DRY-CLOX GEL

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CLOXACILLIN (CLOXACILLIN BENZATHINE)

Available from:

BOEHRINGER INGELHEIM ANIMAL HEALTH CANADA INC.

Dosage:

500MG

Pharmaceutical form:

GEL

Composition:

CLOXACILLIN (CLOXACILLIN BENZATHINE) 500MG

Administration route:

INTRAMAMMARY

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic group:

CATTLE

Product summary:

Active ingredient group (AIG) number: 0131306006

Authorization status:

APPROVED

Authorization date:

2021-06-10

Patient Information leaflet

BOEHRINGER INGELHEIM ANIMAL HEALTH CANADA INC.
DRY-CLOX
® (CLOXACILLIN BENZATHINE) INTRAMAMMARY INFUSION /PROPOSED LABELING
COMPONENTS
BIAH: Version 31OCT2022
Page 1 of 13
PACKAGE INSERT (ENGLISH)
DIN 02173247
PR
DRY-CLOX
®
CLOXACILLIN BENZATHINE INTRAMMARY INFUSION, USP
For intramammary infusion into the dry cow
Veterinary Use Only
Sterile
DESCRIPTION: Dry-Clox® (cloxacillin benzathine) for INTRAMAMMARY
INFUSION into the
DRY COW is a product which provides bactericidal activity against
gram-positive bacteria. The
active agent, cloxacillin benzathine, is a sparingly soluble salt of
the semisynthetic penicillin,
cloxacillin. Cloxacillin is a derivative of 6-amino-penicillanic acid,
and therefore is chemically
related to other penicillins. It has, however, the antibacterial
properties described below, which
distinguish it from certain other penicillins.
ACTIVE INGREDIENT: Each 10 mL disposable sterile syringe contains
cloxacillin benzathine
equivalent to 500 mg of cloxacillin activity in a stable peanut oil
gel.
STORAGE: Do not store above 25°C. Do not freeze.
ACTION: In the non-lactating mammary gland, Dry-Clox® provides
bactericidal levels of the
active antibiotic, cloxacillin, for a prolonged period of time. This
prolonged activity is due to the
low solubility of the cloxacillin benzathine and to the slow-release
oil-gel base. This prolonged
contact between the antibiotic and the pathogenic organism enhances
the probability of a
bacteriological cure.
Cloxacillin is not destroyed by the enzyme, penicillinase, and
therefore, is ACTIVE AGAINST
PENICILLIN-RESISTANT STRAINS OF _STAPHYLOCOCCUS AUREUS_. It is also
active against non-penicillinase-
producing _Staphylococcus aureus_ as well as _Streptococcus
agalactiae_.
The class disc, Methicillin 5 mcg, should be used to estimate the _in
vitro_ susceptibility of
bacteria to cloxacillin.
INDICATIONS: For the treatment of mastitis caused by _Streptococcus
agalactiae _and
_Staphylococcus aureus _in dairy cows during the dry period.
Dry-Clox® has been shown by extens