Suiseng Coli / C
Active substance
ATC code
Species
Pigs (sows and gilts).
Indications
Piglets: For the passive protection of neonatal piglets by means of the active immunisation of breeding sows and gilts to reduce mortality and clinical signs of neonatal enterotoxicosis, such as diarrhoea caused by enterotoxigenic Escherichia coli, which express F4ab (K88ab), F4ac (K88ac), F5 (K99) or F6 (987P) adhesins.
The persistence of these antibodies has not been established.
For the passive immunisation of neonatal piglets against Necrotic Enteritis by means of the active immunisation of breeding sows and gilts to induce seroneutralising antibodies against the β-toxin of Clostridium perfringens type C.
The persistence of antibodies has not been established.
Sows and gilts: For active immunisation of breeding sows and gilts to induce seroneutralising antibodies against α-toxin of Clostridium novyi type B. The relevance of the seroneutralising antibodies was not experimentally determined.
Antibodies have been detected 3 weeks after the completion of the basic vaccination scheme. The persistence of these antibodies has not been established.
Dose to be administered and administration route
Intramuscular, into the neck muscles. Dose: 2 ml/animal.
The basic vaccination scheme consists of two doses: the first dose at approximately 6 weeks before farrowing and a second dose at approximately 3 weeks before farrowing.
It is recommended that the second dose should be given preferably on alternate sides.
Revaccination: on each subsequent gestation, administer one dose 3 weeks before the expected date of farrowing.
It is advisable to administer the vaccine at a temperature between +15 ºC and +25 ºC. Shake before use.
To ensure the correct mixing with Suiseng Diff/A, the same volumes of Suiseng Diff/A and Suiseng Coli/C should be used. All the contents of Suiseng Coli/C should be transferred into a headspace bottle of Suiseng Diff/A (50 ml bottle with 10 doses, 100 ml bottle with 25 doses and 250 ml bottle with 50 doses).
A pre-sterilised transfer needle can be used according to the following instructions:
- Peel the cap of the bottle containing the vaccine Suiseng Coli/C.
- Connect one end of the transfer needle to the bottle of Suiseng Coli/C.
- Peel the cap of the headspace bottle containing the vaccine Suiseng Diff/A.
- Connect the opposite end of the transfer needle to the bottle of Suiseng Diff/A.
- Transfer all the contents of Suiseng Coli/C into the bottle of Suiseng Diff/A. - Once finished, separate both bottles and discard the needle transfer.
Shake well before use. Administer one single dose of 4 ml of the mixed vaccines.
Adverse reactions
Very rare: A small granuloma may occur in the muscle tissue at the injection site.
Uncommon: Injection site nodules can be observed, which disappear within 2-3 weeks.
Common: Temperature increase observed at 6 hours post-vaccination (mean 0.4 ºC, in individual pigs up to 1.2 ºC, uncommonly up to 2 ºC) subsiding without treatment within 24 hours post-vaccination. Palpable inflammatory local reaction (swelling, not more than 2 cm2) which resolves without treatment within 5 days post-vaccination.
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).
Dispensing
POM-V - Prescription Only Medicine – Veterinarian
TRUSTED SOURCE
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Suiseng Coli / C suspension for injection for pigs.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (2 ml) contains:
Active substances:
|
F4ab fimbrial adhesin of E. coli |
≥65% ER60 * |
|
F4ac fimbrial adhesin of E. coli |
≥78% ER70 |
|
F5 fimbrial adhesin of E. coli |
≥79% ER50 |
|
F6 fimbrial adhesin of E. coli |
≥80% ER25 |
|
LT Enterotoxoid of E. coli |
≥55% ER70 |
|
Toxoid Clostridium perfringens, type C |
≥35% ER25 |
|
Toxoid Clostridium novyi type B |
≥50% ER120 |
*% ERx: Percentage of immunized rabbits with a X serological EIA response Adjuvants:
|
Aluminium hydroxide gel |
0.5 g |
|
Ginseng extract (equivalent to ginsenosides) Excipient: |
4 mg (0.8 mg) |
|
Benzyl alcohol (E1519) |
30 mg |
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Suspension for injection.
White-yellowish suspension.
4. CLINICAL PARTICULARS
4.1 Target species
Pigs (sows and gilts).
