Mhyosphere PCV ID

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

Mycoplasma hyopneumoniae, strain 7304 (Nexhyon), expressing the capsid protein of porcine circovirus type 2a, inactivated

MAH:

Laboratorios Hipra, S.A.

ATC_code:

QI09AL08

INN:

Mycoplasma hyopneumoniae and porcine circovirus vaccine (inactivated, recombinant)

therapeutic_group:

Pigs

therapeutic_area:

Immunologicals for suidae, Inactivated viral and inactivated bacterial vaccines

therapeutic_indication:

For the active immunisation of pigs:to reduce lung lesions associated with porcine enzootic pneumonia caused by Mycoplasma hyopneumoniae. Also, to reduce the incidence of these lesions (as observed in field studies).to reduce viraemia, virus load in lungs and lymphoid tissues and the duration of the viraemic period associated with diseases caused by Porcine circovirus type 2 (PCV2). Efficacy against PCV2 genotypes a, b and d has been demonstrated in field studies.to reduce culling rate and the loss of daily weight gain caused by Mycoplasma hyopneumoniae and/or PCV2 related diseases (as observed at 6 months of age in field studies).Mycoplasma hyopneumoniae: Onset of immunity: 3 weeks after vaccinationDuration of immunity: 23 weeks after vaccinationPorcine circovirus type 2:Onset of immunity: 2 weeks after vaccinationDuration of immunity: 22 weeks after vaccinationIn addition, a reduction in nasal and faecal shedding and the duration of nasal excretion of PCV2 was demonstrated in animals challenged at 4 weeks and at 22 weeks after vaccination.

leaflet_short:

Revision: 1

authorization_status:

Authorised

authorization_date:

2020-08-18

PIL

10
PARTICULARS TO APPEAR ON THE OUTER PACKAGE AND THE IMMEDIATE
PACKAGE
Cardboard box with 1 PET vial of 50 doses (10 ml).
Cardboard box with 1 PET vial of 100 doses (20 ml).
Cardboard box with 1 PET vial of 125 doses (25 ml).
Cardboard box with 1 PET vial of 250 doses (50 ml).
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
MHYOSPHERE PCV ID emulsion for injection for pigs
2.
STATEMENT OF ACTIVE SUBSTANCES
Each dose of 0.2 ml contains:
Inactivated recombinant
_Mycoplasma hyopneumoniae_
_cpPCV2_
, strain Nexhyon:
-
_Mycoplasma hyopneumoniae
............................................... RP* ≥1.3 _
-
_Porcine circovirus type_
_ 2_
(
_PCV2) capsid protein ............... RP* ≥1.3 _
* Relative Potency determined by ELISA.
3.
PHARMACEUTICAL FORM
Emulsion for injection.
4.
PACKAGE SIZE
50 doses (10 ml)
100 doses (20 ml)
125 doses (25 ml)
250 doses (50 ml)
5.
TARGET SPECIES
Pigs.
6.
INDICATION(S)
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Intradermal use.
Read the package leaflet before use.
11
8.
WITHDRAWAL PERIOD(S)
Withdrawal period: Zero days.
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
Accidental injection is dangerous.
10.
EXPIRY DATE
EXP {month/year}
Once opened use immediately.
11.
SPECIAL STORAGE CONDITIONS
Store and transport refrigerated.
Do not freeze.
Keep the container in the outer carton in order to protect from light.
12.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE
MATERIALS, IF ANY
Disposal: read package leaflet.
13.
THE
WORDS
“FOR
ANIMAL
TREATMENT
ONLY”
AND
CONDITIONS
OR
RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
For animal treatment only. To be supplied only on veterinary
prescription.
14.
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”
Keep out of the sight and reach of children.
15.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Laboratorios Hipra, S.A.
Avda. la Selva, 135
17170 Amer (Girona)
SPAIN
16.
MARKETING AUTHORISATION NUMBER(S)
EU/2/20/259/001-004
12
17.
MANUFACTURER’S BATCH NUMBER
Batch {number}
13
MINIMUM

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
MHYOSPHERE PCV ID emulsion for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 0.2 ml contains:
ACTIVE SUBSTANCE:
Inactivated recombinant
_Mycoplasma hyopneumoniae_
_cpPCV2_
, strain Nexhyon:
-
_Mycoplasma hyopneumoniae
............................................... RP* ≥1.3 _
-
_Porcine circovirus type_
_ 2_
(
_PCV2) capsid protein ............... RP* ≥1.3 _
_ _
* Relative Potency determined by ELISA.
ADJUVANT:
Light mineral oil ……. 42.40 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion for injection.
White homogeneous emulsion after shaking.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of pigs:
-
to reduce lung lesions associated with porcine enzootic pneumonia
caused by
_Mycoplasma _
_hyopneumoniae_
. Also, to reduce the incidence of these lesions (as observed in field
studies).
-
to reduce viraemia, virus load in lungs and lymphoid tissues and the
duration of the viraemic period
associated with diseases caused by Porcine circovirus type 2 (PCV2).
Efficacy against PCV2
genotypes a, b and d has been demonstrated in field studies.
-
to reduce culling rate and the loss of daily weight gain caused by
_Mycoplasma hyopneumoniae _
and/or PCV2 related diseases (as observed at 6 months of age in field
studies).
_Mycoplasma hyopneumoniae: _
Onset of immunity: 3 weeks after vaccination.
Duration of immunity: 23 weeks after vaccination.
Porcine circovirus type 2:
Onset of immunity: 2 weeks after vaccination.
Duration of immunity: 22 weeks after vaccination.
In addition, a reduction in nasal and faecal shedding and the duration
of nasal excretion of PCV2 was
demonstrated in animals challenged at 4 weeks and at 22 weeks after
vaccination.
3
4.3
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance, to the
adjuvant or to any of the excipients.
4.4
SPEC