Tambocor 10 mg/ml Solution for Injection or Infusion

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Flecainide acetate

Prieinama:

Mylan IRE Healthcare Limited

ATC kodas:

C01BC; C01BC04

INN (Tarptautinis Pavadinimas):

Flecainide acetate

Dozė:

10 milligram(s)/millilitre

Vaisto forma:

Solution for injection/infusion

Recepto tipas:

Not applicable

Gydymo sritis:

Antiarrhythmics, class Ic; flecainide

Autorizacija statusas:

Marketed

Leidimo data:

1984-12-13

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE USER
TAMBOCOR 10MG/ML SOLUTION FOR THE INJECTION OR INFUSION
Flecainide acetate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
K
eep this leaflet. You may need to read it again
-
If you have any further questions, ask your doctor or nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet.
The name of your medicine is Tambocor 10mg/ml Solution for injection,
which will be called
Tambocor throughout this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Tambocor is and what it is used for
2.
What you need to know before you use Tambocor
3.
How to use Tambocor
4.
Possible side effects
5.
How to store Tambocor
6.
Contents of the pack and other information
1.
WHAT TAMBOCOR IS AND WHAT IT IS USED FOR
Tambocor contains the active ingredient flecainide, which belongs to a
group of medicines called anti-
arrhytmics, which control the speed and rhythm of the heart.
Tambocor is used to treat:
-
Arrhythmias (irregular heart beat)
-
Tachycardia (too fast heartbeat)
-
Wolff-Parkinson-White Syndrome (a special kind of heartbeat
irregularity with a disorder of
conduction)
-
Atrial fibrillation and atrial flutter (rapid contraction of muscles
in the heart)
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE TAMBOCOR
DO NOT USE TAMBOCOR:
-
If you are allergic to Flecainide or any of the other ingredients of
this medicine (listed in
section 6). An allergic reaction may include rash, itching, difficulty
breathing or swelling of
the face, lips, throat or tongue.
-
If you are taking a similar anti-arrhythmic drug (other class 1
anti-arrhythmics, e.g.
disopyramide, procainamide, quinidine, lidocaine, mexiletine,
propafenone)
-
If you have had heart problems such as heart failure, heart attack,
heart valve or conduction
problems – your doctor will study your medical history
-
If you have been told you have an electrolyte imbalance (altered blood
salts)
WARNING AN

Prekės savybės

Health Products Regulatory Authority
23 June 2023
CRN00DLCM
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tambocor 10 mg/ml Solution for Injection or Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 10 mg flecainide acetate.
Each 15 ml ampoule contains 150 mg flecainide acetate.
Excipients: contains 38mg of sodium per ampoule.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection or infusion.
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
It is recommended that treatment with Tambocor should be initiated in
hospitals.
‘Tambocor’ injection is indicated when rapid control of the
following arrhythmias is the main clinical requirement.
a)
Ventricular tachyarrhythmias.
b)
AV nodal reciprocating tachycardia when patients have been
unresponsive to beta-blockers or calcium channel blockers
and in the absence of left ventricular dysfunction (See 4.3,
Contra-indications).
c)
Wolff-Parkinson-White Syndrome and similar conditions with accessory
pathways in the absence of left-ventricular
dysfunction (See 4.3, Contraindications).
d)
Atrial fibrillation and atrial flutter when treatment need has been
established and in the absence of left ventricular
dysfunction (See 4.3, Contra-indications).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Initiation of therapy should take place in the hospital environment
with ECG monitoring. ECG monitoring should be maintained
during intravenous infusion.
Adults Only:
a) Bolus injection: Tambocor can be given in an emergency or for rapid
effect by a slow injection of 2mg/kg over not less than
ten minutes, or in divided doses. If preferred, the dose may be
diluted with 5% dextrose and given as a mini-infusion.
Continuous ECG monitoring is recommended in all patients receiving the
bolus dose. The injection should be stopped when
there is control of the arrhythmia.
It is recommended that Tambocor should be administered more slowly to
patients in sustained ventricular tachyca