ZACTRAN 150mgml solution for injection for cattle sheep and pigs

Land: Malaysia

Språk: engelsk

Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiv ingrediens:

Gamithromycin

Tilgjengelig fra:

Agritech Enterprise Sdn. Bhd.

INN (International Name):

Gamithromycin

Enheter i pakken:

100 ml; 250 ml; 100 ml; 50 ml; 250 ml

Produsert av:

Boehringer Ingelheim Animal Health France

Informasjon til brukeren

917553
(Gamithromycin)
(Gamitromicina)
(Gamitromycyna)
NAME OF THE VETERINARY MEDICINAL PRODUCT
ZACTRAN 150 mg/ml solution for injection for cattle, sheep and pigs
Gamithromycin
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
MERIAL - 29 avenue Tony Garnier - 69007 Lyon - France
Manufacturer responsible for batch release:
MERIAL - 4, Chemin du Calquet - 31000 Toulouse - France
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
1 ml contains
Active substance: 150 mg of gamithromycin
Excipients: 1 mg of monothioglycerol
Colourless to pale yellow solution.
INDICATIONS
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 _and _Haemophilus parasuis._
Sheep: Treatment of infectious pododermatitis (foot rot) associated
with virulent
_Dichelobacter nodosus _and _Fusobacterium necrophorum _requiring
systemic treatment.
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.
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 injection site swelling has been reported
commonly, in sheep
and pigs in clinical trials, with occasional pain evident for one day
in sheep. These
local react

Preparatomtale

OIC CENTRALISÉ
MODIFICATION
Design (couleur, photo, pictogramme)
Position et taille des zones de textes
(incluant blue box)
Police/corps de caractère
Taille de l'OIC
Autres....
MYZACTRAN/LEAFLET/008/APR2021
Version : B 230119
PTG : 0137
DIMENSIONS PLIÉ(E)S:
DIMENSIONS À PLAT (MM):
NOIR/BLACK
CYAN
P XXX
MAGENTA
YELLOW
P XXX
P XXX
P XXX
P XXX
NOT ZACTRAN
RECTO
NSe - Composer RH
A 14/04/20 11h00
B 28/04/20 15h00
C 22/05/20 15h00
D 10/03/2021
MY
160 x 30
160 x 360
NA
NAME AND ADDRESS OF
PRODUCT REGISTRATION HOLDER
Agritech Enterprise Sdn Bhd
No 15&17, Jalan Teknologi 3/5A, Pusat Teknologi Sinar Damansara, PJU5
Kota Damansara, 47810 Petaling Jaya, Selangor Darul Ehsan
MANUFACTURED BY
Boehringer Ingelheim Animal Health France,
4 Chemin du Calquet,
31000 Toulouse, France
ACTIVE INGREDIENT
150 mg/ml Gamithromycin
EXCIPIENTS
1. MONOTHIOGLYCEROL
1.0 mg/mL
2. SUCCINIC ACID
40.0 mg/mL
3. Glycerol Formal/Glycerin Formal q.s
1 ml
PRODUCT DESCRIPTION
Colorless to pale yellow liquid
DOSAGE FORM
Parenteral Injection
INDICATIONS
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
Pigs:
Treatment of swine respiratory disease (SRD) associated with
_Actinobacillus pleuropneumoniae_, _Pasteurella multocida, Haemophilus
_
_parasuis_ and
Treatment of infectious pododermatitis (foot rot) associated with
_virulent Dichelobacter nodosus_ and_ Fusobacterium_ necrophorum
CONTRAINDICATION
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
TARGET SPECIES
Cattle, Pigs and Sheep
WARNING AND PRECAUTIONS
_Cattle and pigs_
_Sheep_
reduced by others factors, such as wet environmental conditions, as
well
as inappropriate farm management. Treatment of foot rot should
example providing dry environment. Antibiotic treatment of benign
SPECIAL PRECAUTIONS FOR USE
Us