LANOXIN PAEDIATRICGERIATRIC ELIXIR

Ország: Malajzia

Nyelv: angol

Forrás: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktív összetevők:

DIGOXIN

Beszerezhető a:

Aspen Medical Products Malaysia Sdn Bhd

INN (nemzetközi neve):

DIGOXIN

db csomag:

60 ml

Gyártó:

Aspen Bad Oldesloe GmbH

Betegtájékoztató

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
1
LANOXIN PG ELIXIR
Digoxin (50mcg/ml)
WHAT IS IN THE LEAFLET
1.
What Lanoxin PG Elixir is
used for
2.
How Lanoxin PG Elixir works
3.
Before you use Lanoxin PG
Elixir
4.
How to use Lanoxin PG
Elixir
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Lanoxin PG Elixir
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial number
WHAT LANOXIN PG ELIXIR IS USED
FOR
Lanoxin PG Elixir is used to treat
arrhythmias and heart failure. An
arrhythmia is an irregularity in the
heartbeat, which causes the heart
to skip a beat, beat irregularly or
beat at the wrong speed.
HOW LANOXIN PG ELIXIR WORKS
Lanoxin PG Elixir contains the
active ingredient digoxin which
belongs to a group of medicines
called cardiac glycosides.
Lanoxin PG Elixir works by
correcting irregular heartbeats
to a normal rhythm and
strengthens the force of the
heartbeat, which is why it is
useful in heart failure.
BEFORE YOU USE LANOXIN PG ELIXIR
-
_When you must not use it _
You must not take Lanoxin PG
Elixir if you are allergic to
digoxin, to other cardiac
glycosides or to any of the
other ingredients in this
medicine.
Lanoxin PG Elixir must not be
used in patients with certain
heart problems. Your doctor
will have checked your
medical history before treating
you with this medicine. If you
have any concerns you should
discuss these with your doctor.
-
_Before you start to use it _
If you are pregnant or are
intending to become pregnant
or breastfeeding you must
discuss this with your doctor.
Your doctor will discuss the
possible risks and benefits
involved.
-
_Taking other medicines _
You
MUST
tell your doctor or
pharmacist about all the
medicines you are taking, even
those which you have bought
for yourself without a doctor's
prescription, including herbal
remedies such as St John's wort
and vitamins. Digoxin interacts
with lots of different
medicines. The other
medicines that you may be
taking may increase or
decrease the effect of La

Termékjellemzők

1
LANOXIN
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lanoxin PG Elixir contains the active ingredient Digoxin, 50mcg in 1
ml.
PHARMACEUTICAL FORM
Lanoxin PG Elixir is a clear, yellow, lime-flavoured solution
containing 50mcg (0.050mg)
Digoxin BP in each 1ml of sweetened, aqueous-alcoholic vehicle.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
CARDIAC FAILURE
Digoxin is indicated in the management of chronic cardiac failure
where the dominant problem
is systolic dysfunction. Its therapeutic benefit is greatest in those
patients with ventricular
dilatation.
Digoxin is specifically indicated where cardiac failure is accompanied
by atrial fibrillation.
SUPRAVENTRICULAR ARRHYTHMIAS
Digoxin is indicated in the management of certain supraventricular
arrhythmias, particularly
chronic atrial flutter and fibrillation.
POSOLOGY AND METHOD OF ADMINISTRATION
The dose of digoxin for each patient has to be tailored individually
according to age, lean body
weight and renal function.
Suggested doses are intended only as an initial guide.
The difference in bioavailability between injectable digoxin and oral
formulations must be
considered when changing from one dosage form to another. For example
if patients are
switched
from
oral
to
the
intravenous
formulation
the
dosage
should
be
reduced
by
approximately 33%.
Lanoxin PG Elixir, 50 mcg in 1 ml, is supplied with a graduated
pipette and this should be used
for measurement of all doses.
2
MONITORING
Serum concentrations of digoxin may be expressed in Conventional Units
of ng/ml or SI Units
of nmol/l. To convert ng/ml to nmol/l, multiply ng/ml by 1.28. The
serum concentration of
digoxin can be determined by radioimmunoassay.
Blood should be taken 6 hours or more after the last dose of digoxin.
There are no rigid guidelines as to the range of serum concentrations
that are most efficacious.
Several _post hoc_ analyses of heart failure patients in the Digitalis
Investigation Group trial
demonstrated that at low serum digoxin concentrations (0.5 – 0.9
ng/ml), the use of digoxin
was associ