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Date: Wednesday, July 8, 2020 23:14

Description: pharmaq
Release 2.106
ALPHA JECT® 2-2 emulsion for injection
 
Species: Fish
Therapeutic indication: Immunological veterinary medical products: For fish
Active ingredient: Vaccine Antigens
Product:ALPHA JECT® 2-2 emulsion for injection
Product index: ALPHA JECT 2-2
Fish - meat: Zero degree days
Presentation
An adjuvanted water in oil emulsion vaccine for injection, consisting of inactivated cultures of Aeromonas salmonicida subsp. salmonicida RPS ≥ 80 (Ph. Eur.) and Infectious Pancreatic Necrosis Virus (IPNV) serotype Sp RP 1.5 – 4.8 together with liquid paraffin as an adjuvant.
Uses
Prevents mortality of the disease caused by Aeromonas salmonicida (furunculosis) and reduces mortality of the disease caused by IPNV (infectious pancreatic necrosis) in Atlantic salmon of a minimum weight of 39g. The onset of immunity occurs no later than 600 degree days from vaccination. The protection against Aeromonas salmonicida lasts for at least 12 months post-vaccination. Protection against IPNV has been demonstrated for up to two and a half months in field trials performed with a vaccine containing IPNV and additional antigens to those found in ALPHA JECT 2-2.
Dosage and administration
Fish must be anaesthetised prior to injection. Each fish should be given a single 0.1ml dose of vaccine by intraperitoneal injection. Vaccinate at water temperatures from 1°C - 18°C and preferably below 15°C. The vaccination equipment should be disinfected before use.
The vaccine should be left to slowly reach 15°C – 20°C by keeping it at room temperature. Only administer if the vaccine appears as a homogenous, white to cream coloured emulsion after shaking. If the vaccine shows signs of a brownish water phase in the bottom of the container, it should not be used for vaccination. Contact the distributor for further advice. The vaccine should be shaken prior to use.
To reduce the risk of adverse reactions, it is important to deposit the entire dose in the abdominal cavity. The injection needle should have appropriate diameter and length to penetrate the abdominal wall by 1 - 2 mm. The entire needle should be inserted into the midline approximately one and a half pelvic fin lengths anterior to the base of the pelvic fin.
Administration of the vaccine must be performed using an injection system that prevents back flush of the vaccine into the vaccine tube/container.
Contra-indications, warnings, etc
Do not use in fish intended for broodstock.
An immunisation period of at least 600 degree-days from vaccination to transfer to seawater is recommended.
Do not administer this product to fish which have already received this vaccine. Fish with clinical signs of disease must not be vaccinated. Do not vaccinate at water temperatures below 1°C and above 18°C. Temperatures close to 18°C are suboptimal for Atlantic salmon; thus vaccination should preferably be performed at water temperatures of 15°C or below. Avoid vaccination during smoltification. The severity of the undesirable effects is among other things, dependent on hygiene, vaccination technique, size of the fish at vaccination and water temperature during vaccination.
Occasional mortality may occur if individuals fail to respond or the immune system is suppressed by concurrent infections, poor nutritional status, genetic factors, smoltification or other stressful environmental conditions.
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 other veterinary medicinal product therefore needs to be decided on a case by case basis.
Do not mix with any other veterinary medicinal product.
Adverse reactions
Adverse reactions in the form of visceral adhesions and pigmentation may occur. Adhesions between the abdominal wall and the viscera in addition to pigmentation on the viscera and abdominal wall are normally seen. Vaccinated fish show some growth retardation compared to non-vaccinated fish.
Following injection of an overdose, there is an increased risk of development of more severe lesions in the abdominal cavity, characterised by more severe pigmentation and adhesions between the abdominal wall and viscera.
Withdrawal period
Zero days.
Operator warnings
Ensure that the method of restraint, handling and administration e.g. by the use of guarded needles (such as a protective device attached to the syringe providing a shield against the tip of the needle), minimises the risk of accidental 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 veterinary medicinal 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.
Repeated self-injections may aggravate the effects or cause anaphylactic shock.
Pharmaceutical precautions
Store and transport refrigerated (2°C - 8°C). Do not freeze. Protect from light.
Shelf-life after first broaching the immediate packaging: use within 8 hours and do not re-use opened containers.
Keep out of the sight and reach of children.
For animal treatment only.
Legal category
Legal category: POM-VPS
Packaging quantities
0.5 litre injection bags (corresponding to 5000 doses).
Further information
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Number
Vm 21714/4000
Significant changes