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
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 excipient01 February 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 days23 April 2021Multimin Solution for Injection for Cattle
Foston® 20% w/v, Solution for injectionNew datasheet added.23 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
Solantel 200mg/ml Pour-On Solution for CattleNew Product23 August 2021Solantel 200mg/ml Pour-On Solution for Cattle
Lydaxx 100 mg/ml solution for injection for cattle, pigs and sheepAlignment of the product information to the product information of the reference product01 July 2021Lydaxx 100 mg/ml solution for injection for cattle, pigs and sheep
Eprinex Multi 5 mg/ml pour-on solution for cattle, sheep and goatsRenewal (multiple changes): Name change from 'Eprinex Multi 5mg/ml pour-on for beef and dairy cattle, sheep and goats' to 'Eprinex Multi 5mg/ml pour-on solution for cattle, sheep and goats'. The following wording has moved from 'Special Precautions for use in Animals' to 'Contraindications' - "Avermectins can cause fatalities in dogs, especially Collies, Old English Sheepdogs and related breeds and crosses, and also in turtles/tortoises." In 'Other Precautions' the following text has been updated to "In order to reduce the risk to aquatic ecosystems, treated animals should not have direct access to water bodies for a minimum of two to five weeks after treatment." In 'Amounts to be administered and administration route' the wording "For single application only" has been added and "All the animals belonging to the same group should be treated at the same time." Multiple changes to the "Method of Administration" section under the 'For 250ml and 2litre bottles' and 'For 2.5 and 5 litre back-pack' headings to improve clarity. Addition of the following wording to "Environmental Properties" - "Eprinomectin is very toxic to aquatic organisms, is persistent in soils and may accumulate in sediments." The following wording has been added to Disposal Section "Extremely dangerous to fish and aquatic life".03 September 2021Eprinex Multi 5 mg/ml pour-on solution for cattle, sheep and goats
Zactran 150mg/ml solution for injection for cattle, sheep and pigsChange to 'Amounts to be administered and administration route' section from "The cap may be safely punctured up to 60 times" to "The cap may be safely punctured up to 50 times with a 16G needle and up to 80 times with a 18G needle"01 March 2021Zactran 150mg/ml solution for injection for cattle, sheep and pigs
Bovalto Respi IntranasalAddition of a 10-dose presentation.03 September 2021Bovalto Respi Intranasal
Combiclav Lactating Cow Intramammary SuspensionWithdrawal notes updated14 September 2021Combiclav Lactating Cow Intramammary Suspension
Loxicom 20 mg/ml Solution for Injection for Cattle, Pigs and HorsesAdditional paragraph, "Withdrawal period(s)" added to Clinical Particulars section14 September 2021Loxicom 20 mg/ml Solution for Injection for Cattle, Pigs and Horses
Loxicom 5 mg/ml Solution for Injection for Dogs and CatsClinical Particulars/Adverse Reactions (frequency & seriousness) - additional line "In very rare cases elevated liver enzymes have been reported".14 September 2021Loxicom 5 mg/ml Solution for Injection for Dogs and Cats
Norocillin 30% w/v Suspension for InjectionClinical Particulars/Adverse reactions (frequency & seriousness) additional paragraph added14 September 2021Norocillin 30% w/v Suspension for Injection
Noromectin 1.87% Oral Paste for HorsesPharmaceutical particulars/List of Excipient(s) - added Water for injection14 September 2021Noromectin 1.87% Oral Paste for Horses
