GUMBOHATCH Lyophilisate and Solvent for Suspension for Injection for Chickens

Valsts: Lielbritānija

Valoda: angļu

Klimata pārmaiņas: VMD (Veterinary Medicines Directorate)

Aktīvā sastāvdaļa:

Infectious bursal disease virus

Pieejams no:

Laboratorios Hipra SA

ATĶ kods:

QI01AD09

SNN (starptautisko nepatentēto nosaukumu):

Infectious bursal disease virus

Zāļu forma:

Lyophilisate and solvent for suspension for injection

Receptes veids:

POM-V - Prescription Only Medicine – Veterinarian

Ārstniecības grupa:

Chickens

Ārstniecības joma:

Live Viral Vaccine

Autorizācija statuss:

Authorized

Autorizācija datums:

2019-11-12

Produkta apraksts

Unlimited Renewal: April 2024
AN: 03492/2023
Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
GUMBOHATCH lyophilisate and solvent for suspension for injection for
chickens
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of reconstituted vaccine (0.05 ml for an in ovo dose or 0.2
ml for a
subcutaneous dose) contains:
ACTIVE SUBSTANCE:
Live attenuated infectious bursal disease virus (IBDV), strain 1052
…. 101.18 –
102.80 PU*
* PU: Potency Units
EXCIPIENTS:
Unbound IBDV-specific egg
antibodies………………………….17.07 – 21.32 NU** per
vial
**NU: neutralising units
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Lyophilisate: brown reddish colour.
Solvent: clear colourless solution.
4. CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens and embryonated chicken eggs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of 1-day-old broiler chicks and embryonated
broiler chicken
eggs to reduce clinical signs and lesions of the bursa of Fabricius
caused by very
virulent avian infectious bursal disease virus infection.
The onset of immunity depends on the initial maternally derived
antibodies (MDA)
level of the batch of chickens and even then, will be different for
individual chickens.
In practice, studies in commercial broiler chickens have shown an
onset of immunity
from between 24 days of age and 28 days of age.
Onset of immunity: from 24 days of age.
Duration of immunity: up to 45 days of age.
The efficacy of the vaccine has been demonstrated in broilers having
an average
MDA level from 4,500 to 5,100 ELISA units at hatching.
Unlimited Renewal: April 2024
AN: 03492/2023
Page 2 of 9
4.3 CONTRAINDICATIONS
Do not use in flocks without MDAs against IBDV.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
4.5 SPECIAL PRECAUTIONS FOR USE
i). Special precautions for use in animals
This product should only be used after it has been demonstrated that
very virulent
IBDV strains are epidemiol