Orbenin Ophthalmic Ointment 16.67% w/w Eye Ointment

Nazione: Regno Unito

Lingua: inglese

Fonte: VMD (Veterinary Medicines Directorate)

Principio attivo:

Cloxacillin

Commercializzato da:

Zoetis UK Limited

Codice ATC:

QS01AA90

INN (Nome Internazionale):

Cloxacillin

Forma farmaceutica:

Eye ointment

Tipo di ricetta:

POM-V - Prescription Only Medicine – Veterinarian

Gruppo terapeutico:

Cats, Cattle, Dogs, Horses, Sheep

Area terapeutica:

Antimicrobial

Stato dell'autorizzazione:

Authorized

Data dell'autorizzazione:

1990-09-14

Scheda tecnica

Revised: September 2020
AN: 00732/2020
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Orbenin Ophthalmic Ointment 16.67% w/w Eye Ointment
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ACTIVE INGREDIENT_
G/TUBE
Cloxacillin (as cloxacillin benzathine)
0.5g
_OTHER INGREDIENTS_
Mineral oil base to
3.0g
For the full list of all other excipients see section 6.1
3.
PHARMACEUTICAL FORM
Eye ointment.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle, sheep, horses, dogs and cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of ocular infections in cattle, sheep, horses, dogs
and cats
where susceptible organisms, such as _Staphylococcus aureus_
(including beta-
lactamase producing strains), _Moraxella bovis_ and _Branhamella
ovis_, are
suspected or anticipated as pathogens. A particular indication is
treatment of
New Forest Disease in cattle.
4.3 CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
For external use only.
4.5
SPECIAL PRECAUTIONS FOR USE
(i)
Special precautions for use in animals
Revised: September 2020
AN: 00732/2020
Page 2 of 4
Care should be taken to avoid contamination of the contents during
use.
(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 reactions to these substances may occasionally be
serious.
Do not handle this product if you know you are sensitised, or if you
have
been advised not to work with such preparations. Handle this product
with great care to avoid exposure, taking all recommended precautions.
If you develop symptoms following exposure, such as a skin rash, you
should seek medical advice and show the doctor this warning. Swelling
of the face, lips or eyes, or difficulty with breathing are more
serious
symptoms and