Aivlosin
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
29-03-2021
Charakterystyka produktu
(SPC)
29-03-2021
Sprawozdanie z oceny publicznego
(PAR)
19-10-2020
Składnik aktywny:
tylvalosin
Dostępny od:
ECO Animal Health Europe Limited
Kod ATC:
QJ01FA92
INN (International Nazwa):
tylvalosin
Grupa terapeutyczna:
Pheasants; Chicken; Turkeys; Pigs
Dziedzina terapeutyczna:
Antiinfectives for systemic use, Antibacterials for systemic use, Macrolides
Wskazania:
PigsTreatment and methaphylaxis of swine enzootic pneumonia;Treatment of porcine proliferative enteropathy (ileitis);Treatment and methaphylaxis of swine dysentery.ChickensTreatment and methaphylaxis of respiratory disease associated with Mycoplasma gallisepticum in chickens.PheasantsTreatment of respiratory disease associated with Mycoplasma gallisepticum.TurkeysTreatment of respiratory disease associated with tylvalosin sensitive strains of Ornithobacterium rhinotracheale in turkeys.
Podsumowanie produktu:
Revision: 33
Status autoryzacji:
Authorised
Data autoryzacji:
2004-09-09
Ulotka dla pacjenta
52
B. PACKAGE LEAFLET
53
PACKAGE LEAFLET:
AIVLOSIN 42.5 MG/G PREMIX FOR MEDICATED FEEDING STUFF FOR PIGS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
ECO Animal Health Europe Limited
6th Floor, South Bank House
Barrow Street
Dublin 4
D04 TR29
IRELAND
Manufacturer responsible for batch release:
Acme Drugs s.r.l.
Via Portella della Ginestra 9/a
42025 CAVRIAGO (RE)
ITALY
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Aivlosin 42.5 mg/g premix for medicated feeding stuff for pigs
Tylvalosin (as tylvalosin tartrate)
3.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
ACTIVE SUBSTANCE:
Tylvalosin (as tylvalosin tartrate)
42.5 mg/g.
A beige granular powder.
CARRIER:
Hydrated magnesium silicate, wheat flour.
4.
INDICATIONS
•
Treatment and metaphylaxis of swine enzootic pneumonia caused by
susceptible strains of
_Mycoplasma hyopneumoniae_
. At the recommended dose, lung lesions and weight loss are
reduced but infection with
_Mycoplasma hyopneumoniae_
is not eliminated.
•
Treatment of porcine proliferative enteropathy (ileitis) caused by
_Lawsonia intracellularis_
in
herds where there is a diagnosis based on clinical history,
post-mortem findings and clinical
pathology results.
Treatment and metaphylaxis of swine dysentery in herds, caused by
_Brachyspira hyodysenteriae,_
where the disease has been diagnosed.
5.
CONTRAINDICATIONS
None.
54
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
Pigs.
8.
DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
In-feed use.
For incorporation into dry feed only.
For treatment and metaphylaxis of swine enzootic pneumonia:
The dose is 2.125 mg tylvalosin per kg bodyweight per day in-feed for
7 consecutive days. Secondary
infection by organisms such as
_Pasteurella multoci
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Aivlosin 42.5 mg/g premix for medicated feeding stuff for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Tylvalosin (as tylvalosin tartrate)
42.5 mg/g
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Premix for medicated feeding stuff.
A beige granular powder.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
•
Treatment and metaphylaxis of swine enzootic pneumonia caused by
susceptible strains of
_Mycoplasma_
_hyopneumoniae_
in pigs. At the recommended dose, lung lesions and weight loss
are reduced but infection with
_Mycoplasma hyopneumoniae_
is not eliminated.
•
Treatment of porcine proliferative enteropathy (ileitis) caused by
_Lawsonia intracellularis_
in
herds where there is a diagnosis based on clinical history,
post-mortem findings and clinical
pathology results.
•
Treatment and metaphylaxis of swine dysentery, caused by
_Brachyspira hyodysenteriae _
in herds
where the disease has been diagnosed.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Acute cases and severely diseased pigs with reduced food or water
intake should be treated with a
suitable injectable product.
Generally, strains of
_B. hyodysenteriae_
have higher minimal inhibitory concentration (MIC) values in
cases of resistance against other macrolides, such as tylosin. The
clinical relevance of this reduced
susceptibility is not fully explored. Cross-resistance between
tylvalosin and other macrolides cannot
be excluded.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Good management and hygiene practices should be followed to reduce the
risk of re-infection.
3
It is sound clinical practice to base treatment on susceptibility
testing of the bacteria isolated from the
animal. If this is not possible, therapy should be based on local
(regional, farm level) epidemiological
information about susceptibility of ta
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