HYORESP
Country: Netherlands
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
31-03-2012
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Active ingredient:
mycoplasma hyopneumoniae inactivated 3 ELISAU
Available from:
Merial
ATC code:
QI09AB13
Pharmaceutical form:
Suspension for injection
Therapeutic group:
Mycoplasma
Therapeutic area:
Pigs
Authorization date:
2012-02-24
Summary of Product characteristics
D90_TM
Page 1 of 5
September 2007
SUMMARY OF PRODUCT CHARACTERISTICS
_ _
D90_TM
Page 2 of 5
September 2007
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
HYORESP
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per one dose of 2 ml:
ACTIVE SUBSTANCE:
. Inactivated whole cell _Mycoplasma hyopneumoniae _antigen, at least ...................... 3.0 ELISA.U
*
ADJUVANT:
. Al
+++
(as hydroxide) ......................................................................................................... 4.2 mg
EXCIPIENTS:
. Thiomersal ....................................................................................................................... 0.2 mg
* ELISA.U: Unit of RP (relative potency) compared to
reference vaccine.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection. Milky color
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
- Suckling piglets from the age of 5 days
- Post weaning piglets
- Fattening pigs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of pigs to reduce infection and lung lesions caused by _Mycoplasma _
_hyopneumoniae_.
4.3
CONTRAINDICATIONS
None. See 4.7
4.4
SPECIAL WARNINGS
None.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
.
Apply usual procedures for the handling of the animals.
.
Vaccinate only healthy animals.
.
Shake prior to use.
.
Apply usual aseptic procedures.
Hyoresp
Page 3 of 5
September2007
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL
PRODUCT TO ANIMALS
In case of accidental self-injection, seek medical advice immediately and show
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