digifab package insert

Drug package insert Chan BS Isbister GK OLeary M et al. Consequences of multiple dosing with DIGIFAB have not been evaluated.

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DigiFab package insert.

. 4 5 6. Handles a companys requirements for a complete package that will assist in planning any textile or graphic project. DigiFab is supplied as a sterile purified lyophilized preparation containing 40 mg of digoxin immune Fab protein per vial.

The purpose of this web site is to familiarize potential customers with the company and. Although designed specifically to treat digoxin overdose a product very similar to DigiFab Digibind has been used successfully to treat life-threatening digitoxin overdose. 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.

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. Efficacy and effectiveness of anti-digoxin antibodies in chronic digoxin poisonings from the DORA study ATOM-1.

Digibind Digoxin Immune Fab Ovine is a sterile lyophilized powder of antigen binding fragments Fab derived from specific antidigoxin antibodies raised in sheep. 7 Rx only. Use within 4 hours after reconstitution.

Storage And Handling DigiFab is supplied as a carton that contains 1 vial of product diluent not included. The molecular weight of DigiFab 46000 Da is similar to the molecular weight of Digibind 46200 Da and both compounds can be excreted in urine. Drug package insert Digibind package insert.

One 10 mL glass vial of DigiFab per pack. Digibind and DigiFab are Fab fragments of antidigoxin antibody used in treating life-threatening acute digoxin overdose. Usually given as a single dose.

For DigiFab no filtering required please see package insert pdf - FDA. The contents of one 40-mg vial of DigiFab neutralizes approximately 05 mg of digoxin. You can import profiles you created in software packages from companies such as X-Rite Monaco and Gretag McBeth.

Start with 10 vials followed by an additional 10 vials if needed to avoid a febrile reaction. Administer 6 vials of DIGIFAB in Adults and Children 20 Kg. Chronic digoxin toxicity in the absence of a serum digitalis concentration.

DIPRIVAN 3 Propofol INJECTABLE EMULSION USP. 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. 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.

FOR INTRAVENOUS ADMINISTRATION. If cardiac arrest is imminent it can be given as a bolus injection. Gently swirl the solution by rotating the vial to dissolve the lyophilized powder which has a cake-like appearance.

If toxicity not adequately reversed several hours after the dose or if toxicity recurs an additional dose may be necessary. CROFAB is available as a sterile nonpyrogenic purified lyophilized powder. The dosage of will vary DIGIFAB according to the amount of digoxin to be neutralized.

DigiFab is supplied in a single clear neutral glass vial closed with a butyl rubber stopper and fitted with aluminium flip top seal. Use clinical judgment to. Improvement in signs and symptoms usually begins in 30 minutes or less.

For the treatment of patients with life-threatening or potentially life-threatening digoxin toxicity or overdose. 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.

66 Special Precautions for Disposal. The dosing of DigiFab can vary depending on the amount ingested serum concentration andor suspected chronicity of toxicity. Standard Dilutions Amount of drug Infusion volume Infusion rate Prescribed dose 50 ml 30 min Note.

Digibind was marketed in 1986 while DigiFab was approved for use in 2001. 5 Arrhythmogenic and cardio-depressant effects were seen in animals at significantly higher doses of ropivacaine than bupivacaine. May give 10 vials initially then at.

NDC 50633-120-11 Store at 2 to 8C 36 to 46F. Acute Ingestion of Unknown Quantity Administer 20 vials Larger dose has faster onset but may cause febrile reaction. Each vial contains up to 1 gram of total protein a maximum of 003 mg of mercury and not less than the indicated number of mouse LD50neutralizing units.

The incidence of successful resuscitation. 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. We are able to offer a turnkey printing solution that supports digital printing for both the graphic and textile markets.

Avoid prolonged or vigorous agitation. Digoxin-specific antibody fragment FAb Ovine DIGIFAB is administered by the intravenous route over 30 minutes. Product Information Package Insert -.

Relevant identified uses DigiFab is indicated for the treatment of patients with life-threatening or potentially life-threatening digoxin toxicity or overdose. Strict aseptic technique must always be maintained during handling. Administer 1 vial of DIGIFAB in Infants and Children 20 Kg.

Snake Species Used for Antivenin Component Minimum mouse LD 50 Units per vial C.

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