Suiseng Diff/A - summary of medicine characteristics

ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS

• 1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Suiseng Diff/A suspension for injection for pigs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each dose (2 ml) contains:

Active substances:

Clostridioides difficile , toxoid A (TcdA) Clostridioides difficile , toxoid B (TcdB) Clostridium perfringens type A, a-toxoid * RP: Relative Potency determined by ELISA

Adjuvants:

Aluminium hydroxide gel                                                       ­0.6 g

Ginseng extract (equivalent to ginsenosides)

DEAE-dextran

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Suspension for injection.

Yellowish-white suspension.

4. CLINICAL PARTICULARS4.1 Target species

Pigs (pregnant sows and gilts).

• 4.2 Indications for use, specifying the target species

For the passive immunisation of neonatal piglets by means of the active immunisation of breeding sows and gilts:

• – to prevent mortality and reduce clinical signs and macroscopic lesions caused by C. difficile, toxins A and B.

• – to reduce clinical signs and macroscopic lesions caused by C. perfringens type A, a-toxin.

The reduction of the occurrence of neonatal diarrhoea has been demonstrated under field conditions.

Onset of immunity:

Protection was demonstrated in suckling piglets on the first day of life in challenge studies.

Duration of immunity:

Neutralising protective antibodies transferred via colostrum to the piglets were present up to 28 days after birth in the majority of the piglets.

4.3 Contraindications

Do not use in cases of hypersensitivity to the active substance, to the adjuvant or to any of the excipients.

• 4.4 Special warnings for each target species

Vaccinate healthy animals only.

Protection of piglets is achieved by colostrum intake. Therefore, care should be taken to ensure that each piglet ingests a sufficient quantity of colostrum within the first hours of life.

• 4.5 Special precautions for use

Special precautions for use in animals

Not applicable.

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

None.

• 4.6 Adverse reactions (frequency and seriousness)

Mild local inflammation at the injection site (maximum diameter of 5 cm) which subsided without treatment within 5 days was commonly reported in laboratory studies.

A slight transient increase in body temperature (mean 0.27°C, in individual pigs up to 0.95 °C) which subsided without treatment occurred commonly in preclinical and field studies.

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

• – very common (more than 1 in 10 animals treated displaying adverse reactions

• – 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

Administer the vaccine by deep intramuscular injection in the neck muscles.

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

Shake well before use.

Primary vaccination:

Administer one dose (2 ml) at approximately 6 weeks before farrowing and a second dose (2 ml) at approximately 3 weeks before farrowing.

It is recommended that the second dose is given preferably on alternate sides.

Revaccination:

On each subsequent gestation, administer one dose (2ml) 3 weeks before the expected date of farrowing.

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

None known.

• 4.11 Withdrawal period(s)

Zero days.

• 5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Immunologicals for Suidae, inactivated bacterial vaccines for pigs, clostridium.

ATCvet code: QI09AB12.

The active immunisation of pregnant sows and gilts induces the production of neutralising antibodies against C. difficile, toxins A and B and C. perfringens type A, a-toxin. These antibodies are transferred via the colostrum to the piglets. The uptake of sufficient colostrum within the first hours of life results in a passive protection of piglets.

Efficacy of the vaccine was demonstrated upon intraperitoneal challenge with C. difficile toxin A and B and alpha toxin from C. perfringens type A. The efficacy of the vaccine to reduce the occurrence of diarrhoea was demonstrated under field conditions.

6. PHARMACEUTICAL PARTICULARS6.1 List of excipients

Aluminium hydroxide gel

Ginseng extract

Simethicone

DEAE-dextran

Disodium phosphate dodecahydrate

Potassium chloride

Potassium dihydrogen phosphate

Sodium chloride

Sodium hydroxide

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: 15 months.

Shelf life after first opening the immediate packaging: 10 hours.

6.4. Special precautions for storage

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

Do not freeze.

Protect from light.

• 6.5 Nature and composition of immediate packaging

20 ml, 50 ml, 100 ml and 250 ml PET bottles, closed with bromobutyl-stoppers and aluminium caps.

Pack sizes

• – Cardboard box with 1 PET bottle of 10 doses (20 ml bottle).

• – Cardboard box with 1 PET bottle of 10 doses (50 ml bottle).

• – Cardboard box with 1 PET bottle of 25 doses (50 ml bottle).

• – Cardboard box with 1 PET bottle of 25 doses (100 ml bottle).

• – Cardboard box with 1 PET bottle of 50 doses (100 ml bottle).

• – Cardboard box with 1 PET bottle of 50 doses (250 ml bottle).

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 43 06 60 – Fax. +34 972 43 06 61

E-mail:.com

8. MARKETING AUTHORISATION NUMBER(S)

EU/2/21/278/001–006

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07/12/2021