News from AMTRA
Medicines Update
New MAs and changes made and published to end of July 2020
The points below highlight changes in marketing authorisations (MAs) that may have a significant impact on veterinary surgeons’ prescribing decisions.
New marketing authorisations
New marketing authorisations relevant to veterinary surgeons in the UK that were issued or published in July are listed in Table 1.
Table 1 also indicates where a public assessment report should become available for a product. Where available, links to these reports are accessible by clicking on the relevant product on the VMD’s Product Information Database https://www.gov.uk/check-animal-medicine-licensed
The European Medicines Agency (EMA) publishes European Public Assessment Reports (EPARs) for every veterinary medicine which is authorised through a centralised procedure. Links to these reports are accessible on http://www.ema.europa.eu
TABLE 1
Marketing Authorisations issued/published in July 2020
|
Product name |
Active substance |
Authorisation Holder |
Public Assessment Report to
be made available from VMD? |
|
Bovimox 5 mg/ml pour-on solution for
cattle |
Moxidectin |
EU Pharmaceuticals Ltd |
Yes |
|
Doxytab vet. 15 mg tablets for dogs and
cats |
Doxycycline |
CP Pharma Handelsgesellschaft mbH |
No – RMS Netherlands |
|
Ketabel 100 mg/ml solution for injection Authorised for use in cats, cattle, dogs, goats, guinea pigs,
hamsters, horses, mice, pigs, rabbits, rats, sheep |
Ketamine |
Bela-Pharm GmbH & Co. KG |
No – RMS France |
|
Molecoxan 2.5 mg/ml oral suspension Authorised for use in cattle and sheep |
Diclazuril |
Elanco Europe Ltd |
Yes |
|
Moxidectin EU Pharmaceuticals 5 mg/ml
pour-on solution for cattle |
Moxidectin |
EU Pharmaceuticals Ltd |
Yes |
|
Oxtra DD 100 mg/ml solution for injection
for cattle, sheep, pigs, horses, dogs and cats |
Oxytetracycline |
Support Pharma S.L. |
No – RMS Ireland |
|
Ridamec 5 mg/ml pour-on solution for
cattle |
Moxidectin |
EU Pharmaceuticals Ltd |
Yes |
|
Stenorol Crypto 0.5 mg/ml oral solution
for calves |
Halofuginone |
Huvepharma N.V. |
No – RMS Germany |
|
Unomox 5 mg/ml pour-on solution for
cattle |
Moxidectin |
EU Pharmaceuticals Ltd |
Yes |
Please note that there may be a delay between the issuing of a marketing authorisation to a company and the product being placed on the market.
Changes made to authorisations
Food-producing animals:
Aivlosin 625 mg/g granules for use in drinking water for pigs
(Tylvalosin) (Eco Animal Health Ltd)
Addition of a new indication; ‘Treatment and metaphylaxis of swine enzootic pneumonia caused by susceptible strains of Mycoplasma hyopneumoniae. The presence of the disease in the group must be established before metaphylaxis.’
Addition of related dosing information to section 4.9 of the SPC.
Addition of the following warnings to section 4.4 of the SPC: ‘In severely diseased pigs, if water intake is reduced, pigs should be treated with a suitable injectable veterinary medicinal product prescribed by a veterinarian. At the recommended dose, lung lesions and clinical signs are reduced but infection with Mycoplasma hyopneumoniae is not eliminated.’
Addition of the following warning to section 4.5i: ‘An antibacterial with a lower risk of antimicrobial resistance selection, if available for the same indication, should be used for first line treatment where susceptibility testing suggests the likely efficacy of this approach.’
Denagard 200 mg/ml solution for injection
(Tiamulin) (Elanco Europe Ltd
Authorised for use in pigs
Increase in withdrawal period from 21 to 28 days.
