Cordarone X 150mg/3ml solution for injection ampoules

Երկիր: Միացյալ Թագավորություն

Լեզու: անգլերեն

Աղբյուրը: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ակտիվ բաղադրիչ:

Amiodarone hydrochloride

Հասանելի է:

Sanofi

ATC կոդը:

C01BD01

INN (Միջազգային անվանումը):

Amiodarone hydrochloride

Դոզան:

50mg/1ml

Դեղագործական ձեւ:

Solution for injection

Կառավարման երթուղին:

Intravenous

Դաս:

No Controlled Drug Status

Ռեկվիզորի տեսակը:

Valid as a prescribable product

Ապրանքի ամփոփագիր:

BNF: 02030200; GTIN: 5013417102057 5000283655596

Տեղեկատվական թերթիկ

PACKAGE LEAFLET:
INFORMATION FOR THE USER
CORDARONE® X 150MG/3ML,
SOLUTION FOR INJECTION
amiodarone hydrochloride
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READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
HAVING THIS MEDICINE
• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor,
nurse or pharmacist
• This medicine has been prescribed for you. Do not pass
it on to others. It may harm them, even if their
symptoms are the same as yours
• If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist
IN THIS LEAFLET:
1. What Cordarone X is and what it is used for
2. Before you have Cordarone X
3. How Cordarone X is given
4. Possible side effects
5. How to store Cordarone X
6. Further information
Cordarone X 150mg/3ml, solution for injection (called
Cordarone X in this leaflet) contains a medicine called
amiodarone hydrochloride. This belongs to a group of
medicines called anti-arrhythmics.
It works by controlling the uneven beating of your
heart (called ‘arrhythmias’). Having the injection
helps your heartbeat to return to normal.
Cordarone X is normally only given in a hospital
when a quick response is needed or when tablets
cannot be given. Cordarone X can be used to:
• Treat uneven heartbeats where other medicines
either have not worked or cannot be used
• Treat
an
illness
called
Wolff-Parkinson-White
Syndrome. This is where your heart beats unusually fast
• Treat other types of fast or uneven heartbeats known
as ‘atrial flutter’ or ‘atrial fibrillation'. Cordarone X is
used only when other medicines cannot be used
• Treat fast heartbeats which may happen suddenly
and may be uneven. Cordarone X is used only when
other medicines cannot be used
2. BEFORE YOU HAVE CORDARONE X
DO
NOT
HAVE
THIS
MEDICINE
AND
TELL
YOUR
DOCTOR, PHARMACIST OR NURSE IF:
× You are allergic (hypersensitive) to:
- iodine
- amiodarone
*701117*
SENS DE DEROULEMENT

Ապրանքի հատկությունները

OBJECT 1
CORDARONE X INTRAVENOUS
Summary of Product Characteristics Updated 31-May-2017 | SANOFI
1. Name of the medicinal product
Cordarone X 150mg/3ml Solution for Injection
2. Qualitative and quantitative composition
Each 3ml ampoule contains 150mg amiodarone hydrochloride.
For excipients, see 6.1
3. Pharmaceutical form
Solution for injection.
4. Clinical particulars
4.1 Therapeutic indications
Treatment should be initiated and normally monitored only under
hospital or specialist supervision.
Cordarone X Intravenous is indicated only for the treatment of severe
rhythm disorders not responding to
other therapies or when other treatments cannot be used.
Tachyarrhythmias associated with Wolff-Parkinson-White syndrome.
All types of tachyarrhythmias including supraventricular, nodal and
ventricular tachycardias; atrial flutter
and fibrillation; ventricular fibrillation; when other drugs cannot be
used.
Cordarone X Intravenous can be used where a rapid response is required
or where oral administration is
not possible.
4.2 Posology and method of administration
Cordarone X Intravenous should only be used when facilities exist for
cardiac monitoring, defibrillation,
and cardiac pacing.
Cordarone X Intravenous may be used prior to DC cardioversion.
The standard recommended dose is 5mg/kg bodyweight given by
intravenous infusion over a period of 20
minutes to 2 hours. This should be administered as a dilute solution
in 250ml 5% dextrose. This may be
followed by repeat infusion up to 1200mg (approximately 15mg/kg
bodyweight) in up to 500ml 5%
dextrose per 24 hours, the rate of infusion being adjusted on the
basis of clinical response _(see section _
_4.4)._
In extreme clinical emergency the drug may, at the discretion of the
clinician, be given as a slow injection
of 150-300mg in 10-20ml 5% dextrose over a minimum of 3 minutes. This
should not be repeated for at
least 15 minutes. Patients treated in this way with Cordarone X
Intravenous must be closely monitored,
e.g. in an intensive care unit _(see section 4.4)._
_CHANGEO