Zolvix

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

monepantel

Available from:

Elanco GmbH

ATC code:

QP52AX09

INN (International Name):

monepantel

Therapeutic group:

Sheep

Therapeutic area:

Anthelmintics,

Therapeutic indications:

Zolvix oral solution is a broad spectrum anthelmintic for the treatment and control of gastro-intestinal nematode infections and associated diseases in sheep including lambs, hoggets, breeding rams and ewes. Spectrum of activity includes fourth larvae and adults of: , Haemonchus contortus*;, Teladorsagia circumcincta*;, Teladorsagia trifurcata*;, Teladorsagia davtiani*;, Trichostrongylus axei*;, Trichostrongylus colubriformis;, Trichostrongylus vitrinus;, Cooperia curticei;, Cooperia oncophora;, Nematodirus battus;, Nematodirus filicollis;, Nematodirus spathiger;, Chabertia ovina;, Oesophagostomum venulosum. , * including inhibited larvae. The veterinary medicinal product is effective against strains of these parasites resistant to (pro)benzimidazoles, levamisole, morantel, macrocyclic lactones and H. contortus strains resistant to salicylanilides.,

Product summary:

Revision: 14

Authorization status:

Authorised

Authorization date:

2009-11-04

Patient Information leaflet

13
B. PACKAGE LEAFLET
14
PACKAGE LEAFLET:
ZOLVIX
25 mg/ml oral solution for sheep
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Elanco GmbH
Heinz-Lohmann-Str. 4
27472 Cuxhaven
Germany
Manufacturer responsible for batch release:
Elanco France S.A.S
26 Rue de la Chapelle
F-68330 Huningue
France
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ZOLVIX 25 mg/ml oral solution for sheep
Monepantel
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
Each ml of ZOLVIX orange clear oral solution contains 25 mg of
monepantel
Other ingredients:
RRR-α-tocopherol
Beta-carotene
Maize oil
Propylene glycol
Macrogolglycerol hydroxystearate
Polysorbate 80
Propylene glycol monocaprylate
Propylene glycol dicaprylocaprate
15
4.
INDICATION(S)
ZOLVIX oral solution is a broad spectrum anthelmintic for the
treatment and control of gastro-
intestinal nematode infections and associated diseases in sheep
including lambs, hoggets, breeding
rams and ewes.
Spectrum of activity includes fourth larvae and adults of:
_Haemonchus contortus* _
_Teladorsagia circumcincta* _
_T. trifurcata* _
_T. davtiani* _
_Trichostrongylus axei* _
_T. colubriformis _
_T. vitrinus _
_Cooperia curticei _
_C. oncophora _
_Nematodirus battus _
_N. filicollis _
_N. spathiger _
_Chabertia ovina _
_Oesophagostomum venulosum _
*Including inhibited larvae
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
None known.
If you notice any side effects, even those not already listed in this
package leaflet or you think that the
medicine has not worked, please inform your veterinary surgeon.
7.
TARGET SPECIES
Sheep
16
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Dose table
Bodyweight, kg
Dose, ml
10 – 15
1.5
16 – 20
2
21 – 25
2.5
26 – 30
3
31 – 35
3.5
36 – 40
4
41 – 50
5
51 – 60
6
61 – 70
7
>
70 KG
1 ml for each additional 10 kg
Administer orally with a suitable dose device.
9.
ADVICE ON CORRECT ADMINISTRAT

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ZOLVIX 25 mg/ml oral solution for sheep
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each ml contains 25 mg of monepantel
EXCIPIENT:
RRR-α-tocopherol
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution.
Orange clear solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Sheep
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
ZOLVIX oral solution is a broad spectrum anthelmintic for the
treatment and control of gastro-
intestinal nematode infections and associated diseases in sheep
including lambs, hoggets, breeding
rams and ewes.
Spectrum of activity includes fourth larvae and adults of:
_Haemonchus contortus* _
_Teladorsagia circumcincta* _
_Teladorsagia trifurcata* _
_Teladorsagia davtiani* _
_Trichostrongylus axei* _
_Trichostrongylus colubriformis _
_Trichostrongylus vitrinus _
_Cooperia curticei _
_Cooperia oncophora _
_Nematodirus battus _
_Nematodirus filicollis _
_Nematodirus spathiger _
_Chabertia ovina _
_Oesophagostomum venulosum _
*
including inhibited larvae
3
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The efficacy has not been established in sheep weighing less than 10
kg.
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. It is recommended that product is used not more than twice in
one year.
•
Underdose, which may be due to underestimation of body weight,
misadministration of the
veterinary medicinal product, or lack of calibration of the dose
device.
In order to help delay the development of resistance, users are
advised to check the success of the
treatment (e.g. clinical appearance, faecal egg counts). Suspected
clinical cases of resistance to
anthelmintics should be further investigated using appropria