Engemycin LA 200 mg/ml solution for injection
(Oxytetracycline) (Intervet UK Ltd)
Authorised for use in cattle, pigs, sheep
Change of withdrawal periods to:
Cattle: Meat and offal – 41 days; Milk – 8 days
Sheep: Meat and offal – 24 days; Milk – 7 days
Pigs: Meat and offal – 20 days
Imrestor
(Pegylated Bovine Granulocyte Colony Stimulating Factor) (Eli Lilly and Company Limited)
Authorised for use in cattle
Section 4.6 has been updated to include: ‘Transient local swelling at the injection site as well as inflammatory reactions which resolve within 14 days post treatment may be induced through the subcutaneous administration of the veterinary medicinal product.’
Nobilis IB Ma5
(Infectious bronchitis virus) (Intervet UK Ltd)
Authorised for use in chickens
Addition of a new claim for associated non-mixed use of Nobilis IB Ma5 with Innovax-ND-IBD in the product information (PI) of Nobilis IB Ma5.
Permacyl 236.3 mg/ml powder and solvent for suspension for injection for cattle
(Penethamate hydriodide, micronized) (Divasa – Farmavic S.A)
Paragraph in section 4.6 has been updated to read: ‘In very rare cases the symptoms of adverse reactions range from mild skin reactions such as urticaria and dermatitis to severe reactions such as anaphylactic shock with tremors, vomiting, salivation, gastrointestinal disorders and laryngeal oedema.’
Pharmasin 100 mg/g and 250 mg/g premix for medicated feeding stuff for pigs, broilers and pullets
(Tylosin) (Huvepharma N.V.)
For premix products: In relation to the indication for the treatment of respiratory infections in broilers and pullets, deletion of the recommendation to repeat treatment at 3 – 4 weeks of age from section 4.9 of the SPC.
Porcilis Lawsonia lyophilisate and solvent for emulsion for injection for pigs
(Lawsonia intracellularis) (Intervet International BV);
Porcilis PVC M Hyo emulsion for injection for pigs
(Mycoplasma hyopneumoniae, Porcine circovirus-2) (Intervet International BV);
Porcilis PRRS Lyophilslate and solvent for suspension for injection for pigs
(Porcine respiratory and reproductive syndrome virus) (Intervet International BV)
The respective SPCs are revised to include new associated use combinations to introduce the two- and three-way associated use combinations that are not yet registered for these vaccines (associated, non-mixed use of Porcilis Lawsonia either administered alone or reconstituted in Porcilis PCV M Hyo with Porcilis PRRS administered at the same time but at a different site).
Tyljet 200 mg/ml solution for injection for cattle and pigs
(Tylosin) (Ceva Animal Health Ltd)
and
Tylucyl 200 mg/ml solution for injection for cattle and pigs
(Tylosin) (Vetoquinol UK Ltd)
The following warning has been added to section 4.9 of the SPC: ‘In pigs do not administer more than 5 ml per injection site.’ There has also been a change of the withdrawal period for pigs (meat and offal) from 14 days to 16 days.
Winvil 3 Micro emulsion for injection for Atlantic salmon
(Aeromonas salmonicida subsp. salmonicida, Infectious pancreatic necrosis virus, Moritella viscosa) (Elanco Europe Ltd)
Section 4.6 of the SPC has been updated with frequency and severity of the adverse reactions during production cycle of the fish due to availability of the long-term safety data.
Zulvac BTV suspension for injection for sheep and cattle
(Bluetongue virus) (Zoetis Belgium)
Addition of Serotype 4 strain of Bluetongue Virus (BTV) for use in cattle.
Section 4.6 updated: ‘Cattle administered a 4 ml dose:
A transient increase in rectal temperature, not exceeding 2.7°C, was very commonly observed within 48 hours following vaccination in the laboratory and field safety studies conducted. The pyrexia observed had a maximum duration of 2 days. Local reactions at the injection site of up to 6 cm in diameter, which resolved in a maximum of 8 days, also very commonly appeared in the lab safety study conducted.’
Small Animals
Amoxibactin 50 mg (dogs and cats), 250 mg (dogs), 500 mg (dogs) tablets
Amoxicillin) (Le Vet Beheer B.V.)
Paragraph in section 4.6 has been updated to read: ‘Mild gastrointestinal symptoms (diarrhoea and vomiting) may occur very rarely (less than 1 animal in 10,000 animals treated, including isolated reports) after administration of the product. Hypersensitivity reactions (allergic skin reactions, anaphylaxis) may occur very rarely. In these cases, administration should be discontinued, and a symptomatic treatment given.’
