Bovidec against BVD, foetal protection that lasts

Summary of product characteristics
BVD: why eradication is essential
BVD will remain in a herd as long as PI animals come into contact with pregnant cows or heifers in early
pregnancy, infecting unborn calves, leading to the birth of more PI animals.
The BVD disease cycle
Non-pregnant
naïve animal
Naïve animals in
the first trimester
of pregnancy
Persistently Infected (PI) animals
Naïve animals in
the second trimester
of pregnancy
Naïve animals in
the third trimester
of pregnancy
• BVD persists in herds due to the birth of PI animals.
• Live calves born to PI cows are always PI themselves.
• Live calves born to normal cows exposed to BVD virus in
the first trimester will be also be PI.
Virus infects the cow
Scour, milk drop,
reduced WBC’s.
Usually mild illness. Can
show no clinical signs
Cows will produce
antibodies approximately
2 weeks after infection
Virus infects the cow
in the first three months
of pregnancy
Usually the virus will
terminate the pregnancy
and reduce fertility. However
some foetuses can survive
and are born as Persistently
infected animals
Cows will produce
antibodies approximately
2 weeks after infection.
Will have reproductive
losses or PI’s
Virus infects the cow
in the second three
months of pregnancy
Virus can cause
abortion or congenitally
deformed calves
Cows will produce
antibodies approximately
2 weeks after infection.
Will have reproductive
losses or deformed calves
Virus infects the cow
in the last three
months of pregnancy
At this stage of
pregnancy the foetus
is born weak or it can
also be born as a
normal healthy calf
Bovidec against BVD,
foetal protection that lasts
• PI animals:
• Shed BVD virus at high levels for life.
• Can look entirely normal or stunted and ill-thrifty.
• Often do not survive beyond 2 years of age.
• Some live longer and appear asymptomatic.
• Can develop Mucosal Disease, a fatal wasting
condition (now rarer due to improved
control measures).
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Bovidec.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
(per 4 ml dose)
Active Ingredient
Bovine Viral Diarrhoea (BVD) virus 5 x 106 TCID50. strain KY1203nc (inactivated)
Adjuvant
Quil A
1 mg
Excipients
Thiomersal. For a full list of excipients see Section 6.1
3. PHARMACEUTICAL FORM
Suspension for injection. Pink, aqueous suspension.
4. CLINICAL PARTICULARS
4.1 Target species
Cattle
4.2 Indications for use (specifying the target species)
(i) Adult female breeding cattle.
For the active immunisation of adult female breeding cattle:
1. Prior to insemination/service to prevent infection of
the foetus with BVD Type I virus. Results from studies
available to date indicate that the protection afforded
against BVDV Type I should exist for at least 420 days
post initial vaccination.
2. It has been shown under field conditions that the
vaccine may reduce the incidence of herd infertility
when a diagnosis of infertility is associated with clinical
manifestations of BVD Type I infection.
(ii) Calves from the age of 4 months.
For the active immunisation of calves:
1. To reduce viraemia and viral shedding of BVD Type
I virus, once maternal antibodies have declined. The
duration of immunity is 13 months.
2. To reduce viraemia and the clinical signs of disease
caused by BVD virus Type II, once maternal antibodies
have declined. Results indicate the reduction in
symptoms afforded should persist for at least 21 days
after vaccination.
4.3 Contraindications
Do not administer to animals that have previously shown a
hypersensitivity reaction.
Avoid vaccination of animals, which have intercurrent
disease, are on a course of concomitant therapy or have a
poor nutritional status.
4.4 Special warnings (for each target species)
In any group of animals, a small number of individuals may
fail to respond to vaccination as a result of immunological
incompetence or for some other reason. Satisfactory
immune responses will only be attained in healthy animals.
When pregnant animals are vaccinated, it should be
remembered that the calves they are carrying might have
already been exposed to virus if the dam was naïve in the
earlier stages of pregnancy.
4.5 Special precautions for use
Special precautions for use in animals
None.
Special precautions to be taken by the person
administering the product to animals.
