Orbenin EDC 600 mg Suspensie voor intramammair gebruik
Orbenin EDC 600 mg Suspensie voor intramammair gebruik
Authorised
- Cloxacillin hemibenzathine
Product identification
Medicine name:
Orbenin EDC 600 mg Suspensie voor intramammair gebruik
Orbenin EDC 600 mg Suspension intramammaire
Orbenin EDC 600 mg Suspension zur intramammären Anwendung
Active substance:
- Cloxacillin hemibenzathine
Target species:
-
Cattle (dry cow)
Route of administration:
-
Intramammary use
Product details
Active substance and strength:
-
Cloxacillin hemibenzathine930.80/milligram(s)1.00Syringe
Pharmaceutical form:
-
Intramammary suspension
Withdrawal period by route of administration:
-
Intramammary use
-
Cattle (dry cow)
-
Meat and offal24hour
-
Milk36hourThis delay of 36 hours is only valid with cows in dry period for at least 42 days. In cas of an early delivery (dry period less than 42 days), the milk is not to be used for human consumption till 44 days after treatment.
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QJ51CF02
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Available in:
-
Belgium
Package description:
- Orbenin EDC 120 3.6 g Syringe Intramammary suspension
- Orbenin EDC 60 3.6 g Syringe Intramammary suspension
- Orbenin EDC 24 3.6 g Syringe Intramammary suspension
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Zoetis Belgium
Marketing authorisation date:
Manufacturing sites for batch release:
- Haupt Pharma Latina S.r.l.
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V150841
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
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Package Leaflet
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Labelling
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