Lincoral-S 222 mg/g + 444.7 mg/g powder for use in drinking water

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Lincomycin hydrochloride monohydrate; Spectinomycin sulfate tetrahydrate

Disponible depuis:

Huvepharma NV

Code ATC:

QJ01FF52

DCI (Dénomination commune internationale):

Lincomycin hydrochloride monohydrate; Spectinomycin sulfate tetrahydrate

forme pharmaceutique:

Powder for use in drinking water

Type d'ordonnance:

POM: Prescription Only Medicine as defined in relevant national legislation

Domaine thérapeutique:

lincomycin, combinations

Date de l'autorisation:

2023-09-08

Résumé des caractéristiques du produit

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Lincoral-S 222 mg/g + 444.7 mg/g powder for use in drinking water
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains:
ACTIVE SUBSTANCES:
Lincomycin
222 mg
(equivalent to 251.7 mg of lincomycin hydrochloride monohydrate)
Spectinomycin
444.7 mg
(equivalent to 672.4 mg of spectinomycin sulfate tetrahydrate)
EXCIPIENT:
QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS
Lactose monohydrate
White to almost white powder.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Pigs and chickens.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Pigs
For the treatment and metaphylaxis of porcine proliferative
enteropathy (ileitis) caused by
_Lawsonia intracellularis_
, and associated enteric pathogens (
_Escherichia coli_
).
The presence of the disease in the group must be established before
the veterinary medicinal
product is used.
Chickens
For the treatment and metaphylaxis of chronic respiratory disease
(CRD) caused by
_Mycoplasma _
_gallisepticum _
and
_Escherichia coli _
and associated with a low mortality rate.
The presence of the disease in the group must be established before
the veterinary medicinal
product is used.
3.3 CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substances or
any of the excipients.
Do not use in cases of hepatic dysfunction.
Do not allow rabbits, rodents (e.g. chinchillas, hamsters, guinea
pigs), horses or ruminants access
to water or feeds containing lincomycin. Ingestion by these species
may result in severe
gastrointestinal effects.
Do not use in laying hens.
3.4
SPECIAL WARNINGS
In
_E. coli, _
a significant number 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. intracellularis _
is
_ _
difficult to test
_in vitro_
,
and data about the lincomycin-spectinomycin resistance status in that
species are lacking.
Cross-resistanc