INMEVA, suspension for injection

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Chlamydophila abortus strain A22 inactivated; Salmonella enterica subsp. enterica serovar Abortusovis strain Sao

Dostupné s:

Laboratorios Hipra S.A.

ATC kód:

QI04AB

INN (Mezinárodní Name):

Chlamydophila abortus strain A22 inactivated; Salmonella enterica subsp. enterica serovar Abortusovis strain Sao

Dávkování:

.

Léková forma:

Suspension for injection

Druh předpisu:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutické oblasti:

Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia)

Stav Autorizace:

Authorised

Datum autorizace:

2019-06-14

Charakteristika produktu

Health Products Regulatory Authority
10 February 2022
CRN00CNWW
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
INMEVA, suspension for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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Each 2 ml dose contains:
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ACTIVE SUBSTANCES:
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Inactivated _Chlamydia abortus_ strain A22
​RP* ≥ 1
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Inactivated _Salmonella enterica_ subsp. _enterica_ serovar
Abortusovis strain Sao
​RP* ≥ 1
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*Relative Potency determined by ELISA, using a reference vaccine
demonstrated to be efficacious.
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ADJUVANTS:
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Aluminium hydroxide(Aluminium)
​5.29
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mg
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DEAE Dextran
​20
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mg
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For the full list of excipients, see section 6.1.
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3 PHARMACEUTICAL FORM
Suspension for injection.
Ivory-coloured suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Sheep (ewe).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunization of animals to reduce clinical signs (abortion,
stillbirth, early mortality and hyperthermia) caused by
_Chlamydia abortus,_ abortions caused by _Salmonella _Abortusovis and
to reduce shedding of both pathogens from infected
animals.
Vaccination covers the whole gestation period, when administered
according to section 4.9.
4.3 CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substances, to
the adjuvants or to any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
In farms with recurring reproductive disorders caused by _Chlamydia
abortus _and/or _Salmonella _Abortusovis, it would be
advisable to maintain a high level of immunity within the flock.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Not applicable.
Health Products Regulatory Authority
10 February 2022
CRN00CNWW
Page 2 of 4
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