Ingelvac MycoFlex Suspension for Injection for Pigs

Country: United Kingdom

Bahasa: Inggeris

Sumber: VMD (Veterinary Medicines Directorate)

Bahan aktif:

Mycoplasma hyopneumoniae

Boleh didapati daripada:

Boehringer Ingelheim Limited

Kod ATC:

QI09AB13

INN (Nama Antarabangsa):

Mycoplasma hyopneumoniae

Borang farmaseutikal:

Suspension for injection

Jenis preskripsi:

POM-V - Prescription Only Medicine – Veterinarian

Kumpulan terapeutik:

Pigs

Kawasan terapeutik:

Inactivated Bacterial Vaccine

Status kebenaran:

Authorized

Tarikh kebenaran:

2009-08-04

Ciri produk

Revised: February 2016
AN: 01030/2015
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
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 protection occurs by 2 weeks post vaccination and lasts for
at least 26 weeks.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Page 1 of 5
Revised: February 2016
AN: 01030/2015
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Vaccinate healthy animals only
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.
The freq