ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
Suprelorin 4.7 mg implant for dogs
2.
Active substance:
4.7 mg deslorelin (as deslorelin acetate)
Excipient(s):
For a full list of excipients, see section 6.1.
3.
Implant
White to pale yellow cylindrical implant.
4.
Dogs (Male).
For the induction of temporary infertility in healthy, entire, sexually mature male dogs.
None.
Infertility is achieved from 6 weeks up to at least 6 months after initial treatment. Treated dogs should
therefore still be kept away from bitches on heat within the first six weeks after initial treatment.
One out of 75 dogs treated with the product during clinical trials mated and tied with a bitch on heat
within six months of implantation, but this did not result in pregnancy. Should a treated dog mate with
a bitch between six weeks and six months after treatment, appropriate measures should be taken to
rule out the risk of pregnancy.
Any mating that occurs more than six months after the administration of the product may result in
pregnancy. However, it is not necessary to keep bitches away from treated dogs following subsequent
implantations, provided that the product is administered every six months.
The ability of dogs to sire offspring following their return to normal plasma testosterone levels, after
the administration of the product, has not been investigated.
With respect to testosterone levels (an established surrogate marker of fertility), during clinical trials
more than 80 % of dogs administered one or more implants, returned to normal plasma testosterone
levels (≥0.4 ng/ml) within 12 months of implantation. Ninety-eight percent of dogs returned to normal
plasma testosterone levels within 18 months of implantation. However, data demonstrating the
2
complete reversibility of clinical effects (reduced testicular size, reduced ejaculation volume, reduced
sperm count and reduced libido) including fertility after six months, or repeated implantation, are
limited.
During clinical trials, most of the smaller size dogs (<10 kg) maintained suppressed levels of
testosterone for more than 12 months following implantation. For very large dogs (>40 kg), data are
limited but duration of testosterone suppression was comparable to that seen in medium and large
dogs. The use of the product in dogs of less than 10 kg or more than 40 kg bodyweight, therefore,
should be subject to a risk/benefit assessment performed by the veterinarian.
The use of the product in pre-pubertal dogs has not been investigated. It is therefore recommended that
dogs should be allowed to reach puberty before treatment with the product is initiated.
Data demonstrate that treatment with the product will reduce the libido of the dog, but other
behavioural changes (e.g. male-associated aggression) have not been investigated.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
Pregnant women should not administer the product. Another GnRH analogue has been shown to be
foetotoxic in laboratory animals. Specific studies to evaluate the effect of deslorelin when
administered during pregnancy have not been conducted.
Although skin contact with the product is unlikely, should this occur, wash the exposed area
immediately, as GnRH analogues may be absorbed through the skin.
When administering the product, take care to avoid accidental self-injection by ensuring that animals
are suitably restrained and the application needle is shielded until the moment of implantation.
In case of accidental self-injection, seek medical advice immediately, with a view to having the
implant removed. Show the package leaflet or the label to the physician.
Moderate swelling at the implant site may be observed for 14 days. Histologically, mild local reactions
with chronic inflammation of the connective tissue and some capsule formation and collagen
deposition have been seen at 3 months after administration.
A significant decrease in testicle size will be seen during the treatment period. In very rare cases, a
testicle may be able to ascend the inguinal ring.
Not applicable.
None known.
Subcutaneous use.
3
The recommended dose is one implant per dog, irrespective of the size of the dog.
Disinfection of the implantation site should be undertaken prior to implantation to avoid introduction
of infection. If the hair is long, a small area should be clipped, if required.
Remove Luer Lock cap from the implanter. Attach the actuator to the implanter using the Luer Lock
connection.
