Flukiver Combi 50 mg/ml + 75 mg/ml oral suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Closantel sodium dihydrate; Mebendazole

Available from:

Elanco GmbH

ATC code:

QP52A

INN (International Name):

Closantel sodium dihydrate; Mebendazole

Dosage:

50, 75 milligram(s)/millilitre

Pharmaceutical form:

Oral suspension

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

ANTHELMINTICS

Authorization status:

Authorised

Authorization date:

2012-06-08

Summary of Product characteristics

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Flukiver Combi 50 mg/ml + 75 mg/ml oral suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCES:
50 mg Closantel (as closantel sodium dihydrate)
75 mg Mebendazole
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS
Propylene Glycol
Microcrystalline Cellulose and Sodium Croscarmellose
Hypromellose
Sodium Lauryl Sulphate
Simethicone Emulsion 30%
Water Purified
White to faintly cream-coloured suspension.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Sheep
and lambs.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
For the treatment of mixed parasitic infestations where the action of
both active substances is required.
TREMATODES
Liver flukes:
_Fasciola hepatica_
(adults + 5-8 week-immatures)
NEMATODES
Roundworms
_Haemonchus contortus_
(adults, immatures, inhibited stages and BZ-resistant strains)
_Bunostomum_
sp. (adults)
_Chabertia ovina_
(adults + immatures)
_Oesophagostomum_
spp. (adults)
_Capillaria_
spp. (adults)
_Cooperia_
spp. (adults)
_Nematodirus_
spp. (adults + immatures)
_Teladorsagia circumcincta_
(adults + immatures)
_Trichostrongylus axei_
(adults)
_Trichostrongylus colubriformis_
(adults + immatures)
_Trichostrongylus vitrinus_
(adults)
Lungworms
_Dictyocaulus filaria_
(adults + immatures)
CESTODES
_Avitellina _
spp.
_Moniezia_
spp.
ARTHROPODS
_Oestrus ovis_
(nasal bot) 1st, 2nd and 3rd instar
3.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substances or to
any of the excipients.
3.4
SPECIAL WARNINGS
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 (if any).
Suspected clinical cases of resistance to anthelmintics shou