NOAH Compendium

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Date: Wednesday, December 11, 2019 5:49

Release 6.18
Covexin 10 suspension for injection for sheep and cattle
 
Species: Sheep, Cattle
Therapeutic indication: Immunological veterinary medical products: For cattle, For sheep
Active ingredient: Vaccine Antigens
Product:Covexin® 10 suspension for injection for sheep and cattle
Product index: Covexin 10
Cattle - milk: Zero days
Cattle - meat: Zero days
Sheep - meat: Zero days
Presentation
A fluid, adjuvanted vaccine for injection with a precipitate which resuspends on shaking. Each 1 ml dose contains:
Active Substances
Potency value/ml
C. perfringens type A
toxoid
≥ 0.9 U
C. perfringens type B & C (β)
toxoid
≥ 12.4 U
C. perfringens type D
toxoid (ε)
≥ 5.1 U
C. chauvoei
whole culture
Meets Ph. Eur.
C. novyi toxoid
≥ 1.2 U
C. septicum toxoid
≥ 3.6 U
C. tetani toxoid
≥ 2.5 U
C. sordellii toxoid
≥ 0.8 U
C. haemolyticum
toxoid
≥ 16.5 U
Adjuvant:
Alum
3.03 – 4.09 mg/ml Aluminium
Preservative:
Thiomersal
0.05 – 0.18 mg/ml
Excipient to 1 ml:
Formaldehyde
≤ 0.5 mg/ml
Uses
For the active immunisation of sheep and cattle against diseases associated with infections caused by Clostridium perfringens type A, C.perfringens type B, C.perfringens type C, C.perfringens type D, Clostridium chauvoei, Clostridium novyi type B, Clostridium septicum, Clostridium sordellii and Clostridium haemolyticum and against tetanus caused by Clostridium tetani.
For the passive immunisation of lambs and calves against infections caused by the above mentioned clostridial species (except C.haemolyticum in sheep).
The onset of immunity is two weeks after the primary course.
Duration of active immunity
An anamnestic humoral immune response (immunological memory) to all components was demonstrated 12 months following the primary course of vaccination.
As demonstrated by serology/persistent antibody titre only:
Sheep: 12 months against C. perfringens type A, B, C, and D, C. novyi type B, C. sordellii, C. tetani
< 6 months against C. septicum, C. haemolyticum, C. chauvoei
Cattle: 12 months against C. tetani and C. perfringens type D
< 12 months against C. perfringens type A, B and C
< 6 months against C. novyi type B, C. septicum, C. sordellii, C. haemolyticum, C.chauvoei
Duration of passive immunity as demonstrated by serology/persistent antibody titre only is:
For lambs:
At least 2 weeks for C. septicum and C. chauvoei, at least 8 weeks for C. perfringens type B and C. perfringens type C and at least twelve weeks for C. perfringens type A, C. perfringens type D, C. novyi type B, C. tetani and C. sordellii. No passive immunity was observed for C. haemoloyticum.
For calves:
At least 2 weeks for C. sordellii, and C. haemolyticum, at least 8 weeks for C. septicum and C. chauvoei and at least twelve weeks for C. perfringens type A, C. perfringens type B, C. perfringens type C, C. perfringens type D, C. novyi type B, and C. tetani.
Dosage and administration
Dose
Sheep – from 2 weeks of age
Dose – 1 ml
Cattle – from 2 weeks of age
Dose – 2 ml
Primary vaccination: Two doses should be administered, 4-6 weeks apart.
Booster vaccination: A single dose should be administered at 6 to 12 month intervals.
Administration
By subcutaneous injection at a suitable site. The recommended site is the loose skin on the side of the neck. The bottle should be well shaken before any vaccine is withdrawn. Syringes and needles should be sterile before use and the injection should be made through an area of clean, dry skin taking precautions against contamination.
Use in pregnancy: To provide passive protection of the offspring, via the colostrum, a single booster dose should be administered between 8 and 2 weeks before parturition, provided that animals have received a full primary vaccination course before pregnancy.
Contra-indications, warnings, etc
75 – 100% of animals vaccinated with Covexin 10 may experience reactions to vaccination. These reactions are usually localised swelling or induration at the injection site but may also include mild hyperthermia, abscess or other reaction in the underlying tissues at the injection site.
Swelling at the injection site occurs in the majority of animals. This may reach up to a mean value of 6 cm in sheep and 15 cm diameter in cattle; occasionally reactions of up to 25 cm diameter may be seen in cattle. Most local reactions resolve in 3-6 weeks in sheep and less than 10 weeks in cattle, but may persist longer in a minority of animals. An abscess may develop in some animals. Vaccination may give rise to reactions in the underlying tissues at the injection site.
Skin discolouration at the injection site (which returns to normal as the local reaction resolved) may occur. Localised pain at the injection site for 1-2 days post vaccination may occur.
The local reactions do not affect the general health, demeanour, feeding or weight gain of the animals.
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.
Do not mix with any other veterinary medicinal product.
In the event of an anaphylactic reaction appropriate treatment such as adrenaline should be administered without delay. Do not vaccinate sick or immunodeficient animals.
No side effects other than those described above have been seen when Covexin 10 has been used in sheep and cattle between 8 and 2 weeks prior to parturition. In the absence of specific data, no recommendation can be made for use of the vaccine during the first or second trimester of pregnancy.
Avoid stress in pregnant ewes and cows.
Withdrawal periods
Zero days.
User Warnings
In case of accidental self-injection, seek medical advice immediately showing the package leaflet or the label to the physician.
Pharmaceutical precautions
Shelf-life after first opening the immediate packaging: 8 hours.
Store and transport refrigerated between +2°C and +8°C. Protect from light. Do not freeze.
Avoid the introduction of contamination during use.
Keep out of sight and reach of children.
For animal treatment only.
Legal category
Legal category: POM-VPS
Packaging quantities
50 ml and 100 ml flexible packs.
Not all presentations may be marketed.
Further information
The effectiveness of the vaccine in providing passive immunity to young lambs and calves depends on these animals ingesting adequate amounts of colostrum on the first day of life.
Clinical trials have demonstrated that the presence of maternal antibodies, particularly against C. tetani, C. novyi type B, C. perfringens type A (calves only), C. chauvoei (lambs only) and C. perfringens type D may reduce the antibody response to vaccination in young lambs and calves. Therefore, to ensure an optimal response in young animals with high levels of MDA, the primary vaccination should be delayed until the levels wane, usually after about 8-12 weeks of age.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Marketing Authorisation Number
Vm 42058/4022
Significant changes
GTIN
GTIN description:50 ml:
GTIN:05013457085754
GTIN description:100 ml:
GTIN:05013457085730