This product is only licensed for sale in the Republic Of Ireland

​Active Ingredient: C. perfringens type A, C. perfringens type B & C, C. perfringens type D, C. chauvoei whole culture meets Ph Eur, C. novyi toxoid, C. septicum toxoid, C. tetani toxoid, C. sordellii toxoid, C. haemolyticum toxoid

Target Species: Sheep, cattle

Treats and Controls: Lamb dysentery, pulpy kidney, struck, tetanus,braxy, blackleg and black disease

Administration Method: Subcutaneous injection (under the skin)

Withdrawal Time: There is no withdrawal time for this product

Dosage for cattle: 2 ml per animal. After the initial vaccination a second dose should be given no less than 4 weeks and no more than 6 weeks after.

Dosage for sheep: 1 ml per animal. After the initial vaccination a second dose should be given no less than 4 weeks and no more than 6 weeks after.

Always read the label and all enclosed information for Covexin 10 before administering to animals!

What causes a sheep to be stressed?

Click here to Download Data Sheets

Summary of Product Characteristics 

1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Covexin 10 Suspension for injection for sheep and cattle.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION
C. perfringens type A toxoid                0.5 U#
C. perfringens type B & C toxoid      18.2 IU*
C. perfringens type D toxoid               5.3 IU*
C. chauvoei whole culture meets Ph Eur.**
C. novyi toxoid                                    3.8 IU*
C. septicum toxoid                              4.6 IU*
C. tetani toxoid                                   4.9 IU*
C. sordellii toxoid                                4.4 U1
C. haemolyticum toxoid                    17.4 U#
Adjuvant
Alum                                      3.03 – 4.09 mg/ml Aluminium

Excipient                             0.05 – 0.18 mg/ml

* ELISA According to Ph.Eur.
1 In House ELISA
** Challenge test according to Ph.Eur.
# In vitro toxin neutralisation test based on haemolysis of sheep erythrocytes.

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM
Suspension for injection.
Light brown aqueous suspension that settles on storage.

4 CLINICAL PARTICULARS
4.1 Target Species
Sheep and cattle.

4.2 Indications for use, specifying the target species
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. haemolyticum.

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.

4.3 Contraindications
None.

4.4 Special warnings for each target species
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 (which is after about 8-12 weeks of age, see section 4.2).

4.5 Special precautions for use
Special precautions for use in animals
In the event of an anaphylactic reaction appropriate treatment such as adrenaline should be administered without delay.
Do not vaccinate sick or immunodeficient animals.

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)
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 25cm diameter may be seen in cattle.
Most local reactions resolve within 3-6 weeks in sheep and in 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 first vaccination may occur.
The local reactions do not affect the general health, demeanour, feeding or weight gain of the animals.

4.7 Use during pregnancy, lactation or lay
Pregnancy:
No side effects other than those described under 4.6 were seen when the vaccine was 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 third of pregnancy.
Avoid stress in pregnant ewes and cows.

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
Sheep – from 2 weeks of age         Dose - 1 ml
Cattle – from 2 weeks of age          Dose – 2 ml

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.

Primary vaccination:  Two doses should be administered, 4-6 weeks apart (see section 4.2 and 4.4).
Booster vaccination:   A single dose should be administered at 6 to 12 month intervals (see also point 4.2).

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.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
In calves and lambs, local reactions may increase slightly if twice the recommended dose is administered (refer to
section 4.6).

4.11 Withdrawal Period(s)
Zero days.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES
Immunological for Bovidae:        QI02AB01
Immunological for Ovidae:          QI04AB01

To stimulate active immunity in sheep and cattle against C. chauvoei and the toxins of Clostridium perfringens type A,
C. perfringens type B, C. perfringens type C, C. perfringens type D, C. novyi, C. septicum, C. tetani, C. sordellii, and
C. haemolyticum contained in the vaccine.
To provide passive immunity via the colostrum against the above clostridial infections in young lambs and calves.

6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Alum
Thiomersal
Formaldehyde
Sodium Chloride (0.85% solution)
 

6.2 Incompatibilities
Do not mix with any other vaccine/immunological product.

6.3 Shelf-life
Shelf life of the veterinary medicinal product as packaged for sale: 30 months
Shelf life after first opening the immediate packaging: 8 hours

6.4 Special precautions for storage
Store and transport between +2 °C and +8 °C.
Protect from light.
Do not freeze.

6.5 Nature and composition of immediate packaging
Cardboard box with 1 of 50 ml or 100 ml flexible high density polyethylene bottle and closed with a pharmaceutical
grade rubber bung held in place with an aluminium seal.
Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials
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
Zoetis Ireland Limited
25/28 North Wall Quay
Dublin 1
Ireland

8 MARKETING AUTHORISATION NUMBER(S)
VPA: 10438/009/001

9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 4th May 2009
Date of last renewal: 30th June 2009

