Member State/Marketing Authorisation Number Marketing Authorisation Holder Product invented name Pharmaceutical form Strength/Active substance (INN) Animal species Therapeutic indication Recommended dose

Netherlands NL 10351 AST Beheer BV Sulfatrim Oral Doser Oral paste Active substances per gram: Trimethoprim 66,7 mg Sulfadiazine 333,3 mg Horses Respiratory tract infections associated with Streptococcus spp. and Staphylococcus aureus; gastrointestinal infections associated with E. Coli; urogenital infections associated with beta-hemolytic streptococci; wound infections and abscesses associated with Streptococcus spp. and Staphylococcus aureus 5 mg trimethoprim and 25 mg sulfadiazine per kg body weight per day to a maximum of 5 days. One syringe is intended for 600 kg bodyweight and each syringe is subdivided into 12 markings. The equivalent of one marking is sufficient to treat 50 kg of bodyweight

Netherlands NL 10437 AST Farma BV Sultrisan Orale Paste voor paarden Oral paste Active substances per gram: Trimethoprim 66,7 mg Sulfadiazine 333,3 mg Horses Respiratory tract infections associated with Streptococcus spp. and Staphylococcus aureus; gastrointestinal infections associated with E. coli; urogenital infections associated with beta-hemolytic streptococci; wound infections and abscesses associated with Streptococcus spp. and Staphylococcus aureus 5 mg trimethoprim and 25 mg sulfadiazine per kg body weight per day to a maximum of 5 days. One syringe is intended for 600 kg bodyweight and each syringe is subdivided into 12 markings. The equivalent of one marking is sufficient to treat 50 kg of bodyweight

Belgium 282IS20F7 Schering-Plough NV/SA (Belgium) Tribrissen Pâte orale Oral paste Pro 100 g: Trimethoprim 6,66 g Sulfadiazine 33,34 g Horses Tribrissen Oral Paste is indicated for the treatment of horses with bacterial infections caused by sensitive bacteria, including: — gastro-intestinal infections, — infections of respiratory tracts, — infections of urogenital tracts, — wound infections and cellulitis, — salmonellosis, — as profylacticum for post-operative infections The dose is 30 mg/kg body weight per day. The dose is reached by setting the drive screw on the plunger according to the weight of the horse. Each unit on the scale on the plunger provides sufficient paste for 50 kg body weight. For horses, the following dosages can be applied according to the nature and seriousness of the ailment: — Gastro-intestinal infections: 30 mg/kg/day over 2 applications of 15 mg/kg body weight/day or 1 application of 30 mg/kg/day, during minimal 5 days or until 2 days after the symptoms have disappeared. — Serious acute infections outside of the intestinal tracts (respiratory-urinal tracts): first an injection of Tribrissen 48 % or Duoprim, followed by a daily administration of Tribrissen Oral Paste at 30 mg/kg/day over 2 applications of 15 mg/kg body weight/day or 1 administrations of 30 mg/kg/day, during minimal 5 days or until 2 days after the symptoms have disappeared. — Infections of the genital tracts. Next to an oral treatment during 5 days or until 2 days after the symptoms have disappeared, an intra-uterine treatment will be administered with 10 ml Tribrissen 48 %, diluted in an isotonic solution of 100 ml during 3 days. — Wound infections. Next to an oral treatment during 5 days or until 2 days after the symptoms have disappeared, a local treatment with Tribrissen Dispersible Powder will be administered. For the treatment of Salmonellosis, it is necessary to administer a double dose at 60 mg/kg/day. This dose needs to be administered in 2 times. The treatment must be given during 10 days

Netherlands NL 5055 Schering-Plough NV (Belgium) Tribrissen Oral Paste Oral paste Per 30 mg paste: Sulfadiazine 10 mg Trimethoprim 2 mg Horses — respiratory infections caused by Streptococcus spp., Staphylococcus aureus, — gastro-intestinal infections caused by E. coli, — urogenital infections caused by bèta-haemolytic streptococci, — wounds and abscesses by Streptococcus spp., Staphylococcus aureus 25 mg sulfadiazine and 5 mg trimethoprim per kg BW per day, during maximum 5 days

Sweden 10893 Schering-Plough A/S (Denmark) Tribrissen vet Oral paste Sulfadiazine 333 mg Trimethoprim 67 mg Horses Bacterial infections, for instance infections in wounds, respiratory tract, GI-tract or urogenital system 30 mg of combined active ingredients per kg bodyweight 1-2 times daily, which correspond to 37,5 g paste (one tube) per os to a 500 kg horse 1-2 times daily. Preferably, horses should be treated with an initial injection of Tribrissen Injection, followed by administration of oral paste during 5 days or until no symptoms have been seen for at least 2 days. Treated animals should have free access to water

Iceland MT nr 880040 Schering-Plough A/S (Denmark) Tribrissen vet Oral paste Sulfadiazine 333 mg/g Trimethoprim 67 mg/g Horses Bacterial infections, for instance infections in wounds, respiratory tract, GI-tract or urogenital system 30 mg of combined active ingredients per kg bodyweight 1-2 times daily, which correspond to 37,5 g paste (one tube) per os to a 500 kg horse 1-2 times daily. Preferably, horses should be treated with an initial injection of Tribrissen Injection, followed by administration of oral paste during 5 days or until no symptoms have been seen for at least 2 days. Treated animals should have free access to water

