Rhiniseng
inactivated vaccine to prevent progressive and non-progressive atrophic rhinitis in pigs
Marketing authorisation holder and manufacturer responsible for batch release: LABORATORIOS HIPRA, S.A.
Avda la Selva, 135
17170 Amer (Girona) SPAIN
RHINISENG suspension for injection for pigs.
Each dose of 2 ml contains:
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.
Aluminium hydroxide gel .......................................................................... 6.4 mg (aluminium)
DEAE-Dextran Ginseng
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.
Do not use in case of hypersensitivity to the active substances, to the adjuvants or to any of the excipients.
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 1.5ºC 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.
Pigs (sows and gilts).
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.
Allow the vaccine to reach room temperature (15-25˚C) before administration.
Shake well before use.
Zero days.
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 ºC to 25 ºC.
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 2ºC. 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.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
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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. Not all pack sizes may be marketed.
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
België/Belgique/Belgien HIPRA BENELUX NV Tel. (+32) 09 2964464 | Lietuva LABORATORIOS HIPRA, S.A. Tel. (34) 972 43 06 60 |
Република България LABORATORIOS HIPRA, S.A. Tel. (34) 972 43 06 60 | Luxembourg/Luxemburg HIPRA BENELUX NV Tel: (+32) 09 2964464 |
Česká republika HIPRA SLOVENSKO, s.r.o. Tel. (421) 02 32 335 223 | Magyarország LABORATORIOS HIPRA, S.A. Tel. (34) 972 43 06 60 |
Danmark LABORATORIOS HIPRA, S.A. Tel. (34) 972 43 06 60 | Malta LABORATORIOS HIPRA, S.A. Tel. (34) 972 43 06 60 |
Deutschland HIPRA DEUTSCHLAND GmbH Tel. (+49) 211 698236 – 0 | Nederland HIPRA BENELUX NV Tel. (+32) 09 2964464 |
Eesti LABORATORIOS HIPRA, S.A. Tel. (34) 972 43 06 60 | Norge LABORATORIOS HIPRA, S.A. Tel. (34) 972 43 06 60 |
Ελλάδα HIPRA EΛΛAΣ A.E. Tηλ: (+30) 210 4978660 | Österreich HIPRA DEUTSCHLAND GmbH Tel. (+49) 211 698236 – 0 |
España LABORATORIOS HIPRA, S.A. Tel. (34) 972 43 06 60 | Polska HIPRA POLSKA Sp.z.o.o. Tel. (+48) 22 642 33 06 |
France HIPRA FRANCE Tél. (+33) 02 51 80 77 91 | Portugal ARBUSET, Produtos Farmacêuticos e Sanitários De Uso Animal, Lda Tel. (+351) 219 663 450 |
Hrvatska LABORATORIOS HIPRA, S.A. Tel. (34) 972 43 06 60 | România LABORATORIOS HIPRA, S.A. Tel. (34) 972 43 06 60 |
Ireland HIPRA UK AND IRELAND, Ltd. Tel. (+44) 0115 845 6486 | Slovenija LABORATORIOS HIPRA, S.A. Tel. (34) 972 43 06 60 |
Ísland LABORATORIOS HIPRA, S.A. Tel. (34) 972 43 06 60 | Slovenská republika HIPRA SLOVENSKO, s.r.o. Tel. (421) 02 32 335 223 |
Italia Hipra Italia S.r.l. Tel. ( +39) 030 7241821 | Suomi/Finland LABORATORIOS HIPRA, S.A. Tel. (34) 972 43 06 60 |
Κύπρος LABORATORIOS HIPRA, S.A. Tel. (34) 972 43 06 60 | Sverige LABORATORIOS HIPRA, S.A. Tel. (34) 972 43 06 60 |
Latvija LABORATORIOS HIPRA, S.A. Tel. (34) 972 43 06 60 | United Kingdom HIPRA UK AND IRELAND, Ltd. Tel. (+44) 0115 845 6486 |