Bovaclox DC Xtra

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cloxacillin Benzathine; Ampicillin trihydrate

Available from:

Norbrook Laboratories (Ireland) Limited

ATC code:

QJ51CR50

INN (International Name):

Cloxacillin Benzathine; Ampicillin trihydrate

Dosage:

600, 300 mg/syringe

Pharmaceutical form:

Intramammary suspension

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

combinations of penicillins

Authorization status:

Authorised

Authorization date:

1993-06-11

Summary of Product characteristics

Health Products Regulatory Authority
25 July 2019
CRN00969K
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Bovaclox DC Xtra
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
The active ingredients of Bovaclox DC Xtra are Ampicillin and
Cloxacillin, semi-synthetic penicillin’s derived from
6-aminopencillanic acid.
Each single dose 5.4g syringe contains 600 mg Cloxacillin (as
benzathine salt) and 300mg Ampicillin (as the trihydrate) in a long
acting base.
EXCIPIENT:
Aluminium stearate
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Intramammary Suspension
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Bovaclox DC Xtra is formulated for use in the dairy cow at the point
of drying off, that is, immediately after the last milking of
the lactation in order to treat existing mastitis and to provide
protection against further infections during the dry period.
Bovaclox DC Xtra is a useful aid in reducing the incidence of summer
mastitis in heifers and dry cows at risk.
Bovaclox DC Xtra is active against both Gram-positive and
Gram-negative organisms, which are associated with mastitis and is
effective against _Streptococcus agalactiae_ and other _Streptococcus_
species, Penicillin resistant and sensitive Staphylococci,
_Corynebacterium_ species, _Escherichia coli_ and other susceptible
Gram- negative bacteria.
Cloxacillin benzathine and ampicillin trihydrate in a long-acting base
maintain effective antibacterial levels in the dry cow udder
for up to 10 weeks and are non-irritant to udder tissue.
4.3 CONTRAINDICATIONS
Do not use on cows which have a short dry period.
Not intended for use within 49 days of calving.
(Refer to 4.11 for withdrawal periods)
In cows suffering from hypocalcaemia, it may be necessary to withhold
milk for a longer period until the levels of antibiotic are
below the EU maximum residue limit.
Do not use in animals with known hypersensitivity to the active
ingredient.
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