.

Poisoning with cardioactive steroid. 66 Special Precautions for Disposal. Usually given as a single dose.

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. If cardiac arrest is imminent it can be given as a bolus injection. Although designed specifically to treat digoxin overdose a product very similar to DigiFab Digibind manufactured by GlaxoSmithKline has been used successfully to treat life-threatening digitoxin.

It is also indicated for poisoning from other cardioactive steroids. 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. Start with 10 vials followed by an additional 10 vials if needed to avoid a febrile reaction.

Digibind Digoxin Immune Fab Ovine is a sterile lyophilized powder of antigen binding fragments Fab derived from specific antidigoxin antibodies raised in sheep. 4 DIPRIVAN Propofol Injectable Emulsion USP is a. Acute acute on chronic or chronic digoxin toxicity.

Handles a companys requirements for a complete package that will assist in planning any textile or graphic project. 4 In clinical trials 121 patients who received one n99 2 n21 or 3 n1 doses of VORAXAZE were evaluated for anti-glucarpidase antibodies. Administer 6 vials of DIGIFAB in Adults and Children 20 Kg.

In Australia any unused medicine or waste material should be disposed of by taking to your local. Production of antibodies specific for digoxin involves conjugation of digoxin as a hapten to human albumin. For the treatment of patients with life-threatening or potentially life-threatening digoxin toxicity or overdose.

NDC 50633-120-11 Store at 2 to 8C 36 to 46F. Use clinical judgment to. For DigiFab no filtering required please see package insert pdf - FDA.

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.

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