Equilis Strep E (pack of 10)-Hyperdrug

Presentation One dose (0.2 ml) contains a live, modified strain of Streptococcus equi TW928 109.0 to 109.4 cfu*. *Colony forming units. Uses For the immunisation of horses against Streptococcus equi to reduce clinical signs and occurrence of lymph node abscesses. The onset of immunity is established at two weeks after vaccination. The duration of immunity is up to 3 months. A priming response is maintained for up to six months after basic vaccination. The vaccine is intended for use in horses for which a risk of Streptococcus equi infection has been clearly identified, due to contact with horses from areas where this pathogen is known to be present, e.g. stables with horses that travel to shows and/or competitions in such areas, or stables that obtain or have livery horses from such areas.

Dosage and administration Dosage: 0.2 ml of reconstituted vaccine by submucosal vaccination. Basic vaccination Horses from 4 months of age onwards receive two vaccinations of one dose with a 4 week interval. Revaccination Revaccinate every three months to maintain immunity. A priming response is maintained for up to six months after basic vaccination. Therefore, if continuous immunity is not required, a six-month vaccination interval can be used, with only a single dose of vaccine needed to restore immunity. Allow the solvent to reach room temperature (15°C - 25°C). Aseptically reconstitute the freeze-dried vaccine with 0.3 ml of the sterile solvent provided. Do NOT shake and wait 1 minute after addition of the solvent. Withdraw 0.2 ml of the reconstituted vaccine into the syringe provided with the vaccine (see Figure 1) and connect the applicator to the needle (see Figure 2). Restrain the animal’s head, lift the upper lip and insert the needle into the inside of the upper lip until the applicator rests on the lip. Administer the whole contents of the syringe into the inside of the upper lip (see Figure 3). Figure 1:

Figure 2:

Figure 3:

Contra-indications, warnings, etc Do not use in pregnant or lactating mares. After vaccination a diffusely swollen reaction, which may be warm or painful, develops at the injection site within 4 hours. The reaction is maximal at 2-3 days post vaccination with a maximum area of 3 cm by 8 cm. This swelling resolves completely within 3 weeks and has no effect on the appetite of the vaccinated animal and causes no apparent discomfort. The vaccine organism may establish a small suppurative inflammation locally at the injection site, leading to a disruption of the overlaying lip mucosa and subsequent discharge of fluid and inflammatory cells. A slight cloudy discharge commonly occurs from the mucosal injection site at 3 or 4 days post vaccination. Slight enlargements, which may be transiently painful, of the retropharyngeal and mandibular lymph nodes may occur for a few days after vaccination. Further, an increase in rectal temperature up to 2°C may occur on the day of vaccination. Only healthy horses should be vaccinated. Do not mix with any other veterinary medicinal products except the solvent supplied for use with the vaccine. Do not use antibiotics within one week after vaccination. The vaccine strain is resistant to aminoglycosides, sulphonamides, flumequine, and trimethoprim-sulfa combinations. The vaccine strain is sensitive to penicillins, tetracyclines, macrolides and lincomycin. Withdrawal period Zero days. For animal treatment only. Keep out of reach of children. Pharmaceutical precautions Lyophilisate: Store refrigerated (+2°C to +8°C). Protect from light. Solvent: This medicinal product does not require any special storage conditions. Reconstituted vials should be used within 4 hours. Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.

Legal category POM-V (previously POM). Packaging Quantities 1 pack contains 10 vials with lyophilisate and 10 vials of 0.5 ml solvent, 10 applicators, 10 syringes with needles. Further information Limited information is available on the safety and efficacy from the use of this vaccine with any other. It is therefore recommended that no other vaccines should be administered concurrently or simultaneously. Basic vaccination performed during an outbreak is not efficacious, because immunity is insufficient until basic vaccination has been completed. The vaccine strain is live modified with a limited growth potential in mammalian tissue. It is able to multiply locally at the submucosal injection site for a short period and is shed into the oro-nasal cavity over a few days, but the vaccine strain does not survive on the oro-nasal mucosa and does not disseminate systemically at the recommended dose. Shedding of the vaccine strain from the injection site can be observed for a period of four days after vaccination. From literature, it is known that a very low number of horses may develop purpura haemorrhagica if they are vaccinated shortly after infection. Purpura haemorrhagica has not been observed in any of the safety studies performed during development of Equilis StrepE. As the incidence of purpura haemorrhagica is very low, its occurrence cannot be ruled out completely. For any information about this veterinary medicinal product, please contact the Marketing Authorisation Holder. Marketing authorisation number EU/2/04/043/001. Marketing authorisation holder Intervet International bv Wim de Körverstraat 35 PO Box 31 5830 AA Boxmeer The Netherlands