Orbenin L.A. 200 mg Intramammary Suspension

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:

Authorized

Authorization date:

1995-01-14

Summary of Product characteristics

Revised: September 2020
AN: 00732/2020
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Orbenin L.A. 200 mg Intramammary Suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 3 g dose unit contains the following:
A_ctive ingredient_
Cloxacillin as cloxacillin sodium
200 mg
_Other ingredients_
Vegetable oil base to
3 g
For the full list of all other excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Intramammary suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle and sheep.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Orbenin L.A. is indicated for intramammary use in the treatment of
bovine
mastitis caused by Gram-positive organisms. For the best results it
should
be used at the earliest signs of infection.
The product is also indicated as an intramammary infusion in ewes at
weaning for the treatment and prevention of mastitis. Orbenin is
effective
against
_Streptococcus _
_agalactiae_
and
other
streptococcal
species,
penicillin-resistant
and
sensitive
staphylococci
and
_Actinomyces _
_pyogenes._
In staphylococcal and certain forms of streptococcal mastitis, an
adequate
duration
of
treatment
is
important
in
achieving
both
clinical
and
bacteriological cures. Orbenin L.A. with its slow release
characteristics is
designed to meet these requirements.
4.3
CONTRAINDICATIONS
None.
Revised: September 2020
AN: 00732/2020
Page 2 of 5
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
i)
Special
precautions
for
use
in
animals
Individual
syringes
must
only
be
used
once.
ii)
Special precautions to be taken by the person administering
the veterinary medicinal product to animals
Penicillins
and
cephalosporins
may
cause
hypersensitivity
(allergy)
following
injection,
inhalation,
ingestion
or
skin
contact.
Hypersensitivity
to
penicillins
may
lead
to
cross-
reactions to cephalosporins and vice versa. Allergic reaction to
these substances may occasionally be serious.
Do not handle this product if you know you are sensitised, or if
yo