Protivity
Active substance
ATC code
Species
Cattle.
Indications
For active immunisation of calves from 1 week of age to reduce clinical signs and lung lesions caused by Mycoplasma bovis infection.
Onset of immunity: 12 days after the basic vaccination scheme.
Duration of immunity: has not been established.
Dose to be administered and administration route
Vaccinate cattle by the subcutaneous route in the neck.
Reconstitute the lyophilisate with the solvent to obtain a suspension for injection.
After reconstitution, the suspension should be pinkish to orange-brown turbid in color.
Basic vaccination scheme:
Two doses, each of 2 ml, should be administered 3 weeks apart to calves from 1 week of age. The second dose should preferably be administered on the alternate side of the neck.
Adverse reactions
Cattle:
|
Very common (>1 animal / 10 animals treated): |
injection site swelling1 |
|
Common (1 to 10 animals / 100 animals treated): |
injection site pain2 injection site warmth2 injection site nodule3 |
|
Uncommon (1 to 10 animals / 1,000 animals treated): |
lameness |
1More than 5 cm in diameter observed on the day of vaccine administration and resolving spontaneously within 3 days.
2On the day of vaccine administration.
3Less than 0.8 cm3 in volume observed from 10 days after vaccination and lasting between 1 to 5 days.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See also section 16 of the package leaflet for contact details.
Dispensing
POM-V - Prescription Only Medicine – Veterinarian
TRUSTED SOURCE
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Protivity lyophilisate and solvent for suspension for injection for cattle
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 2 ml contains:
Active substance:
Lyophilisate:
Mycoplasma bovis strain N2805-1, live (attenuated) 0.22 x 107 to 15.50 x 107 CFU* * Colony Forming Units.
Solvent:
Water for injections 2 ml
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
Lyophilisate: slightly coloured (whitish to cream) freeze-dried pellet. Solvent: clear and colourless liquid.
4. CLINICAL PARTICULARS
4.1 Target species
Cattle.
4.2 Indications for use, specifying the target species
For active immunisation of calves from 1 week of age to reduce clinical signs and lung lesions caused by Mycoplasma bovis infection.
Onset of immunity: 12 days after the basic vaccination scheme. Duration of immunity: has not been established.
4.3 Contraindications
None.
4.4 Special warnings for each target species
Vaccinate healthy animals only.
The potential impact of maternally derived antibodies on efficacy of vaccination has not been established.
The product is a live attenuated vaccine. Antimicrobials active against Mycoplasma spp. should not be given 15 days before or after vaccination or during the two-dose basic vaccination scheme as they could interfere with vaccine efficacy. Within these time frames, and in the situation where a clinical condition requires the prescription of antimicrobials, preference should be given to those with no anti-Mycoplasma spp. activity.
4.5 Special precautions for use
Special precautions for use in animals
The safety of the veterinary medicinal product has not been established in breeding bulls.
The live attenuated Mycoplasma bovis vaccine strain may disseminate into synovial fluid, lymph node, middle ear, conjunctiva, tonsil and lung tissue after vaccination.
In a laboratory study conducted using a dose 7-fold higher than the maximum bacterial content, nasal shedding was observed for at least 9 days post-vaccination in an animal vaccinated through intramuscular and subcutaneous routes. However, the vaccine strain did not spread to in-contact control animals.
Distinguishing between field strains and the vaccine strain of M. bovis can be performed by whole genome sequencing tests. Additional information to differentiate the vaccine strain from field strains is available upon request from the marketing authorisation holder.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
No special precautions to be taken by the person administering the veterinary medicinal product to animals are necessary as M. bovis is not considered to present a risk to healthy humans. However, in case of development of adverse reactions following accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Special precautions for the protection of the environment
Not applicable. Other precautions
Not applicable.
4.6 Adverse reactions (frequency and seriousness)
Cattle:
|
Very common (>1 animal / 10 animals treated): |
injection site swelling1 |
|
Common (1 to 10 animals / 100 animals treated): |
injection site pain2 injection site warmth2 injection site nodule3 |
|
Uncommon (1 to 10 animals / 1,000 animals treated): |
lameness |
1More than 5 cm in diameter observed on the day of vaccine administration and resolving spontaneously within 3 days.
2On the day of vaccine administration.
3Less than 0.8 cm3 in volume observed from 10 days after vaccination and lasting between 1 to 5 days.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See also section 16 of the package leaflet for contact details.
4.7 Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
4.8 Interaction with other medicinal products and other forms of interaction
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
4.9 Amount(s) to be administered and administration route
Vaccinate cattle by the subcutaneous route in the neck.
Reconstitute the lyophilisate with the solvent to obtain a suspension for injection.
After reconstitution, the suspension should be pinkish to orange-brown turbid in color.
Basic vaccination scheme:
Two doses, each of 2 ml, should be administered 3 weeks apart to calves from 1 week of age. The second dose should preferably be administered on the alternate side of the neck.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
No other adverse events than those mentioned in section 4.6 (Adverse reactions) were observed after administration of a 10-fold overdose of the vaccine. Swelling at the injection site may have a diameter of more than 5 cm and will spontaneously resolve in 4 days. The volume of the observed nodule may be up to 3 cm3, can be observed from 5 days post vaccination and may last until 16 days after administration of a 10-fold overdose of the vaccine.
4.11 Withdrawal period(s) Zero days.
5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Immunologicals for Bovidae, live bacterial vaccines, mycoplasma for cattle.
ATCvet code: QI02AE05
The vaccine induces an active immunity against Mycoplasma bovis in young calves.
Duration of immunity has not been established. The basic vaccination scheme induces a serological response. Within a laboratory study conducted, a single dose administration approximately 14 weeks after the basic vaccination scheme induced an anamnestic immune response in vaccinated animals.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lyophilisate:
Lactose monohydrate
Potassium dihydrogen phosphate
Dipotassium hydrogen phosphate trihydrate
Monopotassium L-glutamate
Gelatin
Casein hydrolysate
Basal Medium Eagle
Magnesium chloride hexahydrate
Phenol red
Sodium hydrogen carbonate Water for injections
Solvent:
Water for injections
6.2 Major incompatibilities
Do not mix with any other veterinary medicinal product, except solvent supplied for use with the veterinary medicinal product.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after reconstitution according to directions: use immediately.
6.4 Special precautions for storage
Store and transport refrigerated (2 °C – 8 °C).
Keep the vial in the outer carton in order to protect from light.
6.5 Nature and composition of immediate packaging
Type I hydrolytic glass vials containing 10 doses of lyophilisate or 20 ml of solvent.
Lyophilisate: bromobutyl rubber stoppers and aluminium caps. Solvent: chlorobutyl rubber stoppers and aluminium caps.
Cardboard box containing 1 vial with 10 doses of lyophilisate and 1 vial with 20 ml solvent.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Medicines should not be disposed of via wastewater.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Zoetis UK Limited
1st Floor, Birchwood Building
Springfield Drive
Leatherhead
Surrey
KT22 7LP
8. MARKETING AUTHORISATION NUMBER
Vm 42058/5110
9. DATE OF FIRST AUTHORISATION
March 2024
10. DATE OF REVISION OF THE TEXT
March 2024
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
11. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT
Veterinary medicinal product subject to prescription.
Find more product information by searching for the ‘Product Information Database’ or ‘PID’ on www.gov.uk.
Approved 01 March 2024