10 DATE OF REVISION OF THE TEXT
January 2014

 Cattle Injectables
Injectables should be given according to the manufacturer’s instructions at the recommended injection site.
• Always use a clean, sterile syringe and needle. If using a multiple injection gun, ensure the needle is disinfected between injections, e.g. with an automatic sterilisation system.
• If the site to be injected is dirty, clean the skin and swab with an alcohol-impregnated wipe or cotton wool.
• Before injecting, check the expiry date and read the instructions of the product to be used. Some products need to be shaken before use.
• Use the correct-sized needle according to the size of the animal and site of injection.
• Ensure the animal is adequately restrained before attempting the injection.
• Take care to ensure it is given subcutaneously and not intramuscularly. Raise a fold of skin at the injection site (mainly neck but some are ear) recommended by the product manufacturer and inject carefully into the space created.
• If a large dose is to be delivered, it may be advisable to split the dose between two injection sites. After the injection, briefly massage the site to improve the dispersal of the injected material.
• Dispose of the needle and syringe in appropriate clinical waste and sharps containers.

Sheep Subcutaneous injections
Subcutaneous injections need to be administered with care to ensure the product is placed under the skin and not into the fleece or muscle.
The sheep needs to be well restrained, and the skin ‘tented’ away from the underlying muscle.
The preferred injection site is 10–15 cm (4–6 inches) below the ear on the side of the neck (see diagram below). Usually a 1.6 cm (5/8 inch) needle is ideal.
After administration, the site should be gently massaged.

Delivery Information

Delivery Service

Here at Agridirect we have joined forces with DPD to ensure all packages are delivered promptly and safely to you. We ship to all mainland countries within the EU. Deliveries take place Monday to Friday excluding bank holidays. Once your order has been dispatched from our warehouse you will be notified by email. If there is a delay with your order for any reason you will be contacted immediately. 

Due to Brexit we are temporarily unable to ship to the UK. Shipping to Northern Ireland will remain in place.

Delivery Times

Some products have an extended delivery time, this is noted on the products.

Delivery Rates

A selection of the products we sell are only licensed for sale within the Republic Of Ireland and can not be shipped outside of the country. These products are noted as only being available within the Republic of Ireland on the individual product pages.

There may be an addition charge on certain bulky items. This charge will be clearly marked on an applicable products and will be explained on the checkout page before payment has been made.

Agridirect Returns Policy

We’re sorry your purchase didn’t work out. But don’t worry; we have a great returns policy to help you out.

All purchases can be returned to us within 14 days of delivery and returned goods must be received within 14 days from the date you informed us of the return.

Purchases may be opened for inspection but must not be used and must be repackaged securely in the original packaging if you wish to return it.

If we discover goods have been used or there has been a loss in value of the goods due to damage to the goods, while in your care or whilst being returned to us, we will reduce the amount refunded, which may amount to the full cost of the product, to cover loss of value of goods.

All returns should be complete which includes boxes, manuals and accessories that may have been included with the order.

All returns must be packaged appropriately for shipping, we will not accept responsibility for damages or loss which occur during shipping of a return product.

We accept no responsibility for goods damaged or lost while in transit to us. 

How do I return a product?

We have partnered with DPD to make your returns process easy and secure. simply follow the steps below and bring your package to an official DPD pickup point.

1) All returns must be accompanied with a fully filled out returns form which can be downloaded here.

2) To print off your return label click here or visit www.dpd.ie/returns and follow the on-screen instructions. Make sure and use your order number as your reference.

• Select “Continue as Guest”
• Select “Agridirect” from the drop-down menu
• Select your reason for returning
• Select the size of the package you wish to return
• Accept DPD’s terms and conditions
• Fill in your payment details
• Fill in your own details
• Follow the instructions to print off your label

3) Bring your package to a DPD pickup point. To find your nearest drop off point here.

Once the returned product has been received into our warehouse and been fully inspected a refund will be issued.

If you choose not to use the DPD returns service we recommend that you use a method that can be tracked.

For the return of bulk products please contact us at sales@agridirect.ie

I have received a damaged product from you, what should I do?

First off, if you have received a damaged electrical product from us, do not plug it in. Any electrical products that are plugged in are deemed ‘as used and accepted’ and are not accepted as returns. All damages must be reported to us via phone or email within 24hours of receipt of goods. Please ensure you check your items upon delivery.

How do I begin the returns process?

If you wish to begin the return process, please email us at sales@agridirect.ie and ensure the following information is included in your email. Your name, phone number, Order id, the item you wish to return, reason for return and if the product is damaged we require photos of the product.

Once you have sent us all required information a member of our team will assess your claim and will contact you as soon as possible. Please hold off on returning products until a member of our team has called you to confirm.

Refunds

Once the returned product has been returned to us and fully inspected a refund will be issued.

Please Note: A typical timeline for a refund to show in your account is up to 10 working days from the date processed, depending on your bank.