Adenosine 6mg/2ml solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Adenosine

Available from:

Advanz Pharma

ATC code:

C01EB10

INN (International Name):

Adenosine

Dosage:

3mg/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: 5060064792018

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ADENOSINE 3MG/ML SOLUTION FOR INJECTION
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 nurse.
• If
you
get
any
side
effects,
talk
to
your
doctor,
or
nurse.
This
includes
any
side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Adenosine Solution for Injection is and
what it is used for
2. What you need to know before you are
given Adenosine Solution for Injection
3. How you will be given Adenosine Solution for Injection
4. Possible side effects
5. How to store Adenosine Solution for Injection
6. Contents of the pack and other information
1. WHAT ADENOSINE SOLUTION FOR INJECTION IS
AND WHAT IT IS USED FOR
Adenosine
3mg/ml
Solution
for
Injection
(called
Adenosine Solution for Injection throughout the rest
of this leaflet) belongs to a group of
medicines
called antiarrhythmics.
Antiarrhythmics are used to treat an irregular
heartbeat (arrhythmias). Adenosine Solution for
Injection
is
used
during
hospital
tests
to
help
doctors
or
nurses
determine
what
type
of
irregular heartbeat you have. It works by slowing
down electrical impulses in your heart, in turn,
slowing down either a fast or irregular heartbeat.
In children, Adenosine Solution for Injection is
used to bring your child’s heartbeat back to
normal if your child has a type of heart rhythm problem
called ‘paroxysmal supraventricular tachycardia’ (PSVT).
You will usually be in hospital when you receive this
medicine.
2. WHAT YOU NEED TO KNOW BEFORE YOU
ARE GIVEN ADENOSINE SOLUTION FOR INJECTION
DO NOT HAVE ADENOSINE SOLUTION FOR INJECTION
• if you are allergic to adenosine or any of the
other ingredients of this medicine (listed in
section 6);
• if you have an irregular heart rhythm and do
not currently have a pacemaker fitted;
• if
you
have
asthma
or
any
other
severe
breathing problems

Summary of Product characteristics

OBJECT 1
ADENOSINE 3MG/ML SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 26-Sep-2014 | Concordia
International- formerly Focus
Pharmaceuticals Ltd
1. Name of the medicinal product
Adenosine 3mg/ml Solution for Injection
2. Qualitative and quantitative composition
Each 1ml of solution contains 3mg of adenosine.
Each vial contains 6mg of adenosine per 2ml of solution (3mg/ml).
It also contains 3.54mg (0.15mmol) of sodium per 1ml of solution.
For the full list of excipients, see Section 6.1.
3. Pharmaceutical form
Solution for injection (injection).
Clear, colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
Adenosine 3mg/ml Solution for Injection is indicated in adults and
children aged 0 to 18 years.
Adults
Rapid conversion to a normal sinus rhythm of paroxysmal
supraventricular tachycardias, including those
associated with accessory by-pass tracts (Wolff-Parkinson-White
Syndrome).
Diagnostic Indications
Aid to diagnosis of broad or narrow complex supraventricular
tachycardias. Although Adenosine 3mg/ml
Solution for Injection will not convert atrial flutter, atrial
fibrillation or ventricular tachycardia to sinus
rhythm, the slowing of AV conduction helps diagnosis of atrial
activity.
Sensitisation of intra-cavitary electrophysiological investigations.
Paediatric population
Rapid conversion to a normal sinus rhythm of paroxysmal
supraventricular tachycardia in children aged 0
to 18 years.
4.2 Posology and method of administration
Adenosine 3mg/ml Solution for Injection is intended for hospital use
only with monitoring and
cardiorespiratory resuscitation equipment available for immediate use,
if necessary. It should be
administered by rapid IV bolus injection according to the ascending
dosage schedule below. To be certain
the solution reaches the systemic circulation, administer either
directly into a vein or into an IV line. If
given into an IV line, it should be injected as proximally as possible
and followed by a rapid saline flush.
Adenosine 3mg/ml Solution for Injection s