TAMBOCOR INJECTION

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

FLECAINIDE ACETATE

Disponible des:

MEGAPHARM LTD

Codi ATC:

C01BC04

formulario farmacéutico:

SOLUTION FOR INJECTION

Composición:

FLECAINIDE ACETATE 10 MG/ML

Vía de administración:

I.V

tipo de receta:

Required

Fabricat per:

CENEXI , FRANCE

Grupo terapéutico:

FLECAINIDE

Área terapéutica:

FLECAINIDE

indicaciones terapéuticas:

Serious sustained life threatening ventricular arrhthymias that have not respoded to other drugs.

Data d'autorització:

2022-07-31

Informació per a l'usuari

העדוה
לע
הרמחה
(
עדימ
ןולעב )תוחיטב
אפורל
ךיראת
11/05/2015
םש
רישכת
תילגנאב
רפסמו
םושירה
TAMBOCOR INJECTION 106-41-23294-00
םש
לעב
םושירה
םראפאגמ
מ"עב
ספוט
הז
דעוימ
טורפל
תורמחהה
דבלב
!
תורמחהה
תושקובמה
ןולעב
אפורל
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
POSOLOGY AND
METHOD OF
ADMINISTRATION
CHILDREN: Tambocor is not recommended in
children under 12
CHILDREN: Tambocor is not
recommended in children under 12, as
there is insufficient evidence of its use
in this age group.
CONTRAINDICATIONS
Tambocor is contra-indicated in cardiac
failure and in patients with a history of
myocardial infarction who have either
asymptomatic ventricular ectopics or
asymptomatic non-sustained ventricular
tachycardia.
It is also contra-indicated in patients with
long
standing
atrial
fibrillation
in
whom
there has been no attempt to convert to sinus
rhythm,
and
in
patients
with
haemodynamically significant valvular heart
disease.
Unless pacing rescue is available, Tambocor
should not be given to patients with sinus
node dysfunction, atrial conduction defects,
second degree or greater atrioventricular
block, bundle branch
block or distal block.
Hypersensitivity to flecainide or to any of
the excipients.
Tambocor is contra-indicated in cardiac
failure and in patients with a history of
myocardial infarction who have either
asymptomatic ventricular ectopics or
asymptomatic non-sustained ventricular
tachycardia.
Flecainide is contra-indicated in the
presence of cardiogenic shock.
It is also contra-indicated in patients
with long standing atrial fibrillation in
whom there has been no
attempt to
convert
to sinus
rhythm,
and in
patients
with
haemodynamically
significant valvular heart disease.
Known Brugada syndrome.
Unless pacing rescue is available,
Tambocor should not be given to
patients with sinus node dysfunction,
atrial conduction defects, second
degree or greater atrioventricular
block, bundl

Fitxa tècnica

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Tambocor Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL solution for injection contains 10 mg flecainide acetate.
One ampoule containing 15 mL solution for injection contains 150 mg
flecainide acetate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Clear, colourless solution for injection or infusion
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Serious sustained life threatening ventricular arrhthymias that have
not responded to other
drugs.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
In an emergency or for rapid effect, or as a slow intravenous infusion
when prolonged
administration is required.
a) Bolus injection: Administer 2 mg/kg over not less than ten minutes,
or in divided doses.
Alternatively dilute with 5% dextrose and give as a mini-infusion.
Continuous ECG monitoring is recommended. Stop the injection when the
arrhythmia is
controlled.
For sustained ventricular tachycardia, or people with a history of
cardiac failure (who may
become decompensated during administration) give the initial dose over
30 minutes and
monitor the ECG carefully.
The maximum recommended bolus dose is 150 mg.
b) Intravenous infusion: The recommended procedure is to start with a
slow injection of 2
mg/kg over 30 minutes, then continue intravenous infusion at the
following rates:
First hour: 1.5 mg/kg per hour.
Second and later hours: 0.1 - 0.25 mg/kg per hour.
The maximum recommended infusion duration is 24 hours; if exceeded,
and in patients
receiving high doses, monitor plasma levels.
The maximum cumulative dose over the first 24 hours should not exceed
600 mg.
In severe renal impairment (creatinine clearance < 35 ml/min/1.73
sq.m.) reduce the above
dosage recommendations by half.
Oral maintenance dosing should be started as soon as possible after
stopping the infusion.
CHILDREN: Tambocor is not recommended in children under 12, as there
is insufficient
evidence of its use in this age group.
ELDERLY PATIENTS: