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Date: Monday, May 6, 2024 14:23

Release 3.138
Suvaxyn M. hyo Suspension for injection for pigs
 
Species: Pigs
Therapeutic indication: Immunological veterinary medical products: For pigs
Active ingredient: Vaccine Antigens
Product:Suvaxyn® M. hyo Suspension for injection for pigs
Product index: Suvaxyn M. hyo
Pig - meat: Zero days
Incorporating:
Presentation
Suspension for injection.
Each dose (2 ml) contains:
Active substance:
Inactivated Mycoplasma hyopneumoniae, strain P-5722-3
RP* ≥ 1*
Adjuvants:
Carbopol #941
4 mg
Excipients:
Thiomersal
50-115 ppm
EDTA
Amaranth
Sodium Chloride
Sodium phosphate dibasic heptahydrate
Water for injections
*Relative Potency unit determined by ELISA antigen quantification (in vitro potency test) of undiluted serials compared to a reference vaccine.
Uses
Active immunisation against Mycoplasma hyopneumoniae infection in pigs for fattening to reduce the frequency and severity of lung lesions.
Dosage and administration
Intramuscular use.
A dose of 2ml must be administered intramuscularly in the neck behind the ear twice with an interval of 2 weeks, to pigs from the age of 1 week and before the age of 10 weeks.
Advice on correct administration
Shake vaccine well before administration and intermittently during the process of vaccination.
It is good practice to allow the vaccine to warm to body temperature in the hand or pocket before administration, to avoid the discomfort of injection of a cold liquid.
Contra-indications, warnings, etc
Avoid stress in the animals around the time of vaccination.
Vaccinate healthy animals only.
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.
Do not mix with any other veterinary medicinal product.
Adverse reactions
Rarely a slight soft swelling of about 2cm in diameter may be observed at the site of injection. Such swelling spontaneously disappears within a few days after vaccination.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
The administration of an overdose may very commonly result in the same type of reaction as seen after administration of a single dose.
Withdrawal period
Zero days.
User warnings
In case of accidental self-injection seek medical advice immediately and show the package leaflet or label to the physician.
Pharmaceutical precautions
Store and transport refrigerated (2 °C - 8 °C).
Do not freeze.
Protect from light.
Shelf-life after first opening the immediate packaging: use immediately.
Keep out of the sight and reach of children.
For animal treatment only.
Legal category
Legal category: POM-V
Packaging quantities
High density polyethylene (HDPE) bottles containing 100 ml (50 doses) or 250 ml (125 doses) of vaccine closed with chlorobutyl rubber stoppers and sealed with aluminium caps.
Carton box containing 1 bottle of 50 or 125 doses
Carton box containing 10 bottles of 50 or 125 doses
Not all pack sizes may be marketed.
Further information
Disposal
Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with the local requirements.
Marketing Authorisation Number
GB: Vm 42058/5132
NI: Vm 42058/3025
Significant changes
GTIN
GTIN description:50 dose:
GTIN:08714015012454