Care should be taken to avoid self-injection: if this occurs,
seek medical advice and show the package leaflet or label
to the physician.
4.6 Adverse reactions (frequency and seriousness)
Occasional hypersensitivity reactions may occur as with
all vaccines.
Should anaphylaxis occur, use epinephrine (adrenaline).
Transient pyrexia and injection site inflammatory reactions
may occur.
The pyrexia is unassociated with any other clinical illness,
the animals continuing to behave and eat normally.
The local reaction consists of a diffuse, subcutaneous
oedema, which subsides over 2-3 weeks.
4.7 Use during pregnancy and lactation or lay
Can be used during pregnancy.
4.8 Interaction with other medicinal products and other
forms of interaction
No information is available on the compatibility of this
vaccine with any other. Therefore, the safety and efficacy of
this product when used with any other (either when used
on the same day or at different times) has not
been demonstrated.
4.9 Amount(s) to be administered and
administration route
The dose is 4 ml administered by subcutaneous injection.
It is recommended that injection be made high on the
side of the neck. Syringes and needles should be sterile
and the injection made through an area of clean and dry
skin observing aseptic technique. Shake the container well
before use.
Primary Vaccination
Adult Breeding Cattle
Animals should receive 2 doses of vaccine, 3 weeks apart.
The vaccination programme should be completed not less
than 7 days prior to service.
Calves
Animals should receive 2 doses of vaccine, 3 weeks apart.
Calves can be vaccinated from 3.5 months of age once
maternal antibody has declined. Where calves are likely to
be seropositive, the minimum age of primary vaccination
should be 5 months.
Booster Vaccination
A single annual booster dose is recommended. For adult
breeding cattle, booster vaccination should be administered
not less than 7 days prior to service.
4.10 Overdose (symptoms, emergency procedures,
antidotes), if necessary
The administration of an overdose via the subcutaneous
route will result in marked swelling at the injection site
and a transient pyrexia. The duration of the reactions is
unknown but can last for at least 2 weeks and the pyrexia
will resolve within 12-24 hours. No specific treatment is
necessary.
4.11 Withdrawal period(s)
Zero days.
5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Immunologicals for bovidae,
cattle, inactivated viral vaccines.
ATC Vet Code: Q102AA01.
To induce active immunity against BVDV in the
target species.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Quil A. Thiomersal. Minimal Essential Medium
6.2 Incompatibilities
Do not mix with any other veterinary medicinal product.
6.3 Shelf-life
Shelf-life of the veterinary medicinal product as packaged
for sale: 18 months. Shelf-life after first opening the
immediate packaging: Use immediately.
6.4 Special Precautions for Storage
Store and transport refrigerated (2°C – 8°C).
Do not freeze.
6.5 Nature and composition of the immediate packaging
Carton with 6 x 20 ml vials:
Container: Clear Type I glass vial.
Closure:
Bromobutyl rubber stopper with
aluminium overseal
Outer Pack: Cardboard carton with inserted
package leaflet
Carton with single 200 ml vial:
Container: Clear type I glass vial
Closure:
Bromobutyl rubber stopper with
aluminium overseal
Outer Pack: Cardboard carton with inserted
package leaflet
6.6 Special Precautions for the Disposal of the Unused
Product or Wastes Materials
Any unused veterinary medicinal product or waste materials
derived from such veterinary medicinal products should be
disposed of in accordance with the local requirements.
7. MARKETING AUTHORISATION HOLDER
Novartis Animal Vaccines Limited
Frimley Business Park
Frimley, Camberley
Surrey GU16 7SR
8. MARKETING AUTHORISATION NUMBER
Vm 18343/4004
9. DATE OF FIRST AUTHORISATION/RENEWAL
OF THE AUTHORISATION
Date of first authorisation: 22 September 1995
Date of last renewal: 22 September 2005
10. DATE OF REVISION OF THE TEXT
August 2012
Legal category: POM-V
Cows will produce antibodies
approximately 2 weeks
after infection. Abortions
at this stage of pregnancy
are unusual
BVD virus: non-pregnant animals
• Most infections are transient infections (TI) where normal,
non-pregnant animals are exposed to the BVD virus.
