ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
Improvac
solution for injection for pigs
2.
One dose (2 ml) contains:
Active substance:
Gonadotropin releasing factor (GnRF) analogue-protein conjugate
min. 300 μg.
(a synthetic peptide analogue of GnRF conjugated to Diphtheria Toxoid)
Adjuvant:
Diethylaminoethyl (DEAE)-Dextran, an aqueous, non-mineral oil-based adjuvant
300 mg.
Excipient(s):
Thiomersal
0.2 mg.
For a full list of excipients, see section 6.1.
3.
Solution for injection.
4.
Male pigs (from 8 weeks of age).
Induction of antibodies against GnRF to produce a temporary immunological suppression of testicular
function. For use as an alternative to physical castration for the reduction of boar taint caused by the
key boar taint compound androstenone, in entire male pigs following the onset of puberty.
Another key contributor to boar taint, skatole, may also be reduced as an indirect effect. Aggressive
and sexual (mounting) behaviours are also reduced.
The onset of immunity (induction of anti-GnRF antibodies) can be expected within 1 week post
second vaccination. Reduction of androstenone and skatole levels has been demonstrated from 4 to 6
weeks post second vaccination. This reflects the time needed for clearance of boar taint compounds
already present at the time of vaccination as well as the variability of response between individual
animals. Reduction of aggressive and sexual (mounting) behaviours can expected from 1 to 2 weeks
post second vaccination.
Do not use in female pigs. Do not use in male pigs intended for breeding.
Accidental vaccination of male breeding stock may affect subsequent fertility.
2/26
Only healthy animals should be immunised. Improvac has been shown to be safe in male pigs from 8
weeks of age onwards. The recommended time for slaughter is 4 to 6 weeks after the second injection.
If pigs cannot be slaughtered within this recommended period the available trial data support that pigs
may still be sent for slaughter up to 10 weeks after the second injection with minimal risk of boar taint.
An increasing proportion will return to normal function after this time.
As skatole levels are not fully dependent on sexual status, both dietary and hygiene management
procedures to reduce skatole levels are also important.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
Accidental self- injection may produce similar effects in people to those seen in pigs. These may
include a temporary reduction in sexual hormones and reproductive functions in both men and
women and an adverse effect on pregnancy. The risk of these effects occurring is greater after a
second or subsequent accidental injection than after a first injection.
Special care should be taken to avoid accidental self injection and needle stick injury when
administering the product. The product must only be used with a safety vaccinator, which has a
dual safety system providing both a needle guard and a mechanism to prevent accidental
operation of the trigger.
The product must not be administered by pregnant women or those who may be pregnant.
In
case of eye contact, rinse immediately with copious amounts of water. In case of skin contact, wash
immediately with soap and water.
Advice to the user in the event of accidental self injection:
In the event of accidental self- injection, wash the injury thoroughly with clean running water. Seek
prompt medical advice and take the package leaflet with you. Do not administer the product in the
future.
Advice to the physician:
Accidental self- injection could temporarily affect reproductive physiology of both men and women
and may adversely affect pregnancy. If self injection with Improvac is suspected, reproductive
physiology should be monitored by assay of testosterone or oestrogen levels (as appropriate). The risk
of a physiological effect is greater after a second or subsequent accidental injection than after a first
injection. Clinically meaningful suppression of gonadal function should be managed with supportive
endocrine replacement therapy until normal function returns. The patient should be advised not to
administer Improvac
and/or any other products with similar action in the future.
When administered to pigs at the youngest recommended age (8 weeks), injection site swellings of up
to 4x8 cm are very commonly observed. A gradual resolution of the local reactions occurs, but in 20-
30 % of the animals these may persist for more than 42 days.
When administered to older pigs (14–23 weeks of age) injection site swellings ranging from 2 to 5 cm
in diameter are commonly observed, and injection site reactions at slaughter are commonly observed if
the second vaccination is given only 4 weeks before slaughter. A transient increase in rectal
temperature (post-vaccination hyperthermia) of around 0.5 °C may be observed during the 24-hours
period post vaccination.
In very rare cases anaphylactoid type reactions (dyspnoea, collapse, cyanosis and hyper
salivation associated with or without muscle twitching or emesis) have been observed
within a few minutes after the first vaccination with duration up to 30 minutes. In a small
number of animals death occurred following the reaction, however most animals recovered
3/26
without treatment and did not appear to react to subsequent vaccinations.
Do not use in female or male breeding pigs.
