LANOXIN INJECTION

Land: Israel

Språk: engelska

Källa: Ministry of Health

Aktiva substanser:

DIGOXIN

Tillgänglig från:

PERRIGO ISRAEL AGENCIES LTD

ATC-kod:

C01AA05

Läkemedelsform:

SOLUTION FOR INJECTION

Sammansättning:

DIGOXIN 0.5 MG / 2 ML

Administreringssätt:

I.V

Receptbelagda typ:

Required

Tillverkad av:

CENEXI-FONTENAY SOUS BOIS, FRANCE

Terapeutisk grupp:

DIGOXIN

Terapiområde:

DIGOXIN

Terapeutiska indikationer:

For management of chronic cardiac failure,and certain supraventricular arrhythmias.

Tillstånd datum:

2020-07-01

Bipacksedel

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ןכדועמ(
ןכדועמ(
05.2013
05.2013
)
)
ךיראת
2.7.2013
םש
רישכת
תילגנאב
רפסמו
םושירה
LANOXIN INJECTION REG. NO. 101-75-
20033-00
םש
לעב
םושירה :
וגירפ
לארשי
תויונכוס
מ"עב
ספוט
הז
דעוימ
טורפל
תורמחהה
דבלב
!
תורמחהה
תושקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
SPECIAL WARNINGS AND
SPECIAL PRECAUTIONS
FOR USE
For
elective
direct
current cardioversion of
a patient who is taking
digoxin, the drug should
be withheld for 24 hours
before cardioversion is
performed.
In
emergencies, such as
cardiac
arrest,
when
attempting cardioversion
the
lowest
effective
energy
should
be
applied.
Direct
current
cardioversion
is
inappropriate
in
the
treatment of arrhythmias
thought to be caused by
cardiac glycosides.
.
For elective direct current
cardioversion of a patient who
is taking digoxin, the drug
should be withheld for 24 hours
before
cardioversion
is
performed.
In emergencies,
such as cardiac arrest, when
attempting cardioversion the
lowest effective energy should
be applied.
Direct current cardioversion is
inappropriate in the treatment
of arrhythmias thought to be
caused by cardiac glycosides.
Although many patients with
chronic
congestive
cardiac
failure
benefit
from
acute
administration of digoxin, there
are some in whom it does not
lead to constant, marked or
lasting
haemodynamic
improvement. It is therefore
important
to
evaluate
the
response
of
each
patient
individually when Lanoxin is
continued long-term.
Herbal preparations containing
St. John’s wort (Hypericum
perfortum) should not be used
while taking Lanoxin due to the
risk
of
decreased
plasma
concentrations
and
reduced
clinical effects of Lanoxin (see
4.5
–
Interactions).
This
medicinal
product
contains
small
amounts
of
ethanol
(alcohol), less than 100mg per
dose.
INTERACTION WITH
OTHER ME

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Lanoxin
®
Elixir
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Digoxin 0.05 mg/1 ml
For a full list of excipients, see section 6.1.
_ _
3.
PHARMACEUTICAL FORM
Oral solution
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Lanoxin Elixir is indicated whenever digitalis therapy is required for
the treatment of congestive
heart failure, atrial fibrillation and/or flutter and
supra-ventricular tachycardia.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
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.
In cases where cardiac glycosides have been taken in the preceding two
weeks the
recommendations for initial dosing of a patient should be reconsidered
and a reduced dose is
advised.
The difference in bioavailability between injectable digoxin and oral
formulations must be
considered when changing from one dosage form to another. For
exampleif patients are switched
from oral to the I.V. formulation the dosage should be reduced by
approximately 33%.
Adults and paediatric populations over 10 years
_Rapid oral loading: _
If medically appropriate, rapid digitalisation may be achieved in a
number of ways, such as 750 to
1500 micrograms (0.75 to 1.5 mg) as a single dose.
Where there is less urgency, or greater risk of toxicity e.g. in the
elderly, the oral loading dose
should be given in divided doses six hours apart, with approximately
half the total dose given as the
first dose.
Clinical response should be assessed before giving each additional
dose (see section 4.4).
_Slow oral loading: _
In some patients, for example those with mild heart failure,
digitalisation may be achieved more
slowly with doses of 250 to 750 micrograms (0.25 to 0.75 mg) daily for
one week followed by an
appropriate maintenance dose. A clinical response should be seen
within one week.
The choice between slow and rapid oral loading depends on the cl