Cevac Transmune Lyophilisate and Solvent for Suspension for Injection

Do not use in1-day-old chickens hatched from eggs vaccinated in-ovo with Cevac
Transmune.
4.4 Special warnings for each target species
Vaccinate healthy animals only.
Chicken embryos on the 18
th
day of incubation
In-ovo injection equipment must be used for in-ovo administration. Device(s) used for the
reconstitution of the vaccine and for injection should be sterile and free from any residues of
chemical disinfectant.
The device should be proven to safely and effectively deliver the appropriate 0.05 ml dose
of the vaccine directly into the amniotic cavity or the embryo.
Before every in-ovo application the vaccination technique can be checked by use of a
colour solution. The manufacturer's instructions of the device must be strictly followed. For
cleaning of the instrument only products approved by the manufacturer may be used.
It is recommended to use 0.4-0.8 mm diameter needles, having length from 25-28 mm and
perforation air pressure between 3.5 bar (50 psi) and 5 bar (72 psi).
1-day-old broiler chickens
Automatic syringe may be used for subcutaneous administration. Device(s) used for the
reconstitution of the vaccine and for injection should be sterile and free from any residues of
chemical disinfectant. The device should be proven to safely and effectively deliver the
appropriate 0.1 ml dose of the vaccine. The instructions for use of this device should be
strictly followed.
The vaccine must be inoculated under the skin of the neck of the 1-day-old broiler
chickens. For cleaning of the automatic syringe, only products approved by the
manufacturer may be used.
Residues of chemical disinfectant on the inner surface of devices and equipment used for
reconstitution and application can destroy live virus and decrease the efficacy of the
vaccine.

Revised: September 2025
AN: 01717/2025
4.5 Special precautions for use
Special precautions for use in animals
Chicken embryos on the 18
th
day of incubation
The vaccine contains a strain of "intermediate-plus" virulence. In birds without MDA the
inoculation of the vaccine results in significant immunosuppression and bursal damage.
Therefore, it is not recommended to vaccinate eggs coming from flocks with MDA titre
levels in 1-day-old chickens lower than 3,000 ELISA units.
Preliminary survey to be used to estimate MDA level of the chicks: 20, 1-day-old chicks
originating from the same breeding flock should be sampled to measure their serological
status to IBDV. The results of this sampling will indicate if the MDA level can be expected to
be at least 3,000 ELISA units in the hatches of the following 4 weeks from this flock, and
therefore that they are suitable for Cevac Transmune vaccination. According to results and
needs, this survey has to be repeated at different times of the laying period.
The vaccine virus is excreted by vaccinated birds and can spread to susceptible birds
and can be detected in unvaccinated birds 4-7 days later. To control the spread of the
virus, the immunisation devices used for injection and the hatchery premises should be
decontaminated after vaccination.
Chickens from vaccinated eggs should not be mixed with chickens from unvaccinated
eggs.
Precautions should be taken regarding between-house spread. Whole site vaccination is
recommended. Poultry houses should be decontaminated between batches of chickens.
Satisfactory protection can be achieved only in properly developed embryos at the 18
th
day
of hatching. It is suggested to candle the eggs to be injected and discard eggs containing
dead embryos.
1-day-old broiler chickens
The vaccine contains a strain of "intermediate-plus" virulence. In birds without MDA the
inoculation of the vaccine results in significant immunosuppression and bursal damage.
Therefore, it is not recommended to vaccinate chicks coming from flocks with 1-day-old
MDA titre levels lower than 3,000 ELISA units.
Preliminary survey to be used to estimate MDA level of the chicks: 20, 1-day-old chicks
originating from the same breeding flock should be sampled to measure their serological
status to IBDV. The results of this sampling will indicate if the MDA level can be expected to
be at least 3,000 ELISA units in the hatches of the following 4 weeks from this flock, and
therefore that they are suitable for Cevac Transmune vaccination. According to results and
needs, this survey has to be repeated at different times of the laying period.
The vaccine virus is excreted by vaccinated birds and can spread to susceptible birds
and can be detected in unvaccinated birds 4-7 days later. To control the spread of the
virus, the immunisation devices used for injection and the hatchery premises should be
decontaminated after vaccination.
Vaccinated chickens should not be mixed with unvaccinated chickens.
Precautions should be taken regarding between-house spread. Whole site vaccination is
recommended. Poultry houses should be decontaminated between batches of chickens.
Satisfactory protection can be achieved only in healthy 1-day-old chickens.

