Ingelvac MycoFlex Suspension for Injection for Pigs

Страна: Велика Британія

мова: англійська

Джерело: VMD (Veterinary Medicines Directorate)

Активний інгредієнт:

Mycoplasma hyopneumoniae

Доступна з:

Boehringer Ingelheim Limited

Код атс:

QI09AB13

ІПН (Міжнародна Ім'я):

Mycoplasma hyopneumoniae

Фармацевтична форма:

Suspension for injection

Тип рецепту:

POM-V - Prescription Only Medicine – Veterinarian

Терапевтична група:

Pigs

Терапевтична области:

Inactivated Bacterial Vaccine

Статус Авторизація:

Authorized

Дата Авторизація:

2009-08-04

Характеристики продукта

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