• Over a period of weeks they raise a natural immune response, but
until then they will be virus positive.
• Eventually, once the immune response has developed, they will test
antibody positive, virus negative.
• It is important to retest suspected PI animals to avoid culling
previously TI animals.
BVD virus: pregnant animals
• Infection in the first trimester results in abortion or the birth of a
persistently infected (PI) calf. These PI animals recirculate disease
in the herd.
For use in National BVD Eradication Schemes
420 days foetal protection
• The only BVD vaccine with a once-a-year herd booster
•Licensed
• Infection in the second trimester results in: abortion, congenitally
deformed or weak calves.
• Infection in the third trimester has less effect on the more
developed foetus and infected calves will be born normal.
For further information contact Novartis Animal Health UK Ltd, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR Tel. 01276 694402
Bovidec contains inactivated BVD virus adjuvanated in Quil A and preserved in thiomersal 0.013%. Bovidec ® is a registered trademark
of Novartis AG, Basel, Switzerland. Advice on the use of this or alternative medicines must be sought from the medicines prescriber.
Use medicines responsibly (www.noah.co.uk/responsible). Legal category POM-V. FAB/12/1120 rdp19223 Nov ‘12
BOVIDEC BVD Virus Vaccine
For annual herd vaccination
• Suitable for use in National BVD Eradication Schemes.
•Licensed 420 days foetal protection.
How to control BVD
Bovidec in action
Helping farmers to implement BVD eradication plans will help break the cycle of BVD infection.
BVD eradication plans should focus on: planning, investigation, vaccination and biosecurity.
The Mitchell family, Bob, Betty and Margo, started BVD
testing in October 2010, and vaccinating in January 2011,
working alongside local Veterinary Surgeon Amira NasimHopfer of Tay Valley Vets. So far, of the 181 calves born on
Drumdreel Farm in 2011 none have died, compared to a
mortality rate for the previous five years of between 12%
and 14%.
Planning:
• Ideal for use in dairy and beef herds.
• Licensed claim for reduction of infertility due to BVD type I.
• Licensed for use in calves to protect against BVD types I and II.
Discuss the objectives of BVD control with your farmer clients.
Consider recommending a closed herd versus a herd where cattle
are constantly arriving and departing, a high risk for spreading the
BVD virus.
BVD Eradication Schemes
Symptoms
BVD is a complex, costly disease which only eradication will prevent.
BVD virus infection implicates the reproductive and immune systems.
It is a pestivirus, transmitted by the Bovine Viral Diarrhoea Virus, with
Whilst the effects of immunosupression can be hard to quantify, often
persistently infected (PI) animals being the main source of infection,
without obvious clinical signs, detrimental effects include:
shedding large amounts of virus.
Cows
For the health of their national herds, both Scotland and the Republic
• More cows culled as barren.
of Ireland have already implemented BVD Eradication Schemes and,
• More services to get cows in calf.
Economic benefits
Discuss the economic benefits: BVD control makes sound financial
sense, delivered by improved calf health and increased productivity.
Studies commissioned by Animal Health Ireland estimate the cost of
BVD to be:
• €30 (£27)/cow in suckler herds
• €48 (£43)/cow in dairy herds
in the UK, pilot schemes are underway. Bovidec, with its ‘once a
• Extended calving indices.
Scottish government studies estimate BVD eradication to be worth
year’ flexibility, plays a vital part in such schemes which comprise:
• Abortions and neonatal deaths.
£50-80 million in increased output and reduced business costs over
• Viral diarrhoea.
the next 10 years: around £15,800 per year in additional dairy output
• Mucosal disease.
and £2,000 per year for non-dairy businesses.
• Ill thrift with increased susceptibility to diseases.
Investigation:
• Testing to determine herd status.
• Responsible management of PI animals.
•Vaccination.
• Herd monitoring.
• Sensible biosecurity measures.