The product should be implanted subcutaneously in the loose skin on the back between the lower neck
and the lumbar area. Avoid injection of the implant into fat, as release of the active substance might be
impaired in areas of low vascularisation. Lift the loose skin between the shoulder blades. Insert the
entire length of the needle subcutaneously. Fully depress the actuator plunger and, at the same time,
slowly withdraw the needle. Press the skin at the insertion site as the needle is withdrawn, and
maintain pressure for 30 seconds. Examine the syringe and needle to ascertain that the implant has not
remained within the syringe or needle, and that the spacer is visible. It may be possible to palpate the
implant
in situ
.
Repeat administration every six months to maintain efficacy.
Do not use the product if the foil pouch is broken.
The biocompatible implant does not require removal. However, should it be necessary to end
treatment, implants may be surgically removed by a veterinarian. Implants may be located using
ultrasound.
No adverse reactions have been observed following simultaneous subcutaneous administration of up to
10 implants.
Not applicable.
5.
Pharmacotherapeutic group: Gonadotrophin-releasing hormones (GnRH), ATCvet code: QH01CA93.
5.1 Pharmacodynamic properties
The GnRH agonist, deslorelin, acts by suppressing the function of the pituitary-gonadal axis when
applied in a low, continuous dose. This suppression results in the failure of treated animals to
synthesise and/or release follicle stimulating hormone (FSH) and luteinising hormone (LH), the
hormones responsible for the maintenance of fertility.
The continuous low dose of deslorelin will reduce the functionality of the male reproductive organs,
libido and spermatogenesis and lower the plasma testosterone levels, from 4-6 weeks after
implantation. A short transient increase in plasma testosterone may be seen immediately after
implantation. Measurement of plasma concentrations of testosterone has demonstrated the persistent
pharmacological effect of the continuing presence of deslorelin in the circulation for at least
six months following administration of the product.
4
5.2 Pharmacokinetic particulars
It has been shown that plasma deslorelin levels peak 7 to 35 days following administration of an
implant containing 5 mg radiolabelled deslorelin. The substance can be directly measured in the
plasma up to approximately 2.5 months post implantation. The metabolism of deslorelin is rapid.
6.
6.1 List of excipients
Hydrogenated palm oil
Lecithin
Sodium acetate anhydrous
6.2 Incompatibilities
None known.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years
6.4 Special precautions for storage
Store in a refrigerator (2
°
C – 8
°
C).
Do not freeze.
6.5 Nature and composition of immediate packaging
The implant is supplied in a pre-loaded implanter. Each pre-loaded implanter is packaged in a sealed
foil pouch, which is subsequently sterilised. The final sales presentation consists of a cardboard carton
containing either two or five individually foil wrapped implanters that have been sterilised, together
with an implanting device (actuator) that is not sterilised. The actuator is attached to the implanter
using the Luer Lock connection.
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. The actuator can be re-used.
7.
VIRBAC S.A.
1ère avenue 2065 m L.I.D.
06516 Carros
France
8.
EU/2/07/072/001-002
5
9.
10/07/2007
10.
01/07/2010
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency
http://www.ema.europa.eu
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
6
1.
Suprelorin 9.4 mg implant for dogs
2.
Active substance:
9.4 mg deslorelin (as deslorelin acetate)
For a full list of excipients, see section 6.1.
3.
White to pale yellow cylindrical implant.
4.
Dogs (male).
For the induction of temporary infertility in healthy, entire, sexually mature male dogs.
None.
Infertility is achieved from 8 weeks up to at least 12 months after initial treatment. Treated dogs
should therefore still be kept away from bitches on heat within the first 8 weeks after initial treatment.
In 2 out of 30 dogs in the clinical trial infertility was not achieved until approximately 12 weeks after
initial treatment, but in most cases these animals are not capable of successfully siring offspring.
Should a treated dog mate with a bitch between 8 and 12 weeks after treatment, appropriate measures
should be taken to rule out the risk of pregnancy.
Any mating that occurs more than 12 months after the administration of Suprelorin may result in
pregnancy. However, it is not necessary to keep bitches away from treated dogs following subsequent
implantations for the initial 8 week period, provided that the veterinary medicinal product is
administered every 12 months.
