Novocillin LC 1000 mg intramammary suspension for lactating cows

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Oxacillin sodium

Available from:

Pharmanovo Veterinärarzneimittel GmbH

ATC code:

QJ01CF04

INN (International Name):

Oxacillin sodium

Dosage:

1000 milligram(s)

Pharmaceutical form:

Intramammary suspension

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

oxacillin

Authorization status:

Authorised

Authorization date:

2021-10-15

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Novocillin LC 1000 mg intramammary suspension for lactating cows (AT,
BG, CY, CZ, DE, EE, HU,
IE, IS, IT, LT, PL, RO, UK(NI))
Novocillin LC intramammary suspension for lactating cows (FR)
Novocillin 1000 mg intramammary suspension for lactating cows (ES, PT)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each intramammary syringe of 10 g contains:
ACTIVE SUBSTANCE:
Oxacillin sodium
1000 mg
(equivalent to 1042.5 mg Oxacillin sodium monohydrate or 948 mg
oxacillin)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Intramammary suspension
White to almost white suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle (lactating cows)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of clinical mastitis caused by
_Staphylococcus _
spp. (including β-lactamase producing strains)
and
_Streptococcus _
spp. susceptible to oxacillin.
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance,
penicillin, cephalosporin or to any of the
excipients.
Do not use in cases of resistance to isoxazolyl penicillins and
cephalosporins.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
In the case of severe swelling of the udder quarter, obstructive
swelling of the milk duct and/or
obstruction of the milk ducts by cell detritus, the veterinary
medicinal product must be administered
with caution to avoid pain and injuries of the teat canal.
Use of the product should be based on identification and
susceptibility testing of the target pathogens.
If this is not possible, therapy should be based on epidemiological
information and knowledge of
susceptibility of the target bacteria at farm level, or at
local/regional level.
Use of the product deviating from the instructions given in the SPC
may increase the prevalence of
bacteria resistant to oxacillin and may decrease the effectiveness of
the treatment.
Use of the product sho