Toxovax

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Toxoplasma gondii tachyzoites s48

Prieinama:

Intervet Ireland Limited

ATC kodas:

QI04AN01

INN (Tarptautinis Pavadinimas):

Toxoplasma gondii tachyzoites s48

Dozė:

.

Vaisto forma:

Concentrate and solvent for suspension for injection

Recepto tipas:

POM: Prescription Only Medicine as defined in relevant national legislation

Farmakoterapinė grupė:

Sheep

Gydymo sritis:

toxoplasma

Terapinės indikacijos:

Immunological - Live Vaccine

Autorizacija statusas:

Authorised

Leidimo data:

2003-08-18

Prekės savybės

Health Products Regulatory Authority
15 December 2021
CRN00CL0L
Page 1 of 5
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. 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. Immuno-competence
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
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
None.
Health Products Regulatory Authority
15 December 2021
CRN00CL0L
Page 2 of 5
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
PRODUCT TO ANIMALS
Toxovax should not be hand