Orbolan Lactating 200 mg Intramammary Suspension for Cattle and Sheep

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Cloxacillin

Available from:

Zoetis UK Limited

ATC code:

QJ51CF02

INN (International Name):

Cloxacillin

Pharmaceutical form:

Intramammary suspension

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle, Sheep

Therapeutic area:

Antimicrobial intramammary

Authorization status:

Expired

Authorization date:

2015-10-14

Summary of Product characteristics

Revised: November 2019
AN: 01122/2019
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Orbolan Lactating 200 mg intramammary suspension for cattle and sheep
[UK]
Orbenin Lactation 200 mg intramammary suspension for cattle and sheep
[NL]
Orbenin LA 200 mg intramammary suspension for lactating cattle and
sheep [DE,
ES, PT]
Orbelux LA 200mg intramammary suspension for cattle and sheep [PL]
Orbenin Lattazione 200 mg intramammary suspension for cattle and sheep
[IT]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 3 g dose unit contains the following:
ACTIVE SUBSTANCE:
Cloxacillin as cloxacillin sodium
200 mg
EXCIPIENT:
Butylhydroxyanisole (E 320)
0.558 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Intramammary suspension.
An off-white viscous suspension
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle (lactating cows) and sheep (sheep for meat production)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Lactating cows
For the treatment of mastitis associated with staphylococcal and
streptococcal
species sensitive to cloxacillin.
Ewes
For the treatment of subclinical infections of the udder during the
dry period,
associated with staphylococcal species and _Trueperella pyogenes_
sensitive to
cloxacillin.
Revised: November 2019
AN: 01122/2019
Page 2 of 5
4.3
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to cloxacillin,
other β-lactam
antibiotics or to any of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
For the best results in cattle, the product should be used at the
earliest signs of
infection.
In staphylococcal and certain forms of streptococcal mastitis, an
adequate duration of
treatment is important in achieving both clinical and bacteriological
cures.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Individual syringes must only be used once.
Official, national and regional antimicrobial policies should be taken
into account
when the product is used.
Use of the product should b