Panacur AquaSol
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
26-04-2018
Fachinformation
(SPC)
26-04-2018
Öffentlichen Beurteilungsberichts
(PAR)
26-04-2018
Wirkstoff:
fenbendazole
Verfügbar ab:
Intervet International BV
ATC-Code:
QP52AC13
INN (Internationale Bezeichnung):
fenbendazole
Therapiegruppe:
Pigs; Chicken
Therapiebereich:
Anthelmintics, , Benzimidazoles and related substances, fenbendazole
Anwendungsgebiete:
For the treatment and control of gastro-intestinal nematodes in pigs infected with:Ascaris suum (adult, intestinal and migrating larval stages);Oesophagostomum spp. (adult stages);Trichuris suis (adult stages).For the treatment of gastro-intestinal nematodes in chickens infected with:Ascaridia galli (L5 and adult stages);Heterakis gallinarum (L5 and adult stages);Capillaria spp. (L5 and adult stages).
Produktbesonderheiten:
Revision: 6
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2011-12-09
Gebrauchsinformation
B. PACKAGE LEAFLET
14
PACKAGE LEAFLET:
PANACUR AQUASOL 200 MG/ML SUSPENSION FOR USE IN DRINKING WATER FOR
PIGS AND CHICKENS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands
Manufacturer responsible for batch release:
Intervet Productions S.A.
Rue de Lyons
27460 Igoville
France
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Panacur AquaSol 200 mg/ml suspension for use in drinking water for
pigs and chickens
Fenbendazole
3.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
The veterinary medicinal product is a white to off-white suspension
for use in drinking water
containing 200 mg/ml of fenbendazole and 20 mg/ml of benzyl alcohol
(E1519).
4.
INDICATION(S)
Pigs:
Treatment and control of gastro-intestinal nematodes in pigs infected
with:
_-_
_ _
_Ascaris suum _
(adult, intestinal and migrating larval stages)
_-_
_ _
_Oesophagostomum _
spp. (adult stages)
_-_
_ _
_Trichuris suis _
(adult stages)
Chickens:
Treatment of gastro-intestinal nematodes in chickens infected with:
_-_
_ _
_Ascaridia galli _
(L5 and adult stages)
_-_
_ _
_Heterakis gallinarum _
(L5 and adult stages)
_-_
_ _
_Capillaria_
spp. (L5 and adult stages)
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
None known.
15
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
Pigs and chickens.
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
In drinking water use.
To ensure administration of the correct dose, body weight should be
determined as accurately as
possible; accuracy of the dosing device should be checked.
Pigs:
The dose is 2.5 mg fenbendazole per kg body weight per day (equivalent
to 0.0125 ml Panacur
AquaSol). For the treatment and control of
_Ascaris suum_
and
_Oesophagostomum _
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Fachinformation
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Panacur AquaSol 200 mg/ml suspension for use in drinking water for
pigs and chickens
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBSTANCE:
Fenbendazole
200 mg
EXCIPIENT:
Benzyl alcohol (E1519)
20 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
White to off-white suspension for use in drinking water.
The suspension particles are in the sub micron size range.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs and chickens
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Pigs:
Treatment and control of gastro-intestinal nematodes in pigs infected
with:
-
_Ascaris suum _
(adult, intestinal and migrating larval stages)
_- Oesophagostomum _
spp. (adult stages)
-
_Trichuris suis _
(adult stages)
Chickens:
Treatment of gastro-intestinal nematodes in chickens infected with:
_- Ascaridia galli _
(L5 and adult stages)
_- Heterakis gallinarum _
(L5 and adult stages)
_- Capillaria _
spp. (L5 and adult stages)
_ _
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Parasitic resistance to any particular class of anthelmintic may
develop following frequent repeated
use of an anthelmintic of that class.
2
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
In the absence of available data, treatment of chicken less than 3
weeks of age should be based on a
benefit/risk assessment by the responsible veterinarian.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
This veterinary medicinal product may be toxic to humans after
ingestion. Embryotoxic effects cannot
be excluded. Pregnant women must take extra precautions when handling
this veterinary medicinal
product.
Avoid contact with skin, eye and mucous membranes. People with known
hypersensitivity to
fenbendazole should avoid contact with the veterinary medicinal
product.
Personal protective equipment consisting of gloves should be worn when
ha
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