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Date: Wednesday, May 14, 2025 9:16

Release 2.51
Gallimune 302 ND+IB+EDS (Great Britain)
 
Species: Chickens
Therapeutic indication: Immunological veterinary medical products: For chickens
Active ingredient: Vaccine Antigens
Product:Gallimune 302 ND+IB+EDS
Product index: Gallimune 302 ND+IB+EDS
Poultry - meat: Zero days.
Poultry - eggs: Zero days.
Withdrawal notes: Not to be used within 2 weeks before the onset of lay and during the laying period
Incorporating:
Qualitative and quantitative composition
Active substances:
Each 0.3 ml dose of vaccine contains: Inactivated Newcastle Disease virus, Ulster 2C strain, at least 50PD50*; Inactivated Infectious Bronchitis virus, Mass41 strain, at least 18 HI.U; Inactivated Egg Drop Syndrome virus (EDS76), V127 strain, at least 180 HI.U. The concentrations are expressed by the antibody titre obtained during the potency test. One unit (U) corresponding to an antibody titre of 1. HI: haemagglutination inhibiting
*Minimum protective dose according to monograph 0870 of Ph. Eur.
Adjuvant: Paraffin oil 170 to 186 mg
Excipient(s): Thiomersal, at most 30 μg, Formaldehyde, at most 43.2 μg
Pharmaceutical form
Water-in oil emulsion for injection.
Clinical particulars
Target species
Chickens (breeder and layer pullets).
Indications for use
Booster immunisation of breeder and layer pullets after vaccination with live vaccines against:
- Newcastle Disease virus, in order to reduce egg drop linked to Newcastle Disease infection,
- Infectious Bronchitis virus, in order to reduce egg drop linked to Infectious Bronchitis infection caused by the Mass41 strain.
Active immunisation of breeder and layer pullets in order to reduce egg drop linked to infection with Egg Drop Syndrome virus EDS76 without priming.
Onset of immunity: 4 weeks after vaccination
Duration of immunity: one laying period.
Contra-indications
None.
Special warnings for each target species
None.
Special precautions for use in animals
Vaccinate only healthy animals.
Special precautions to be taken by the person administering the product to animals
To the user: This 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 product, seek prompt medical advice even if only a very small amount is injected and take the package insert with you. If pain persists for more than 12 hours after medical examination, seek medical advice again.
To the physician: This product contains mineral oil. Even if small amounts have been injected, accidental injection with this 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.
Adverse reactions
No palpable reactions were observed following the injection of one dose of vaccine. In clinical studies, lesions linked to the oily adjuvant were observed histologically three weeks after injection in 87% of cases, e.g. small quantities of oily residues and occasional aseptic micro-abscesses.
Use during pregnancy, lactation or lay
Not to be used within 2 weeks before the onset of laying and during the laying period.
Interactions
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. 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.
Amounts to be administered and administration route
Administer one dose (0.3 ml) by intramuscular route from the age of 18 weeks and at least 4 weeks after the priming with live vaccines against Newcastle Disease (strain Hitchner B1 or VG/GA) and Infectious Bronchitis (strain Mass H120).
Shake well before use. 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.
Overdose
In addition to the adverse effects mentioned, transitory apathy and slight oedema at injection site may occur after the administration of a double dose of vaccine.
Withdrawal period
Zero days.
ATCvet code: QI01AA13
Inactivated vaccine in oily adjuvant against Newcastle Disease, Infectious Bronchitis and Egg Drop Syndrome (EDS76).
The vaccine stimulates active immunity of breeder and layer pullets against Egg Drop Syndrome (EDS76) (without priming), Newcastle Disease and Infectious Bronchitis, subsequent to priming with live vaccines against these diseases.
Pharmaceutical particulars
Major incompatibilities
Do not mix with any other vaccine/immunological product.
Shelf life
Shelf life of the product as packaged for sale: 18 months. Use immediately after opening.
Special precautions for storage
Store and transport between +2 °C and +8 °C, protected from light. Do not freeze.
Immediate packaging
Polypropylene bottles containing 1000 doses.
Disposal
Any unused product or waste materials derived from such products should be disposed of in accordance with local requirements.
Marketing Authorisation Number
Vm 08327/5012
Significant changes
Legal category
Legal category: POM-V
GTIN
GTIN description:Gallimune 302 1000 dose
GTIN:03661103006824