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SUVAXYN Aujeszky i.n./i.m., freeze-dried vaccine to be re-suspended in o/w emulsion, for injection for pigs

Description

Freeze-dried fraction:
Active substanceper 2 ml dose of reconstituted emulsion
Live attenuated Aujeszky's Disease Virus, strain Bartha K61 > 105.2 CCID50*
* CCID50 = the quantity of virus, which infects 50% of the cell cultures inoculated.
Diluent:
One dose of 2 ml contains:
Adjuvants:
Aluminium hydroxide2.1 mg
Mineral oil (Marcol 52)450 μl
Mannide mono oleate (Arlacel A)15 μl
Polysorbate 80 (Tween 80)17 μl
Alluminio idrossido (Alhydrogel 2%)2.1 mg

INDICATIONS

For the vaccination of pigs to prevent the mortality and clinical signs of Aujeszky’s Disease and to reduce the excretion of Aujeszky’s Disease field virus.

CONTRAINDICATIONS

Vaccinate only healthy animals.

ADVERSE REACTIONS

The vaccine contains an adjuvant and a temporary reaction may occur at the site of injection.
Any vaccine can cause anaphylactic reactions: use epinephrine (adrenaline), possibly combined with a fast-acting corticosteroid, as an antidote.
Slight, transient and local reactions up to 2 cm in diameter after first vaccination and up to 5 cm after second vaccination may occur up to 50% of the pigs. In general these reactions disappear within 3 weeks post primary vaccination. A transient increase in body temperature, up to about 40,5oC and lasting for up to 2 days, may occur in a small number of pigs after vaccination.

TARGET SPECIES

Pigs.

DOSAGE, ROUTE AND METHOD OF ADMINISTRATION

One dose of 2 ml per animal by intramuscular use in the neck behind the ear.
The freeze-dried vaccine should be re-suspended in Suvaxyn o/w emulsion. The re-suspended vaccine should be administered intramuscularly in the neck behind the ear.
Vaccination schedule:
Fatteners:
Experiments have shown that the vaccine is generally effective, with regard to clinical protection, in a single dose given to fattening pigs at the start of the fattening period.
The highest suppressing of excretion of field virus following a natural infection is achieved when the vaccine is administered re-suspended in Suvaxyn o/w emulsion and administered twice with an interval of 3-4 weeks.
Breeding stock:
For the vaccination of breeding stock the vaccine should be re-suspended in Suvaxyn o/w emulsion. The first vaccination is advised at the age of 10-14 weeks with a second 3-4 weeks later. Revaccination before the first mating of breeding gilts is recommended in case of field virus eradication programmes.
Sows have to be revaccinated in every gestation between 3 and 6 weeks before farrowing. In case of field virus eradication programmes, sows can be vaccinated every 4 months on a whole herd basis.

ADVICE ON CORRECT ADMINISTRATION

Do not administer in conjunction with other medicinal products. Vaccinate only healthy animals.
Avoid stress both before, during an after vaccination.

WITHDRAWAL PERIOD

Zero days

SHELF LIFE

Shelf-life of the veterinary medicinal product as packaged for sale:
National label conditions must be observed by country.
Product after reconstitution: 1 hour.

SPECIAL STORAGE PRECAUTIONS

Store and transport refrigerated (2oC - 8oC).
Do not freeze.
Protect from light.

SPECIAL WARNINGS

No information is available on the safety and efficacy from the concurrent use of this vaccine with any other. It is therefore recommended that no other vaccines should be administered within 14 days before or after vaccination with this product. Wash and disinfect hands and equipment after use.

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.

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

OTHER INFORMATION

ATCvet code: QI09AD01.
Nature and composition of immediate packaging and presentations
Cardboard box with 1 vial of powder and 1 bottle of solvent or 10 vials of powder and 10 bottles of solvent for injection
Powder for emulsion for injection:
7-ml vials of Type I hydrolytic glass containing 10, 50 or 100 doses of freeze-dried powder.
The vials are closed with a butyl rubber stopper and sealed with an aluminium cap.
Solvent for emulsion for injection:
20 ml, 100 ml or 200 ml bottles of Type I hydrolytic glass containing solvent for the 10- doses, 50-doses or 100-doses presentation. The bottles are closed with a butyl rubber stopper and sealed with an aluminium cap.
Not all pack sizes may be marketed.
National label conditions must be observed by country.

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