Product class:
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Authorized package
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Medicinal product class:
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For human use
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Package code:
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1112409
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Name of medicinal product:
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AMIOKORDIN
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Active substances:
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|
ATC code:
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C01BD01
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Dosage form:
|
solution for injection
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Route of administration:
|
intravenous use
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Strengh:
|
50mg 1ml
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Amount in package:
|
3ml 5TK
|
Legal status for supply*:
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Subject to medicinal prescription
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Class of active substance:
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|
Additional information:
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|
Indication:
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Paroxysmal supraventricular tachycardia (including Wolff-Parkinson-White syndrome), atrial fibrillation and flutter, ventricular tachyarrhythmias, when other drugs are ineffective, contraindicated or have caused severe adverese reactions.
Note: Amiokordin solution for injection is used only when rapid response to treatment is required or when oral treatment is not possible.
|
Safety features:
|
Yes
|
Summary of product characteristics (SPC):
|
(last updated March 28, 2022)
|
Package information leaflet (PIL):
|
EST (last updated March 28, 2022)
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Labelling:
|
(last updated October 6, 2020)
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Last imported to Estonia:
|
November 27, 2023
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Marketing authorization holder:
|
KRKA d.d. Novo mesto
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Marketing authorization number:
|
418003
|
Marketing authorization issued on:
|
August 8, 2003
|
Marketing authorization expires on:
|
Unlimited
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Marketing authorization procedure type:
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National
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Reference price:
|
|
Under reference price:
|
|
Reference price of daily dose:
|
|
Entry/Changing date:
August 7, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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