Supaverm Oral Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Closantel sodium dihydrate; Mebendazole

Available from:

Elanco GmbH

ATC code:

QP52AC09; QP52AG09

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:

mebendazole; closantel

Authorization status:

Authorised

Authorization date:

2012-04-27

Summary of Product characteristics

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Supaverm 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 carmellose sodium
Hypromellose
Sodium Laurilsulfate
Simethicone emulsion 30%
Purified Water
Citric Acid 0.5% solution (for pH adjustment)
Sodium Hydroxide 1N solution (for pH adjustment)
White suspension.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Sheep and lambs.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
For the treatment and control of liver fluke, gastro-intestinal
nematodes, lungworms, cestodes and
larval stages of some arthropods.
TREMATODES:
LIVER FLUKES:
_Fasciola hepatica _
(adults + 5-8 week immatures)
_Fasciola gigantica _
(adults + 8 week immatures)
NEMATODES:
ROUNDWORMS:
_Haemonchus contortus _
(adults, immatures, inhibited stages and BZ-resistant strains)
_Bunostomum _
spp. (adult)
_Chabertia ovina _
(adults + immatures)
_Gaigeria pachyscelis _
(adults + immatures)
_Oesophagostomum _
spp. (adults)
_Capillaria _
spp. (adults)
_Cooperia _
spp. (adults)
_Nematodirus _
spp. (adults + immatures)
_Ostertagia circumcinta _
(adults + immatures)
_Trichostrongylus axei _
(adults)
_Trichostrongylus colubriformis _
(adults + immatures)
_Trichostrongylus vitrinus _
(adults)
_Trichuris ovis _
(adults)
_Strongyloides papillosus _
(adults + immature)
LUNGWORMS:
_Dictyocaulus filaria _
(adults + immatures)
CESTODES:
_Avitellina _
spp.
_Moniezia _
spp.
ARTHROPODS:
_Oestrus ovis _
(nasal bot) 1
st
, 2
nd
and 3
rd
instar.
Ticks (
_Ixodes ricinus_
) feeding on sheep at the time of treatment are likely to produce
fewer viable
eggs.
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 cou