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.
Subcutaneous use.
Entire male pigs from 8 weeks of age onwards should be vaccinated with 2 doses of 2 ml at least
4 weeks apart, with the second dose given 4 to 6 weeks prior to slaughter. In case of suspected
misdosing, the animal should be revaccinated immediately.
Administer by subcutaneous injection in the neck, immediately behind the ear, using a safety
vaccinator with a short needle to give 12 to 15 mm penetration. The needle should be directed
perpendicular to the skin surface. Avoid introduction of contamination. Avoid injecting pigs that are
wet and dirty.
Administration of a double dose of Improvac (4 ml) to 8 week old piglets very commonly resulted in
palpable injection site reactions. The largest reactions were seen around 7 days post administration
when the maximum size was 13x7 cm. By two weeks post administration the maximum size had
decreased to 8x4 cm, showing a gradual resolution of the local reactions. A transient increase in body
temperature of 0.2 to 1.7 °C was observed during the 24 hours after administration, returning to
normal after two days. The general health of the animals was not affected.
Zero days.
5.
Pharmacotherapeutic group: Immunologicals for suidae, ATCvet code: (application made for
QI09AX)
Immunisation with Improvac induces an immune response against endogenous gonadotrophin
releasing factor (GnRF), a factor that controls testicular function via the gonadotropic hormones LH
and FSH. The active ingredient in this immunological is a synthetically produced analogue of GnRF,
which is conjugated with an immunogenic carrier protein. The conjugate is adjuvanted to increase the
level and duration of effect.
The effects of immunisation derive from the reduction in testicular function resulting from reduced
GnRF activity. This leads to reduced production and concentration of testosterone and other testicular
steroids, including androstenone, one of the main substances responsible for boar taint. A reduction of
typical male behaviour such as mounting and aggressiveness can be expected after the second
vaccination.
4/26
Boars given an initial dose of Improvac are immunologically primed but retain their full testicular
function until they receive the second dose, which induces a strong immune response to GnRF and
causes temporary immunological suppression of testicular function. This directly controls the
production of androstenone and, by removing the inhibitory effect of testicular steroids on hepatic
metabolism, indirectly reduces levels of skatole.
This effect is apparent within one week of treatment but it may take up to 3 weeks for any existing
concentrations of boar taint compounds to be reduced to insignificant levels.
6.
6.1 List of excipient(s):
DEAE-Dextran
Thiomersal
Urea
Water for injections
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: 2 years.
Shelf life after first opening: 28 days at 2–8 °C. After first broaching with a sterile needle, the
container should be returned to the refrigerator. The container can be broached once more only during
the next 28 days, then discarded immediately after use.
6.4. Special precautions for storage
Store and transport refrigerated (2 C–8 C).
Do not freeze. Protect from light.
6.5 Nature and composition of immediate packaging
Immediate packaging:
Polyethylene bottle of 20 ml (10 doses), 100 ml (50 doses) or 250 ml (125 doses) sealed with a rubber
closure and secured with an aluminium cap.
Outer packaging:
Cardboard box with 1 bottle of 20 ml.
Cardboard box with 12 bottles of 20 ml.
Cardboard box with 1 bottle of 100 ml.
Cardboard box with 10 bottles of 100 ml.
Cardboard box with 1 bottle of 250 ml.
Cardboard box with 4 bottles of 250 ml.
Not all pack sizes may be marketed.
6.6
Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
5/26
7.
PFIZER Limited
Ramsgate Road
Sandwich, Kent
CT13 9NJ
United Kingdom
8.
20 ml x 12 - EU/2/09/095/001
100 ml x 10 - EU/2/09/095/002
250 ml x 4 - EU/2/09/095/003
20 ml - EU/2/09/095/004
100 ml - EU/2/09/095/005
250 ml - EU/2/09/095/006
9.
11 May 2009
20 December 2010
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
6/26
ANNEX II
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR
BATCH RELEASE
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
WITH REGARD TO SAFE AND EFFECTIVE USE
D. STATEMENT OF THE MRLs
7/26
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer of the biological active substance(s)
Diphtheria Toxoid:
Pfizer Inc.
601 Cornhusker Highway, Lincoln,
Nebraska 68521
USA
Synthetic GnRF peptide analogue:
Auspep Clinical Peptides PTY Ltd.
15, Mareno Road, Tullamarine, 3052
Victoria
Australia
GnRF analogue-protein conjugate:
Pfizer Animal Health S.A.
