ADENOSINE VIATRIS adenosine 6 mg/2 mL injection pre-filled syringe

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Viambatanisho vya kazi:

adenosine, Quantity: 6 mg

Inapatikana kutoka:

Alphapharm Pty Ltd

INN (Jina la Kimataifa):

adenosine

Dawa fomu:

Injection, solution

Tungo:

Excipient Ingredients: water for injections; sodium chloride

Njia ya uendeshaji:

Intravenous Bolus

Vitengo katika mfuko:

5 syringes

Dawa ya aina:

(S4) Prescription Only Medicine

Matibabu dalili:

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.

Bidhaa muhtasari:

Visual Identification: Clear colourless solution free from visible particles; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Idhini hali ya:

Registered

Idhini ya tarehe:

2009-08-10

Tabia za bidhaa

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