Product class:
|
Authorized package
|
Medicinal product class:
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Veterinary medicine
|
Package code:
|
1798724
|
Name of medicinal product:
|
Butasal-100
|
Active substances:
|
|
ATC code:
|
QA12CX92
|
Dosage form:
|
solution for injection
|
Route of administration:
|
intramuscular use; subcutaneous use; intravenous use
|
Strengh:
|
100mg+0,05mg 1ml
|
Amount in package:
|
100ml 1TK
|
Legal status for supply*:
|
Subject to medicinal prescription
|
Class of active substance:
|
|
Additional information:
|
|
Indication:
|
As supportive treatment of metabolic or reproductive disorders.
In case of peri-parturient metabolic disorders, tetany and paresis (milk fever), the
product should be administered in addition to magnesium and calcium, respectively.
|
Safety features:
|
No
|
Summary of product characteristics (SPC):
|
(last updated May 7, 2021)
|
Package information leaflet (PIL):
|
EST (last updated May 7, 2021)
|
Labelling:
|
(last updated May 7, 2021)
|
Withdrawal time:
|
Veis, hobune
Lihale ja söödavatele kudedele: 0 päeva.
Piimale: 0 tundi.
|
Species:
|
koer, hobune, kass, veis
|
Last imported to Estonia:
|
December 31, 2022
|
Marketing authorization holder:
|
Interchemie Werken De Adelaar Eesti aktsiaselts
|
Marketing authorization number:
|
2233
|
Marketing authorization issued on:
|
May 5, 2020
|
Marketing authorization expires on:
|
May 5, 2025
|
Marketing authorization procedure type:
|
Mutual recognition
|
Entry/Changing date:
January 21, 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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