Do not use in breeding animals. Do not use during the whole pregnancy. Do not use during lactation.
Accidental injection of male breeding stock may affect subsequent fertility.
Only healthy animals should be immunised. Improvac has been shown to be safe in male and female pigs from 8 weeks of age onwards. In male pigs, the recommended time for slaughter is 4 to 6 weeks after the final injection. If male pigs cannot be slaughtered within this recommended period the available trial data support that pigs may still be sent for slaughter up to 10 weeks after the second injection with minimal risk of boar taint. An increasing proportion will return to normal function after this time.
As skatole levels are not fully dependent on sexual status, both dietary and hygiene management procedures to reduce skatole levels are also important.
In female pigs, the duration of immunological suppression of ovarian function has been demonstrated for 9 weeks after the second vaccination. An increasing proportion of female pigs may be expected to return to normal function after this time.
When administered to pigs at the youngest recommended age (8 weeks), injection site swellings of up to 4 x 8 cm are very commonly observed. A gradual resolution of the local reactions occurs, but in 20-30% of the animals these may persist for more than 42 days.
When administered to older pigs (14 - 23 weeks of age) injection site swellings may occur very commonly. Injection site swellings ranging from 2 to 5 cm in diameter are commonly observed, and injection site reactions at slaughter are commonly observed if the second vaccination is given only 4 weeks before slaughter.
In a small number of animals, death occurred following the reaction, however most animals recovered without treatment and did not appear to react to subsequent vaccinations.
Very common
(>1 animal / 10 animals treated):
injection site swelling 2-8 cm in diameter
elevated temperature (around 0.5 °C during the 24 hours after vaccination in males and around 1.0 – 1.3 °C during the 24 hours after vaccination in females)
Very rare
(<1 animal / 10,000 animals treated, including isolated reports):
anaphylactoid reaction (dyspnoea, collapse, cyanosis and hypersalivation associated with or without twitching or emesis) within a few minutes after vaccination with a duration of up to 30 minutes
Administration of a double dose of Improvac (4 ml) to 8 week old piglets very commonly resulted in palpable injection site reactions. The largest reactions were seen around 7 days post administration when the maximum size was 13 x 7 cm. By two weeks post administration the maximum size had decreased to 8 x 4 cm, showing a gradual resolution of the local reactions. A transient increase in body temperature of 0.2 to 1.7°C was observed during the 24 hours after administration, returning to normal after two days. The general health of the animals was not affected.
No information is available on the safety and efficacy of this immunological veterinary medicinal product when used with any other veterinary medicinal product. A decision to use this immunological veterinary medicinal product before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Do not mix with any other veterinary medicinal product.
Operator Warnings
Accidental self-injection may produce similar effects in people to those seen in pigs. These may include a temporary reduction in sexual hormones and reproductive functions in both men and women and an adverse effect on pregnancy. The risk of these effects occurring is greater after a second or subsequent accidental injection than after a first injection.
Special care should be taken to avoid accidental self-injection and needle stick injury when administering the product. The product must only be used with a safety vaccinator which has a dual safety system providing both a needle guard and a mechanism to prevent accidental operation of the trigger.
The veterinary medicinal product must not be administered by pregnant women or those who may be pregnant at that time. In case of eye contact, rinse immediately with copious amounts of water. In case of skin contact, wash immediately with soap and water.
Advice to the user in the event of accidental self-injection:
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.
In the event of accidental self-injection, wash the injury thoroughly with clean running water. 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. Do not administer the veterinary medicinal product in the future.
Advice to the physician:
Accidental self-injection could temporarily affect reproductive physiology of both men and women and may adversely affect pregnancy. If self injection with Improvac is suspected, reproductive physiology should be monitored by assay of testosterone or oestrogen levels (as appropriate). The risk of a physiological effect is greater after a second or subsequent accidental injection than after a first injection. Clinically meaningful suppression of gonadal function should be managed with supportive endocrine replacement therapy until normal function returns. The patient should be advised not to administer Improvac and/or any other products with similar action in the future.
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.
Other precautions:
The safety and efficacy of the veterinary medicinal product in non-target species such as horses has not been evaluated. Adverse events have been observed in horses including serious anaphylactic type reactions which have led to fatalities.
Withdrawal period
Zero days.