ADENOSINE VIATRIS adenosine 6 mg/2 mL solution for injection vial

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

adenosine, Quantity: 6 mg

Saatavilla:

Alphapharm Pty Ltd

INN (Kansainvälinen yleisnimi):

adenosine

Lääkemuoto:

Injection, solution

Koostumus:

Excipient Ingredients: sodium chloride; water for injections

Antoreitti:

Intravenous Bolus

Kpl paketissa:

6 x 2 mL

Prescription tyyppi:

(S4) Prescription Only Medicine

Käyttöaiheet:

Therapeutic Indications: ADENOSINE VIATRIS is indicated for the rapid conversion to a normal sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White syndrome). Diagnostic Indications: ADENOSINE VIATRIS is indicated as an aid to diagnosis of broad or narrow QRS complex supraventricular tachycardias. Although ADENOSINE VIATRIS is not effective in converting atrial flutter, atrial fibrillation or ventricular tachycardia to sinus rhythm, the slowing of AV conduction helps diagnosis of atrial activity. In this respect adenosine should be used as an adjunct to, but not a replacement for, clinical and ECG observations. It should be used only when, despite all diagnostic attempts, doubt still persists. ADENOSINE VIATRIS can also be used for improved diagnostic sensitivity of intracavity electrophysiological investigations.

Tuoteyhteenveto:

Visual Identification: Clear colourless solution free from visible particles; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

2009-08-10

Pakkausseloste

ADENOSINE MYLAN
_Adenosine 6 mg/2 mL injection_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Adenosine Mylan.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking adenosine against
the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
Adenosine Mylan is used to treat a
condition called paroxysmal
supraventricular tachycardia
(including a condition called Wolff-
Parkinson-White syndrome). This is
when the heart beats too rapidly. If
left untreated, this condition can be
life threatening.
Adenosine can also be used as an aid
to doctors to understand how your
heart is working.
It works by slowing down the
electrical impulses that control heart
rhythm. This allows the heart rhythm
to return to normal.
Adenosine is only given in hospitals.
It is given to you as an injection. The
effect of this medicine only lasts for
a couple of minutes.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another use.
There is no evidence this medicine is
addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN IT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
adenosine, the active ingredient
•
any of the ingredients listed at the
end of this leaflet
Some of the symptoms of an allergic
reaction may include
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
YOU MUST NOT BE GIVEN THIS
MEDICINE IF:
•
you have asthma
•
you have a heart disorder (e.g.
heart block or si

Valmisteyhteenveto

AUSTRALIAN PRODUCT INFORMATION
ADENOSINE MYLAN INJECTION
_Adenosine 6mg/2mL _
1
NAME OF THE MEDICINE
Adenosine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Adenosine Mylan is a sterile solution for intravenous injection (rapid
bolus), available in clear glass vials and
pre-filled syringes. Each vial or pre-syringe contains adenosine and
sodium chloride in water for injections,
pH between 4.5 and 7.5.
For the full list of excipients, see Section
6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Clear colourless solution free from visible particles.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
THERAPEUTIC INDICATIONS
Adenosine
Mylan
is
indicated
for
the
rapid
conversion
to
a
normal
sinus
rhythm
of
paroxysmal
supraventricular tachycardias, including those associated with
accessory bypass tracts (Wolff-Parkinson-
White syndrome).
DIAGNOSTIC INDICATIONS
Adenosine Mylan is indicated as an aid to diagnosis of broad or narrow
QRS complex supraventricular
tachycardias. Although adenosine is not effective in converting atrial
flutter, atrial fibrillation or ventricular
tachycardia to sinus rhythm, the slowing of AV conduction helps
diagnosis of atrial activity. In this respect
adenosine should be used as an adjunct to, but not a replacement for,
clinical and ECG observations. It should
be used only when, despite all diagnostic attempts, doubt still
persists.
Adenosine Mylan can also be used for improved diagnostic sensitivity
of intracavity electrophysiological
investigations.
4.2
DOSE AND METHOD OF ADMINISTRATION
Adenosine Mylan should be used only in hospitals with monitoring and
cardiorespiratory resuscitation
equipment available for immediate use. It should be administered by
rapid intravenous 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
administered into an IV line it should be injected as
proximally as possible, and followed by a rapid saline flush.
Adenosine Mylan should on