United Kingdom Vm 00201/4064 Schering-Plough Limited (UK) Tribrissen Oral Paste Oral paste Active constituents % w/w: Sulfadiazine 33,3 % w/w Trimethoprim 6,7 % w/w Horses The product is recommended for the treatment of bacterial diseases in horses including: — alimentary tract infections, — upper and lower respiratory tract infections, including strangles, — infected wounds and cellulitis, — salmonellosis, — antibacterial medication in surgical cases where asepsis cannot be guaranteed 30 mg of combined active ingredients per kg bodyweight daily. This dose is provided by adjusting the screw-gauge on the plunger of the syringe according to the bodyweight of the horse. Each division on the plunger provides sufficient paste to medicate 50 kg bodyweight. Each syringe provides a daily dose for a 500 kg horse. The dose may be administered once daily, or the daily dose may be divided and administered at 12 hourly intervals, for five days or until two days after symptoms have subsided, to a maximum of five days

Ireland VPA 10277/41/1 Schering-Plough Limited (UK) Tribrissen Oral Paste Oral paste Each gram contains: Sulfadiazine 333 mg Trimethoprim 67 mg Horses The product is recommended for the treatment of bacterial diseases in horses including: — alimentary tract infections, — upper and lower respiratory tract infections, including strangles, — infected wounds and cellulitis, — salmonellosis, — antibacterial medication in surgical cases where asepsis cannot be guaranteed 30 mg of combined active ingredients per kg bodyweight daily. This dose is provided by adjusting the screw-gauge on the plunger of the syringe according to the bodyweight of the horse. Each division on the plunger provides sufficient paste to medicate 50 kg bodyweight. Each syringe provides a daily dose for a 500 kg horse. The dose may be administered once daily, or the daily dose may be divided and administered at 12 hourly intervals, for five days or until two days after symptoms have subsided, to a maximum of five days. Preferably, horses should be treated initially with an initial injection of Tribrissen Injection 48 % or Trivetrin Injection followed by daily administration of Tribrissen Oral Paste. For the treatment of salmonellosis, it is necessary to give double the above dose rate, i.e. 60 mg of combined active ingredients per kg bodyweight per day. This should be given as two equally divided doses per day. Treatment should be continued for at least ten days

Denmark 18146 ScanVet Animal Health A/S Norodine Vet Oral Paste Oral paste Trimethoprim 58 mg/g Sulfadiazine 288,3 mg/g Horses Infections in horses caused by micro-organisms sensitive to trimethoprim + sulphonamide The paste is presented in a syringe of plastic with the dose to treat 50 kg of horse. The daily dose is 30 mg combined active ingredients per kg body weight the equivalent to the contents of one syringe for a 500 kg horse

Ireland VPA 10999/23/1 Norbrook Laboratories Ltd Norodine Equine Oral Paste Oral paste Each 4,31 g dose contains: Trimethoprim 5,8 % w/w Sulfadiazine 28,83 % w/w Horses Norodine Equine Paste is indicated in the treatment of bacterial infections In horses caused by sensitive micro-organisms including: — Escherichia coli, — Staphylococcus spp., — Streptococcus spp. The daily dose is 30 mg of combined actives per kg bodyweight by oral administration. Treatment should be continued until 2 days after symptoms have resolved, up to a maximum of 5 days

Norway 96-1182 ScanVet Animal Health AS Norodine Vet Oralpasta Oral paste 1 g contains: Trimethoprim 58,00 mg Sulfadiazine 288,30 mg Horses Infections in horses caused by micro-organisms sensitive to trimethoprim + sulphonamide The equivalent of one syringe is to treat 50 kg of body weight, from 50 kg to 500 kg. The daily dose is 0,09 g oral paste (5 mg trimetoprim + 25 mg sulfadiazin) per kg body weight. This is equivalent to the contents of one syringe for a 500 kg horse

Sweden 10966 Norbrook Laboratories Ltd Hippotrim Vet Oral paste 1 g contain: Sulfadiazine 288,3 mg Trimethoprim 58,0 mg Horses Infections in horses caused by micro-organisms sensitive to trimetoprim + sulphonamide, e.g. infections in the airways, GI-tract, urogenital-tract and wound infections 45 g/500 kg horse alternatively 52 g/600 kg (equal to 30 mg/kg of the combined active substances) 1-2 times a day. The treatment should continue in 5 days or until 2 days with no symptoms have passed. The dosing-device is graded and each grade equals a dose for 50 kg bodyweight

United Kingdom Vm 02000/4098 Norbrook Laboratories Ltd Norodine Equine Paste Oral paste Each 45 g syringe contains: Trimethoprim 2,6 g and Sulfadiazine 13,0 g Horses Infections in horses caused by micro-organisms sensitive to trimetoprim + sulphonamide, e.g. infections in the airways, GI-tract, urogenital-tract and wound infections 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

United Kingdom Vm 00015/4028 Boehringer Ingelheim Ltd Equitrim Equine Oral Paste Oral paste Trimethoprim 5,78 % w/w Sulfadiazine 28,89 % w/w Horses Treatment of bacterial infections in horses caused by sensitive microorganisms including: Escherichia coli, Staphylococcus spp., Streptococcus spp. The product may be effective in alimentary tract infection such as diarrhoea; respiratory infections including pneumonia, pleurisy, strangles; wounds, septicaemia and general infections The daily dose is 30 mg combined active ingredients per kg body weight. Each syringe contains one daily dose for a 500 kg horse. Each division the dial-a-dose plunger provides sufficient medication to treat 50 kg of body weight. Treatment should be continued for up to 5 days or until 2 days after symptoms have resolved, up to a maximum of 5 days