Ingelvac MycoFlex Suspension for Injection for Pigs

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: VMD (Veterinary Medicines Directorate)

Viambatanisho vya kazi:

Mycoplasma hyopneumoniae

Inapatikana kutoka:

Boehringer Ingelheim Animal Health UK Ltd

ATC kanuni:

QI09AB13

INN (Jina la Kimataifa):

Mycoplasma hyopneumoniae

Dawa fomu:

Suspension for injection

Dawa ya aina:

POM-V - Prescription Only Medicine – Veterinarian

Kundi la matibabu:

Pigs

Eneo la matibabu:

Inactivated Bacterial Vaccine

Idhini hali ya:

Authorized

Idhini ya tarehe:

2009-08-04

Tabia za bidhaa

Revised: July 2021
AN: 00995/2020
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
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 (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
EXCIPIENTS:
For the 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 immunity:
2 weeks post vaccination
Duration of immunity:
at least 26 weeks.
4.3
CONTRAINDICATIONS
None.
Revised: July 2021
AN: 00995/2020
Page 2 of 5
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
In case of anaphylactic-type reactions, the administration of
epinephrine is recommended.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
Not applicable.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
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.