INGELVAC MycoFLEX 50ml

1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Ingelvac MycoFLEX suspension for injection for pigs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Inactivated Mycoplasma hyopneumoniae, J Strain Isolate B-3745.
Each dose of 1 ml of inactivated vaccine contains:
Active substance:
Mycoplasma hyopneumoniae: > 1 RP*

*Relative Potency (ELISA test) by comparison with a reference vaccine.
Adjuvant: Carbomer: 1 mg
For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM
Suspension for injection.
Clear to slightly opalescent, pink to brown suspension for injection.

4. CLINICAL PARTICULARS
4.1 Target species
Pigs (fattening pigs or future breeders until first reproductive service).
4.2 Indications for use, specifying the target species
For active immunisation of pigs from 3 weeks of age to reduce lung lesions following infection with Mycoplasma hyopneumoniae.
Onset of protection occurs by 2 weeks post vaccination and lasts for at least 26 weeks.
4.3 Contraindications
None.
4.4 Special warnings
None.
4.5 Special precautions for use
Special precautions for use in animals
Only healthy animals should be vaccinated.
In case of anaphylactic reactions, the administration of epinephrine is recommended.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
None.
4.6 Adverse reactions (frequency and seriousness)
Adverse reactions are uncommon: transient swelling up to four centimetres in diameter, sometimes associated with redness of the skin, may be observed at the injection site. These swellings may last up to five days.
A transient mean increase in rectal body temperature of about 0.8 °C lasting up to 20 hours after vaccination may be observed.
4.7 Use during pregnancy, lactation or lay
Not applicable.
4.8 Interaction with other medicinal products and other forms of interaction
Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Boehringer Ingelheim’s Ingelvac CircoFLEX and administered at one injection site.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above. 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.
4.9 Amounts to be administered and administration route
Shake well before use.
Single intramuscular injection of one dose (1 ml), preferably in the neck of pigs from 3 weeks of age.
Avoid introduction of contamination during use.
Avoid multiple broaching.
Vaccine devices should be used in accordance with the device instructions provided by the manufacturer.
Use equipment that prevents flush back of the veterinary medicinal product.
When mixed with Ingelvac CircoFLEX:
 Vaccinate only pigs from 3 weeks of age.
When mixed with Ingelvac CircoFLEX the following equipment should be used:
 Use the same pack sizes of Ingelvac CircoFLEX and Ingelvac MycoFLEX.
 Use the appropriate pack sizes for the number of pigs to be vaccinated.
 Use two separate pre-sterilized transfer needles.
 Use a pre-sterilized transfer container (HDPE or EVA plastic container, Type I or Type II glass containers closed with natural latex, polybutene-1 rubber or siliconised chlorobutyl stoppers) of at least the double volume of an individual bottle size.
 Pre-sterilized transfer containers and transfer needles (CE certified) are commonly available via medical equipment suppliers.
To ensure correct mixing follow the steps as described below:
1. Connect one end of the first transfer needle to the vaccine bottle of Ingelvac CircoFLEX.

2. - Connect the opposite end of the transfer needle to the transfer container.
- Aseptically transfer the Ingelvac CircoFLEX vaccine to the transfer container by inverting the vaccine bottle. If needed, gently press the vaccine bottle to facilitate the transfer.
- After transfer of the full content, disconnect and discard the transfer needle and the empty vaccine bottle from the transfer container.
3. Connect one end of the second transfer needle to the vaccine bottle of Ingelvac MycoFLEX.
4. To transfer the Ingelvac MycoFLEX vaccine into the transfer container already filled with Ingelvac CircoFLEX, repeat step 2.
5. To ensure appropriate mixing of the vaccines, shake the transfer container well until the mixture is of uniform orange to reddish colour. During vaccination the uniformity of the coloured mixture should be monitored and maintained by continuous agitation.
6. Administer one single injection dose (2 ml) of the mixture intramuscularly per pig, irrespective of body weight. For administration, vaccine devices should be used in accordance with the device instructions provided by the manufacturer.
Use the entire content of the transfer container immediately after mixing. Any unused mixture or waste material should be disposed of in accordance with local requirements.
The package leaflet of Ingelvac CircoFLEX should also be consulted before the administration of the mixed product.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Following the administration of a 4-fold overdose of vaccine no adverse reactions other than those described under section 4.6 have been observed.
4.11 Withdrawal period
Zero days.

5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Mycoplasma vaccine
ATC vet code: QI09AB13
This vaccine is designed to stimulate the development of an active immune response to Mycoplasma hyopneumoniae.

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium chloride
Water for injection
6.2 Incompatibilities
Do not mix with any other veterinary medicinal product, except with Boehringer Ingelheim ́s Ingelvac CircoFLEX.
6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 21 months
Use immediately after opening.