Lismay 444.7 mg/g + 222.0 mg/g powder for use in drinking water for pigs

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Spectinomycin; Lincomycin

Disponibil de la:

Laboratorios Maymó, S.A.

Codul ATC:

QJ01FF52

INN (nume internaţional):

Spectinomycin; Lincomycin

Dozare:

444.7,222.0 milligram(s)/gram

Forma farmaceutică:

Powder for use in drinking water

Tip de prescriptie medicala:

POM: Prescription Only Medicine as defined in relevant national legislation

Zonă Terapeutică:

lincomycin, combinations

Statutul autorizaţiei:

Authorised

Data de autorizare:

2020-03-06

Caracteristicilor produsului

Health Products Regulatory Authority
29 May 2020
CRN009L82
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Lismay 444.7 mg/g + 222.0 mg/g powder for use in drinking water for
pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g contains:
​
ACTIVE SUBSTANCES
​
​
Spectinomycin (as spectinomycin sulfate tetrahydrate) . . . . . . . .
. . . . . . . . . . . . . . . . . . .
​
444.7 mg
​
Lincomycin (as lincomycin hydrochloride) . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . .
​
222.0 mg
​
​
​
​
EXCIPIENTS
​
​
​
Sodium Benzoate (E-211) . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
​
10.67 mg
​
​
​
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Powder for use in drinking water.
Whitish powder.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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.
4.3 CONTRAINDICATIONS
Do not use in known cases of hypersensitivity to the active substances
or any of the excipients.
Do not use in known cases of hepatic dysfunction.
Do not allow rabbits or rodents (eg chinchillas, hamsters, guinea
pigs), horses or ruminants to access to water or feed
containing lincomycin. Ingestion by these species may result in severe
gastrointestinal effects.
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 and
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