Polocainum Hydrochloricum 5% Cum Adrenalino 0,005% (50 mg + 0,05 mg)/ml Roztwór do wstrzykiwań
Polocainum Hydrochloricum 5% Cum Adrenalino 0,005% (50 mg + 0,05 mg)/ml Roztwór do wstrzykiwań
Authorised
- Epinephrine
- Procaine hydrochloride
Product identification
Medicine name:
Polocainum Hydrochloricum 5% Cum Adrenalino 0,005% (50 mg + 0,05 mg)/ml Roztwór do wstrzykiwań
Active substance:
- Epinephrine
- Procaine hydrochloride
Target species:
-
Horse
-
Cattle
Route of administration:
-
Perineural use
Product details
Active substance and strength:
-
Epinephrine0.05milligram(s)/millilitre1.00milligram(s)/millilitre
-
Procaine hydrochloride50.00milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Perineural use
- Horse
-
Meat and offal5week
-
- Cattle
-
Milk5week
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QN01B
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Poland
Package description:
- Available only in Polish
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Fixed combination application (Article 13b of Directive No 2001/82/EC)
Marketing authorisation holder:
- Biowet Drwalew Sp. z o.o.
Marketing authorisation date:
Manufacturing sites for batch release:
- Drwalewskie Zakłady Przemysłu Bioweterynaryjnego S.A.
Responsible authority:
- Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
- 0732
Date of authorisation status change:
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Package Leaflet
This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 4/02/2022
Summary of Product Characteristics
This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 4/02/2022
Labelling
This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 6/02/2023
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