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Summary of Product Characteristics.
Name of the veterinary medicinal product
M+PACŪ
Presentation
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Quantity/1 ml dose |
M. hyopneumoniae, inactivated |
>1.47 RPU (Relative Potency Unit) |
Light mineral oil |
0.134 ml |
Sorbitan mono oleate |
0.023 ml |
Polysorbate 80 |
0.043ml |
Aluminium (as hydroxide) |
1.0 mg |
Excipients qs one dose of 1 ml |
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Ethanol96% |
0.02 ml |
Glycerol |
0.05 ml |
Sodium chloride (035% w/v) |
qs1 ml |
Thiomersal (BP) |
0.10 mg |
Uses
For the active immunisation of healthy pigs from 7 days of age against infection caused by Mycoplasma hyopneumoniae, in order to reduce frequency and severity of lung lesions as demonstrated in controlledlaboratory studies, and to induce seroconversion as demonstrated under field conditions.
Dosage and administration
Dose;
- Pigs from 7 days of age: 1 ml.
- Two doses should be administered. 14-28 days apart.
- Pigs from 21 days of age; single dose of 2 ml or two doses of 1 ml administered 14-28 days apart
- For vaccination with two doses of 1 ml given 2-4 weeks apart, protection has been demonstrated
35 days post initial dose. The duration of immunity is at least 6 months. In field studies, only
seroconversion has been demonstrated in pigs receiving two 1 ml doses.
- For vaccination with one dose of 2 ml, protection has been shown 24 days after vaccination.
Duration of immunity is at least 6 months after vaccination.
Administration: By intramuscular injection. The recommended site is the side of the neck and for two
dose administration use alternate sides.
The bottle should be well shaken before any vaccine is withdrawn.
There is no need to warm the vaccine before use.
Syringes and needles should be sterilised before use and the injection should be made through an area
of clean, dry skin taking precautions against contamination.
Follow usual aseptic procedures.
Centra-indications, warnings, etc.
A small proportion of pigs may experience polypnea and dizziness within 5-10 minutes of first
vaccination. This resolves within 4 hours without treatment or further adverse effect on the animal.
An increase in respiration rate may also occur in a small proportion of piglets within a few hours of
injection with either a 1 or 2 ml dose. Hyperthermia may occur in a small proportion of piglets given1 ml (<39.8°C) and a higher proportion given 2 ml (mean 40.2°C), returning to normal within 24-48 hours. The
incidence of adverse effects reduces to <1% after the second vaccination.
Local reactions at the injection site can occur in around 7% of pigs but are restricted to a slight swelling
(<2 cm diameter) which disappears within 24-48 hours of injection.
In rare cases (<0.1%) a granuloma may occur in the muscle at the injection site which may last over 21 days
but resolves over time. Correct aseptic technique will reduce this possibility further.
Piglets vaccinated from 7 days of age: Under laboratory conditions, piglets from 4 weeks of age after administration
of two doses of 1 ml at 2-4 weeks interval produced a protective immune response in the presence of passively
acquired antibodies. Furthermore, under field conditions piglets from 6 days old produced a serological
response in the presence of such antibodies.
Piglets vaccinated from 21 days of age: Analysis of laboratory data after the administration of a single 2 ml dose
have shown no correlation between antibody level of maternal origin at the time of vaccination and the efficacy
of vaccination; this suggests that maternally derived immunity in piglets does not interfere with vaccination.
Do not vaccinate unhealthy animals.
Do not vaccinate pregnant or lactating animals.
No information is available on the concurrent use of this vaccine with any other. It is therefore recommended
that no other vaccine should be administered within 14 days before or after vaccination with this product.
Withdrawal period: Zero days
Operator warning
This product contains mineral oil. Accidental injection/self injection may result in severe pain and swelling,
particularly if injected into a joint or finger, and in rare cases in the loss of the affected finger if prompt^
medical attention is not given.
If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount"
is injected and take the package insert with you. If pain persists for more than 12 hours after medicalj
examination, seek medical advice again.
To the Physician: This product contains mineral oil. Even if small amounts have been injected, accidental injection
with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the
loss of a digit Expert PROMPT surgical attention is required and may necessitate eariy incision and irrigation
of the injected area, especially where there is involvement of finger pulp or tendon.
For animal treatment only Keep out of reach of children
Pharmaceutical precautions
Store between +2°C and +8°C including during transport Protect from light Do not freeze. M+PAC should not be mixed with other medicaments or vaccines. Part used containers of the vaccine should be discarded within 8 hours of opening.
Any unused product or waste material should be disposed of in accordance with national requirements.
Avoid the introduction of contamination during use.
Legal category
Prescription Only Medicine
Package quantities
50 ml bottle, 100 ml bottle
Further information
In any animal population there may be a small number of individuals which fail to respond fully to vaccination.
Successful vaccination depends upon correct storage and administration of the vaccine together with the
animal's ability to respond. This can be influenced by such factors as genetic constitution, intercurrent infection,
age, the presence of maternally-derived antibodies, nutritional status, concurrent drug therapy and stress.
Marketing authorisation number
Vm 00201/4179 (UK)
VPA 10277/87/1 (Ireland)
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