1. NAME OF THE VETERINARY MEDICINAL PRODUCT. ALPHA JECT micro 6 emulsion for injection for Atlantic salmon 2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Transcription

1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ALPHA JECT micro 6 emulsion for injection for Atlantic salmon 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance(s): 1 dose (0.05 ml) contains: Formaldehyde inactivated cultures of: Aeromonas salmonicida subsp. salmonicida RPS 1 80 (Ph. Eur.) Listonella anguillarum serotype O1 RPS 1 75 (Ph. Eur.) Listonella anguillarum serotype O2a RPS 1 75 (Ph. Eur.) Vibrio salmonicida RPS 1 90 (Ph. Eur.) Moritella viscosa RPS 1 60 Infectious Pancreatic Necrosis Virus (IPNV) serotype Sp 0.1 AU 2 1 RPS (Relative Percentage Survival) is based on results from challenge studies and calculated according to the following quotation: [1-(% mortality in vaccinated fish/%mortality in mock vaccinated fish)] x AU: Antigenicity Units (measure of the quantity of virus antigen) Adjuvant(s): Liquid paraffin. Excipient(s): See section PHARMACEUTICAL FORM Emulsion for injection. 4. CLINICAL PARTICULARS 4.1 Target species Atlantic salmon (Salmo salar) of a minimum weight of 25 g. 4.2 Indications for use, specifying the target species Atlantic salmon: For active immunisation to reduce clinical signs and mortality of the diseases caused by Aeromonas salmonicida (furunculosis), Vibrio salmonicida (coldwater vibriosis), Listonella anguillarum serotype O1and O2a (classical vibriosis), Moritella viscosa (winter sore) and IPNV (Infectious Pancreatic Necrosis). 1

2 4.3 Contraindications None. 4.4 Special warnings for each target species None. 4.5 Special precautions for use Special precautions for use in animals Do not administer this product to fish which have already received this vaccine. Fish with clinical symptoms of disease shall not be vaccinated. Do not vaccinate at water temperatures below 1 C or above 18 C. Vaccination should preferably be performed at water temperatures of 15 C or below. Avoid vaccination during smoltification. The severity of undesirable effects is among other things dependent on hygiene, vaccination technique, fish size at vaccination and water temperature the first 6-12 weeks after vaccination. Special precautions to be taken by the person administering the veterinary medicinal product to animals Ensure that the method of handling and administration e.g. by the use of guarded needles (such as a protecting device attached to the syringe providing a shield against the tip of the needle), minimises the risk of accidental self-injection. The product should not be administered by pregnant women. People with known hypersensitivity to fish vaccines should avoid contact with the product. Repeated self-injections may aggravate the effects or cause anaphylactic shock. 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 ischemic 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. 4.6 Adverse reactions (frequency and seriousness) Oil adjuvants are associated with increased risk of adverse reactions in the form of visceral adhesions and pigmentation in the abdomen. Normally these reactions are moderate and can be removed manually, without downgrading the value of the fish at slaughter. Moderate changes according to the Speilberg scale are classified as < 2 in average score, where single fish scores may scatter from 1 to 3. More extensive changes may occur in single fish (Speilberg score 4), but this occurs normally with less than 3 % of the vaccinated population. 2

3 Due to stress during vaccination, the fish may have temporary reduced appetite leading to a transient growth rate reduction. 4.7 Use during pregnancy, lactation or lay Fertility: Do not use in fish intended for future broodstock, as the potential effect of vaccination on the spawning function has not been investigated. 4.8 Interaction with other medicinal products and other forms of interaction No information is available regarding possible interaction between this vaccine and any other vaccine. The safety and efficacy of this vaccine when used with any other veterinary medicinal product (either on the same day or at other times), is not documented. 4.9 Amounts to be administered and administration route The recommended dosage is 0.05 ml per fish. The vaccine is intended for administration by intraperitoneal (i.p.) injection. The fish should be anaesthetised prior to injection. It is recommended to starve the fish for a minimum of 48 hours before vaccination. The vaccination equipment should be thoroughly cleaned/sterilised before use. The vaccine should be left to slowly reach 15 C 20 C by keeping it at room temperature. The vaccine should be well shaken prior to use by squeezing and shaking for approx. 2 minutes. To reduce the risk of adverse reactions, it is important to deposit the entire dose in the abdominal cavity. The injection needle used should have appropriate length to penetrate the abdominal wall by 1-2 mm. The entire needle should be inserted into the midline about one fin length anterior to the base of the pelvic fin. Only administer if the vaccine appears as a homogenous, cream coloured emulsion after shaking.the vaccine should not be used if the vaccine shows signs of a brownish water phase in the bottom of the container. Contact the veterinary surgeon or the distributor for further advice Overdose (symptoms, emergency procedures, antidotes), if necessary Following injection of an overdose, there is an increased risk of development of severe adverse reactions Withdrawal period(s) 0 degree days. 5. IMMUNOLOGICAL PROPERTIES Pharmacotherapeutic group: Infectious pancreatic necrosis (IPN) virus, aeromonas, moritella, vibrio ATCvet code: QI10AL02 To stimulate the development of active immunity against Aeromonas salmonicida, Listonella anguillarum serotype O1, Listonella anguillarum serotype O2a, Vibrio salmonicida, Moritella viscosa and infectious pancreatic necrosis virus (IPNV) in Atlantic salmon. For the bacterial antigens, the onset of immunity occurs no later than 520 degree days after vaccination and for IPNV no later than 600 degree days. 3

4 In an experimental challenge trial it has been documented better protection for vaccinated than control fish lasting up to 12 months for infections caused by Aeromonas salmonicida, Vibrio salmonicida, and Listonella anguillarum serotype O1 and O2a and up to 6 months for infections caused by Moritella viscosa. The results show RPS 60 -values of between % for Moritella viscosa and % for the other antigens. The duration of protection for IPNV is not documented. Specific antibodies will be present in the fish up to 15 months after vaccination. 6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients Liquid paraffin (mineral oil) and emulsifiers. The vaccine may contain formaldehyde (<0.5g/l) as a residue after inactivation. 6.2 Incompatibilities Do not mix with any other veterinary vaccine or immunological product. 6.3 Shelf life Shelf-life of the veterinary medicinal product as packaged for sale: 18 months Shelf-life after first opening the immediate packaging: 12 hours 6.4. Special precautions for storage Store and transport refrigerated (2 C 8 C). Do not freeze. Protect from light. 6.5 Nature and composition of immediate packaging Injection bags made of a multilayer plastic foil. The giving port is closed with a rubber stopper. Pack size: 250 ml and 500 ml. 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. 7. MARKETING AUTHORISATION HOLDER PHARMAQ AS Skogmo Industriområde 7863 Overhalla 8. MARKETING AUTHORISATION NUMBER(S) MT-nr

5 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION ALPHA JECT micro 6 10 DATE OF REVISION OF THE TEXT PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable. 5