digifab package insert
DigiFab Digoxin Immune Fab Ovine is a sterile purified lyophilized preparation of digoxin-immune ovine Fab monovalent immunoglobulin fragments. Use within 4 hours after.
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Drug package insert Chan BS Isbister GK OLeary M et al.
. We hereby approve the draft package insert labeling submitted under supplement number 5218 dated June 9. 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. 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.
Relevant identified uses DigiFab is indicated for the treatment of. The recommended dosage of INFLECTRA for pediatric patients 6 years and older with moderately to severely active CD is 5 mgkg given as an intravenous induction regimen at 0 2 and 6 weeks followed by a maintenance regimen of 5 mgkg every 8. DigiFab package insert.
Free digoxin levels are decreased to zero within 1 min of Fab fragment administration but total serum digoxin levels are markedly increased. The contents of one 40-mg vial of DigiFab neutralizes approximately 05 mg of digoxin. Stability Miscellaneous INDICATIONS AND USAGE.
If toxicity not adequately reversed several hours after the dose or if toxicity recurs an additional dose may be necessary. It is recommended that it be infused through a 022-micron membrane filter to ensure no undissolved particulate matter is administered. NDC 50633-120-11 Store at 2 to 8C 36 to 46F.
The reconstituted product should be used promptly. This antidote is expensive 5000 per vial and not. Reconstitution Reconstitute each vial of DIGIFab with 4 mL Sterile Water for Injection USP.
Efficacy and effectiveness of anti-digoxin antibodies in chronic digoxin poisonings from the DORA study ATOM-1. Each vial of DIGIFab contains 40 mg of digoxin immune Fab protein and is intended for one-time use only. For the treatment of patients with life-threatening or potentially.
If cardiac arrest is imminent it can be given as a bolus injection. 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. The pH of the reconstituted solution is in between 45-55.
If not used immediately store under refrigeration at 2 to 8C 36 to 46F for up to 4 hours. 7 Rx only. DigiFab is indicated for the treatment of patients with life-threatening or potentially life-threatening digoxin toxicity or overdose.
17 PATIENT COUNSELING INFORMATION. FOR INTRAVENOUS ADMINISTRATION. DIGIFAB digoxinspe- cific antibody fragment FAb Ovine Powder for Injection is a sterile purified lyophilized off-white powder of digoxin-specific antibody ovine Fab monovalent immunoglobulin fragments.
The dosing of DigiFab can vary depending on the amount ingested serum concentration andor suspected chronicity of toxicity. Drug package insert Digibind package insert. Use within 4 hours after reconstitution.
Acute ingestion of known Dose in vials Amount of digoxin ingested in mg amounts of digoxin 05 mgvial Chronic digoxin toxicity Dose in vials and known serum digitalis. 4 5 6. Strict aseptic technique must always be maintained during handling.
DigiFab is supplied as a sterile purified lyophilized preparation containing 40 mg of digoxin immune Fab protein per vial. DigiFab is prepared by injecting sheep with digoxin-dicarboxymethylamine a digoxin analog followed by isolation of antidigoxin antibody from the blood papain digestion and then purification of the Fab fragment using affinity chromatography. Digoxin Immune Fab Ovine Tradename.
Administer 6 vials of DIGIFAB in Adults and Children 20 Kg. Storage And Handling DigiFab is supplied as a carton that contains 1 vial of product diluent not included. Administer CROFAB as soon as possiblein patients whodevelop any signs of envenomation eg local injury coagulation abnormality orsystemic signs.
The product is intended for intravenous administration after reconstitution with 4 mL of Sterile. DIPRIVAN 3 Propofol INJECTABLE EMULSION USP. Use clinical judgment to.
Although designed specifically to treat digoxin overdose a product very similar to DigiFab Digibind has been used successfully to treat life-threatening digitoxin overdose. Usually given as a single dose. Accompany the prescription product labeling.
Since human experience is limited and the consequences of repeated. DigiFab is supplied as a carton that contains 1 vial of product diluent not included. NDC 50633-120-11 - Store at 2 to 8C 36 to 46F.
DIGIBIND Digoxin Immune Fab Ovine is administered by the intravenous route over 30 minutes. The absence of a serum digitalis concentration Administer 1 vial of DIGIFAB in Infants and Children 20 Kg. The molecular weight of DigiFab 46 000 Da is similar to the molecular weight of Digibind 46 200 Da.
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