Norodine Equine Oral Paste Species: Horses and other equidae Therapeutic indication: Pharmaceuticals: Antimicrobials: Oral preparations: Others Active ingredient: Sulfadiazine (Sulphadiazine), Trimethoprim Product:Norodine Equine Oral Paste Product index: Norodine Equine Oral Paste Withdrawal notes: Not to be used in horses intended for human consumption. Treated horses may never be slaughtered for human consumption. Qualitative and quantitative composition Active Substance: Trimethoprim 5.80 %w/w Sulfadiazine 28.83 %w/w Excipients: Methyl Parahydroxybenzoate 0.18 %w/w Propyl Parahydroxybenzoate 0.02 %w/w For a full list of excipients, see section "Pharmaceutical Particulars" Pharmaceutical form Oral Paste. A creamy white paste for oral administration Clinical particulars Target species Horses. Indications for use, specifying the target species Indicated in the treatment of bacterial infections in horses caused by sensitive microorganisms including: Escherichia coli Rhodococcus (Corynebacterium) equi Staphylococcus spp Streptococcus spp The product may be effective in alimentary tract infections including diarrhoea, respiratory infections including pneumonia, pleurisy, strangles, wounds, septicaemia and general infections. Contra-indications None. Special Warnings for each target species No special precautions. Special precautions for use Special precautions for use in animals Use of the following product should be based on susceptibility testing and take into account official and local antimicrobial policies. Not recommended in horses with known hypersensitivity, severe hepatic dysfunction or cardiac arrhythmias. Do not use the same syringe to treat more than one animal unless horses are running together or in direct contact with each other on the same premises. Special precautions to be taken by the person administering the veterinary medicinal product to animals Take care to avoid skin and eye contact. Gloves and suitable eye protection should be worn whilst handling this product. Wash hands and exposed skin after use. Sulphonamides may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to sulphonamides may lead to cross reactions with other antibiotics. Allergic reactions to these substances may occasionally be serious. 1. Do not handle this product if you know you are sensitive to sulphonamides. 2. If you develop symptoms following exposure such as a skin rash, you should seek medical advice and show the doctor this warning. Adverse reactions (frequency and seriousness) No undesirable effects. Use during pregnancy, lactation or lay Can be safely administered during pregnancy and lactation. Interaction with other medicinal products and other forms of interaction Drug absorption may be greater if food is withheld for a few hours prior to dosing. Amounts to be administered and administration route Adjust screw gauge on dial-a-dose plunger to the bodyweight of the horse. Remove cap from nozzle. Place nozzle in the corner of mouth. Depress plunger depositing paste on upper surface of tongue. The daily dose is 30 mg of combined actives per kg bodyweight by oral administration. Treatment should be continued for up to 5 days or until 2 days after symptoms have resolved. Each syringe provides one daily dose for a 500 kg horse. Each division on the dial-a-dose plunger provides sufficient product to treat 50 kg of bodyweight. Replace cap after use. Overdose (symptoms, emergency procedures, antidotes), if necessary No treatment specified. Withdrawal period Not to be used in horses intended for human consumption. Treated horses may never be slaughtered for human consumption. The horse must have been declared as not intended for human consumption under national horse passport legislation.