TARGET SPECIES: Cattle and sheep, from old 2 months.
INDICATIONS: Rompervac 4+ is indicated for the active immunization of cattle and sheep against enterotoxemia caused by Cl. perfringens: anaerobic enteritis of cattle, anaerobic enterotoxemia of sheep, and anaerobic dysentery of lambs. It is administered to cattle and sheep, from the age of 2 months.
Preventive vaccination, in enzootic outbreaks, is done in the spring before going out to pasture.
Preventive vaccination also applies to animals that are transferred from areas that are free of the disease to areas where the disease develops enzootically.
Vaccination as a necessity, in new outbreaks, applies whenever appropriate to clinically healthy animals.
Establishment of immunity: 14 days after the second administration.
Immunity is maintained, in vaccinated animals, by revaccination every 6 months.
1 ml contains:
Anaculture and toxoid of Cl. perfringens, types:
- Type A ≥ 80 DLM/ml
- Type B ≥ 400 DLM/ml
- Type C ≥ 400 DLM/ml
- Type D ≥ 80 DLM/ml
≥10 lU antitoxin beta/ml*
≥ 5 lU antitoxin epsilon/ml*
≥ 2 IU antitoxin alfa/ml*
* Serum titer after inactivation induced by the active substance contained in the minimum vaccine dose (2 ml), repeatedly inoculated in rabbits.
Adjuvant: Aluminum hydroxide, formaldehyde, thiomersal (sodium merthiolate).
Do not vaccinate sick animals, or animals suffering from transport stress.
Systemic reactions: a slight increase in body temperature, by up to 0.5°C, in adult animals, and by up to 0.6°C, in calves and lambs, on the day of inoculation and the next day;
Frequently, a minor and temporary decrease (for 2-3 days) of milk production in sheep, as a cumulative effect of the vaccine and vaccination maneuvers.
Frequently, the following local reactions may occur:
- Swelling at the site of inoculation, which recedes within 48 hours, in adult sheep, and 72 hours, in lambs, respectively;
- Vaccine nodules of approx. 2 cm in 66.7% of calves and 62% of lambs, and of approximately 1.5 cm in 52% of adult sheep. These usually go away, without complications, and can be felt on palpation, with sizes of up to 0.5 cm 6 weeks after inoculation. Approximately 4% of nodules in sheep and 4.9% of nodules in lambs form abscesses, and heal within 14 days.
Such reactions are common to aluminum hydroxide-adjuvanted vaccines.
A minor (3.8-4%) and temporary (2-3 days) decrease in milk production, as a cumulative effect of the vaccine and vaccination maneuvers, may occur; it was noticed while testing the vaccine in field conditions, in sheep.
Although not observed after Rompervac 4+ vaccination, anaphylactic reactions are possible and may occur after the administration of biological products. Therefore, it is recommended to keep the animals under observation for 1-2 hours after vaccination and, if necessary, to intervene with an antihistamine (e.g. epinephrine).
The frequency of adverse reactions is defined using the following convention:
- Very frequent (more than 1 in 10 animals experiencing adverse reactions during treatment);
- Frequent (more than 1, but less than 10 in 100 animals);
- Less frequent (more than 1, but less than 10 in 1,000 animals);
- Rare (more than 1, but less than 10 in 10,000 animals);
- Very rare (less than 1 in 10,000 animals, including isolated reports).
If you notice any serious reactions or other effects not stated in this leaflet, please inform your veterinarian.
In cattle (calves over old 2 months), the vaccine is administered by subcutaneous (s.c.) injection, in a 5 ml dose, with a booster dose after 21-28 days.
In adult sheep, the vaccine is administered by subcutaneous (s.c.) injection, in a 2 ml dose, with a booster dose after 21-28 days.
In lambs (over the age of 2 months), the vaccine is administered by subcutaneous (s.c.) injection, in a 4 ml dose, in two separate spots, with a booster dose after 21-28 days.
RECOMMENDATIONS FOR PROPER ADMINISTRATION
Do not inoculate the vaccine other than subcutaneously.
Prior to inoculation, bring the vaccine to room temperature and homogenize it by stirring. Administer the vaccine with sterile syringes and needles, and disinfect the site of inoculation with alcohol.
Keep out of the reach and sight of children. Store and transport refrigerated (2-8°C). Keep away from frost. Keep away from sunlight. Do not use after the expiration date stated on the packaging. The shelf life of the veterinary medicinal product after first opening the primary packaging: 6 hours. Do not use the vaccine if you notice any cracks or leaks in the bottle.
Not all pack sizes may be marketed.