GUMBOHATCH Lyophilisate and Solvent for Suspension for Injection for Chickens

Država: Velika Britanija

Jezik: engleski

Izvor: VMD (Veterinary Medicines Directorate)

Aktivni sastojci:

Infectious bursal disease virus

Dostupno od:

Laboratorios Hipra SA

ATC koda:

QI01AD09

INN (International ime):

Infectious bursal disease virus

Farmaceutski oblik:

Lyophilisate and solvent for suspension for injection

Tip recepta:

POM-V - Prescription Only Medicine – Veterinarian

Terapijska grupa:

Chickens

Područje terapije:

Live Viral Vaccine

Status autorizacije:

Authorized

Datum autorizacije:

2019-11-12

Svojstava lijeka

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