SUMMARY OF PRODUCT CHARACTERISTICS

Birnagen Forte As Emulsion for Injection for Atlantic Salmon

Active Substances

1 dose (0.1 ml) contains:

Inactivated Aeromonas salmonicida (As27) RPS₆₀* ≥80%

Inactivated Infectious Pancreatic Necrosis RP** ≥ 1.22

Virus (IPNV)

* RPS₆₀: Relative Percent Survival

** RP: relative potency compared to a reference vaccine.

Adjuvant

Mineral oil (Drakeol 6VR) 43.62%

Excipients

Formaldehyde (residual inactivant) < 0.5% (w/v)

See section 6.1 for a complete list of excipients

Emulsion for injection.

4.1 Target Species

Atlantic salmon (Salmo salar) weighing at least 35 g.

For the active immunisation of Atlantic salmon (Salmo salar) to prevent mortality due to infection with Aeromonas salmonicida (furunculosis).

The onset of immunity to A. salmonicida is no later than 430 degree days following vaccination.

The duration of immunity to A. salmonicida has been demonstrated up to 2000 degree days following vaccination.

For the active immunisation of Atlantic salmon to reduce clinical signs and mortality due to infection with Infectious Pancreatic Necrosis Virus (IPNV).

In laboratory trials, the onset of immunity to IPNV has been shown to be no later than 771 degree days following vaccination.

In field trials, the vaccine has been shown to reduce mortality compared to controls in the face of IPNV challenge after transfer to sea 600 degree days after vaccination.

Do not use if there are any signs of furunculosis or IPNV disease in the fish. See section 4.7.

Vaccinate only healthy fish. It is recommended that all fish within the stock population are vaccinated in order to reduce infection spread.

Fish should be starved for a period of at least 24 hours and preferably 48 hours prior to vaccination and preferably at least 24 hours post vaccination. Feed should gradually be re-introduced to fish post vaccination over several days until full appetite is resumed.

The user should note that physical and environmental conditions pre-vaccination, at the time of and post-vaccination influence the side effects seen in fish from site to site. These conditions include fish size, health and condition, water temperature, correct vaccination practice including handling and stress pre and post vaccination.

i. Special precautions for use in animals

Not applicable.

ii. Special precautions to be taken by the person administering the medicinal product to animals

Ensure that the method of restraint, handling and administration, e.g. by the use of guarded needles, minimizes the risk of accidental injection/self injection.

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.

Fish may take up to 5 days to return to feeding. Appetite and weight gain may be reduced for 21 days after vaccination.

Vaccination may cause some degree of visceral adhesions within the peritoneal cavity, a characteristic of vaccines that incorporate an oil adjuvant. Adhesions may be moderate or even severe if vaccine is not properly delivered into the body cavity. Peak occurrence of side effects in correctly vaccinated fish are typically observed 3 to 6 months post sea transfer. Melanisationof viscera and muscle may also occur.

At 6 months post sea transfer, the incidence of mild adhesions (not noticeable to the layman) was very common (>93% of vaccinated fish) and of moderate adhesions was common (<7% of vaccinated fish).

Do not use in fish selected for broodstock.

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.

Administration of the vaccine must be performed using an injection system that prevents back-flush of the vaccine in to the vaccine tube/container.

Shake product well before use.

The vaccine should be warmed to 15-20°C before use. For injection use, each litre of vaccine is sufficient to vaccinate 10,000 fish. To use, fish are anaesthetised until immobilised and administered 0.1 ml intraperitoneally, on the midline, one pelvic fin length ahead of the pelvic girdle. It is recommended that fish be at least 35 g in size for injection administration. A minimum water temperature of 2°C for vaccination is recommended.

It is essential to mix the vaccine prior to and during treatment to ensure correct consistency of the product for administration/treatment. Oil based vaccines are best injected at 15-20ºC to ensure ease of vaccination for vaccinator and to avoid damage to the fish.

No adverse reactions other than those described in section 4.6 are observed following administration of a two-fold overdose.

Zero degree days.

To stimulate active immunity against Aeromonas salmonicidaand Infectious Pancreatic Necrosis Virus (IPNV).

ATC vet code:QI10AA01/AB01

Mineral oil (Drakeol 6VR)

Sorbitan sesquioleate

Polyoxyethylene sorbitan monooleate

Formaldehyde (residual inactivant)

Phosphate buffered saline

Do not mix with any other veterinary medicinal product.

Shelf-life of the veterinary medicinal product as packaged for sale: 1 year.

Shelf-life after first opening the immediate packaging: Use within 10 hours. Any partly used containers of vaccine should be discarded at the end of each day’s operations.

6.4 Special precautions for storage

Store and transport refrigerated (2°C – 8°C).
Do not freeze.
Protect from light.

1000 ml EVA (plastic) intravenous bag with a plastic screw cap (ABS terluran/high density polyethylene) closure and a plastic clamp off device.

Any unused product or waste material should be disposed of in accordance with national requirements.

7. MARKETING AUTHORIZATION HOLDER

Novartis Animal Vaccines Ltd

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

8. MARKETING AUTHORISATION NUMBER

Vm 18343/4015

9. DATE OF FIRST AUTHORISATION

Date:13 August 2010

10. DATE OF REVISION OF THE TEXT

Date:June 2013

APPROVED 20/06/13