Denagard 12.5% w/v Concentrate for Oral Solution

Nazione: Regno Unito

Lingua: inglese

Fonte: VMD (Veterinary Medicines Directorate)

Principio attivo:

Tiamulin Hydrogen Fumarate

Commercializzato da:

Elanco Europe Ltd

Codice ATC:

QJ01XQ01

INN (Nome Internazionale):

Tiamulin Hydrogen Fumarate

Forma farmaceutica:

Oral solution

Tipo di ricetta:

POM-V - Prescription Only Medicine – Veterinarian

Gruppo terapeutico:

Chickens, Pigs, Turkeys

Area terapeutica:

Antimicrobial

Stato dell'autorizzazione:

Authorized

Data dell'autorizzazione:

1992-07-31

Scheda tecnica

Revised: October 2020
AN: 00986/2020
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Denagard 12.5% w/v Concentrate for Oral Solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance
Tiamulin hydrogen fumarate
125.0 mg/ml
12.5% w/v
Excipients
Antimicrobial preservatives
Methyl parahydroxybenzoate
0.9 mg/ml
0.09% w/v
Propyl parahydroxybenzoate
0.1 mg/ml
0.01% w/v
For full list of excipients see section 6.1
3.
PHARMACEUTICAL FORM
Concentrate for oral solution.
Pale yellow aqueous solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs, chickens and turkeys
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
PIGS:
For the treatment, prevention and control of swine dysentery caused by
_Brachyspira _
_hyodysenteriae_ and complicated by Fusobacterium and Bacteroides spp.
CHICKENS:
For the reduction in the severity of disease caused by mycoplasmas.
TURKEYS:
For the reduction in the severity of disease caused by mycoplasmas.
4.3
CONTRAINDICATIONS
Animals and birds should not receive products containing monensin,
narasin or
salinomycin, during or for at least seven days before or after
treatment. Severe
growth depression or death may result.
Revised: October 2020
AN: 00986/2020
Page 2 of 6
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
In order to avoid interactions between tiamulin and the incompatible
ionophores
monensin, narasin and salinomycin, the feed mill supplying the feed
should be
notified that tiamulin will be used and that these products should not
be included in
the feed or contaminate the feed.
The feed should be tested for the ionophores prior to use if there is
any suspicion
that contamination of the feed might occur. If an interaction does
occur, stop tiamulin
water medication immediately and replace with fresh water. Remove
contaminated
feed as soon as possible and replace with feed not containing the
tiamulin-
incompatible ionophores.
4.5
SPECIAL PRECAUTIONS FOR USE
i)
Special precautions for use in animals
Not applicable.
ii)
Special precautions