NOAH Compendium

Printed from NOAH Compendium (https://www.noahcompendium.co.uk). (c) Copyright NOAH Compendium 2024. All Rights Reserved.
Date: Sunday, May 19, 2024 0:40

Release 3.27
Gallimune Se+St
 
Species: Chickens
Therapeutic indication: Immunological veterinary medical products: For chickens
Active ingredient: Vaccine Antigens
Product:Gallimune Se+St
Product index: Gallimune Se+St
Poultry - meat: Zero days
Poultry - eggs: Zero days
Withdrawal notes: Not to be used within 2 weeks before the onset of the laying period or during the laying period.
Incorporating:
Qualitative and quantitative composition
Each 0.3 ml dose of vaccine contains:
Active substances: Inactivated Salmonella Enteritidis PT4, at least 171 SAT.U, Inactivated Salmonella Typhimurium DT 104, at least 149 SAT.U
The concentrations are expressed by the antibody titre obtained during the potency test. One unit (U) corresponding to an antibody titre of 1. SAT: Slow Agglutination Test .
Adjuvant: Paraffin oil q.s. 0.3 ml
Excipient: Thiomersal, at most 30 μg
For the full list of excipients, see below.
Pharmaceutical form
Water-in oil white emulsion for injection.
Clinical particulars
Target species
Chickens (layer pullets).
Indications for use
For active immunisation of layer pullets to:
- Reduce Salmonella Enteritidis dissemination in the ovary, as demonstrated 4 days after challenge;
This has been tested 25 weeks after vaccination and has been demonstrated to persist until 58 weeks of age.
- Reduce Salmonella Typhimurium and Salmonella Enteritidis dissemination in the intestinal tract.
This has been tested 4 weeks after vaccination and has been demonstrated to persist until 61 weeks of age for Salmonella Typhimurium and 52 weeks of age for Salmonella Enteritidis.
Contra-indications
Please refer to Use during pregnancy, lactation and lay.
Special warnings for each target species
None.
Special precautions for use in animals
Vaccinate only healthy animals. 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 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 leaflet 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. Small lesions linked to the oily adjuvant, e.g. small quantities of oily residues, were observed at the injection site three weeks after the injection and may persist through lay and decline over time. A slight delay in the onset of lay may be observed, however no impact on peak production or overall egg productivity has been observed.
Use during pregnancy, lactation or lay
Not to be used within 2 weeks before the onset of the laying period or during the laying period.
Interactions
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.
Amounts to be administered and administration route
Inject by intramuscular route 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. 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 effects mentioned, inflammatory reactions have been observed at the injection site after administration of twice the recommended dose of vaccine.
Withdrawal period
Zero days.
ATCvet code: QI01AB01
Inactivated vaccine in oily adjuvant against Salmonella Enteritidis and Salmonella Typhimurium. The vaccine stimulates active immunity of layer pullets against Salmonella Enteritidis and Salmonella Typhimurium. The SE strain is classified as phagotype 4, the ST strain is classified as Definitive Type DT 104. Although the following has not been investigated, the vaccine may be expected to reduce Salmonella Enteritidis transovarian egg contamination and Salmonella Typhimurium and Salmonella Enteritidis egg shell contamination.
Pharmaceutical particulars
Excipients
Thiomersal, Formaldehyde, Ester of fatty acids and ethoxylated polyols, Ester of fatty acids and polyols, Water for injections.
Major incompatibilities
Do not mix with any other veterinary medicinal 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 refrigerated between +2 °C and +8 °C, protected from light. Do not freeze. Keep the bottle in the outer carton.
Immediate packaging
Single 300 ml polypropylene bottle of 1,000 doses. Box of 10 x 300 ml bottles of 1,000 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 08327/4222
Significant changes
Legal category
Legal category: POM-V
GTIN
GTIN description:Gallimune SE + ST 1,000 dose
GTIN:3661103021964