SPIROVET 600 000 IU/ML SOLUTION FOR INJECTION FOR CATTLE
SPIROVET 600 000 IU/ML SOLUTION FOR INJECTION FOR CATTLE
Authorised
- Spiramycin
Product identification
Medicine name:
SPIROVET 600 000 IU/ML SOLUTION FOR INJECTION FOR CATTLE
Spirovet 600 000 j.m./ml Roztwór do wstrzykiwań
Active substance:
- Spiramycin
Target species:
-
Cattle
Route of administration:
-
Intramuscular use
Product details
Active substance and strength:
-
Spiramycin600000.00/international unit(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intramuscular use
-
Cattle
-
Meat and offal75dayMastitis (30 000 IU of spiramycin per kg bodyweight (i.e. 5 ml of product per 100 kg bodyweight) twice at 24h of interval).
-
Milkno withdrawal periodRespiratory infections (100 000 IU of spiramycin per kg bodyweight (i.e. 5 ml of product per 30 kg bodyweight) twice at 48h of interval).
In case of treatment at the dose required for respiratory diseases, the veterinary medicinal product is not authorised for use in animals producing milk for human consumption. -
Meat and offal75dayRespiratory infections (100 000 IU of spiramycin per kg bodyweight (i.e. 5 ml of product per 30 kg bodyweight) twice at 48h of interval).
-
Milk14dayMastitis (30 000 IU of spiramycin per kg bodyweight (i.e. 5 ml of product per 100 kg bodyweight) twice at 24h of interval).
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QJ01FA02
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Poland
Available in:
-
Poland
Package description:
- Box containing 1 glass vial of 50 ml
- Box containing 1 glass vial of 50 ml
- Box containing 1 glass vial of 250 ml
- Box containing 1 plastic vial of 50 ml
- Box containing 1 plastic vial of 100 ml
- Box containing 1 plastic vial of 250 ml
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Ceva Animal Health Polska Sp. z o.o.
Marketing authorisation date:
Manufacturing sites for batch release:
- CEVA Santé Animale
Responsible authority:
- Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
- 2218
Date of authorisation status change:
Reference member state:
-
France
Procedure number:
- FR/V/0244/001
Concerned member states:
-
Bulgaria
-
Czechia
-
Denmark
-
Estonia
-
Hungary
-
Ireland
-
Latvia
-
Lithuania
-
Poland
-
Portugal
-
Slovakia
-
Slovenia
-
United Kingdom (Northern Ireland)
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.
Polish (PDF)
Published on: 19/03/2025
Package Leaflet
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in another language below.
Polish (PDF)
Published on: 19/03/2025
Labelling
This document does not exist in this language (English). You can find it
in another language below.
Polish (PDF)
Published on: 19/03/2025
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