Amiodarone hydrochloride 30 mg/ml concentrate for solution for injection/infusion

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

Amiodarone hydrochloride

Доступна з:

Accord Healthcare Ireland Ltd.

Код атс:

C01BD01

ІПН (Міжнародна Ім'я):

Amiodarone hydrochloride

Дозування:

30 milligram(s)/millilitre

Фармацевтична форма:

Concentrate for solution for injection/infusion

Терапевтична области:

amiodarone

Статус Авторизація:

Not marketed

Дата Авторизація:

2021-09-24

інформаційний буклет

_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMIODARONE HYDROCHLORIDE 30 MG/ML CONCENTRATE FOR SOLUTION FOR
INJECTION/INFUSION
amiodarone hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist or
nurse.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Amiodarone hydrochloride is and what it is used for
2.
What you need to know before you use Amiodarone hydrochloride
3.
How to use Amiodarone hydrochloride
4.
Possible side effects
5.
How to store Amiodarone hydrochloride
6.
Contents of the pack and other information
1.
WHAT AMIODARONE HYDROCHLORIDE IS AND WHAT IT IS USED FOR
Amiodarone hydrochloride contains the active substance amiodarone
hydrochloride, which belongs to a
group of medicines called anti-arrhythmics. It works by controlling
the uneven beating of your heart
(called arrhythmias).
Amiodarone hydrochloride treatment is used for adults in:
•
Serious, symptomatic, tachycardic ventricular arrhythmias.
•
Symptomatic cardiac arrhythmias requiring treatment with a rapid
heartbeat and origin in the atrium
(tachycardia supraventricular cardiac arrhythmias), such as:
•
AV junctional tachycardia, supraventricular tachycardia in WPW
syndrome, where your heart beats
unusually fast or
•
Paroxysmal atrial fibrillation (fast or uneven heartbeats).
This indication applies to patients who do not respond to treatment
with other antiarrhythmic drugs or
for whom other antiarrhythmic drugs are not indicated.
Amiodarone hydrochloride
_ _
is given when a quick response is needed or if you are unable to take
tablets.
Your doctor will give you this medicine and you will be monitored
under hospital or specialist
supervision.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE AMIODARONE HYDROC

Характеристики продукта

Health Products Regulatory Authority
26 May 2022
CRN00CQSK
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amiodarone hydrochloride 30 mg/ml concentrate for solution for
injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains 30 mg amiodarone hydrochloride.
Each syringe of 10 ml contains 300 mg amiodarone hydrochloride.
Excipient with known effect
Each syringe contains

20 mg/ml of benzyl alcohol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for injection/infusion
Clear colourless to pale yellow solution, practically free from
particulates.
pH 3.0‐5.0
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Amiodarone hydrochloride is indicated for the treatment of adult
patients with:

Serious, symptomatic, tachycardic ventricular arrhythmias.
Symptomatic tachycardic supraventricular arrhythmias requiring
treatment, such as

AV junctional tachycardia,

Supraventricular tachycardia in Wolff‐Parkinson‐White syndrome or

paroxysmal atrial fibrillation.
This indication applies to patients who do not respond to treatment
with other antiarrhythmics or for whom other
antiarrhythmics are not indicated.
Treatment should be initiated and normally monitored only under
hospital or specialist supervision.
The injection solution can normally only be used in a hospital, when a
rapid response is required or when oral administration is
not possible. The injection solution must only be used to initiate
therapy.
Health Products Regulatory Authority
26 May 2022
CRN00CQSK
Page 2 of 18
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
For _ATTACK OR INITIAL TREATMENT_, intravenous injection or
intravenous infusion is possible. Intravenous injection is generally
not
recommended. Whenever possible, intravenous infusion should be
preferred (see also section 4.4).
INTRAVENOUS INFUSION
_Initial or attack dose:_The standard recommended dose is 5mg/kg
bodyweight given by intravenous infusion over a period o