Curazole 100 mg/ml oral suspension for horses

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Fenbendazole

Dostopno od:

Univet Limited

Koda artikla:

QP52AC13

INN (mednarodno ime):

Fenbendazole

Farmacevtska oblika:

Oral suspension

Tip zastaranja:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapevtsko območje:

fenbendazole

Datum dovoljenje:

2022-12-23

Lastnosti izdelka

2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Curazole 100 mg/ml oral suspension for horses.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Fenbendazole
100 mg
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE
COMPOSITION
IF THAT INFORMATION IS
ESSENTIAL
FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUC
t
_ _
Methyl Parahydroxybenzoate (E218)
2 mg
Propyl Parahydroxybenzoate (E216)
0.2 mg
Sodium Metabisulphite
1 mg
Polysorbate 80
Sodium Citrate
Citric Acid
Simethicone Emulsion
Xanthan Gum
Purified Water
A white to off white suspension.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Horses.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
For the treatment of immature and mature stages of nematodes of the
gastro-intestinal and respiratory
tract, including encysted mucosal small strongyle larvae
(cyathostomes). The veterinary medicinal
product has an ovicidal effect on roundworm eggs.
For the treatment of horses infected with adult large strongyles and
adult and larval small strongyles.
For the treatment of ascarids and
_Oxyuris equi_
.
3.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
3.4
SPECIAL WARNINGS
3
Unnecessary use of antiparasitics or use deviating from the
instructions given in the SPC may increase
the resistance selection pressure and lead to reduced efficacy. The
decision to use the product should
be based on confirmation of the parasitic species and burden, or of
the risk of infection based on its
epidemiological features, for each individual animal / herd.
Repeated use for an extended period, particularly when using the same
class of substances, increases
the risk of resistance development. Within a herd, maintenance of
susceptible refugia is essential to
reduce that risk. Systematically applied interval-based treatment and
treatment of a whole herd should
be avoided. Instead, if feasible, only selected individual animals or
subgroups should be treated
(targeted s