Rhiniseng

Rhiniseng is a vaccine containing a non-toxic recombinant derivative of the Pasteurella multocida toxin and inactivated Bordetella bronchiseptica cells (inactivated means that the bacteria are killed so that they cannot cause the disease anymore). Rhiniseng is presented in fluid form as a suspension for injection, which is stored in a glass or plastic bottle.

Rhiniseng is used for the protection of piglets via the sow’s colostrum (first milk) after injection of sows and gilts. It is used to reduce the clinical signs and lesions of a disease called progressive and non-progressive atrophic rhinitis, as well as to reduce weight loss associated with Bordetella bronchiseptica and Pasteurella multocida infections during the fattening period.

Rhiniseng is a vaccine against a bacterial disease. When it is given to sows, the animal’s immune system (their natural defence mechanism) learns how to make antibodies (a special type of protein) to fight the disease. These antibodies are then transferred to the piglets via the colostrum they receive. In the future, if the sows are exposed to the abovementioned bacteria, the immune system will be able to make those antibodies quicker and this will help their piglets to fight the disease and its after-effects such as weight loss.

The safety of Rhiniseng was demonstrated in several well conducted and reported laboratory and field studies. Results demonstrated that the vaccination of sows, gilts and boars according to the vaccination programme did not provoke unacceptable local or systemic reactions after vaccination and no significant differences in reproductive parameters between vaccinated and placebo-treated animals were recorded either.

Overall, the safety of this vaccine has been well documented and reported for the target animals, the user, the consumer and the environment.

The efficacy of Rhiniseng was demonstrated for the category of the target species for which the vaccine is recommended (gilts and sows) by the recommended route of administration (intramuscular) using the proposed schedule of administration (first vaccination at six to eight weeks before farrowing and revaccination three to four weeks later). The field efficacy results supported those obtained from the laboratory studies.

Direct therapeutic benefit: Rhiniseng reduces the incidence and severity of the disease called progressive and non-progressive atrophic rhinitis in pigs.

Additional benefits: As a consequence of reduced atrophic-rhinitis disease, the incidence of respiratory symptoms and subsequent treatment with antibiotics of the pigs is also reduced. The pigs that have received antibodies against progressive atrophic rhinitis via colostrum need a shorter time to reach slaughter weight.

The risk using this inactivated vaccine can be classified as minimal.

Main potential risks for the vaccine are:

• for the target animal: there are mild and transitory local reactions at the injection site, resolving within a few days and a transiently elevated body temperature within acceptable limits. This is reflected in the relevant sections of the summary of product characteristics (SmPC);
• for the user: accidental self-injection is the only identified risk and an appropriate warning has been included in the SmPC to reflect the (small) risk;
• for the environment: no risk identified from the use of this inactivated vaccine;
• for the consumer: all components have been investigated and no risk for the consumer has been identified.

In case of accidental self-injection, only a minor injection-site reaction is expected.

Zero days.

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Rhiniseng exceed the risks for the treatment of piglets via colostrum from sows and gilts actively immunised with the vaccine to prevent the clinical signs and lesions of progressive and non-progressive atrophic rhinitis and recommended that Rhiniseng be given a marketing authorisation. The benefit-risk balance may be found in the scientific discussion module of this EPAR.

The European Commission granted a marketing authorisation valid throughout the European Union, for Rhiniseng to Laboratorios Hipra S.A. on 16 September 2010. Information on the prescription status of this product may be found on the label / outer package.