Huvebiotic 330 mg/100 mg Intramammary solution

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Neomycin sulfate; Lincomycin hydrochloride

Διαθέσιμο από:

Huvepharma NV

Φαρμακολογική κατηγορία (ATC):

QJ51RF03; QJ51RG01

INN (Διεθνής Όνομα):

Neomycin sulfate; Lincomycin hydrochloride

Δοσολογία:

330/100 mg/syringe

Φαρμακοτεχνική μορφή:

Intramammary solution

Τρόπος διάθεσης:

POM: Prescription Only Medicine as defined in relevant national legislation

Θεραπευτική περιοχή:

lincomycin, combinations with other antibacterials; neomycin, combinations with other antibacterials

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2021-10-29

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
20 January 2022
CRN00CQ2Z
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Huvebiotic 330 mg/100 mg Intramammary solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES
Each 10 ml syringe contains:
Lincomycin (as hydrochloride) 330 mg
Neomycin (as sulphate) 100 mg
EXCIPIENTS
Disodium edetate 5 mg
For the full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Intramammary solution.
Clear colourless to slightly yellow liquid.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (lactating cows).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of mastitis in cattle during the lactation period
caused by:

Staphylococcus species (both penicillinase and non-penicillinase
producers) including _Staphylococcus aureus_
susceptible to lincomycin and/or neomycin_,_

Streptococcus species including _Streptococcus agalactiae_,
_Streptococcus dysgalactiae_ and _Streptococcus uberis _
susceptible to lincomycin and/or neomycin,

Coliform bacteria including _Escherichia coli _susceptible to
neomycin.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
i. Special precautions for use in animals
Use of the product should be based on susceptibility testing of the
bacteria isolated from the animal. If this is not possible,
therapy should be based on local (regional, farm level)
epidemiological information about susceptibility of the target
bacteria.
Official, national and regional antimicrobial policies should be taken
into account when the product is used.
Use of the product deviating from the instructions given in the SPC
may increase the prevalence of bacteria resistant to
lincomycin and neomycin and may decrease the effectiveness of
treatment with other liconsamides, macrolides, streptogramin
Health Products Regulatory Authority
20 January 2022
CRN00CQ2Z
Page 2 of 4
B and aminoglycosides, due to the potential for cross-resistance. The
feeding to