Digibind

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Digoxin-specific antibody fragment F(ab)

Available from:

GlaxoSmithKline Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

DIGIBIND(R) INJECTION
1
DIGIBIND(R) INJECTION
_Digoxin-specific Fab fragments_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully and
keep it while being treated.
Do not throw it away.  You may
want to read it again.
This leaflet answers some common
questions about Digibind Injection.
It does not contain all of the
available information.
It does not take the place of talking
to your doctor.
If you have any more questions about
your medicine, ask your doctor.
All medicines have risks and
benefits.  Your doctor has weighed
the expected benefits of you being
given Digibind Injection against the
risks this medicine could have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR.
WHAT IS DIGIBIND
INJECTION USED FOR?
Digibind Injection is an antidote
used to treat life-threatening digoxin
or digitoxin overdose.
Digibind Injection belongs to a
group of medicines called the antigen
binding fragments.
Digibind is a sterile freeze-dried
powder of antigen binding fragments
(Fab) obtained from  antidigoxin
antibodies raised in sheep.
The Fab fragments react with digoxin
or digitoxin in the blood to prevent
death from digoxin/digitoxin
overdose.
Your doctor may have prescribed
Digibind Injection for another
reason.
Digibind Injection is not addictive.
BEFORE YOU ARE GIVEN
DIGIBIND INJECTION
_DIGIBIND INJECTION SHOULD_
_NOT BE USED IF:_
*
THE EXPIRY DATE (EXP) PRINTED
ON THE PACK HAS PASSED.
*
THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING
_TELL YOUR DOCTOR IF:_
Where possible, tell your doctor if:
*
YOU HAVE EVER HAD AN ALLERGIC
REACTION TO DIGOXIN-SPECIFIC FAB
FRAGMENTS OR ANY OF THE
INGREDIENTS LISTED TOWARD THE
END OF THIS LEAFLET.
*
YOU ARE ALLERGIC TO FOODS, DYES,
PRESERVATIVES OR ANY OTHER
MEDICINES.
*
YOU HAVE RECEIVED DIGIBIND
INJECTION PREVIOUSLY.
*
YOU HAVE EVER HAD AN ALLERGIC
REACTION TO PAPAIN,
CHYMOPAPAIN OR OTHER PAPAYA

Summary of Product characteristics

Digibind Injection Issue No. 4
1
PRODUCT INFORMATION
DIGIBIND
®
 INJECTION
NAME OF THE MEDICINE
Digibind, Digoxin immune Fab (Ovine), is a sterile lyophilized
powder of antigen binding
fragments (Fab) derived from specific antidigoxin antibodies raised
in sheep.  Production of
antibodies specific for digoxin involves conjugation of digoxin
as a hapten to human albumin.
Sheep are immunised with this material to
produce antibodies specific for the antigenic
determinants of the digoxin molecule.  The antibody is then papain
digested and digoxin-
specific Fab fragments of the antibody are isolated and purified by
affinity chromatography.
These antibody fragments have a molecular weight of approximately
46,200.
DESCRIPTION
Each vial which will bind approximately 0.5 mg of digoxin (or
digitoxin) contains 38 mg of
digoxin-specific Fab fragments derived from sheep plus 75 mg of
sorbitol as a stabiliser and
28 mg of sodium chloride.  It contains no preservatives.
Digibind is administered by intravenous injection after
reconstitution with Sterile Water for
injection (4 mL per vial).
PHARMACOLOGY
After intravenous injection of Digoxin immune Fab (Ovine) in the
baboon, digoxin specific Fab
fragments are excreted in the urine with a biological half-life of
about 9 to 13 hours.  In
humans with normal renal function the half-life appears to be 15 to
20 hours.  Experimental
studies in animals indicate that these antibody fragments have a
large volume of distribution
in the extracellular space, unlike whole antibody which distributes
in a space only about twice
the plasma volume.  Ordinarily, following administration of Digibind,
improvement in signs and
symptoms of digitalis intoxication begins within one-half hour or
less.  The affinity of Digibind
for digoxin is high and greater than that of
digoxin for its receptor (sodium, potassium
ATPase).  The average affinity of Digibind for digitoxin is
approximately 1.55 
×
 10
10
M
-1
.
Digibind binds molecules of digoxin,