Calves
Screening herds to identify and remove PI animals is a vital first step
•Deformed calves – e.g. brain-damage, cataracts etc.
to BVD eradication and control. Options include:
• Calves born weak and dying.
Bulk milk antibody test
• More cases of pneumonia and scouring.
• Increased mortality.
• Poor health.
• Reduced sale weights and numbers.
• A positive result indicates past or current exposure.
• Useful for ongoing screening to monitor milking herds over a
period of time.
• Of limited value when trying to identify individual infected animals.
Bulk milk Polymerase Chain Reaction test (PCR)
• A positive result indicates active infection in the milking herd
Blood antibody test
• Use to screen young animals (6 to 9 months of age) to determine if
there is active disease in the herd.
• Positive = animal has either been vaccinated or exposed to
BVD virus in the past.
• In young animals, this must be the ‘recent past’, suggesting current
virus and disease in the herd.
PI Identification – herd screening
• Positive antibody/virus results from a group of representative
animals indicate whole herd individual tissue or blood testing to
identify PI animals should be carried out.
• If active disease is confirmed, screen the herd for BVD virus to
identify and remove all affected animals.
• Blood samples and milk samples can be pooled (at the laboratory)
Vaccination:
A vaccination plan with ‘once-a-year’ Bovidec ensures
maximum immunity is present at the beginning of the animals’
breeding season. Vaccinations should be carried out according to
label instructions.
First vaccination
• 2 vaccinations (primer and booster) given 3 weeks apart.
• Complete course no less than 7 days before service.
Annual booster
One single annual booster is recommended. Significant farmer
benefits include better value and less animal handling, saving time,
effort and stress.
Dose
“We couldn’t understand why we were losing so many
calves,” said Bob. “We were seeing rotavirus, E. coli,
enteritis, Cryptosporidium, pneumonia IBR and coccidiosis.
Nothing seemed to help, no matter how much colostrum
was given to them in the first 6 hours, so with the Scottish
Government declaring Scotland should be BVD free, Amira
advised that we test for BVD.”
Single annual herd booster
A milk test revealed no PI animals, but that half the herd
had been exposed to the infection. Further testing in the
young stock led to one PI animal being culled immediately.
4ml s/c.
Needing to vaccinate all breeding animals they opted for
Bovidec with its single annual herd booster: “With a dairy
herd breeding all year around, vaccinating every two
can be tested to identify the particular animal/s causing the
Biosecurity
months just isn’t practical.”
positive result .
BVD requires the same biosecurity as any other disease. However,
Youngstock PIs were still a concern, and 60 unvaccinated
animals revealed four positive results. 100 vaccinated
animals were also tested with one pool of ten testing positive
for virus. Individual testing in the positive pool, revealed a
further PI. Vaccinating PI animals has no effect so they had to
be removed from the herd. Ear notching all new born calves
for antigen at 4 - 6 weeks old, returned negative results.
for BVD virus screening.
• If a pool is BVD virus positive, then retained individual samples
Ear punch tissue test
• Evaluates an individual animal’s status.
• Preferred test in the Republic of Ireland’s BVD
Eradication programme.
• Can be carried out at birth, by farmers,
and submitted to laboratories.
• Not affected by maternally
derived antibodies.
• Positive results identify PI
requiring individual animal tissue or blood testing to identify
animals (however, animals may
PI animals.
be transiently infected (TI).
on-going monitoring, to measure its effectiveness, is recommended
and can include:
• Four quarterly bulk milk tests.
• Tissue testing all calves born in the year.
• Blood antibody testing a group of young stock.
181 calves – not one lost
“Out of 181 calves born this year, we have not lost one,” said
Mr Mitchell. “It’s a huge benefit and if we keep rearing calves
this healthy, it must improve the adult portion of the herd.”
• Useful for screening.
Recheck in two to three weeks
Amira Nasim-Hopfer agrees: “Beating BVD requires
teamwork between vets and farmers. The Mitchells have
seen clear results within the year, with calf mortality falling
• Useful for identifying sources of infection.
before culling).
from upward of 14% to nothing, which speaks for itself.”
Out of 181 calves born this year,
we have not lost one