Toxovax

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: VMD (Veterinary Medicines Directorate)

Aktívna zložka:

Toxoplasma gondii

Dostupné z:

MSD Animal Health UK Limited

ATC kód:

QI04AN01

INN (Medzinárodný Name):

Toxoplasma gondii

Forma lieku:

Concentrate for solution for injection

Typ predpisu:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutické skupiny:

Sheep

Terapeutické oblasti:

Live Parasitic Vaccine

Stav Autorizácia:

Authorized

Dátum Autorizácia:

2005-10-19

Súhrn charakteristických

Revised: December 2021
Amended pages: 00902/2021
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Toxovax
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2 ml dose of diluted vaccine contains:
ACTIVE SUBSTANCE:
≥ 10
5
_Toxoplasma gondii _tachyzoites S48
For a full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate and diluent for suspension for injection.
Concentrate: cloudy suspension.
Diluent (Unisolve): colourless solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Sheep (ewes).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of susceptible breeding female sheep to
reduce
the effects of infection by _Toxoplasma gondii_, namely early
embryonic death,
barrenness and abortion.
Vaccination with Toxovax is known to protect for at least two lambing
seasons.
4.3
CONTRAINDICATIONS
Do not vaccinate animals less than 3 weeks before mating.
Do not use during pregnancy.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Toxoplasma is only one of the causes of abortion in sheep.
Where abortion occurs in sheep which have been vaccinated with Toxovax
then it is recommended that veterinary advice is sought immediately to
clarify
the likely cause.
Revised: December 2021
Amended pages: 00902/2021
Page 2 of 6
Care should be taken in handling such abortions as susceptible humans
may
be at risk of infection.
A good immune response is reliant on the reaction of an immunogenic
agent
and a fully competent immune system.
Immunogenicity of the vaccine antigen will be reduced by poor storage
or
inappropriate administration.
Immunocompetence of the animal may be compromised by a variety of
factors
including poor health, nutritional status, genetic factors, concurrent
drug
therapy and stress.
Only healthy animals should be vaccinated.
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
None.
ii.
Special precautions to be taken by the person administering the
product to animals
Toxovax should not be handled by pregnant women