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Date: Monday, May 20, 2024 7:03

Description: 2021 logo_HIPRA
Release 3.63
Rhiniseng
 
Species: Pigs
Therapeutic indication: Immunological veterinary medical products: For pigs
Active ingredient: Vaccine Antigens
Product:Rhiniseng
Product index: Rhiniseng
Pig - meat: Zero days
Incorporating:
Qualitative and quantitative composition
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 6.4 mg (aluminium)
DEAE-Dextran
Ginseng
Excipient:
Qualitative composition of excipients and other constituents
Quantitative composition if that information is essential for proper administration of the veterinary medicinal product
Formaldehyde
0.8 mg
Simethicone
Disodium phosphate dodecahydrate
Potassium dihydrogen phosphate
Sodium chloride
Potassium chloride
Water for injections
White homogeneous suspension.
Pharmaceutical form
Suspension for injection
White homogeneous suspension
Clinical particulars
Target species
Pigs - sows and gilts
Indications for use
For the 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.
Contra-indications
Do not use in case of hypersensitivity to the active substances, to the adjuvants or to any of the excipients.
Special warnings
--- (for GB only) None
--- (for NI only) Vaccinate healthy animals only.
Special precautions for use
Special precautions for safe use in target species
--- (for GB only) Vaccinate only healthy animals
--- (for NI only) Not applicable
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.
--- (for NI only ) Special precautions for the protection of the environment:
Not applicable
Adverse reactions
--- (Adverse reactions for GB only as described in the GB version of the SPC. There is a different version for NI)
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 is common 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 is common 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).
--- (Adverse reactions for NI only as described in the NI version of the SPC. There is a different version for GB)
Pigs (sows and gilts):
Common
(1 to 10 animals / 100 animals treated):
Injection site swelling1 Elevated temperature2
Very rare
(<1 animal / 10,000 animals treated, including isolated reports):
Anaphylactic-type reaction (severe allergic reaction)3
1 After the administration of one dose of vaccine a 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.
2 An 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 1.5º C may occur. This rectal temperature increase is spontaneously resolved within 24 hours without treatment.
3 An appropriate symptomatic treatment should be administered without delay.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
--- (end of the NI-specific section. The following text applies for the whole of UK unless there is specific mentions for GB or NI)
Use during pregnancy, lactation or lay
Can be used during pregnancy.
Interactions
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.
Amounts to be administered and administration route
Intramuscular use.
Allow the vaccine to reach room temperature (15-25˚C) before administration.
Shake well before 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.
Overdose
No adverse reactions other than already mentioned under point 4.6 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.
--- (for NI only) Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable
--- (end of NI specific section) ---
Withdrawal periods
Zero Days
Pharmacological particulars
Immunological properties
ATCvet code: QI09AB04.
To stimulate active immunity in order to provide passive immunity to the progeny against atrophic rhinitis associated with Bordetella bronchiseptica and Pasteurella multocida infections.
Pharmaceutical particulars
Excipients
Aluminium hydroxide
DEAE-dextran
Ginseng
Formaldehyde
Simethicone
Disodium phosphate dodecahydrate
Potassium dihydrogen phosphate
Sodium chloride
Potassium chloride
Water for injections
Major incompatibilities
Do not mix with any other veterinary medicinal product.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after first opening the immediate packaging: 10 hours stored at room temperature.
Special precautions for storage
Store and transport refrigerated (2 °C to 8 °C)
Protect from light.
Do not freeze.
Immediate packaging
Type I colourless glass vials of 20 ml
Type II colourless glass vials of 50 ml and 100 ml
The vials are closed with a rubber stopper and aluminium cap.
20 ml, 50 ml, 100 ml and 250 ml Polyethylene (PET) bottles closed with a rubber stopper and aluminium cap.
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 GB only ) --- Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
--- (for GB only ) --- Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products.
Medicines should not be disposed of via wastewater or household waste.
Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.
Marketing Authorisation Holder (if different from distributor)
LABORATORIOS HIPRA, S.A.
Avda. la Selva, 135
17170 Amer (Girona)
SPAIN
Tel. +34 972 430660
Fax. +34 972 430661
E-mail: hipra@hipra.com
Marketing Authorisation Number
UK(GB): Vm 17533/5009
UK (NI): EU/2/10/109/001-009
Significant changes
Date of the first authorisation or date of renewal
16.09.2010.
Date of renewal 30.06.2015.
Any other information
Nil
Legal category
Legal category: POM-V
GTIN
GTIN description:RHINISENG 10ds
GTIN:08427711129844
GTIN description:RHINISENG 25ds
GTIN:08427711129851