ADENOSINE BAXTER adenosine 30 mg/10 mL solution for infusion vial

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Nunua Sasa

Shusha Tabia za bidhaa (SPC)
07-03-2018

Viambatanisho vya kazi:

adenosine, Quantity: 30 mg

Inapatikana kutoka:

Baxter Healthcare Pty Ltd

Dawa fomu:

Solution

Tungo:

Excipient Ingredients: sodium chloride; water for injections

Njia ya uendeshaji:

Intravenous

Vitengo katika mfuko:

5 x 10 mL vials, 10 x 10 mL vials

Dawa ya aina:

(S4) Prescription Only Medicine

Matibabu dalili:

Intravenous adenosine (30 mg/10 mL) is a coronary vasodilator for use in conjunction with radionuclide myocardial perfusion imaging, in patients unable to exercise adequately.

Bidhaa muhtasari:

Visual Identification: Clear, colourless to almost colourless solution essentially free from visible particles.; Container Type: Vial; 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:

2018-03-07

Tabia za bidhaa

                                Version 1.0
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1
AUSTRALIAN PRODUCT INFORMATION
ADENOSINE BAXTER 30 MG/10 ML (ADENOSINE)
1
NAME OF THE MEDICINE
Adenosine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 30 mg of adenosine in 10 mL of a 0.9% w/v solution
of sodium chloride in sterile water for
injections.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
ADENOSINE BAXTER 30 mg/10 mL is a clear, colourless to almost
colourless solution essentially free from
visible particles sterile solution for intravenous infusion, provided
in clear glass vials.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Intravenous
adenosine
is
a
coronary
vasodilator
for use
in
conjunction
with
radionuclide
myocardial
perfusion imaging, in patients unable to exercise adequately.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADENOSINE BAXTER 30 mg/10 mL is intended for use in hospitals, where
facilities for cardiac monitoring and
resuscitation are available.
DIAGNOSTIC DOSE
Adults
1.
ADENOSINE BAXTER 30 mg/10 mL should be administered undiluted as a
continuous peripheral
intravenous infusion at a dose of 140 µg/kg/min over fixed time
interval of six minutes (total dose
0.84 mg/kg) using an infusion pump. Separate venous sites for
ADENOSINE BAXTER 30 mg/10 mL and
radionuclide administration are recommended to avoid an adenosine
bolus effect.
2.
After three minutes of ADENOSINE BAXTER 30 mg/10 mL infusion, the
radionuclide is injected.
3.
Heart rate and blood pressure should be recorded at 1 minute
intervals, and ECG should be monitored
continuously during ADENOSINE BAXTER 30 mg/10 mL infusion. To avoid an
adenosine bolus effect,
blood pressure should be measured in the arm opposite to the ADENOSINE
BAXTER 30 mg/10 mL
infusion.
The table below is given as a guide for adjustment of the infusion
rate of undiluted ADENOSINE BAXTER 30
mg/10 mL, in line with body weight (total dose 0.84 mg/kg).
Patient Weight
_(kg)_
Infusion Rate
_(mL/min)_
45-49
2.1
50-54
2.3
55-59
2.6
Version 1.0
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