Amiodarone 150mg/3ml concentrate for solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Amiodarone hydrochloride

Available from:

hameln pharma Ltd

ATC code:

C01BD01

INN (International Name):

Amiodarone hydrochloride

Dosage:

50mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02030200; GTIN: 4260016650873

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
AMIODARONE HYDROCHLORIDE 50 MG/ML
Concentrate for Solution for Injection/Infusion
Active substance: Amiodarone hydrochloride
HAMELN
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READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 or pharmacist.
→ If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in
this leaflet.
HAMELN
WHAT IS IN THIS LEAFLET:
1. What Amiodarone is and what it is used for
2. What
you
need
to
know
before
you
are
given
Amiodarone
3. How Amiodarone is given
4. Possible side effects
5. How to store Amiodarone
6. Contents of the pack and other information
1.
WHAT AMIODARONE IS AND WHAT IT IS USED
FOR
WHAT IS AMIODARONE USED FOR?
Amiodarone is used to treat irregular beating of your
heart
called
“arrhythmias”.
Amiodarone
works
by
controlling your heart if it is not beating normally.
Amiodarone as a solution for injection is normally only
given when a quick response is needed or if you are
unable to take tablets.
Your doctor will give you the injection and you will be
monitored under hospital or specialist supervision.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE
GIVEN AMIODARONE
DO NOT USE AMIODARONE:
•
if you are allergic (hypersensitive) to amiodarone,
iodine or any of the other ingredients of this medicine
(listed in section 6).
•
if you have a slower than usual heartbeat (called sinus
bradycardia) or are suffering from an illness which
causes irregular heartbeats (e.g. sino-atrial block, sick
sinus syndrome).
•
if you have any other problems with your heart and
do NOT have a pacemaker, for example if you have AV
block (a type of heart conduction disorder).
•
if your thyroid gland is not working properly. Your
doctor should test your t

Summary of Product characteristics

OBJECT 1
AMIODARONE HYDROCHLORIDE 50 MG/ML
CONCENTRATE FOR SOLUTION FOR INJECTION/INFUSION
Summary of Product Characteristics Updated 21-Feb-2017 | hameln
pharmaceuticals ltd
1. Name of the medicinal product
Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for
Injection/Infusion
2. Qualitative and quantitative composition
1 ml Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for
Injection/Infusion contains 50
mg amiodarone hydrochloride equivalent to 46.9 mg amiodarone.
Each ampoule with 3 ml of Amiodarone Hydrochloride 50 mg/ml
Concentrate for Solution for
Injection/Infusion contains 150 mg amiodarone hydrochloride.
One ampoule of Amiodarone Hydrochloride 50 mg/ml Concentrate for
Solution for Injection/Infusion
diluted as recommended in 250 ml of 5 % w/v Glucose Intravenous
Infusion results in a concentration of
0.6 mg/ml of amiodarone hydrochloride.
Excipients:
1 ml Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for
Injection/Infusion contains 22.2
mg of benzyl alcohol.
Each ampoule with 3 ml contains 66.6 mg of benzyl alcohol.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Concentrate for Solution for Injection and Infusion.
Clear pale yellow sterile solution practically free from particles, in
a clear and colourless glass ampoule.
pH: 3.5-4.5
4. Clinical particulars
4.1 Therapeutic indications
Amiodarone hydrochloride is indicated for the treatment of serious
cardiac arrhythmias, in cases where
other therapies are not effective or contraindicated:
- atrial arrhythmias, including atrial fibrillation or flutter
- AV nodal arrhythmias and AV reentrant tachycardia, e.g. as a
manifestation of Wolff-Parkinson-White
syndrome
- life-threatening ventricular arrhythmias, including persistent or
non-persistent ventricular tachycardia or
episodes of ventricular fibrillation
Treatment should be initiated and normally monitored only under
hospital or specialist supervision.
Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for
Injection/Infusion can be used