Amiodarone 300mg/10ml solution for injection pre-filled syringes

দেশ: যুক্তরাজ্য

ভাষা: ইংরেজি

সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)

সক্রিয় উপাদান:

Amiodarone hydrochloride

থেকে পাওয়া:

Martindale Pharmaceuticals Ltd

এটিসি কোড:

C01BD01

INN (আন্তর্জাতিক নাম):

Amiodarone hydrochloride

ডোজ:

30mg/1ml

ফার্মাসিউটিকাল ফর্ম:

Solution for injection

প্রশাসন রুট:

Intravenous

শ্রেণী:

No Controlled Drug Status

প্রেসক্রিপশন টাইপ:

Valid as a prescribable product

পণ্য সারাংশ:

BNF: 02030200; GTIN: 5014124170032

তথ্য লিফলেট

WHAT IS IN THIS LEAFLET:
1. What Amiodarone Injection is, and what it is used for
2. What you need to know before you are given Amiodarone Injection
3. How Amiodarone Injection is given
4. Possible side effects
5. How to store Amiodarone Injection
6. Contents of the pack and other information
1. WHAT AMIODARONE INJECTION IS AND WHAT IT IS USED FOR
Amiodarone Injection contains the active substance amiodarone
hydrochloride. It 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.
Amiodarone Injection is normally only given in a hospital when a quick
response is needed or when tablets cannot be given. Amiodarone
Injection
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.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN
AMIODARONE INJECTION
YOU MUST NOT BE GIVEN AMIODARONE INJECTION IF:
• You are allergic to amiodarone hydrochloride, iodine or to any of
the other
ingredients of this medicine (listed in section 6)
• You have heart problems such as heart block, which can cause a
slow heart
rate (such as sino-atrial heart block, sinus bradycardia, high grade
AV block,
bifascicular or trifascicular block or sinus node disease) and you do
not have
a pacemaker
• You have heart failure or weakness of the heart muscle
(cardiomyopathy)
• You have or have had thyroid problems. Your doctor will test your
thyroid
before giving you this medicine
• You have severe breathing problems
• You have very low blood pressure
• You are taking other medicines that can make your heartbeat very
quickly
(these are listed in below under the section ‘Taking other
medicines’)
• You are pregnant, think you may be pregnant

পণ্য বৈশিষ্ট্য

OBJECT 1
AMIODARONE 30MG/ML INJECTION
Summary of Product Characteristics Updated 19-Sep-2016 | Martindale
Pharma
1. Name of the medicinal product
Amiodarone 30mg/ml Injection
2. Qualitative and quantitative composition
Each 10ml pre-filled syringe contains 300mg amiodarone hydrochloride
equivalent to 30mg amiodarone
hydrochloride per ml.
Excipients:
Each pre-filled syringe contains:
- 20mg/ml of benzyl alcohol
- 112mg of iodine
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection/infusion
Amiodarone 30mg/ml Injection is a clear, slightly yellow solution,
practically free from particulates.
4. Clinical particulars
4.1 Therapeutic indications
Treatment should be initiated and normally monitored only under
hospital or specialist supervision.
Amiodarone 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.
Amiodarone can be used where a rapid response is required or where
oral administration is not possible.
4.2 Posology and method of administration
ROUTE OF ADMINISTRATION: intravenous use.
Amiodarone should only be used when facilities exist for cardiac
monitoring, defibrillation, and cardiac
pacing.
Amiodarone 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% w/v dextrose. This may
be followed by repeat infusion up to 1200mg (approximately 15mg/kg
bodyweight) in up to 500ml 5%
w/v 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