Noropraz, 18.7 mg/g + 140.3 mg/g Oral Paste for HorsesClinical Particulars/Adverse reactions (frequency & seriousness) - additional paragraph added14 September 2021Noropraz, 18.7 mg/g + 140.3 mg/g Oral Paste for Horses
Thyronorm 5 mg/ml Oral Solution for CatsClinical Particulars/Special precautions for use: additional line 'In hyperthyroid cats, gastrointestinal disorders are common and may interfere with the success of the oral therapy.'14 September 2021Thyronorm 5 mg/ml Oral Solution for Cats
Thyronorm 5 mg/ml Oral Solution for CatsClinical Particulars/Adverse reactions (frequency & seriousness): additional paragraph added14 September 2021Thyronorm 5 mg/ml Oral Solution for Cats
PROGRAM Plus film-coated tablets 2.3mg/46 mgReduction in shelf life from 5 to 3 years16 September 2021PROGRAM Plus film-coated tablets 2.3mg/46 mg
PROGRAM Plus film-coated tablets 5.75mg/115 mgReduction in shelf life from 5 to 3 years16 September 2021PROGRAM Plus film-coated tablets 5.75mg/115 mg
PROGRAM Plus film-coated tablets 11.5mg/230 mgReduction in shelf life from 5 to 3 years16 September 2021PROGRAM Plus film-coated tablets 11.5mg/230 mg
PROGRAM Plus film-coated tablets 23mg/460 mgReduction in shelf life from 5 to 3 years16 September 2021PROGRAM Plus film-coated tablets 23mg/460 mg
Mepidor 20mg/ml InjectionAt the time of renewal there has been a change in the wording of Section 4.7 to include additional information21 September 2021Mepidor 20mg/ml Injection
Canishield® Medicated Collar for Dogs (GB)Legal Category29 September 2021Canishield® Medicated Collar for Dogs (GB)
Arti-Cell Forte suspension for injection for horsesChange in Marketing Authoristion Holder07 July 2021Arti-Cell Forte suspension for injection for horses
FIPROtec® Spray 2.5 mg/ml Cutaneous Spray, Solution for Cats and Dogs (GB)Legal Category29 September 2021FIPROtec® Spray 2.5 mg/ml Cutaneous Spray, Solution for Cats and Dogs (GB)
Avishield® IBD Plus Lyophilisate for Use in Drinking Water for ChickensNew product08 October 2021Avishield® IBD Plus Lyophilisate for Use in Drinking Water for Chickens
Avishield® ND, Lyophilisate for Oculonasal Suspension/Use in Drinking Water for Chickens and TurkeysMinor change to name and updated text08 October 2021Avishield® ND, Lyophilisate for Oculonasal Suspension/Use in Drinking Water for Chickens and Turkeys
Equibactin® 250 mg/g + 50 mg/g Oral Powder for HorsesNew product08 October 2021Equibactin® 250 mg/g + 50 mg/g Oral Powder for Horses
Equipalazone® 1 g Oral PasteNew product08 October 2021Equipalazone® 1 g Oral Paste
Equisolon® Oral Powder for HorsesNew product08 October 2021Equisolon® Oral Powder for Horses
Metrobactin® Tablets for Dogs and CatsSafety related update to SPC08 October 2021Metrobactin® Tablets for Dogs and Cats
Mirataz® 20 mg/g Transdermal Ointment for CatsNew product08 October 2021Mirataz® 20 mg/g Transdermal Ointment for Cats
Prevomax® 10 mg/ml Solution for Injection for Dogs and CatsChange of NI MAH from Le Vet Beheer to Dechra Regulatory BV08 October 2021Prevomax® 10 mg/ml Solution for Injection for Dogs and Cats
Rexxolide® 100 mg/ml Solution for Injection for Cattle, Pigs and SheepNew product08 October 2021Rexxolide® 100 mg/ml Solution for Injection for Cattle, Pigs and Sheep
Sympagesic® 500 mg/ml + 4 mg/ml Solution for Injection for Horses, Cattle, Pigs and DogsNew product08 October 2021Sympagesic® 500 mg/ml + 4 mg/ml Solution for Injection for Horses, Cattle, Pigs and Dogs
Vetoryl® Hard Capsules for DogsAddition of 5mg strength08 October 2021Vetoryl® Hard Capsules for Dogs
Product nameChange detailChange dateDatasheet