Summary of Product Characteristics

1 Name of the immunological veterinary medicinal product 
Suspension for injection

2 Qualitative and quantitative composition

2.1 Active substances
Composition per dose (2 ml):
Inactivated Mycoplasma hyopneumoniae strain J  ≥1.0 guinea pig-ED80

1 ED80: 1/4 dose of vaccine administered twice with an interval of 15 days induces seroconversion (M. hyopneumoniae specific antibodies) in (at least) 80 percent of the laboratory animals

2.2 Excipients
Preservatives: Methyl parahydroxybenzoate 2.4 mg

2.3 Adjuvants for which knowledge is necessary for the proper administration of the medicinal product
Levamisole (as hydrochloride) 1.8 mg
Carbomer 10 mg

3 Pharmaceutical form  
Suspension for injection.

4 Immunological properties 
The vaccine contains the strain J of Mycoplasma hyopneumoniae inactivated with bromoethylenimine and adjuvanted with levamisole and carbomer. The vaccine induces an active immunity in fattening pigs vaccinated at 7 days old against M. hyopneumoniae as demonstrated by virulent challenge.

ATC Vet code: QI09AB13

5 Clinical particulars
5.0 Target species 
Species: Pigs (fattening pigs).
Age: from 7 days of age onwards.

5.1 Indications for use, specifying the target species
Fattening pigs: For active immunisation of healthy susceptible piglets between 7 and 10 days of age to reduce lung lesion scores and weight loss associated with Mycoplasma hyopneumoniae infection.

Duration of immunity of 70 days after the first vaccination has been shown by experimental infection. Onset and longer duration of immunity have not been investigated in laboratory trials. But, under field conditions, improved weight gain and feed conversion rate over the growth period (6 months) have been demonstrated.

5.2 Contra-indications 
Do not use in unhealthy animals.
Do not use in helminth infested pigs due to risk of selection for levamisole and benzimidazole resistant helminths.
See section “pregnancy and lactation”

5.3 Undesirable effects (frequency and seriousness)
A slight transient rise in temperature up to 1ºC 1-2 days after each vaccination can be seen.

After vaccination, vomiting, trembling and apathy have occasionally been observed.

Occasionally anaphylactic reactions may occur in some sensitive animals. Under these circumstances appropriate treatment should be administered.

Long lasting microscopic lesions at the injection site (multifocal to diffuse granulomatous myositis with presence of granular, eosinophilic material) may be detected after vaccination.

5.4 Special precautions for use

5.5 Pregnancy and lactation   
Pregnancy: do not use during the whole part of the pregnancy.
Lactation: do not use during lactation.
Fertility: do not use in breeding animals.

5.6 Interaction with other vaccines and medicinal products when administered in combination with the vaccine
No information is available on the safety and efficacy from the concurrent use of this vaccine with any other. It is therefore recommended that no other vaccines should be administered within 14 days of this vaccine.

5.7 Posology and method of administration
Recommended vaccination scheme:
Administer one dose of 2 ml per pig, at 7 to 10 days of age. This 2 ml dose should be repeated after 21 days. Vaccinate pigs by deep intramuscular injection into the neck muscles at the cervical-lateral area behind the ear. It is recommended that the second dose should be given preferably on alternate sides.

Pigs should not be revaccinated after completion of the recommended primary regime.

It is recommended that the vaccine should be allowed to warm to a temperature of between +15 ºC and + 25 ºC before administration.
Shake before use.

5.8 Overdose (symptoms, emergency procedures, antidotes) (if necessary)
No effects other than those indicated under section “undesirable effects” have been observed following administration of twice the recommended dose. The rise in rectal temperature and microscopic lesions at the injection site are more severe than after administration of a single dose.

5.9 Special warnings for each target species
The development of immunity may be slower in animals with passive immunity.

5.10 Withdrawal period 
Meat: 2 days.

5.11 Special precautions to be taken by the person administering the medicinal product to animals
In case of accidental self injection of vaccine seek for medical advice and show the package insert to the physician.

6 Pharmaceutical particulars   

6.1 Major incompatibilities 
Do not mix with any other vaccine/immunological product.

6.2 Shelf-life
24 months. Shelf-life after first opening: use immediately after first opening.

6.3 Special precautions for storage
Store and transport at 2ºC - 8ºC. Do not freeze.

6.4 Nature and contents of container 
The container consists of 20 ml (10 doses) Type I coloured glass vials (Eur. Phar.) and 100 ml (50 doses) Type II coloured glass vials (Eur. Phar.), Type II rubber stoppers (Eur. Phar.) and aluminium caps.

Package size(s)
- Cardboard box with one glass vial of 10 doses with a rubber stopper and aluminium cap.
- Cardboard box with one glass vial of 50 doses with a rubber stopper and aluminium cap.
- Cardboard box with 10 glass vials of 10 doses with a rubber stopper and aluminium cap.

6.5 Name of corporate name and address or registered place of business of the Marketing Authorisation Holder
Avda. La Selva, 135
17170 - AMER (Girona) Spain
E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.  

6.6 Special precautions for the disposal of unused product or waste materials
Any unused product or waste material should be disposed of in accordance with national requirements.

7. Marketing Authorization No.

8. Date of Authorization
First authorization: 

8.1 Date of Revision of the text