1, rue Laid Burniat
1348 Louvain-la-Neuve
Belgium
Name and address of the manufacturer responsible for batch release
Pfizer Animal Health S.A.
1, rue Laid Burniat
1348 Louvain-la-Neuve
Belgium
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
Veterinary medicinal product subject to prescription.
The holder of this marketing authorisation must inform the European Commission about the marketing
plans for the medicinal product authorised by this decision.
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
REGARD TO SAFE AND EFFECTIVE USE
Not applicable
D. STATEMENT OF THE MRLs
As the active substance (Gonadotropin releasing factor (GnRF) analogue-protein conjugate) is
intended to produce immunity as part of an immunological veterinary medicinal product it
consequently does not fall within the scope of Commission Regulation (EU) No 37/2010.
The following constituents of Improvac are included in table 1 of the annex to Commission Regulation
(EU) No 37/2010 as follows:
8/26
Pharmacologically
active substance
Marker
residue
Animal
species
MRL
Target
tissues
Other provisions Therapeutic
classification
Thiomersal
NOT
APPLI-
CABLE
All food
producing
species
No
MRL
required
NOT
APPLI-
CABLE
For use only as
preservatives in
multidose
vaccines at a
concentration not
exceeding 0.02 %.
NO ENTRY
Urea
NOT
APPLI-
CABLE
All food
producing
species
No
MRL
required
NOT
APPLI-
CABLE
NO ENTRY
NO ENTRY
In addition to the above constituents the product contains the following excipients: DEAE
(Diethylaminoethyl) -Dextran and water for injection. These excipients are considered as not falling
within the scope of Regulation (EC) No 470/2009.
9/26
ANNEX III
LABELLING AND PACKAGE LEAFLET
10/26
A LABELLING
11/26
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Cardboard boxes, 12 x 20 ml, 10 x 100 ml and 4 x 250 ml HDPE bottles
1.
Improvac solution for injection for pigs
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
One dose (2 ml) contains:
Active substance:
Gonadotropin releasing factor (GnRF) analogue-protein conjugate
min. 300 µg.
Adjuvant:
DEAE-Dextran, an aqueous, non-mineral oil-based adjuvant
300 mg.
Excipient(s):
Thiomersal
0.2 mg.
3.
Solution for injection
4.
PACKAGE SIZE
12 x 10 doses (12 x 20 ml).
10 x 50 doses (10 x 100 ml).
4 x 125 doses (4 x 250 ml).
5.
Male pigs (from 8 weeks of age).
6.
Induction of antibodies against GnRF to produce a temporary immunological suppression of testicular
function. For use as an alternative to physical castration for the reduction of boar taint caused by the
key boar taint compound androstenone, in entire male pigs following the onset of puberty. Another
key contributor to boar taint, skatole, may also be reduced as an indirect effect. Aggressive and sexual
(mounting) behaviours are also reduced.
12/26
(a synthetic peptide analogue of GnRF conjugated to Diphtheria Toxoid)
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Subcutaneous use.
Two doses of 2 ml should be administered to entire male pigs by subcutaneous injection at least
4 weeks apart, with the second dose given 4 to 6 weeks prior to slaughter.
Read the package leaflet before use.
8.
Withdrawal period: Zero days.
9.
SPECIAL WARNING
Accidental self-injection is dangerous – read package leaflet before use.
10. EXPIRY DATE
EXP {month/year}
Once broached, the container should be returned to the refrigerator and then can be broached once
more during the next 28 days, then discarded immediately after use.
11. SPECIAL STORAGE CONDITIONS
Store and transport refrigerated.
Do not freeze.
Protect from light.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Dispose of waste material in accordance with local requirements.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only - to be supplied only on veterinary prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
13/26
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
12 x 20 ml - EU/2/09/095/001
10 x 100 ml - EU/2/09/095/002
4x 250 ml - EU/2/09/095/003
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
14/26
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Cardboard boxes, 1 x 20 ml, 1 x 100 ml and 1 x 250 ml HDPE bottles
1.
Improvac solution for injection for pigs
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
One dose (2 ml) contains:
Active substance:
Gonadotropin releasing factor (GnRF) analogue-protein conjugate
min. 300 µg.
Adjuvant:
DEAE-Dextran, an aqueous, non-mineral oil-based adjuvant
300 mg.
Excipient(s):
Thiomersal
0.2 mg.
3.
Solution for injection
4.