Carporal 40 mg / 160 mg tablets for dogs
(Carprofen) (Le Vet Beheer B.V.)
Paragraph in section 4.6 has been updated to read: ‘Typical undesirable effects associated with NSAIDs such as vomiting, soft faeces/diarrhoea, faecal occult blood, loss of appetite and lethargy have been reported very rarely. These adverse reactions occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.’
Endectrid spot-on solution for dogs (range)
(Imidacloprid, Moxidectin) (Bayer plc)
Section 4.6 has been updated to include: ‘The product may, in very rare cases, cause transient local skin sensitivity reactions including increased itching, hair loss, greasy fur and redness at application site. On rare occasion, vomiting can occur.’
Fipronil Pyriproxyfen Virbac spot-on solution (range for dogs and cats)
(Fipronil, Pyriproxyfen) (Virbac)
Paragraph in section 4.6 has been updated to read: ‘In very rare cases, according to the accumulated experience on these active ingredients within spot on pharmaceutical forms, transient cutaneous reactions at the application site (squamosis, local alopecia, pruritus, erythema, skin discolouration) and general pruritus or alopecia may be observed after use. In very rare instances, hypersalivation, reversible neurologic symptoms (hyperesthesia, depression, nervous symptoms), respiratory signs or vomiting might occur.’
Fipronil-(S)-Methoprene Ceva Spot-on Solution (range for dogs and cats)
((S)-Methoprene, Fipronil) (Ceva Sante Animale)
Paragraph in section 4.6 has been updated to read: Transient cosmetic effects at the application site such as spiking of the hair, wet appearance, dry residue or slight scaling were very rarely observed in spontaneous reports. These changes do not affect the safety or the efficacy of the product.
Transient hypersalivation (mainly due to the excipients of the product) after licking the product and vomiting after swallowing were observed very rarely in spontaneous reports.
Alopecia and pruritus at application site have been reported very rarely based on post marketing safety experience.’
Leucofeligen FeLV/RCP lyophilisate and solvent for suspension for injection for cats
(Feline calicivirus; Feline leukemia virus; Feline panleukopenia virus; Feline viral rhinotracheitis virus) (Virbac)
The onset of immunity for the calicivirus component of the vaccine changed to 3 weeks after first injection of primary vaccination.
Panacur 18.75% oral paste
(Fenbendazole) (Intervet UK Ltd)
Authorised for use in cats and dogs
The practical dosage recommendations have been updated to indicate that only puppies and kittens weighing greater than 1 kg should be treated with this product. The following warning has been added to the product literature: ‘Owing to the reduced dose rate for treatment of pregnant dogs (25 mg fenbendazole/kg bodyweight daily) which cannot accurately be attained when using the Panacur Paste 5 g syringe, it is recommended that alternative formulations of fenbendazole be used.’
Simparica tablets for oral use in dogs (range)
(Sarolaner) (Zoetis Belgium)
Paragraph in section 4.6 has been updated to include: ‘Mild and transient gastrointestinal signs such as vomiting and diarrhoea and systemic disorders such as lethargy, anorexia/inappetence may occur in very rare cases based on post marketing experience. These signs typically resolve without treatment. Neurological disorders such as tremor, ataxia or convulsion may occur in vary rare cases based on post marketing experience. In most cases these signs are transient.’
Zycortal 25 mg/ml prolonged-release suspension for injection for dogs
(Desoxycortone pivalate) (Dechra Limited)
Section 4.6 has been updated to include: ‘Injection site pain has been reported as an uncommon reaction.’
In prescribing these veterinary medicines, veterinary surgeons should be aware that changes to the Summary of Product Characteristics (SPC), labels and leaflets may, in certain cases, change how the medicines should be used. The timing of when such changes have to be taken into account will depend on the circumstances, but as a general rule unless a prescriber has been advised otherwise by the manufacturer or the VMD the labelling instructions on the pack from which the product is dispensed should be followed.
