BioBos Mastiguard suspension for injection
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Polyvalent inactivated vaccine against bovine mastitis.
| type of preparative: | Vaccines |
|---|---|
| target species animals: | Cattle |
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2ml dose contains:
Active substances:
Escherichia coli, strain 5117, J5, inactivated RP ≥ 1*
Staphylococcus aureus, strain DSM 4910, inactivated RP ≥ 1*
*) Relative potency (RP) is determined by comparing the antibody level with the antibody level in serum of mice prepared with a reference batch of vaccine compliant with the challenge test in target animals.
Adjuvant:
Aluminum hydroxide hydrated for adsorption 2% 0.4 ml
Excipients:
|
Qualitative composition of excipients and other constituents |
Quantitative composition if that information is essential for proper administration of the veterinary medicinal product |
|
Thiomersal |
0.2 mg |
|
Formaldehyde |
≤ 1 mg |
|
Sodium chloride |
- |
|
Water for injections |
- |
A light liquid with greyish sediment. Grey turbid liquid after shaking.
CLINICAL INFORMATION
Target species
Cattle (cows and heifers).
Indications for use for each target species
For active immunisation of healthy cows and heifers, in herds of dairy cattle with repeated occurrence of mastitis, to reduce the occurrence of subclinical mastitis, the incidence and severity of clinical symptoms of mastitis caused by mucoid strains of Staphylococcus aureus and Escherichia. coli.
Onset of immunity: 6 days after parturition
Duration of immunity: 150 days after parturition
Contraindications
None.
Special warnings
The whole herd needs to be immunized.
Immunization must be considered as part of a comprehensive preventive program against mastitis, which should address all factors important for a good condition of the mammary gland (for example: milking technique, milking and correct husbandry principles, hygiene, nutrition, housing, bedding, cow comfort, air and water quality, health monitoring) and other zootechnical procedures.
Vaccinate healthy animals only.
Special precautions for use
Special precautions for safe use in the target species:
Not applicable.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
In case of 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.
Adverse events
Cattle (cows and heifers):
|
Very rare (<1 animal / 10,000 animals treated, including isolated reports): |
Injection site swelling1 Injection site pain2 Elevated temperature3 |
1 swelling (on average 5 cm2), which disappears within 1 to 2 weeks at the latest
2 which will disappear spontaneously within a maximum of 4 days
3 a slight and transient increase in body temperature of about 1°C, up to 2°C in some dairy cows, may occur in the first 24 hours after the injection
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 its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Pregnancy and lactation:
Can be used during pregnancy and lactation.
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.
Administration routes and dosage
Intramuscularuse.
The vaccine must be heated to 15-25 °C and shaken slightly before application. Apply one dose (2 ml) intramuscularly preferably in the gluteal region according to the following scheme:
- First injection is 45 days before expected delivery date.
- Second injection is 3 weeks after the first application.
Each injection is recommended to be applied to the opposite half of the body.
This complete immunization program must be repeated with each pregnancy.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
Not applicable.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
Withdrawal periods
Zero days.
IMMUNOLOGICAL INFORMATION
ATCvet code: QI02AB17
To stimulate active immunity against Staphylococcus aureus strains and E. coli causing bovine mastitis.
PHARMACEUTICAL PARTICULARS
Major incompatibilities
Do not mix with any other veterinary medicinal product.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years
Shelf life after first opening the immediate packaging: 10 hours
Special precautions for storage
Store and transport refrigerated (2 °C – 8 °C).
Protect from frost.
Protect from light.
Nature and composition of immediate packaging
Type I glass vials of 10 ml with chlorobutyl elastomer closure and aluminium or flip off caps.
Type II glass vials of 50 or 100 ml with chlorobutyl elastomer closure and aluminium or flip off caps.
Translucent plastic (HDPE) vials of 15, 60 or 120 ml with chlorobutyl elastomer closure and aluminium or flip off caps.
Package size
Plastic box of 10 glass or plastic vials of 5 doses (10 ml)
Cardboard box of 1 glass or plastic vial of 5 doses (10 ml), 25 doses (50 ml), 50 doses (100 ml)
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Medicines should not be disposed of via wastewater or household waste.
Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.