PACKAGE SIZE
1 x 10 doses (1 x 20 ml).
1 x 50 doses (1 x 100 ml).
1 x 125 doses (1 x 250 ml).
5.
Male pigs (from 8 weeks of age).
6.
Induction of antibodies against GnRF to produce a temporary immunological suppression of testicular
function. For use as an alternative to physical castration for the reduction of boar taint caused by the
key boar taint compound androstenone, in entire male pigs following the onset of puberty. Another
key contributor to boar taint, skatole, may also be reduced as an indirect effect. Aggressive and sexual
(mounting) behaviours are also reduced.
Read the package leaflet before use.
15/26
(a synthetic peptide analogue of GnRF conjugated to Diphtheria Toxoid)
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Subcutaneous use.
Two doses of 2 ml should be administered to entire male pigs by subcutaneous injection at least
4 weeks apart, with the second dose given 4 to 6 weeks prior to slaughter.
Read the package leaflet before use.
8.
Withdrawal period: Zero days.
9.
SPECIAL WARNING
Accidental self-injection is dangerous – read package leaflet before use.
10. EXPIRY DATE
EXP {month/year}
Once broached, use within 28 days.
11. SPECIAL STORAGE CONDITIONS
Store and transport refrigerated.
Do not freeze.
Protect from light.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Dispose of waste material in accordance with local requirements.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only - to be supplied only on veterinary prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
16/26
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
20 ml - EU/2/09/095/004
100 ml - EU/2/09/095/005
250 ml - EU/2/09/095/006
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
17/26
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
100 ml and 250 ml HDPE bottles
1.
Improvac solution for injection for pigs
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
GnRF analogue-protein conjugate min. 300 µg/2 ml dose
3.
4.
PACKAGE SIZE
50 doses (100 ml).
125 doses (250 ml).
5.
Male pigs (from 8 weeks of age).
6.
For the reduction of boar taint. Read package leaflet before use.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
For subcutaneous use.
Two doses of 2 ml at least 4 weeks apart, with the second dose 4–6 weeks before slaughter.
8.
Withdrawal period: Zero days.
9.
SPECIAL WARNING
Accidental self-injection is dangerous.
18/26
10. EXPIRY DATE
EXP {month/year}
Once broached, use within 28 days.
11. SPECIAL STORAGE CONDITIONS
Store and transport refrigerated.
Do not freeze.
Protect from light.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only - to be supplied only on veterinary prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
19/26
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
20 ml bottle
1.
Improvac solution for injection for pigs
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
GnRF analogue-protein conjugate min. 300 µg/2 ml
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
10 doses (20 ml)
4.
ROUTE(S) OF ADMINISTRATION
Subcutaneous use.
5.
Withdrawal period: Zero days.
6.
BATCH NUMBER
Lot {number}
7.
EXPIRY DATE
EXP {month/year}
Once broached, use within 28 days.
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
9.
SPECIAL WARNING
Accidental self-injection is dangerous – read package leaflet before use.
20/26
B. PACKAGE LEAFLET
21/26
PACKAGE LEAFLET
Improvac, solution for injection for pigs
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder
:
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
Manufacturer for the batch release
:
Pfizer Animal Health S.A.
1 Rue Laid Burniat
B-1348 Louvain-la-Neuve
Belgium
2.
Improvac solution for injection for pigs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Once dose (2 ml) contains:
Active substance:
Gonadotropin releasing factor (GnRF) analogue-protein conjugate
min. 300 µg.
(a synthetic peptide analogue of GnRF conjugated to Diphtheria Toxoid)
Adjuvant:
Diethylaminoethyl (DEAE)-Dextran, an aqueous, non-mineral oil-based adjuvant
300 mg.
Excipient(s):
Thiomersal
0.2 mg.
4.
Induction of antibodies against GnRF to produce a temporary immunological suppression of testicular
function. For use as an alternative to physical castration for the reduction of boar taint caused by the
key boar taint compound androstenone, in entire male pigs following the onset of puberty.
Another key contributor to boar taint, skatole, may also be reduced as an indirect effect. Aggressive
and sexual (mounting) behaviours are also reduced.
The onset of immunity (induction of anti-GnRF antibodies) can be expected within 1 week post
second vaccination. Reduction of androstenone and skatole levels has been demonstrated from 4 to 6
weeks post second vaccination. This reflects the time needed for clearance of boar taint compounds
already present at the time of vaccination as well as the variability of response between individual
22/26
animals. Reduction of aggressive and sexual (mounting) behaviours can expected from 1 to 2 weeks
post second vaccination.
