NOAH Compendium

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Date: Wednesday, December 12, 2018 21:47

MSD-AH
Release 2.9
Bravoxin 10 Suspension for injection for cattle and sheep
 
Species: Sheep, Cattle
Therapeutic indication: Immunological veterinary medical products: For cattle, For sheep
Active ingredient: Vaccine Antigens
Product:Bravoxin™ 10 Suspension for injection for cattle and sheep
Product index: Bravoxin 10
Cattle - milk: Zero hours
Cattle - meat: Zero days
Sheep - meat: Zero days
Qualitative and quantitative composition
Each 1 ml dose of vaccine contains:
Active substance
Potency per ml
Clostridium 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 type B 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#
* ELISA According to PhEur
1 In House ELISA
** Guinea pig challenge test according to PhEur
# In vitro toxin neutralisation test based on haemolysis of sheep erythrocytes.
Adjuvant
Aluminium potassium sulphate (alum)
3,026 - 4,094 ppm
Excipients
Thiomersal
0.05 - 0.18 mg
Formaldehyde
≤ 0.5 mg/ml
For a full list of excipients, see section “Pharmaceutical particulars”.
Pharmaceutical form
Suspension for injection.
Light brown aqueous suspension that settles on storage.
Clinical particulars
Target species
Cattle and sheep.
Indications for use
For the active immunisation of sheep and cattle against disease 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
Two weeks after the primary vaccination 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 types A, B, C and D; C. novyi type B; C. sordellii and C. tetani.
< 6 months against C. septicum; C. haemolyticum and C. chauvoei.
Cattle:
12 months against C. tetani and C. perfringens type D.
< 12 months against C. perfringens types A, B and C.
< 6 months against C. novyi type B; C. septicum; C. sordellii; C. haemolyticum and 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 12 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 12 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.
Contra-indications
Do not vaccinate sick or immunodeficient animals.
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 (MDA), 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 “Indications for use”).
Special precautions for use
In the event of an anaphylactic reaction appropriate treatment such as adrenaline should be administered without delay.
Operator warnings:
In the case of accidental self-injection, encourage bleeding and wash the area immediately with water. If a local reaction develops, seek medical advice showing the package leaflet or the label to the physician.
Adverse reactions
75 - 100% of animals vaccinated with Bravoxin 10 may experience reactions to vaccination.
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.
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 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.
Use during pregnancy, lactation or lay
No side effects other than those described in section “Adverse Reactions” 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, the use of the vaccine is not recommended during the first or second third of pregnancy. Avoid stress in pregnant ewes and cows.
Interactions
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.
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.
Shake well before use. 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.
Booster vaccination: A single dose should be administered at 6 to 12 month intervals.
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.
Overdose
In calves and lambs, local reactions may increase slightly if twice the recommended dose is administered (refer to section “Adverse Reactions”).
Withdrawal periods
Zero days.
Pharmacological particulars
Immunological properties
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.
ATCvet codes: QI02AB01
Pharmaceutical particulars
Excipients
Aluminium potassium sulphate (alum), Thiomersal, Formaldehyde and Sodium Chloride (0.85% solution).
Major incompatibilities
Do not mix with any other veterinary medicinal product.
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.
Special precautions for storage
Store and transport refrigerated (2 °C - 8 °C). Protect from light. Do not freeze.
Immediate packaging
Cardboard box with 1 flexible low density polyethylene bottle of 20, 50 or 100 ml with a pharmaceutical grade halogenobutyl rubber bung held in place with an aluminium seal. Not all pack sizes may be marketed.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Number
Vm 01708/4585
Significant changes
Date of the first authorisation or date of renewal
23 May 2014.
Date of revision of the text
May 2014.
Any other information
For animal treatment only. Keep out of the sight and reach of children.
Legal category
Legal category: POM-VPS
GTIN
GTIN description:Bravoxin 10 1x50ml:
GTIN:08713184126054,
GTIN description:Bravoxin 10 1 x 100ml:
GTIN:08713184133748