Special precautions i) Special precautions for use in animals 1. In the event of an anaphylactic reaction appropriate treatment such as adrenaline should be administered without delay. 2. Do not vaccinate sick or immunodeficient animal iii)Other precautions None Adverse reactions (Frequency & seriousness) 1. 75 – 100% of animals vaccinated with Covexin 10 may experience reactions to vaccination. 2. Most commonly reported adverse reactions are 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. 3. 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. 4. 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. 5. An abscess may develop in some animals. 6. Vaccination may give rise to reactions in the underlying tissues at the injection site. 7. Skin discolouration at the injection site (which returns to normal as the local reaction resolved) may occur. 8. Localised pain at the injection site for 1-2 days post first vaccination may occur. 9. The local reactions do not affect the general health, demeanour, feeding or weight gain of the animals. Duration of active immunity: An anamnestic humoral immune response (immunological memory) to all components was demonstrated 12 months following the primary course of vaccination. Contraindications None Composition Each 1 ml dose of vaccine contains Active substances Potency value/mL C. perfringens type A (α) toxoid ≥ 0.5 U# C. perfringens type B & C (β) toxoid ≥ 18.2 IU* C. perfringens type D (ε) toxoid ≥ 5.3 IU* C. chauvoei whole culture ≥ 90% protection** 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 Aluminium potassium sulphate (alum) 3,026 – 4,094 ppm Excipients Thiomersal 0.12-0.18mg Formaldehyde≤ 0.05% w/v PHARMACEUTICAL FORM 1. Suspension for injection. 2. Light brown aqueous suspension that settles on storage. Target species Sheep and cattle from 2 weeks of age
20 dirhams
200 dirhams
Special precautions i) Special precautions for use in animals 1. In the event of an anaphylactic reaction appropriate treatment such as adrenaline should be administered without delay. 2. Do not vaccinate sick or immunodeficient animal iii)Other precautions None Adverse reactions (Frequency & seriousness) 1. 75 – 100% of animals vaccinated with Covexin 10 may experience reactions to vaccination. 2. Most commonly reported adverse reactions are 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. 3. 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. 4. 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. 5. An abscess may develop in some animals. 6. Vaccination may give rise to reactions in the underlying tissues at the injection site. 7. Skin discolouration at the injection site (which returns to normal as the local reaction resolved) may occur. 8. Localised pain at the injection site for 1-2 days post first vaccination may occur. 9. The local reactions do not affect the general health, demeanour, feeding or weight gain of the animals. Duration of active immunity: An anamnestic humoral immune response (immunological memory) to all components was demonstrated 12 months following the primary course of vaccination. Contraindications None Composition Each 1 ml dose of vaccine contains Active substances Potency value/mL C. perfringens type A (α) toxoid ≥ 0.5 U# C. perfringens type B & C (β) toxoid ≥ 18.2 IU* C. perfringens type D (ε) toxoid ≥ 5.3 IU* C. chauvoei whole culture ≥ 90% protection** 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 Aluminium potassium sulphate (alum) 3,026 – 4,094 ppm Excipients Thiomersal 0.12-0.18mg Formaldehyde≤ 0.05% w/v PHARMACEUTICAL FORM 1. Suspension for injection. 2. Light brown aqueous suspension that settles on storage. Target species Sheep and cattle from 2 weeks of age
available