4.2 Indications for use, specifying the target species
Piglets: For the passive protection of neonatal piglets by means of the active immunisation of breeding sows and gilts to reduce mortality and clinical signs of neonatal enterotoxicosis, such as diarrhoea caused by enterotoxigenic Escherichia coli, which express F4ab (K88ab), F4ac (K88ac), F5 (K99) or F6 (987P) adhesins.
The persistence of these antibodies has not been established.
For the passive immunisation of neonatal piglets against Necrotic Enteritis by means of the active immunisation of breeding sows and gilts to induce seroneutralising antibodies against the β-toxin of Clostridium perfringens type C.
The persistence of antibodies has not been established.
Sows and gilts: For active immunisation of breeding sows and gilts to induce seroneutralising antibodies against α-toxin of Clostridium novyi type B. The relevance of the seroneutralising antibodies was not experimentally determined.
Antibodies have been detected 3 weeks after the completion of the basic vaccination scheme. The persistence of these antibodies has not been established.
4.3 Contraindications
None.
4.4 Special warnings for each target species
Vaccinate healthy animals only
4.5 Special precautions for use
Special precautions for use in animals
Hypersensitivity reactions may occur in sensitive animals. In the event of an anaphylactic reaction appropriate treatment such as adrenaline should be administered without delay.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
4.6 Adverse reactions (frequency and seriousness)
Very rare adverse reactions:
- A small granuloma may occur in the muscle tissue at the injection site. The administration of the vaccine can cause the appearance of a small (less than 3 cm), local, transitory swelling (for 24-48 hours). In a few cases, temporary small nodules can be observed, which disappear within 2-3 weeks.
- The vaccination may cause a slight increase in body temperature for a transient period after vaccination (4-6 hours after injection).Unusually, an increase in rectal temperature higher than 1.5ºC, lasting less than 6 hours, may occur.
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
Pregnancy and lactation:
Can be used during pregnancy from 6 weeks before the expected farrowing date.
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, into the neck muscles. Dose: 2 ml/animal.
The basic vaccination scheme consists of two doses: the first dose at approximately 6 weeks before farrowing and a second dose at approximately 3 weeks before farrowing .
It is recommended that the second dose should be given preferably on alternate sides.
Revaccination: on each subsequent gestation, administer one dose 3 weeks before the expected date of farrowing.
It is advisable to administer the vaccine at a temperature between +15ºC and +25ºC. Shake before use.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
No effects other than those indicated under section 4.6. have been observed following the administration of a double dose.
4.11 Withdrawal period(s) Meat and offal: Zero days.
5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Inactivated bacterial vaccine: Escherichia coli+Clostridial vaccine.
ATCvet code: QI09AB08.
Stimulates development of protective adhesin-specific Escherichia coli antibodies and seroneutralising antibodies against the heat labile (LT) enterotoxin of Escherichia coli, Clostridium perfringens type C and Clostridium novyi type B.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Aluminium hydroxide gel
Ginseng
Benzyl alcohol
Simethicone
Disodium phosphate dodecahydrate
Potassium chloride
Potassium dihydrogen phosphate
Sodium 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: 18 months. Shelf life after first opening the immediate packaging: 10 hours.
6.4 Special precautions for storage
Store and transport refrigerated (2 ºC-8 ºC). Protect from light. Do not freeze.
6.5 Nature and composition of immediate packaging
20 ml, 50 ml and 100 ml Type-I colourless glass vials, closed with type I rubber stoppers and aluminium caps.
20 ml, 50 ml, 100 ml and 250 ml PET plastic vials, closed with type I rubber stoppers and aluminium caps.
Pack sizes:
Cardboard box with 1 glass or PET vial of 10 doses (20 ml).
Cardboard box with 1 glass or PET vial of 25 doses (50 ml).
Cardboard box with 1 glass or PET vial of 50 doses (100 ml). Cardboard box with 1 PET vial of 125 doses (250 ml).
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
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Laboratorios Hipra SA
Avda La Selva 135
17170 Amer (Girona)
Spain
8. MARKETING AUTHORISATION NUMBER
Vm 17533/5015
9. DATE OF FIRST AUTHORISATION
01 May 2020
10. DATE OF REVISION OF THE TEXT
November 2023
Approved 07 November 2023
| Art. Nr. | 17533/5015 |
|---|---|
| EAN | 8427711129493 |
