Lactatrim MC Lactating Cow Intramammary Suspension.

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Trimethoprim; Sulphadiazine

Saatavilla:

Norbrook Laboratories (Ireland) Limited

ATC-koodi:

QJ51E

INN (Kansainvälinen yleisnimi):

Trimethoprim; Sulphadiazine

Annos:

40, 200 mg/syringe

Lääkemuoto:

Intramammary suspension

Prescription tyyppi:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeuttinen alue:

SULFONAMIDES AND TRIMETHOPRIM FOR INTRAMAMMARY USE

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

1996-10-18

Valmisteyhteenveto

Health Products Regulatory Authority
27 February 2019
CRN008WGG
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Lactatrim MC Lactating Cow Intramammary Suspension.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
EACH 8 G SYRINGE CONTAINS:
Active substances
Trimethoprim 40 mg
Sulphadiazine 200 mg
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Intramammary suspension.
A white to off-white suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (Lactating)
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The veterinary medicinal product is an intramammary suspension for the
broad spectrum treatment of clinical mastitis in
lactating cattle caused by organisms sensitive to the
Trimethoprim/Sulphadiazine combination.
Clinically, the veterinary medicinal product has been shown to be
effective in the routine treatment of mastitis in lactating cows.
The veterinary medicinal product exerts a bactericidal activity at
concentrations attained in the udder.
_In vitro_ the veterinary medicinal product is effective against
gram-positive and gram-negative bacteria including _Streptococcus _
_agalactiae_, _Streptococcus dysgalactiae_, _Streptococcus uberis_ and
other streptococcal species, staphylococcal spp.,
_Corynebacterium pyogenes_, _Eschericha coli_, and other gram-negative
bacteria.
4.3 CONTRAINDICATIONS
Do not use in cattle with known sulphonamide sensitivity, with hepatic
damage or with blood dyscrasias.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Only for lactating cows, do not administer in dry periods.
Whenever possible, the veterinary medicinal product should only be
used based on susceptibility testing.
Official and local antimicrobial policies should be taken into account
when the veterinary medicinal product is used. Use of the
veterinary medicinal product deviating from the instructions given in
the SPC may increase the prevalence of bacteria resistant
to the active su