DigiFab Digoxin-specific antibody fragment f(Ab) (ovine) 40mg powder for injection vial

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

Digoxin-specific antibody fragment F(ab) (Ovine), Quantity: 40 mg

Disponível em:

Phebra Pty Ltd

DCI (Denominação Comum Internacional):

Digoxin-specific antibody fragment F(ab) (Ovine)

Forma farmacêutica:

Injection, powder for

Composição:

Excipient Ingredients: mannitol; sodium acetate

Via de administração:

Intravenous

Unidades em pacote:

1 vial per carton

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

Digoxin-specific antibody fragment F(Ab) (Ovine) DigiFab is indicated for the treatment of known (or strongly suspected) life-threatening digoxin toxicity associated with ventricular arrhythmias, progressive bradycardia, or second or third degree heart block not responsive to atropine, and where additional measures besides withdrawal of digoxin and correction of serum electrolyte abnormalities are considered necessary. Consequences of multiple dosing with DigiFab have not been evaluated.

Resumo do produto:

Visual Identification: White or off-white friable cake. Colourless to pale yellow solution when reconstituted.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status de autorização:

Licence status A

Data de autorização:

2014-02-14

Folheto informativo - Bula

DIGIFAB
 POWDER FOR INJECTION
CONTAINS 40 MG DIGOXIN-SPECIFIC ANTIBODY FRAGMENTS F(AB) (OVINE)
_ _
_Dij-i-fab _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DIGIFAB Injection. It
does not contain all the available
information. It does not take the place
of talking to your doctor.
All medicines have risks and benefits
.
Your doctor has weighed the risks of
you being given DIGIFAB Injection
against the benefits they expect it will
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR.
KEEP THIS LEAFLET IN A SAFE PLACE.
You may need to read it again.
WHAT DIGIFAB INJECTION
IS USED FOR
DIGIFAB Injection is an antidote used
to treat life-threatening digoxin
overdose.
_ _
_ _
DIGIFAB Injection belongs to a group
of medicines called the antigen binding
fragments.
DIGIFAB is a sterile freeze-dried
powder of antigen binding fragments
(Fab) obtained from antidigoxin
antibodies raised in sheep.
Fab fragments react with digoxin in the
blood to prevent death from digoxin
overdose.
The total number of people treated
with this medication in trials is small
and the data regarding dosing and
outcomes are limited.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it for
another reason.
This medicine is available only with a
doctor’s prescription.
BEFORE YOU ARE GIVEN
DIGIFAB INJECTION
_WHEN YOU MUST NOT BE GIVEN _
_IT_
_ _
YOU SHOULD NOT BE GIVEN DIGIFAB
INJECTION IF YOU HAVE AN ALLERGY TO:
•
Any medicine containing digoxin-
specific Fab fragments
•
Any of the ingredients listed at the
end of this leaflet.
•
Papain, chymopapain, or other
papaya extracts
•
Any other similar medicines.
_ _
_ _
Some of the symptoms of an allergic
reaction may include:
•
Shortness of breath
•
Wheezing or difficulty breathing
•
Swelling of the face, lips, tongue or
other parts of the body
•
Rash, itching or hives on the skin.
IF YOU ARE NOT SURE WHETHER YOU
SHOULD B

Características técnicas

PRODUCT INFORMATION
Australian Product Information – DIGIFAB
®
Page 1 of 14
Version 02
DIGIFAB
®1 POWDER FOR INJECTION
(DIGOXIN-SPECIFIC ANTIBODY FRAGMENT F(AB) (OVINE))
1
NAME OF THE MEDICINE
Digoxin-specific antibody fragment F(Ab) (Ovine)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of DIGIFAB Powder for Injection, will bind approximately 0.5
mg digoxin, contains 40 mg of digoxin-
specific antibody fragment F(Ab).
These fragments are obtained from blood of healthy sheep immunized
with a digoxin derivative, digoxin-
dicarboxymethoxylamine
(DDMA),
a
digoxin
analogue
which
contains
the
functionally
essential
cyclopentaperhydrophenanthrene:lactone ring moiety coupled to keyhole
limpet hemocyanin (KLH).
The final product is prepared by isolating the immunoglobulin fraction
of the ovine serum, digesting it with papain
and isolating the digoxin-specific Fab fragments by affinity
chromatography.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
DIGIFAB, digoxin-specific antibody fragment F(Ab) (Ovine) Powder for
Injection, is a sterile, purified, lyophilized
off-white powder of digoxin-specific antibody ovine Fab (monovalent)
immunoglobulin fragments.
The pH of the reconstituted solution is in between 4.5-5.5.
The product is intended for intravenous administration after
reconstitution with 4 mL of Sterile Water for Injection.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Digoxin-specific antibody fragment F(Ab) (Ovine) DIGIFAB is indicated
for the treatment of known (or strongly
suspected) life-threatening digoxin toxicity associated with
ventricular arrhythmias, progressive bradycardia, or
second or third degree heart block not responsive to atropine, and
where additional measures besides withdrawal
of digoxin and correction of serum electrolyte abnormalities are
considered necessary. Consequences of multiple
dosing with DIGIFAB have not been evaluated.
4.2
D
OSE AND METHOD OF ADMINISTRATION
1
DIGIFAB
®
is a registered trademark of BTG International Inc.
PRO