Revised: September 2025
AN: 01717/2025
Special precautions to be taken by the person administering the veterinary medicinal
product to animal
Vaccinating personnel should wash and disinfect hands after use.
4.6 Adverse reactions (frequency and seriousness)
In vaccinated chickens, mild to moderate lymphocyte depletion is very commonly observed
after the vaccine take, which is maximal at around 7 days after vaccine take. After 7 days,
this depletion decreases and is followed by lymphocyte repopulation and regeneration of the
bursa of Fabricius. In some cases, the replication of the vaccine strain may be prolonged
(e.g. due to presence of very high maternal antibody titres in 1 day old chicks), and bursa
scores can reach a maximum of 2.8 between 35 and 42 days of age, which does not affect
the production parameters of the flock.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
4.7 Use during pregnancy, lactation or lay
Do not use in eggs intended for hatching of layers or broiler breeders.
Do not use in 1-day-old chickens intended for layers or broiler breeders.
4.8 Interaction with other medicinal products and other forms of interaction
Safety and efficacy data are available which demonstrate that this vaccine can be mixed
and administered with Vectormune ND by in-ovo or subcutaneous vaccination. The mixed
products protect against Avian Infectious Bursal Disease (IBD) viruses, Newcastle disease
virus and Marek’s disease virus. The safety and efficacy of the mixed vaccines are not
different from those described for the vaccines administered separately. Read also the
product information of Vectormune ND before use.
For the associated reconstitution of Vectormune ND and Cevac Transmune, the Cevac
Solvent Poultry should be used.
In-ovo:
One single dose of 0.05 ml is injected into each 18-day-old embryonated broiler chicken
egg.
Match the dose size of the vaccines and the Cevac Solvent Poultry according to the table
below.
Vectormune NDCevac TransmuneCevac Solvent Poultry 2 x 2,000 doses2 x 2,000 doses200 ml1 x 4,000 doses1 x 4,000 doses200 ml2 x 4,000 doses2 x 4,000 doses400 ml4 x 4,000 doses4 x 4,000 doses800 ml5x4000 doses5x4000 doses1000 ml

Revised: September 2025
AN: 01717/2025
6x4000 doses6x4000 doses1200 ml8x4000 doses8x4000 doses1600 ml
Subcutaneous use:
One single injection of 0.2 ml per chick is applied at one day of age.
Match the dose size of the vaccines and the Cevac Solvent Poultry according to the table
below.
Vectormune NDCevac TransmuneCevac Solvent Poultry2 x 1,000 doses1 x 2,000 doses400 ml1 x 2,000 doses1 x 2,000 doses400 ml2 x 2,000 doses2 x 2,000 doses800 ml1 x 4,000 doses1 x 4,000 doses800 ml4000 + 1000 doses4000 + 1000 doses1000 ml3 x 2000 doses3 x 2000 doses1200 ml2 x 4000 doses2 x 4000 doses1600 ml
Draw up 2 ml of Cevac Solvent Poultry into a 5 ml syringe then draw up the thawed content
of Vectormune ND ampoule in it.
Draw up 2 ml of Cevac Solvent Poultry into another 5 ml syringe then dissolve the content
of Cevac Transmune vial in it.
Transfer the dissolved vaccines into the solvent bag and mix by gentle agitation.
No information is available on the safety and efficacy of this vaccine when used with any
other veterinary medicinal product, except Vectormune ND. A decision to use this vaccine
before or after any other veterinary medicinal product therefore needs to be made on a
case-by-case basis.
4.9 Amounts to be administered and administration route
In-ovo administration
The vaccine is to be administered once at the 18
th
day of embryonation using in-ovo
equipment. The injection volume is 0.05 ml per dose for in-ovo administration. The vaccine
is delivered to the amnion sac or, rarely, into the body of the embryo causing no decrease in
hatchability.
Use sterile devices and equipment for reconstitution and for administration of the vaccine.
Subcutaneous administration
The vaccine is to be administered once at 1-day of age, automatic syringe may be used.
The injection volume is 0.1 ml per dose for subcutaneous administration. The vaccine is
delivered under the skin of the neck.
Use sterile devices and equipment for reconstitution and for administration of the vaccine.
Reconstitution of the vaccine
For the reconstitution of Cevac Transmune, PBS, Saline solution or Cevac Solvent Poultry
can be used.

Revised: September 2025
AN: 01717/2025
In-ovo administration of 0.05 ml per dose:
1. Calculate and prepare the required volume of the reconstituted vaccine as follows:
Cevac TransmuneSolvent1 x 2,000 doses100 ml1 x 4,000 doses200 ml1 x 5,000 doses250 ml2 x 2,500 doses25

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