5.
Do not use in female pigs. Do not use in male pigs intended for breeding.
6.
When administered to pigs at the youngest recommended age (8 weeks), injection site swellings of up
to 4x8 cm are very commonly observed. A gradual resolution of the local reactions occurs, but in 20–
30 % of the animals these may persist for more than 42 days.
When administered to older pigs (14–23 weeks of age) injection site swellings ranging from 2 to 5 cm
in diameter are commonly observed, and injection site reactions at slaughter are commonly observed if
the second vaccination is given only 4 weeks before slaughter.
A transient increase in rectal temperature (post-vaccination hyperthermia) of around 0.5 °C may be
observed during the 24-hours period post vaccination.
In very rare cases anaphylactoid type reactions (dyspnoea, collapse, cyanosis and hyper
salivation associated with or without muscle twitching or emesis) have been observed
within a few minutes after the first vaccination with duration up to 30 minutes. In a small
number of animals death occurred following the reaction, however most animals recovered
without treatment and did not appear to react to subsequent vaccinations.
7.
Male pigs (from 8 weeks of age).
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
2 ml, by subcutaneous injection (injection given under the skin).
9.
ADVICE ON CORRECT ADMINISTRATION
Entire male pigs from 8 weeks of age onwards should be vaccinated with 2 doses of 2 ml at least
4 weeks apart, with the second dose given 4 to 6 weeks prior to slaughter. In case of suspected
misdosing, the animal should be revaccinated immediately.
Administer by subcutaneous injection in the neck, immediately behind the ear, using a safety
vaccinator with a short needle to give 12 to 15 mm penetration. The needle should be directed
perpendicular to the skin surface. Avoid introduction of contamination. Avoid injecting pigs that are
wet and dirty.
The recommended time for slaughter is 4 to 6 weeks after the second injection. If pigs cannot be
slaughtered within this recommended period the available trial data support that pigs may still be sent
for slaughter up to 10 weeks after the second injection with minimal risk of boar taint.
10. WITHDRAWAL PERIOD
Zero days.
23/26
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
Store and transport refrigerated (2 C–8 C).
Do not freeze.
Protect from light.
Do not use after the expiry date stated on the label.
After first broaching with a sterile needle, the container should be returned to the refrigerator. The
container can be broached once more only during the next 28 days, then discarded immediately after
use.
12. SPECIAL WARNING(S)
Only healthy animals should be immunised. Improvac has been shown to be safe in male pigs from 8
weeks of age onwards. Accidental vaccination of male breeding stock may affect subsequent fertility.
The recommended time for slaughter is 4 to 6 weeks after the second injection. If pigs cannot be
slaughtered within this recommended period the available trial data support that pigs may still be sent
for slaughter up to 10 weeks after the second injection with minimal risk of boar taint. An increasing
proportion will return to normal function after this time.
As skatole levels are not fully dependent on sexual status, both dietary and hygiene management
procedures to reduce skatole levels are also important.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
Accidental self injection may produce similar effects in people to those seen in pigs. These may
include a temporary reduction in sexual hormones and reproductive functions in both men and
women and an adverse effect on pregnancy. The risk of these effects occurring is greater after a
second or subsequent accidental injection than after a first injection.
Special care should be taken to avoid accidental self injection and needle stick injury when
administering the product. The product must only be used with a safety vaccinator which has a
dual safety system providing both a needle guard and a mechanism to prevent accidental
operation of the trigger.
The product must not be administered by pregnant women or those who may be pregnant.
In
case of eye contact, rinse immediately with copious amounts of water. In case of skin contact, wash
immediately with soap and water. The product should be stored safely out of the reach of children.
Advice to the user in the event of accidental self injection:
In the event of accidental self injection, wash the injury thoroughly with clean running water. Seek
prompt medical advice and take the package leaflet with you. Do not administer the product in the
future.
Advice to the physician:
Accidental self injection could temporarily affect reproductive physiology of both men and women
and may adversely affect pregnancy. If self injection with Improvac is suspected, reproductive
physiology should be monitored by assay of testosterone or oestrogen levels (as appropriate). The risk
of a physiological effect is greater after a second or subsequent accidental injection than after a first
injection. Clinically meaningful suppression of gonadal function should be managed with supportive
endocrine replacement therapy until normal function returns. The patient should be advised not to
administer Improvac and/or any other product with similar action in the future.
