BISEPTYL
BISEPTYL
Authorised
- Spectinomycin sulfate
- Lincomycin hydrochloride
Product identification
Medicine name:
BISEPTYL
Active substance:
- Spectinomycin sulfate
- Lincomycin hydrochloride
Target species:
-
Cattle
-
Pig
-
Dog
Route of administration:
-
Intramuscular use
Product details
Active substance and strength:
-
Spectinomycin sulfate100.00milligram(s)1.00millilitre(s)
-
Lincomycin hydrochloride50.00milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intramuscular use
- Cattle
-
Meat and offal14day
-
Milkno withdrawal periodLeche: No usar en animales en lactación cuya leche se destine al consumo humano
-
- Pig
-
Meat and offal14day
-
- Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QJ01RA94
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Spain
Available in:
-
Spain
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Well-established use application (Article 13a of Directive No 2001/82/EC)
Marketing authorisation holder:
- Laboratorios Syva S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
- Laboratorios Syva S.A.U.
Responsible authority:
- Spanish Agency For Medicines And Health Products
Authorisation number:
- 1197 ESP
Date of authorisation status change:
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
This document does not exist in this language (English). You can find it
in another language below.
Spanish (PDF)
Published on: 13/09/2024
Package Leaflet
This document does not exist in this language (English). You can find it
in another language below.
Spanish (PDF)
Published on: 13/09/2024
Labelling
This document does not exist in this language (English). You can find it
in another language below.
Spanish (PDF)
Published on: 13/09/2024
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