New and updated data sheets.
The following list of new and updated data sheets will be of interest to website users. The list is of those products that companies have chosen to highlight, and thus may not be exhaustive.
Product nameChange detailChange dateDatasheet
AVINEW NEO effervescent tablet for chickens and turkeysAdd new species - turkeys18 August 2020AVINEW NEO effervescent tablet for chickens and turkeys
Aivlosin 625 mg/g Granules for Use in Drinking Water for PigsUpdated withdrawal period: Pig - meat: Meat and offal: 2 days20 August 2020Aivlosin 625 mg/g Granules for Use in Drinking Water for Pigs
Aivlosin 625 mg/g Granules for Use in Drinking Water for PigsAdditional indication: Treatment and metaphylaxis of Swine Enzootic Pneumonia caused by susceptible strains of Mycoplasma hyopneumoniae.20 August 2020Aivlosin 625 mg/g Granules for Use in Drinking Water for Pigs
Aivlosin 625 mg/g Granules for Use in Drinking Water for PigsDosage for the additional indication: Swine Enzootic Pneumonia caused by susceptible strains of Mycoplasma hyopneumoniae.20 August 2020Aivlosin 625 mg/g Granules for Use in Drinking Water for Pigs
Osurnia® Ear Gel for DogsNew Product17 September 2020Osurnia® Ear Gel for Dogs
Zycortal® 25 mg/ml Prolonged-release Suspension for Injection for DogsSafety changes to SPC during renewal - Addition of injection site pain and change of frequency of pancreas disorders17 September 2020Zycortal® 25 mg/ml Prolonged-release Suspension for Injection for Dogs
Apovomin® 3 mg/ml Solution for Injection for DogsNew Product13 October 2020Apovomin® 3 mg/ml Solution for Injection for Dogs
Avishield® IB GI-13, Lyophilisate for Oculonasal Suspension/Use in Drinking Water for ChickensNew product13 October 2020Avishield® IB GI-13, Lyophilisate for Oculonasal Suspension/Use in Drinking Water for Chickens
Avishield® IB H120, Lyophilisate for Oculonasal Suspension/Use in Drinking Water for ChickensNew product13 October 2020Avishield® IB H120, Lyophilisate for Oculonasal Suspension/Use in Drinking Water for Chickens
Avishield® ND B1, Lyophilisate for Oculonasal Suspension/Use in Drinking Water for ChickensNew product13 October 2020Avishield® ND B1, Lyophilisate for Oculonasal Suspension/Use in Drinking Water for Chickens
Bupredine Multidose® 0.3 mg/ml Solution for Injection for Dogs, Cats and HorsesNew product13 October 2020Bupredine Multidose® 0.3 mg/ml Solution for Injection for Dogs, Cats and Horses
Cefabactin® TabletsNew product13 October 2020Cefabactin® Tablets
Cosacthen® 0.25 mg/ml Solution for Injection for DogsNew product13 October 2020Cosacthen® 0.25 mg/ml Solution for Injection for Dogs
Dilaterol® 25 micrograms/ml Syrup for HorsesNew product13 October 2020Dilaterol® 25 micrograms/ml Syrup for Horses
Dormazolam® 5 mg/ml Solution for Injection for HorsesNew product13 October 2020Dormazolam® 5 mg/ml Solution for Injection for Horses
Equibactin® Vet. (333 mg/g + 67 mg/g) Oral Paste for HorsesNew product13 October 2020Equibactin® Vet. (333 mg/g + 67 mg/g) Oral Paste for Horses
Equipalazone® Original 1 g Oral PowderChange of name13 October 2020Equipalazone® Original 1 g Oral Powder
Euthasol® Vet. 400 mg/ml Solution for InjectionNew product13 October 2020Euthasol® Vet. 400 mg/ml Solution for Injection
Floxabactin® TabletsNew product13 October 2020Floxabactin® Tablets
Fungiconazol® Tablets for DogsNew product13 October 2020Fungiconazol® Tablets for Dogs
Laxatract® 667 mg/ml Syrup for Dogs and CatsNew product13 October 2020Laxatract® 667 mg/ml Syrup for Dogs and Cats
Meloxidolor® 5 mg/ml Solution for Injection for Dogs, Cats, Cattle and PigsNew product13 October 2020Meloxidolor® 5 mg/ml Solution for Injection for Dogs, Cats, Cattle and Pigs
Nerfasin® Solution for InjectionNew product13 October 2020Nerfasin® Solution for Injection
Novaquin® 15 mg/ml Oral Suspension for HorsesNew product13 October 2020Novaquin® 15 mg/ml Oral Suspension for Horses
Osurnia® Ear Gel for DogsNew product13 October 2020Osurnia® Ear Gel for Dogs
Phenoleptil® Tablets for DogsNew product13 October 2020Phenoleptil® Tablets for Dogs
Rominervin® 10 mg/ml Solution for Injection for HorsesNew product13 October 2020Rominervin® 10 mg/ml Solution for Injection for Horses
Sedadex® 0.5 mg/ml Solution for Injection for Dogs and CatsNew product13 October 2020Sedadex® 0.5 mg/ml Solution for Injection for Dogs and Cats
Torphadine® 10 mg/ml Solution for Injection for Dogs, Cats and HorsesNew product13 October 2020Torphadine® 10 mg/ml Solution for Injection for Dogs, Cats and Horses
Tranquinervin® 10 mg/ml Solution for Injection for HorsesNew product13 October 2020Tranquinervin® 10 mg/ml Solution for Injection for Horses
Betamox LA 150 mg/ml Suspension for InjectionUpdated withdrawal Periods:
Cattle:
Meat: 39 days
Milk: 4.5 days
Sheep:
Meat: 29 days
Pigs
Meat: 42 days
04 December 2020Betamox LA 150 mg/ml Suspension for Injection
