Ingelvac MycoFLEX suspension for injection for pigs

Ingelvac MycoFLEX suspension for injection for pigs.

Presentation

Suspension for injection.

Clear to slightly opalescent, pink to brown suspension for injection.

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

Uses

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.

Dosage and administration

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.

Vaccination devices should be used in accordance to 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 volumes of Ingelvac CircoFLEX and Ingelvac MycoFLEX.

•Use a pre-sterilized transfer needle. Pre-sterilized 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 transfer needle to the vaccine bottle of Ingelvac MycoFLEX.

2.- Connect the opposite end of the transfer needle to the vaccine bottle of Ingelvac CircoFLEX..

-Transfer the Ingelvac CircoFLEX vaccine into the vaccine bottle of Ingelvac MycoFLEX. If needed, gently press the vaccine bottle of Ingelvac CircoFLEX to facilitate the transfer.

-After the transfer of the full content of Ingelvac CircoFLEX, disconnect and discard transfer needle and empty vaccine bottle of Ingelvac CircoFLEX.

3.To ensure appropriate mixing of the vaccines, gently shake the vaccine bottle of Ingelvac MycofLEX 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.

4.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 vaccine mixture 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.

Contra-indications, warnings, etc

Withdrawal period: Zero days

Adverse reactions are very rare (less than 1 animal in 10,000 animals, including isolated reports):

-anaphylactic-type reactions may occur and should be treated symptomatically (e.g. epinephrine)

-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.

The frequency of adverse reactions is defined using the following convention:

-very common (more than 1 in 10 animals displaying adverse reactions 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).

Only healthy animals should be vaccinated.

In case of anaphylactic-type reactions, the administration of epinephrine is recommended.

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.

Overdose: Following the administration of a 4-fold overdose of vaccine no adverse reactions other than those described above have been observed.

Incompatibilities: Do not mix with any other veterinary medicinal product, except with Boehringer Ingelheim´s Ingelvac CircoFLEX.

Disposal Advice: Any unused product or waste materials should be disposed of in accordance with local requirements.

Pharmaceutical precautions

Store and transport between +2°C and +8°C

Do not freeze.

Protect from light.

Do not use after the expiry date (EXP) which is stated on the carton and the bottle.

Shelf life after first opening the immediate packaging: 10 hours

For animal treatment only.

Keep out of sight and reach of children.

Legal category

POM-V

Packaging Quantities

Either 1 or 12 bottles of 10 ml (10 doses), 50 ml (50 doses), 100 ml (100 doses), or 250 ml (250 doses) packed in a cardboard box. Not all pack sizes may be marketed.