SPECTOLIKEL 50/100 mg/ml solution for injection for calves, sheep and pigs
SPECTOLIKEL 50/100 mg/ml solution for injection for calves, sheep and pigs
Authorised
- Spectinomycin
- Lincomycin
Product identification
Medicine name:
SPECTOLIKEL 50/100 mg/ml solution for injection for calves, sheep and pigs
Spectoliphen 50 mg/ml Oplossing voor injectie voor kalveren, schapen en varkens
Spectoliphen 50 mg/ml Solution injectable pour veaux, ovins et porcins
Spectoliphen 50 mg/ml Injektionslösung für Kälber, Schafe und Schweine
Active substance:
- Spectinomycin
- Lincomycin
Target species:
-
Sheep
-
Pig
-
Cattle
Route of administration:
-
Intramuscular use
Product details
Active substance and strength:
-
Spectinomycin100.00/milligram(s)1.00millilitre(s)
-
Lincomycin50.00/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intramuscular use
-
Sheep
-
Meat and offal15dayMilk: not authorised for use in animals producing milk for human consumption.
-
-
Pig
-
Meat and offal14day
-
-
Cattle
-
Meat and offal23day
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QJ01FF52
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Available in:
-
Belgium
Package description:
- 250 ml translucent polypropylene vials, with bromobutyl stopper and aluminium cap with FLIP-OFF seal.
- 100 ml translucent polypropylene vials, with bromobutyl stopper and aluminium cap with FLIP-OFF seal.
- 6x250 ml translucent polypropylene vials, with bromobutyl stopper and aluminium cap with FLIP-OFF seal.
- 10X100 ml translucent polypropylene vials, with bromobutyl stopper and aluminium cap with FLIP-OFF seal.
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:
- KELA Kempisch Laboratorium Kela Laboratoria
Marketing authorisation date:
Manufacturing sites for batch release:
- S P Veterinaria S.A.
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V445137
Date of authorisation status change:
Reference member state:
-
Portugal
Procedure number:
- PT/V/0111/001
Concerned member states:
-
Belgium
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Package Leaflet
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Labelling
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