Linco-Spectin 100, 222/444.7 mg/g Powder for use in drinking water for pigs and chickens

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Spectinomycin; Lincomycin

Διαθέσιμο από:

Zoetis Belgium S.A.

Φαρμακολογική κατηγορία (ATC):

QJ01FF52

INN (Διεθνής Όνομα):

Spectinomycin; Lincomycin

Δοσολογία:

222, 444.7 milligram(s)/gram

Φαρμακοτεχνική μορφή:

Powder for use in drinking water

Τρόπος διάθεσης:

POM: Prescription Only Medicine as defined in relevant national legislation

Θεραπευτική ομάδα:

Chickens, Pigs

Θεραπευτική περιοχή:

lincomycin, combinations

Θεραπευτικές ενδείξεις:

Antibacterial

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2015-02-06

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
31 July 2020
CRN009WJ5
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Linco-Spectin 100, 222/444.7 mg/g Powder for use in drinking water for
pigs and chickens
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains:
ACTIVE SUBSTANCES:
​
Lincomycin (as lincomycin hydrochloride)
​222 mg
​
Spectinomycin (as spectinomycin sulphate)
​444.7 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for use in drinking water.
White pale powder
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs and chickens.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Pigs
For the treatment and metaphylaxis of porcine proliferative
enteropathy (ileitis) caused by _Lawsonia intracellularis_, and
associated enteric pathogens (_Escherichia coli_) susceptible to
lincomycin and spectinomycin.
The presence of the disease in the group must be established before
the product is used.
Chickens
For the treatment and metaphylaxis of chronic respiratory disease
(CRD) caused by _Mycoplasma gallisepticum _and _Escherichia _
_coli _susceptible to lincomycin and spectinomycin, and associated
with a low mortality rate.
The presence of the disease in the flock must be established before
the product is used.
4.3 CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substances or any
of the excipients.
Do not use in case of hepatic dysfunction.
Do not allow rabbits, rodents (e.g. chinchillas, hamsters, guinea
pigs), horses or ruminants to access to water or feeds
containing lincomycin. Ingestion by these species may result in severe
gastrointestinal effects.
Do not use in laying hens.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
In _E. coli,_a significant part of the strains show high MIC values
(minimum inhibitory concentrations) against the
lincomycin-spectinomycin combination and may be clinically resistant,
although no breakpoint is defined.
Due to technical constraints the susceptibility of _L. intracel