Orbenin Dry Cow 500 mg Intramammary Suspension

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Cloxacillin Benzathine

Disponible des:

Zoetis Belgium S.A.

Codi ATC:

QJ51CF02

Designació comuna internacional (DCI):

Cloxacillin Benzathine

Dosis:

500 mg/syringe

formulario farmacéutico:

Intramammary suspension

tipo de receta:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupo terapéutico:

Cattle

Área terapéutica:

cloxacillin

indicaciones terapéuticas:

Antibacterial

Estat d'Autorització:

Authorised

Data d'autorització:

1997-10-01

Fitxa tècnica

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Orbenin Dry Cow 500 mg intramammary suspension
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Each 3g intramammary syringe contains: ACTIVE SUBSTANCE:
Cloxacillin (as cloxacillin benzathine)
500 mg
_ _
EXCIPIENTS:
_ _
QUALITATIVE COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS_ _
QUANTITATIVE COMPOSITION IF THAT
INFORMATION IS ESSENTIAL FOR PROPER
ADMINISTRATION OF THE VETERINARY MEDICINAL
PRODUC
t
_ _
Mineral oil base to
_ _
3 g
Stearic Acid
Aluminium stearate
_ _
Liquid Paraffin
_ _
_ _
_ _
Sterile off-white hydrophobic intramammary suspension.
_ _
_ _
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
_ _
Cattle.
3.2
INDICATIONS FOR USE FOR EACH 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.
3.3
CONTRAINDICATIONS
_ _
Do not use in the lactating cow.
In common with other penicillins, cloxacillin 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 cases of hypersensitivity to the active substance or to
any of the excipients.
3.4
SPECIAL WARNINGS
None.
_ _
_ _
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
_ _
Not applicable.
_ _
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 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 m