Adenosine 30mg/10ml solution for infusion vials

Ország: Egyesült Királyság

Nyelv: angol

Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Letöltés Betegtájékoztató (PIL)
19-06-2018
Letöltés Termékjellemzők (SPC)
19-06-2018

Aktív összetevők:

Adenosine

Beszerezhető a:

Wockhardt UK Ltd

ATC-kód:

C01EB10

INN (nemzetközi neve):

Adenosine

Adagolás:

3mg/1ml

Gyógyszerészeti forma:

Solution for infusion

Az alkalmazás módja:

Intravenous

Osztály:

No Controlled Drug Status

Recept típusa:

Valid as a prescribable product

Termék összefoglaló:

BNF: 02030200; GTIN: 5012727907383

Betegtájékoztató

                                8
CUSTOMER
PRODUCT NAME
ITEM CODE
OUR REF
DATE
PREVIOUS VERSION
PHARMACODE NO
MATERIAL
FLAT SIZE
FOLD SIZE
VIEW PANEL
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PACKING DETAILS
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COLOURS BACK
CUSTOMER
PRODUCT NAME
ITEM CODE
OUR REF
PROOF NO
DATE
PREVIOUS VERSION
PHARMACODE NO
MATERIAL
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CP Pharmaceuticals Limited
ADENOSINE 30MG/10ML
SOLUTION FOR INFUSION
105569/3-S2S
SO44387
One
10/04/2015
105569/2-S2S
Supplied
50gsm Opaque
300 x 148
148 x 27/25
PHARMACODE TO VIEW
PARALLEL
Shrinkwrapped in trays
BLACK
BLACK
8
CUSTOMER
PRODUCT NAME
ITEM CODE
OUR REF
DATE
PREVIOUS VERSION
PHARMACODE NO
MATERIAL
FLAT SIZE
FOLD SIZE
VIEW PANEL
FOLD DETAIL
PACKING DETAILS
COLOURS FRONT
COLOURS BACK
SO44387_105569/3-S2S_P1.indd 1
10/04/2015 15:35
SO44387_105569/3-S2S_P1.indd 2
10/04/2015 15:35
                                
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Termékjellemzők

                                OBJECT 1
ADENOSINE 30MG/10ML SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 10-Jun-2015 | Wockhardt UK
Ltd
1. Name of the medicinal product
Adenosine 30mg/10ml Solution for Infusion
2. Qualitative and quantitative composition
Each vial contains 30mg of adenosine per 10ml (3mg/ml).
Excipient: each vial contains approximately 36 mg of sodium per vial
(10ml).
For a full list of excipients, see Section 6.1.
3. Pharmaceutical form
Solution for infusion.
A clear, colourless solution free from visible particles.
4. Clinical particulars
4.1 Therapeutic indications
Intravenous (IV) adenosine infusion is a coronary vasodilator for use
in conjunction with radionuclide
myocardial perfusion imaging in patients who cannot exercise
adequately or for whom exercise is
inappropriate.
4.2 Posology and method of administration
Adenosine infusion is intended for use in hospitals with monitoring
and cardio-respiratory resuscitation
equipment available for immediate use if necessary.
It should be administered following the same procedure as for exercise
testing where facilities for cardiac
monitoring and cardio-respiratory resuscitation are available. During
administration of adenosine infusion
continuous ECG control is necessary as life-threatening arrhythmia
might occur. Heart rate and blood
pressure should be monitored every minute.
ADULTS:
1. Adenosine infusion should be administered undiluted as a continuous
peripheral intravenous infusion at
a dose of 140 µg/kg/min for six minutes using an infusion pump.
Separate venous sites for adenosine
infusion and radionuclide administration are recommended to avoid an
adenosine bolus effect.
2. After three minutes of adenosine infusion, the radionuclide is
injected to ensure sufficient time for peak
coronary blood flow to occur. The optimal vasodilator protocol is
achieved with six minutes of adenosine
infusion.
3. To avoid an adenosine bolus effect, blood pressure should be
measured in the arm opposite to the
adenosine infusion.
The table below is given as a guide for ad
                                
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