Target species
Chickens (pullets).
Indications for use for each target species:
For active immunisation of pullets to:
- Reduce Salmonella Enteritidis dissemination in the ovary, as demonstrated 4 days after challenge;
Onset of immunity: 25 weeks after vaccination.
Duration of immunity: 58 weeks of age.
- Reduce Salmonella Typhimurium and Salmonella Enteritidis dissemination in the intestinal tract.
Onset of immunity: 4 weeks after vaccination
Duration of immunity: 61 weeks of age for Salmonella Typhimurium and 52 weeks of age for Salmonella Enteritidis.
Contraindications
None.
Special warnings
Vaccinate only healthy animals.
Special precautions for use
Special precautions for safe use in the target species:
Vaccination causes a serological response in chickens which may interfere with a surveillance program based solely on serological screening without confirmatory bacteriology.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
To the user:
This veterinary medicinal product contains mineral oil. Accidental injection/self-injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given.
If you are accidentally injected with this veterinary medicinal product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.
If pain persists for more than 12 hours after medical examination, seek medical advice again.
To the physician:
This veterinary medicinal product contains mineral oil. Even if small amounts have been injected, accidental injection with this veterinary medicinal product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
Special precautions for the protection of the environment:
Not applicable.
Adverse reactions
Adverse events
Chickens:
Undetermined frequency (cannot be estimated from the available data): | Injection site lesion1, Delayed onset of lay2. |
1Mild, may occur 3 weeks after injection and may persist through laying period and decline over time. 2Slightly delayed onset of lay may occur, without impact on peak production or overall egg productivity.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Laying birds:
Not to be used within 2 weeks before the onset of the laying period or during the laying period.
Interaction with other medicinal products and other forms of interaction
Safety and efficacy data are available which demonstrate that the vaccine can be administered on the same day but not mixed with inactivated vaccines for chickens from the Boehringer Ingelheim Gallimune range against Egg Drop Syndrome (EDS76), Newcastle Disease, Infectious Bronchitis (Mass41) and Avian Rhinotracheitis (Swollen Head Syndrome).
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the products mentioned above. A decision to use this vaccine before or after any other veterinary product therefore needs to be made on a case by case basis.
Administration routes and dosage
Intramuscular use.
Injection of one dose (0.3 ml) of vaccine, according to the following vaccination schedule:
- First injection: from the age of 6 weeks;
- Second injection: at the age of 16 weeks.
The interval between the two injections should be at least 4 weeks and at most 10 weeks.
Shake well before use. The emulsion is homogeneous after shaking.
Apply usual aseptic procedures.
Do not use syringes with natural rubber or butyl elastomer pistons.
Equipment including needles and syringes must be sterile before use.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
In addition to the effects mentioned in paragraph “Adverse events”, inflammatory reactions have been observed at the injection site after administration of a double dose of vaccine.
Withdrawal period
Zero days.