Rhiniseng - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

RHINISENG suspension for injection for pigs

• 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder and manufacturer responsible for batch release : LABORATORIOS HIPRA, S.A.

Avda la Selva, 135

17170 Amer (Girona)

SPAIN

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

RHINISENG suspension for injection for pigs.

• 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

Each dose of 2 ml contains:

Active substances:

Inactivated Bordetella bronchiseptica, strain 833CER:......­.............­.............­........9.8 BbCC()

Recombinant Type D Pasteurella multocida toxin (PMTr):......­.............­.........> 1 MED63()

• () Bordetella bronchiseptica Cell Count in log10.

• ( ) Murine Effective Dose 63: vaccination of mice with 0.2 ml of a 5-fold diluted vaccine by subcutaneous route induces seroconversion in at least 63 % of the animals.

Adjuvants:

Aluminium hydroxide gel

DEAE-Dextran

Ginseng

Excipient:

Formaldehyde.­.............­.............­.............­.............­.............­.............­.............­.............­......... 0.8 mg

White homogeneous suspension.

For passive protection of piglets via colostrum after active immunisation of sows and gilts to reduce the clinical signs and lesions of 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.

Challenge studies have demonstrated that passive immunity lasts until piglets are 6 weeks of age while in clinical field trials, the beneficial effects of vaccination (reduction in nasal lesion score and weight loss) are observed until slaughter.

• 5. CONTRAINDI­CATIONS

Do not use in case of hypersensitivity to the active substances, to the adjuvants or to any of the excipients.

• 6. ADVERSE REACTIONS

Common adverse reactions:

• – Transient local reactions may occur after the administration of one dose of vaccine. A transient slight swelling of less than 2 to 3 cm in diameter can occur at the injection site which may last up to five days and occasionally up to two weeks.

• – A transient increase in body temperature of about 0.7°C can occur during the first 6 hours after injection. An increase of rectal temperature up to 1.5°C may occur. This rectal temperature increase is spontaneously resolved within 24 hours without treatment.

Very rare adverse reactions:

• – Anaphylactic type reactions have been reported in spontaneous reports and appropriate symptomatic treatment is recommended.

The frequency of adverse reactions is defined using the following convention:

• – very common (more than 1 in 10 animals treated displaying adverse reaction(s))

• – common (more than 1 but less than 10 animals in 100 animals treated )

• – uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

• – rare (more than 1 but less than 10 animals in 10,000 animals treated)

• – very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

• 7. TARGET SPECIES

Pigs (sows and gilts).

• 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Intramuscular use.

Administer one dose of 2 ml by intramuscular injection in the neck muscles according to the following schedule:

Basic vaccination: sows and gilts which have not been previously vaccinated with the product should be given two injections with an interval of 3–4 weeks. The first injection should be administered 6–8 weeks before the expected date of farrowing.

Revaccination: a single injection should be given 3–4 weeks prior to each subsequent farrowing.

• 9. ADVICE ON CORRECT ADMINISTRATION

Allow the vaccine to reach room temperature (15–25°C) before administration.

Shake well before use.

Zero days.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Store and transport refrigerated (2 °C to 8 °C).

Protect from light.

Do not freeze.

Do not use after the expiry date stated on the label.

Shelf life after first opening the immediate packaging: 10 hours stored at 15 °C to 25 °C.

• 12. SPECIAL WARNING(S)

Special precautions for use in animals :

Only healthy animals should be vaccinated.

Special precautions to be taken by the person administering the veterinary medicinal product to animals :

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

Pregnancy : Can be used during pregnancy.

Interaction with other medicinal products and other forms of interaction:

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.

Overdose (symptoms, emergency procedures, antidotes) :

No adverse reactions other than already mentioned under point “Adverse reactions” can be expected, except for an increase of rectal temperature up to 2°C. This rectal temperature increase is spontaneously resolved within 24 hours without treatment.

Discoloration of muscular fibres of the inoculation site (0.5 cm wide x 2 cm long) may be observed at necropsy in 10% of animals. This discoloration is attributable to aluminium hydroxide and may be observed up to seven weeks after the injection of a double dose of vaccine.

Incompatibilities :

Do not mix with any other veterinary medicinal product.

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

• 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency.

• 15. OTHER INFORMATION

Pack sizes:

• – Cardboard box with 1 or 10 glass vials of 10 doses.

• – Cardboard box with 1 glass vial of 25 doses.

• – Cardboard box with 1 glass vial of 50 doses.

• – Cardboard box with 1 or 10 PET bottles of 10 doses.

• – Cardboard box with 1 PET bottle of 25 doses.

• – Cardboard box with 1 PET bottle of 50 doses.

• – Cardboard box with 1 PET bottle of 125 doses.