Zuprevo
Nchi: Umoja wa Ulaya
Lugha: Kiingereza
Chanzo: EMA (European Medicines Agency)
Taarifa za kipeperushi
(PIL)
03-02-2022
Tabia za bidhaa
(SPC)
03-02-2022
Ripoti ya Tathmini ya umma
(PAR)
12-08-2015
Viambatanisho vya kazi:
tildipirosin
Inapatikana kutoka:
Intervet International BV
ATC kanuni:
QJ01FA
INN (Jina la Kimataifa):
tildipirosin
Kundi la matibabu:
Pigs; Cattle
Eneo la matibabu:
Antiinfectives for systemic use
Matibabu dalili:
40-mg/ml solution for injection for pigsTreatment and metaphylaxis of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica and Haemophilus parasuis sensitive to tildipirosin.The presence of the disease in the herd should be confirmed before metaphylaxis is implemented.180-mg/ml solution for injection for cattleFor the treatment and prevention of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni sensitive to tildipirosin.The presence of the disease in the herd should be confirmed before preventive treatment.
Bidhaa muhtasari:
Revision: 4
Idhini hali ya:
Authorised
Idhini ya tarehe:
2011-05-06
Taarifa za kipeperushi
24
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
CATTLE
VIAL (20 ML, 50 ML)
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ZUPREVO 180 mg/ml solution for injection for cattle
tildipirosin
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
180 mg/ml of tildipirosin
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
20 ml
50 ml
4.
ROUTE OF ADMINISTRATION
SC
5.
WITHDRAWAL PERIOD
Withdrawal period: Meat and offal: 47 days.
See package leaflet.
6.
BATCH NUMBER
Batch:
7.
EXPIRY DATE
EXP:
Once opened, use by:
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
25
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
CATTLE
VIAL (100 ML, 250 ML)
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ZUPREVO 180 mg/ml solution for injection for cattle
tildipirosin
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
180 mg/ml of tildipirosin
3.
PHARMACEUTICAL FORM
Solution for injection
4.
PACKAGE SIZE
100 ml
250 ml
5.
TARGET SPECIES
Cattle
6.
INDICATION(S)
7.
METHOD AND ROUTE OF ADMINISTRATION
Subcutaneous injection
Read the package leaflet before use.
8.
WITHDRAWAL PERIOD
Withdrawal period: Meat and offal: 47 days.
Not authorised for use in lactating animals producing milk for human
consumption.
Do not use in pregnant animals, which are intended to produce milk for
human consumption, within 2
months of expected parturition.
9.
SPECIAL WARNINGS
26
Read the package leaflet before use.
Accidental injection is dangerous.
10.
EXPIRY DATE
EXP:
Once opened, use by:
11.
SPECIAL STORAGE CONDITIONS
Do not store above 25
°
C.
12.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Disposal:
_ _
read package leaflet.
13.
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
For animal treatment only. To be supplied only on veterinary
prescription.
14.
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”
Keep out of the sight and reach of children.
15.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Intervet International B. V.
Soma hati kamili
Tabia za bidhaa
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ZUPREVO 40 mg/ml solution for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
ACTIVE SUBSTANCE:
Tildipirosin
40 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear yellowish solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment and metaphylaxis of swine respiratory disease (SRD)
associated with
_Actinobacillus _
_pleuropneumoniae_
,
_Pasteurella multocida, Bordetella bronchiseptica _
and
_ Haemophilus parasuis_
sensitive to tildipirosin.
The presence of the disease in the herd should be confirmed before
metaphylaxis is implemented.
4.3
CONTRAINDICATIONS
Do not use in case of hypersensitivity to macrolide antibiotics or to
any of the excipients.
Do not administer intravenously.
Do not administer simultaneously with other macrolides or lincosamides
(see section 4.8)
4.4
SPECIAL WARNINGS
In line with responsible use principles, metaphylactic use of Zuprevo
is only indicated in severe
outbreaks of SRD caused by the indicated pathogens. Metaphylaxis
implies that clinically healthy
animals in close contact with diseased animals are administered the
veterinary medicinal product at the
same time as the treatment of the clinically diseased animals, to
reduce the risk for development of
clinical signs.
The efficacy of metaphylactic use of Zuprevo was demonstrated in a
placebo controlled multi-centre
field study, when outbreak of clinical disease was confirmed (i.e.
animals in at least 30% of the pens
sharing the same airspace showed clinical signs of SRD, including at
least 10% animals per pen within
1 day; or 20% within 2 days or 30% within 3 days). Following
metaphylactic use, approximately 86%
of the healthy animals remained free of clinical signs of disease (as
compared to approximately 65% of
animals in the untreated control group).
3
4.5
SPECIAL PRECAUTIONS FOR USE
Special p
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