Cevac Chlamydia

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: VMD (Veterinary Medicines Directorate)

Δραστική ουσία:

Chlamydophila abortus

Διαθέσιμο από:

Ceva Animal Health Ltd

Φαρμακολογική κατηγορία (ATC):

QI04AE01

INN (Διεθνής Όνομα):

Chlamydophila abortus

Φαρμακοτεχνική μορφή:

Powder and solvent for solution for injection

Τρόπος διάθεσης:

POM-V - Prescription Only Medicine – Veterinarian

Θεραπευτική ομάδα:

Sheep

Θεραπευτική περιοχή:

Live Bacterial Vaccine

Καθεστώς αδειοδότησης:

Authorized

Ημερομηνία της άδειας:

2005-10-19

Αρχείο Π.Χ.Π.

Revised: September 2022
AN: 01548/2022
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF VETERINARY MEDICINAL PRODUCT
CEVAC
®
CHLAMYDIA
2. QUALITATIVE AND QUANTITATIVE COMPOSITION OF PRODUCT
Active ingredient Live, attenuated strain ts1B _Chlamydophila abortus
_10
5.0
-10
6.9
IFU*
per dose *Inclusion-body Forming Units
Cevac
®
Chlamydia diluents
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Powder plus solvent for injection.
4. CLINICAL PARTICULARS
4.1 TARGET SPECIES
Susceptible female breeding sheep
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of susceptible breeding female sheep to
reduce abortion
caused by _Chlamydophila abortus _infection.
4.3 CONTRA-INDICATIONS
Do not vaccinate animals less than 4 weeks before mating. Do not
vaccinate
pregnant animals Do not vaccinate animals which are being treated with
antimicrobials, particularly tetracyclines.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
_Chlamydophila abortus _is only one of the causes of abortion in
sheep. If abortion
rates remain unchanged in flocks which have been vaccinated with Cevac
®
Chlamydia it is recommended that veterinary advice is sought. The
epidemiology of
abortion due to _Chlamydophila abortus _in ewes involves a long
incubation period.
Ewes that abort in any lambing season have usually been infected at
the previous
lambing. Field trial data indicate that vaccinating incubating ewes
will reduce the
incidence of abortion, but a proportion can still go on to abort. Care
should be taken
in handling such abortions as susceptible humans may be at risk of
infection.
Revised: September 2022
AN: 01548/2022
Page 2 of 5
4.5 SPECIAL PRECAUTIONS FOR USE, INCLUDING SPECIAL PRECAUTIONS TO BE
TAKEN BY
THE PERSON ADMINISTERING THE MEDICINAL PRODUCT TO ANIMALS
i. Special precautions for use in animals
Not applicable.
ii. Special precautions to be taken by the person administering the
medicinal
product to animals
Cevac® Chlamydia should not be handled by pregnant women or women of
c