Vecoxan 2.5 mg/ml Oral Suspension for lambs and calves

Држава: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Diclazuril

Доступно од:

Intervet Ireland Limited

АТЦ код:

QP51AJ03

INN (Међународно име):

Diclazuril

Дозирање:

2.5 milligram(s)/millilitre

Фармацеутски облик:

Oral suspension

Тип рецептора:

POM: Prescription Only Medicine as defined in relevant national legislation

Терапеутска област:

diclazuril

Статус ауторизације:

Authorised

Датум одобрења:

2000-02-04

Карактеристике производа

Health Products Regulatory Authority
24 November 2020
CRN00C1S3
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Vecoxan 2.5 mg/ml Oral Suspension for lambs and calves
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
​
Active substance:
​
Diclazuril
2.5 mg
Excipients:
​
Methyl parahydroxybenzoate (E218)
1.8 mg
Propyl parahydroxybenzoate
0.2 mg
For a full list of excipients see 6.1
​
3 PHARMACEUTICAL FORM
White, oral suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Ovine (lambs) and bovine (calves).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In lambs:
Prevention of coccidiosis caused by _Eimeria crandallis_ and _Eimeria
ovinoidalis_.
In calves:
Prevention of coccidiosis caused by _Eimeria bovis_ and _Eimeria
zuernii_.
If there is no recent and confirmed history of clinical coccidiosis,
the presence of coccidia in the flock or herd should be
confirmed by faecal sampling prior to treatment.
4.3 CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Avoid underdosing which may be due to underestimation of body weight,
misadministration of the product or lack of
calibration of the dosing device (if any).
Calves: in certain cases, only a transient reduction of oocyst
shedding may be achieved.
Suspected clinical cases of resistance to anticoccidials should be
further investigated using appropriate tests (e.g. Faecal Egg
Count Reduction Test). Where the results of the test(s) strongly
suggest resistance to a particular antiprotozoal, an anticoccidial
belonging to another pharmacological class and having a different mode
of action should be used.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
The preferred timing of treatment is directed by the known
epidemiology of _Eimeria spp._ and the presence of coccidia in the
flock or herd should be confirmed by faecal sampling prior to
treatment, if there is no recent and confirmed