Zactran
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
25-05-2021
Charakterystyka produktu
(SPC)
25-05-2021
Sprawozdanie z oceny publicznego
(PAR)
07-03-2018
Składnik aktywny:
gamithromycin
Dostępny od:
Boehringer Ingelheim Vetmedica GmbH
Kod ATC:
QJ01FA95
INN (International Nazwa):
gamithromycin
Grupa terapeutyczna:
Cattle; Pigs; Sheep
Dziedzina terapeutyczna:
Antibacterials for systemic use
Wskazania:
CattleTreatment and metaphylaxis of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni. The presence of the disease in the herd should be established before metaphylactic use.PigsTreatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis and Bordetella bronchiseptica.SheepTreatment of infectious pododermatitis (foot rot) associated with virulent Dichelobacter nodosus and Fusobacterium necrophorum requiring systemic treatment.
Podsumowanie produktu:
Revision: 12
Status autoryzacji:
Authorised
Data autoryzacji:
2008-07-24
Ulotka dla pacjenta
21
B. PACKAGE LEAFLET
22
PACKAGE LEAFLET:
ZACTRAN 150 MG/ML SOLUTION FOR INJECTION FOR CATTLE, SHEEP AND 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:
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY
Manufacturer responsible for batch release:
Boehringer Ingelheim Animal Health France SCS
4, Chemin du Calquet
31000 Toulouse
France
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ZACTRAN 150 mg/ml solution for injection for cattle, sheep and pigs
Gamithromycin
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
1 ml contains
Active substance: 150 mg of gamithromycin
Excipients: 1 mg of monothioglycerol
Colourless to pale yellow solution.
4.
INDICATION(S)
Cattle:
Treatment and metaphylaxis of bovine respiratory disease (BRD)
associated with
_Mannheimia _
_haemolytica_
,
_Pasteurella multocida_
and
_Histophilus somni_
.
The presence of the disease in the herd should be established before
metaphylactic use.
Pigs:
Treatment of swine respiratory disease (SRD) associated with
_Actinobacillus pleuropneumoniae, _
_Pasteurella multocida,Haemophilus parasuis and Bordetella
bronchiseptica._
Sheep:
Treatment of infectious pododermatitis (foot rot) associated with
virulent
_Dichelobacter nodosus_
and
_Fusobacterium necrophorum_
requiring systemic treatment.
5.
CONTRAINDICATIONS
Do not use in case of hypersensitivity to a certain type of
antibiotics called macrolides or to any of the
excipients.
Do not use this veterinary medicinal product simultaneously with other
macrolides or antibiotics
known as lincosamides.
23
6.
ADVERSE REACTIONS
During clinical trials transient injection site swellings were
observed.
•
Visible injection site swellings associated with occasional slight
pain may develop very
commonly in cattle for one day. The swellings typically resolve within
3 to 14 days but may
persist in some animals for up to 35 days after treatment.
•
Mild to moderate i
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ZACTRAN 150 mg/ml solution for injection for cattle, sheep and pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
ACTIVE SUBSTANCE:
Gamithromycin
150 mg
EXCIPIENT(S):
Monothioglycerol
1 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Colourless to pale yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle, sheep and pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cattle:
Treatment and metaphylaxis of bovine respiratory disease (BRD)
associated with
_Mannheimia _
_haemolytica_
,
_Pasteurella multocida_
and
_Histophilus somni_
. The presence of the disease in the herd
should be established before metaphylactic use.
Pigs:
Treatment of swine respiratory disease (SRD) associated with
_Actinobacillus pleuropneumoniae, _
_Pasteurella multocida, Haemophilus parasuis _
and
_Bordetella bronchiseptica. _
Sheep:
Treatment of infectious pododermatitis (foot rot) associated with
virulent
_Dichelobacter nodosus_
and
_Fusobacterium necrophorum_
requiring systemic treatment.
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to macrolide antibiotics or to
any of the excipients.
Do not use this veterinary medicinal product simultaneously with other
macrolides or lincosamides
(see section 4.8).
3
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Cattle and pigs:
None.
Sheep:
The efficacy of antimicrobial treatment of foot rot might be reduced
by other factors, such as wet
environmental conditions, as well as inappropriate farm management.
Treatment of foot rot should
therefore be undertaken along with other flock management tools, for
example providing dry
environment. Antibiotic treatment of benign foot rot is not considered
appropriate.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Use of the veterinary medicinal product should be based on
susceptibility testing and take into account
official and local policies on the
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