Covexin®10

A multiclostridial vaccine for cattle and sheep from 2 weeks of age to prevent mortality, lesions and clinical signs of disease caused by Clostridium perfringens type A (haemorrhagic enteritis), C. perfringens type B (lamb dysentery), C. perfringens type C (necrotic enteritis), C. perfringens type D (pulpy kidney), C. chauvoei (black quarter), C. novyi type B, C. septicum (malignant oedema), C. tetani (tetanus), C. sordellii (sudden death syndrome) and C. haemolyticum (C. novyi type D).

FOR ANIMAL USE ONLY

COVEXIN® 10

Reg. No. G3354 (Act 36/1947)

Namibia Reg. No. V05/24.4/413 [NS0]

Clostridial vaccine for sheep and cattle

INDICATIONS

For the active immunisation of sheep and cattle from 2 weeks of age to prevent mortality, lesions and clinical signs of disease caused by Clostridium perfringens type A (enterotoxaemia, haemorrhagic enteritis), C. perfringens type B (lamb dysentery),
C. perfringens type C (necrotic enteritis), C. perfringens type D (enterotoxaemia/pulpy kidney), C. chauvoei (blackleg/black quarter), C. novyi type B (infectious necrotic hepatitis), C. septicum (malignant oedema), C. tetani (tetanus), C. sordellii (sudden death syndrome/haemorrhagic enteritis) and C. haemolyticum (bacillary haemoglobinuria).

IMMUNITY

Immunity is established within 14 days of administration of the second dose and lasts for

1 year.

COMPOSITION

STRAINPOTENCY VALUE/DOSE
C. perfringens type A toxoid≥ 0,5 IU
C. perfringens type B toxoid≥ 10 IU β/≥ 5 IU ٤
C. perfringens type C toxoid≥ 10 IU β
C. perfringens type D toxoid≥ 5 IU ٤
C. chauvoei whole cultureMeets Ph. Eur.
C. novyi toxoid≥ 3,5 IU
C. septicum toxoid≥ 2,5 IU
C. tetani toxoid≥ 2,5 IU
C. sordellii toxoid≥ 1,0 U
C. haemolyticum toxoid≥ 10 U

STORAGE INSTRUCTIONS

  • Store between 2 ºC – 8 ºC in a refrigerator.
  • Do not freeze.
  • Protect from light.
  • Use within 8 hours of opening.
  • Do not store partially used containers for future use.

WARNINGS

  • Withdrawal period: Do not slaughter animals for human consumption within 21 days* of vaccination.
  • Vaccinate healthy animals only.
  • It is not recommended that other vaccines be administered within 14 days before or after vaccination with Covexin® 10.
  • The injection should be made through an area of clean, dry skin.
  • Cattle: Swelling may occur at the site of injection which should resolve within 1 to

2 months post-vaccination. The incidence and severity may be higher in calves less than 1 month of age.

  • Sheep: Swelling may occur at the site of injection which should resolve within 1 to

2 months post-vaccination.

  • As with any vaccine, occasional hypersensitivity reactions may occur. In such cases, consult your veterinarian.
  • KEEP OUT OF REACH OF CHILDREN, UNINFORMED PERSONS AND ANIMALS.
  • Although this vaccine has been tested under a large variety of conditions, failure thereof may ensue as a result of a wide range of reasons. If this is suspected, seek veterinary advice and notify the registration holder.

* 21 days is a standard withdrawal period set according to South African legislation, for all vaccine products. If required by national legislation another withdrawal period may also be licensed, e.g., 0 days.

PRECAUTIONS

  • Observe aseptic precautions. Ensure that all vaccination equipment (containers, syringes and needles) is clean and sterile prior to and during use. Use sterile equipment when administering the vaccine.
  • Do not use disinfectants or antiseptics to sterilise any equipment.
  • It is good vaccination practice, when handling the vaccine, to avoid contact with the eyes, hands and clothing.
  • Do not eat, drink or smoke whilst handling the product.
  • Destroy any unused vaccine and dispose of all the empty vaccine containers and disposable equipment after use in accordance with National Environmental Management: Waste Act, 2008 (Act No. 59 of 2008).
  • Do not contaminate rivers, dams or any water sources with containers or waste.

DOSAGE AND DIRECTIONS FOR USE – USE ONLY AS DIRECTED

  • Shake well before and during use.
  • Administer subcutaneously, preferably in the loose skin on the side of the neck.

Dosage

  • Sheep and lambs over 2 weeks of age

Two injections of 1 mℓ each, at an interval of 6 weeks, and a booster annually thereafter.

The vaccine course should be completed at least 2 weeks before maximum immunity is required i.e., a risk period, or in pregnant ewes during lambing.

Previously sensitised ewes should be injected 2 to 6 weeks before lambing is due to commence. This provides passive protection of the lamb, via the colostrum, for up to

12 weeks.

Covexin® 10 may be used in lambs as young as 2 weeks of age, regardless of serum antitoxin levels acquired from maternal transfer.

  • Cows and calves over 2 weeks of age

Two injections of 2 mℓ each, at an interval of 6 weeks, and a booster annually thereafter.

Previously sensitised cows should be injected 2 to 6 weeks before calving is due to commence. This provides passive protection of the calf, via the colostrum, for up to

12 weeks.

Covexin® 10 may be used in calves as young as 2 weeks of age, regardless of serum antitoxin levels acquired from maternal transfer.

PRESENTATION

50 mℓ or 100 mℓ light brown aqueous suspension in a low density polyethylene flexible bottle, closed with a pharmaceutical grade rubber bung held in place with an aluminium seal. Not all pack sizes may necessarily be marketed.

REGISTRATION HOLDER                                                      

Cooper Veterinary Products (Pty) Ltd.

20 Spartan Road, Spartan

1619, RSA

Tel: +27 (0) 11 923 9300                                                            

E-mail: msdahza@msd.com

www.msd-animal-health.co.za

DATE OF PUBLICATION OF THIS PACKAGE INSERT

30 October 2003