24/26
Interactions with other medicinal products
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.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
20 December 2010
15. OTHER INFORMATION
Immunisation with Improvac induces an immune response against endogenous gonadotrophin
releasing factor (GnRF), a factor that controls testicular function via the gonadotropic hormones LH
and FSH. The active ingredient in this immunological is a synthetically produced analogue of GnRF,
which is conjugated with an immunogenic carrier protein. The conjugate is adjuvanted to increase the
level and duration of effect.
The effects of immunisation derive from the reduction in testicular function resulting from reduced
GnRF activity. This leads to reduced production and concentration of testosterone and other testicular
steroids, including androstenone, one of the main substances responsible for boar taint. Moreover,
fully immunised boars develop metabolic characteristics typical of surgically castrated animals,
including reduced concentrations of skatole, another key contributor to boar taint. A reduction of
typical male behaviour such as mounting and aggressiveness can be expected after the second
vaccination.
Boars given an initial dose of Improvac are immunologically primed but retain their full testicular
function until they receive the second dose, which induces a strong immune response to GnRF and
causes temporary immunological suppression of testicular function. This effect is apparent within one
week of treatment but it may take up to 3 weeks for any existing concentrations of boar taint
compounds to be reduced to insignificant levels.
Polyethylene bottle of 20 ml (10 doses), 100 ml (50 doses) or 250 ml (125 doses) sealed with a rubber
closure and secured with an aluminium cap.
Pack sizes:
Cardboard box with 1 bottle of 20 ml.
Cardboard box with 12 bottles of 20 ml.
Carbboard box with 1 bottle of 100 ml.
Cardboard box with 10 bottles of 100 ml.
Cardboard box with 1 bottle of 250 ml.
Cardboard box with 4 bottles of 250 ml.
Not all pack sizes may be marketed.
For any information about this veterinary medicinal product, please contact the local representative of
the marketing authorisation holder.
25/26
AT: Pfizer Corporation Austria Ges.m.b.H.
Tel: +43 (0)1 52 11 57 20
IT: Pfizer Italia s.r.l.
Tel: +39 06 3318 2933
BE: Pfizer Animal Health s.a.
Tel./Tél.: +32 (0)2 554 62 11
LT: Pfizer Animal Health
Tel.: +370 5 269 17 96
BG: Pfizer H.C.P. Corporation
Tel: + 359 2 970 43 21
LU: Pfizer Animal Health s.a.
Tél/Tel: + 32 (0)2 554 62 11
CZ: Pfizer Animal Health
Tel: +420 283 004 111
LV: Pfizer Animal Health
Tel: +370 5 269 17 96
CY: Kύπρος
Τηλ.: +30 210 6785800
MT: Agrimed Limited
Tel: +356 21 465 797
DE: Pfizer GmbH
Tel: +49 (0)30 55 00 55 01
NL: Pfizer Animal Health B.V.
Tel: +31 (0)10 4064 600
DK: Orion Pharma Animal Health
Tlf: +45 49 12 67 65
NO: Orion Pharma Animal Health
Tlf: +47 40 00 41 90
EE: Pfizer Animal Health
Tel: +370 5 269 17 96
PL: Pfizer Trading Polska Sp. z o.o.
Tel: +48 22 335 62 00
EL: Pfizer Hellas A.E.
Τηλ.: +30 210 6785800
PT: Laboratórios Pfizer, Lda.
Tel: +351 21 423 55 00
ES: Pfizer S.A.
Tel: +34 91 4909900
RO: Pfizer Romania SRL
Tel: + 0040 21 207 28 93
FI: Pfizer Oy Animal Health
Puh/Tel: +358 (0)9 4300 40
SE: Orion Pharma Animal Health
Tel: +46 (0)8 623 64 40
FR: Pfizer
Tél: +33 (0)1 58 07 46 00
SI: Pfizer Luxemburg SARL
Tel: +386 (0) 1 52 11 670
HU: Pfizer Kft.
Tel: +361 488 3695
SK: Pfizer Luxembourg SARL o.z.
Pfizer AH
Tel: + 421 2 3355 5500
IE: Pfizer Healthcare Ireland, trading as:
Pfizer Animal Health
Tel: + 353 (0) 1 467 6500
UK: Pfizer Ltd
Tel: +44 (0) 1304 616161
IS: Icepharma hf,
Tel: +354 540 80 00
26/26
Source: European Medicines Agency
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