Država: Malezija
Jezik: engleski
Izvor: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Gamithromycin
Agritech Enterprise Sdn. Bhd.
Gamithromycin
100 ml; 250 ml; 100 ml; 50 ml; 250 ml
Boehringer Ingelheim Animal Health France
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 Pročitajte cijeli dokument
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 Pročitajte cijeli dokument