Zactran 150 mg/ml Solution for Injection for Cattle, Sheep and Pigs

Երկիր: Միացյալ Թագավորություն

Լեզու: անգլերեն

Աղբյուրը: VMD (Veterinary Medicines Directorate)

Ակտիվ բաղադրիչ:

Gamithromycin

Հասանելի է:

Boehringer Ingelheim Vetmedica GmbH

ATC կոդը:

QJ01FA95

INN (Միջազգային անվանումը):

Gamithromycin

Դեղագործական ձեւ:

Solution for injection

Ռեկվիզորի տեսակը:

POM-V - Prescription Only Medicine – Veterinarian

Թերապեւտիկ խումբ:

Cattle, Pigs, Sheep

Թերապեւտիկ տարածք:

Antimicrobial

Լիազորման կարգավիճակը:

Authorized

Հաստատման ամսաթիվը:

2008-07-24

Ապրանքի հատկությունները

Revised: March 2021
AN: 01533/2020
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
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.
Revised: March 2021
AN: 01533/2020
Page 2 of 7
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).
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
susc