Ubroseal Blue Dry Cow 2.6 g intramammary suspension for cattleIntramammary suspension changed from white to blue by addition of Indigo Carmine AL Lake E 132 excipient29 January 2021Ubroseal Blue Dry Cow 2.6 g intramammary suspension for cattle
Somulose® Solution for InjectionWithdrawal notes: Additional text 'Not to be used in animals intended for human or animal consumption due to the risk of secondary intoxication'04 February 2021Somulose® Solution for Injection
Somulose® Solution for InjectionContraindications: change to text04 February 2021Somulose® Solution for Injection
Somulose® Solution for InjectionAdverse Reactions: Additional text and frequency of adverse reactions04 February 2021Somulose® Solution for Injection
Librela® solution for injection for dogsNew Product26 February 2021Librela® solution for injection for dogs
CircoMax Myco Emulsion for injection for pigsNew Product26 February 2021CircoMax Myco Emulsion for injection for pigs
Thyforon® Flavoured Tablets for DogsSafety related updates/additions to Adverse Reactions following PSUR assessment report and as a result of comments during Repeat Use Procedure10 December 2020Thyforon® Flavoured Tablets for Dogs
Multimin Solution for Injection for CattleMeat withdrawal period now 28 days27 April 2021Multimin Solution for Injection for Cattle
Foston® 20% w/v, Solution for injectionNew datasheet added.28 April 2021Foston® 20% w/v, Solution for injection
Solensia® 7 mg/ml solution for injection for catsNew Product04 May 2021Solensia® 7 mg/ml solution for injection for cats
Lutalyse 5 mg/ml Solution for InjectionChange to cattle meat withdrawal period12 May 2021Lutalyse 5 mg/ml Solution for Injection
Enterisol Ileitis lyophilisate and solvent for oral suspension for pigsThe vaccine modulates the composition of the microbiome. Published literature suggests that this can reduce the Salmonella spp. prevalence in the acute phase of the infection and the seroprevalence at slaughter in L. intracellularis and Salmonella enterica co-infected pigs.24 May 2021Enterisol Ileitis lyophilisate and solvent for oral suspension for pigs
Emeprid® 5 mg/ml solution for injection for dogs and catsAdverse Reactions- text updated28 June 2021Emeprid® 5 mg/ml solution for injection for dogs and cats
Pracetam® 400 mg/ml solution for use in drinking water for pigsUpdated text throughout Clinical particulars including; special precautions for use, adverse reactions, use during pregnancy and lactation, amounts to be administered and overdose.28 June 2021Pracetam® 400 mg/ml solution for use in drinking water for pigs
Rispoval 2 / BRSV + Pi3 Lyophilisate and solvent for suspension for injection for cattleNew Product01 July 2021Rispoval 2 / BRSV + Pi3 Lyophilisate and solvent for suspension for injection for cattle
Vetbromide 600mg tablets for dogsNEW PRODUCT05 July 2021Vetbromide 600mg tablets for dogs
Kexxtone 32.4g continuous-release intraruminal device for cattleKeep dogs away from treated animals. Accidental ingestion of active ingredient by dogs has resulted in fatal consequences. In case of suspected ingestion by dogs, seek veterinary advice immediately.25 June 2021Kexxtone 32.4g continuous-release intraruminal device for cattle
Versifel® FeLV suspension for injection for catsNew Datasheet07 July 2021Versifel® FeLV suspension for injection for cats
Kesium® 40mg/10mg & 50mg/12.5mg chewable tablets for cats & dogs and Kesium® 200mg/50mg, 400mg/100mg & 500mg/125mg chewable tablets for dogsName Changes for Kesium range - product names changed throughout SPC07 July 2021Kesium® 40mg/10mg & 50mg/12.5mg chewable tablets for cats & dogs and Kesium® 200mg/50mg, 400mg/100mg & 500mg/125mg chewable tablets for dogs
Stresnil 40 mg/ml Solution for Injection for PigsDo not re-inject if the animal is unresponsive to the initial dose, allow full recovery before re-injecting on a different day.01 March 2021Stresnil 40 mg/ml Solution for Injection for Pigs
Stresnil 40 mg/ml Solution for Injection for PigsWithdrawal period Meat and offal: 18 days.15 December 2020Stresnil 40 mg/ml Solution for Injection for Pigs
Daxocox tablets for dogsNew Product13 July 2021Daxocox tablets for dogs
Bovalto Respi IntranasalAdverse Event section text "Very commonly, a slight and transient nasal discharge may occur the first three days after vaccination without any adverse consequence for in-contact animals.The local reactions observed and their frequency relate to observations following administration of an overdose under controlled laboratory conditions" replaced by "A hypersensitivity reaction may very rarely occur, which may require appropriate symptomatic treatment."

Overdose text "No adverse effect other than that mentioned in Adverse Reactions" replaced by "A slight and transient nasal discharge was observed the first three days after the administration of an overdose without any adverse consequence for in-contact animals."
25 June 2021Bovalto Respi Intranasal
Product nameChange detailChange dateDatasheet