Rhiniseng - summary of medicine characteristics

SUMMARY OF PRODUCT CHARACTERISTICS

• 1. NAME OF THE VETERINARY MEDICINAL PRODUCT

RHINISENG suspension for injection for pigs.

2. 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:

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

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Suspension for injection.

White homogeneous suspension.

4. CLINICAL PARTICULARS4.1 Target species

Pigs (sows and gilts).

• 4.2 Indications for use, specifying the target species

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.

4.3 Contraindications

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

• 4.4 Special warnings for each target species

None.

• 4.5 Special precautions for use

Special precautions for use in animals

Vaccinate only healthy animals.

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.

• 4.6 Adverse reactions (frequency and seriousness)

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).

• 4.7 Use during pregnancy, lactation or lay

Can be used during pregnancy.

4.8 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.

• 4.9 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.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

No adverse reactions other than already mentioned under point 4.6 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.

• 4.11 Withdrawal period(s)

Zero days.

• 5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Inactivated bacterial vaccines (Bordetella and Pasteurella) for pigs.

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.

6. PHARMACEUTICAL PARTICULARS6.1 List of excipients

Aluminium hydroxide

DEAE-dextran

Ginseng

Formaldehyde

Simethicone

Disodium phosphate dodecahydrate

Potassium dihydrogen phosphate

Sodium chloride

Potassium chloride

Water for injections

6.2 Major incompatibilities

Do not mix with any other veterinary medicinal product.

6.3 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.

6.4. Special precautions for storage

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

Protect from light.

Do not freeze.

• 6.5 Nature and composition of 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.

• 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

7. MARKETING AUTHORISATION HOLDER

LABORATORIOS HIPRA, S.A.

Avda la Selva, 135

17170 Amer (Girona)

SPAIN

Tel. +34 972 430660

Fax. +34 972 430661

E-mail:

8. MARKETING AUTHORISATION NUMBER(S)

EU/2/10/109/001–009

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 16/09/2010

Date of last renewal: 30/06/2015