Oxfencare Oral Suspension

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Oxfendazole

Dostępny od:

Ancare Ireland Ltd.

Kod ATC:

QP52AC02

INN (International Nazwa):

Oxfendazole

Dawkowanie:

22.65 milligram(s)/millilitre

Forma farmaceutyczna:

Oral suspension

Typ recepty:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupa terapeutyczna:

Cattle, Sheep

Dziedzina terapeutyczna:

oxfendazole

Wskazania:

Endoparasiticide

Status autoryzacji:

Authorised

Data autoryzacji:

1992-06-09

Charakterystyka produktu

Health Products Regulatory Authority
31 January 2022
CRN00CRDM
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Oxfencare Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance
Oxfendazole
22.65
mg
Excipients
Formaldehyde Solution
2.0
mg
Potassium sorbate
1.0
mg
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension.
Aqueous off white free flowing suspension
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and sheep.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the control of sensitive mature and immature gastrointestinal
roundworms, lungworms and tapeworms in cattle and sheep,
including:
Gastro‑intestinal roundworms:
_Ostertagia_ spp.
_Haemonchus_ spp.
_Trichostrongylus _spp.
_Nematodirus _spp_., _including _N. battus_
_Cooperia _spp.
_Capillaria_ spp.
_Oesophagostomum _spp.
_Chabertia_ spp.
_Trichuris_ spp.
Lungworms:
_Dictyocaulus _spp.
Tapeworms:_Monezia _spp.
4.3 CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to the active
ingredient.Do not use in sheep producing milk for human
consumption.
Health Products Regulatory Authority
31 January 2022
CRN00CRDM
Page 2 of 4
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Care should be taken to avoid the following practices because they
increase the risk of development of resistance and could
ultimately result in ineffective therapy:
- Too frequent and repeated use of anthelmintics from the same class,
over an extended period of time.
- Underdosing, which may be due to underestimation of body weight,
misadministration of the product, or lack of calibration
of the dosing device.
Suspected clinical cases of resistance to anthelmintics 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 anthelmintic, an anthelmintic
belonging to another pharmacological class and having a different mode
of action should be used.
4.5