ORBENIN DRY COW 500 MG INTRAMAMMARY SUSPENSION

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CLOXACILLIN (AS CLOXACILLIN BENZATHINE BP (VET))

Available from:

Zoetis Belgium S.A.

ATC code:

QJ51CF02

INN (International Name):

CLOXACILLIN (AS CLOXACILLIN BENZATHINE BP (VET))

Dosage:

500 mg/syringe

Pharmaceutical form:

intramammary Suspension

Prescription type:

POM

Therapeutic group:

Bovine

Therapeutic area:

Cloxacillin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2017-03-10

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Orbenin Dry Cow 500 mg Intramammary Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 3g dose unit contains:
Active Substance
Cloxacillin (as cloxacillin benzathine)
500mg
Excipients
Mineral oil base to
3g
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Sterile off-white hydrophobic intramammary suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the infusion of cows at drying off, to treat mastitis infections
and to provide protection against further infections during
the dry period.
4.3 CONTRAINDICATIONS
Do not use in the lactating cow.
If lactating cows are accidentally infused, milk should be withheld
from the bulk supply
for 35 days or less time if testing shows it to be free from
antibiotic residues.
In common with other penicillins, cloxicillin
should not be used orally or parenterally in rabbits, guinea-pigs,
hamsters or gerbils.
Caution is advised in its use in other
very small herbivores.
Do not use in animals with known sensitivity to the active ingredient.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
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4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTION(S) FOR USE IN ANIMALS
None.
SPECIAL PRECAUTIONS TO BE T