Zactran 150mg/ml solution for injection for cattle 250ml

Target species Cattle, sheep and pigs. Indications for use Cattle: Treatment and metaphylaxis of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni. The presence of 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. Contra-indications 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 'Interactions' section). Special warnings for each target species Cattle and pigs: None. Sheep: The efficacy of antimicrobial treatment of foot rot might be reduced by others 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. 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 use of antimicrobials in farm animals. Special precautions to be taken by the person administering the veterinary medicinal product to animals People with known hypersensitivity to the macrolide class should avoid contact with the veterinary medicinal product. Gamithromycin may cause irritation to eyes and/or skin. Avoid contact with skin or eyes. If eye exposure occurs, flush eyes immediately with clean water. If skin exposure occurs, wash the affected area immediately with clean water. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. Wash hands after use. 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 slight pain evident for one day in sheep. These local reactions are transient, and typically resolve within 2 (pigs) to 4 (sheep) days. The frequency of adverse reactions is defined using the following convention: -Very common (more than 1 in 10 animals treated displaying adverse reaction(s)) -Common (more than 1 but less than 10 animals in 100 animals treated) -Uncommon (more than 1 but less than 10 animals in 1,000 animals treated) -Rare (more than 1 but less than 10 animals in 10,000 animals treated) -Very rare (less than 1 animal in 10,000 animals treated, including isolated reports). Use during pregnancy, lactation or lay Based on laboratory animal data, gamithromycin has not produced any evidence of specific developmental or reproductive effects. The safety of gamithromycin during pregnancy and lactation has not been evaluated in cattle, sheep and pigs. Use only according to the risk/benefit assessment by the responsible veterinarian. Interactions Cross resistance may occur with other macrolides. Avoid simultaneous administration of antimicrobials with a similar mode of action such as other macrolides or lincosamides.