NOAH Compendium

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Date: Monday, April 29, 2024 6:13

Release 5.53
Suvaxyn MH-One Emulsion for injection for pigs
 
Species: Pigs
Therapeutic indication: Immunological veterinary medical products: For pigs
Active ingredient: Vaccine Antigens
Product:Suvaxyn® MH-One Emulsion for injection for pigs
Product index: Suvaxyn MH-One
Pig - meat: Zero days
Incorporating:
Presentation
Brownish-grey emulsion.
Qualitative composition
Quantitative composition (2.0ml dose)
Active Substances:
Inactivated Mycoplasma hyopneumoniae, strain P-5722-3
RP* (undiluted) ≥ 1.00
Adjuvants:
Carbopol #941
4.00 mg
Squalane**
3.24 mg
Excipients:
Thiomersal
0.20 mg
* Relative Potency unit determined by ELISA antigen quantification (in vitro potency test) compared to a reference vaccine.
** As component of MetaStim (that also contains Pluronic L-121 and Polysorbate 80).
Uses
For the active immunisation of pigs of a minimum age of 7 days to reduce lung lesions that are caused by Mycoplasma hyopneumoniae.
Onset of immunity: 2 weeks following vaccination.
Duration of immunity: 6 months.
Dosage and administration
One dose of 2.0 ml per animal should be administered intramuscularly in the neck to pigs from the age of 7 days onwards.
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
Do not use in pregnant or lactating animals.
Administer only to animals in good health.
Avoid stress in the animals around the time of vaccination.
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 medicinal product.
Adverse reactions
Systemic adverse reactions, such as body temperature increases (up to 1.9°C), depression, shivering and bristling are very common at 4 hours post vaccination. These reactions resolve spontaneously within 24 hours without treatment. Anaphylactic reactions and nervous signs are uncommon.
Local tissue reactions in the form of a palpable (but not visible) swelling at the injection site are very common and last for up to 2 days. The area of local tissue reactions may reach 0.3 cm in diameter.
The frequency of possible adverse effects is defined using the following convention:
- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)
- common (more than 1 but less than 10 animals in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals)
- rare (more than 1 but less than 10 animals in 10,000 animals)
- very rare (less than 1 animal in 10,000 animals, including isolated reports).
After administration of a two-fold maximum dose by the recommended route, no other symptoms than those described above can be observed. However, the duration may be prolonged (body temperature increases up to 2 days and local tissue reactions up to 3 days) and the area of local tissue reactions may reach 1.0 cm in diameter. Administration of an overdose of the vaccine has not been investigated in 1 week-old pigs.
Withdrawal period
Zero days.
User warnings
This product contains animal oil. In case of accidental self-injection, seek medical advice immediately and show package leaflet or label to the physician.
Pharmaceutical precautions
Store and transport refrigerated (2°C - 8°C).
Protect from light. Do not freeze.
Do not use after the expiry date stated on the label.
Shelf-life after first opening: use immediately.
Keep out of the sight and reach of children.
For animal treatment only.
Legal category
Legal category: POM-V
Packaging quantities
Carton box containing 1 or 10 bottles of 10, 50 or 125 doses.
Not all pack sizes may be marketed.
Further information
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Number
Vm 42058/4139
Significant changes
GTIN
GTIN description:50 dose:
GTIN:08714015020220