Covexin®10

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 (enterotoxemia, haemorrhagic enteritis), C. perfringens type B (lamb dysentery), C. perfringens type C (necrotic enteritis), C. perfringens type D (enterotoxemia/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 is established within 14 days of administration of the second dose and lasts for 1 year.

COMPOSITION

STORAGE

• Store between 2 ºC and 8 ºC.
• Do not freeze.
• Protect from light.
• Opened bottles should be discarded within 8 hours of opening.

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 this product.
• Only sterile syringes and needles should be used. The injection should be made through an area of clean, dry skin.
• Partially used containers and vaccination equipment should be discarded according to local waste disposal regulations at the end of the day’s operations, as under field conditions it may be difficult to avoid accidental contamination.
• Cattle: Swelling may occur at the site of injection which should resolve within 1 to 2 months. 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.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED
Shake well before and during use.
Administration
Subcutaneous injection, 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 period of risk, 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.
The vaccine 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. The vaccine may be used in calves as young as 2 weeks of age regardless of serum antitoxin levels acquired from maternal transfer.

REGISTRATION HOLDER
Cooper Veterinary Products (Pty) Ltd.
Private Bag X2026
Isando, 1600, RSA
Tel: +27 (0) 11 923 9300

MARKETED BY
MSD Animal Health
20 Spartan Road, Spartan
1619, RSA
Tel: +27 (0) 11 923 9300
Fax: +27 (0) 11 392 3158
www.msd-animal-health.co.za

DATE OF PUBLICATION OF PACKAGE INSERT
30 October 2003

SLEGS VIR DIEREGEBRUIK

COVEXIN®10
Reg. Nr. G3354 (Wet 36/1947)
Namibië Reg. Nr. V05/24.4/413 NS0

Klostridiale entstof vir skape en beeste.

INDIKASIES
Vir die aktiewe immunisering van skape en beeste vanaf ‘n ouderdom van 2 weke om sterftes, letsels en kliniese tekens te verhoed van siektes veroorsaak deur Clostridium perfringens tipe A (enterotoksemie, rooiderm), C. perfringens tipe B (bloedpens), C. perfringens tipe C (nekrotiese enteritis), C. perfringens tipe D (enterotoksemie/bloednier), C. chauvoei (sponssiekte), C. novyi tipe B (aansteeklike nekrotiese hepatitis), C. septicum (kwaadaardige edeem), C. tetani (tetanus), C. sordellii (skielike dood sindroom/hemorragiese enteritis) en C. haemolyticum (basillêre hemoglobinurie).
Immuniteit word 14 dae ná enting met die tweede dosis teweeggebring en is vir 1 jaar doeltreffend.

SAMESTELLING

BERGING

• Berg tussen 2 °C en 8 °C.
• Moenie vries nie.
• Beskerm teen lig.
• Vernietig alle houers binne 8 ure ná oopmaak.

WAARSKUWINGS

• Onttrekkingsperiode:Moenie diere vir menslike gebruik slag binne 21 dae* na inenting nie.
• Ent slegs gesonde diere.
• Dit word nie aanbeveel dat ander entstowwe binne 14 dae voor of na enting met hierdie produk toegedien word nie.
• Slegs steriele spuite en naalde moet gebruik word. Die inspuiting moet deur skoon, droë vel toegedien word.
• Gedeeltelik gebruikte houers en inentingstoerusting moet vernietig word volgens plaaslike afvalbestuursregulasies aan die einde van die dag se gebruik, siende dat dit moeilik is om onder veldtoestande toevallige kontaminasie van die entstof te vermy.
• Beeste: ‘n Swelsel by die plek van inenting mag voorkom, maar behoort binne 1 tot 2 maande te verdwyn. Die voorkoms en ernstigheid mag hoër wees in kalwers jonger as 1 maand oud.
• Skape: ‘n Swelsel by die plek van inenting mag voorkom, maar behoort binne 1 tot 2 maande te verdwyn.
• Soos met alle entstowwe mag hipersensitiwiteitsreaksies af en toe voorkom. Raadpleeg u veearts in so ‘n geval.
• HOU BUITE BEREIK VAN KINDERS, ONINGELIGTE PERSONE EN DIERE.
• Alhoewel hierdie entstof breedvoerig onder ‘n wye verskeidenheid toestande getoets is, mag dit faal as gevolg van verskeie redes. Indien dit vermoed word, raadpleeg ‘n veearts en verwittig die registrasiehouer.

GEBRUIKSAANWYSINGS – GEBRUIK SLEGS SOOS AANGEDUI
SKUD GOED VOOR EN GEDURENDE GEBRUIK.
Toediening
Onderhuise insputing, verkieslik in die los vel op die sykant van die nek.

Dosis
Skape en lammers ouer as 2 weke
Twee inspuitings van 1 mℓ elk, met ‘n tussenpose van 6 weke en ‘n jaarlikse skraagdosis.
Die entingskursus behoort ten minste 2 weke voor maksimum immuniteit verlang word voltooi te wees d.w.s óf ‘n risikoperiode óf in dragtige ooie gedurende lamming.
Ooie wat reeds gesensitiseer is behoort 2 tot 6 weke voor lamming geënt te word. Dit sal passiewe beskerming oordra via die biesmelk en lammers sal beskerm wees vir tot 12 weke.
Lammers van 2 weke oud kan geënt word, ongeag die serumvlak van moederlike antitoksiene oorgedra.

Koeie en kalwers ouer as 2 weke
Twee inspuitings van 2 mℓ elk, met ‘n tussenpose van 6 weke en ‘n jaarlikse skraagdosis.
Koeie wat reeds gesensitiseer is behoort 2 tot 6 weke voor kalwing geënt te word. Dit sal passiewe beskerming oordra via die biesmelk en kalwers sal beskerm wees vir tot 12 weke.
Kalwers van 2 weke oud kan ingeënt word, ongeag die serumvlak van moederlike antitoksiene oorgedra.

REGISTRASIEHOUER
Cooper Veterinary Products (Pty) Ltd.
Privaatsak X2026
Isando, 1600, RSA
Tel: +27 (0) 11 923 9300

BEMARK DEUR
MSD Animal Health
Spartanweg 20, Spartan
1619, RSA
Tel: +27 (0) 11 923 9300
Faks: +27 (0) 11 392 3158
www.msd-animal-health.co.za

DATUM VAN PUBLIKASIE VAN VOUBILJET
30 Oktober 2003