In certain cases, the implant may be lost from a treated dog. If loss of the implant is suspected in
connection with the first implantation, this can be confirmed by observing no reduction in scrotal
circumference or plasma testosterone levels after 8 weeks from the suspected date of loss, as both
should reduce under correct implantation. If loss of the implant is suspected following re-implantation
after 12 months, a progressive increase will be seen in scrotal circumference and/or plasma
testosterone levels. In both of these circumstances a replacement implant should be administered.
7
The ability of dogs to sire offspring following their return to normal plasma testosterone levels, after
the administration of the veterinary medicinal product, has not been investigated.
With respect to testosterone levels (an established surrogate marker of fertility), during clinical trials
68 % of dogs administered one implant, returned to fertility within 2 years of implantation. 95% of
dogs had returned to normal plasma testosterone levels within 2.5 years of implantation. However,
data demonstrating the complete reversibility of clinical effects (reduced testicular size, reduced
ejaculation volume, reduced sperm count and reduced libido) including fertility after 12 months, or
repeated implantation, are limited.
Due to limited data, the use of Suprelorin in dogs of less than 10 kg or more than 40 kg bodyweight
should be subject to a risk/benefit assessment performed by the veterinarian. During clinical trials with
Suprelorin 4.7 mg, the mean duration of testosterone suppression was 1.5 times longer among smaller
size dogs (<10 kg) compared with all larger dogs.
The use of Suprelorin in pre-pubertal dogs has not been investigated. It is therefore recommended that
dogs should be allowed to reach puberty before treatment with the veterinary medicinal product is
initiated.
Data demonstrate that treatment with Suprelorin will reduce the libido of the dog, but other
behavioural changes (e.g. male-associated aggression) have not been investigated.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
Pregnant women should not administer Suprelorin. Another GnRH analogue has been shown to be
foetotoxic in laboratory animals. Specific studies to evaluate the effect of deslorelin when
administered during pregnancy have not been conducted.
Although skin contact with the veterinary medicinal product is unlikely, should this occur, wash the
exposed area immediately, as GnRH analogues may be absorbed through the skin.
When administering the veterinary medicinal product, take care to avoid accidental self-injection by
ensuring that animals are suitably restrained and the application needle is shielded until the moment of
implantation.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or
the label to the physician, with a view to having the implant removed.
Moderate swelling at the implant site may be observed for 14 days. Histologically, mild local reactions
with chronic inflammation of the connective tissue and some capsule formation and collagen
deposition have been seen at 3 months after administration.
A significant decrease in testicle size will be seen during the treatment period. In very rare cases, a
testicle may be able to ascend the inguinal ring.
Not applicable.
8
None known.
Subcutaneous use.
The recommended dose is one implant per dog, irrespective of the size of the dog.
Disinfection of the implantation site should be undertaken prior to implantation to avoid introduction
of infection. If the hair is long, a small area should be clipped, if required.
Remove Luer Lock cap from the implanter. Attach the actuator to the implanter using the Luer Lock
connection.
The veterinary medicinal product should be implanted subcutaneously in the loose skin on the back
between the lower neck and the lumbar area. Avoid injection of the implant into fat, as release of the
active substance might be impaired in areas of low vascularisation. Lift the loose skin between the
shoulder blades. Insert the entire length of the needle subcutaneously. Fully depress the actuator
plunger and, at the same time, slowly withdraw the needle. Press the skin at the insertion site as the
needle is withdrawn, and maintain pressure for 30 seconds. Examine the syringe and needle to
ascertain that the implant has not remained within the syringe or needle, and that the spacer is visible.
It may be possible to palpate the implant
in situ
.
Repeat administration every 12 months to maintain efficacy.
Do not use the veterinary medicinal product if the foil pouch is broken.
The biocompatible implant does not require removal. However, should it be necessary to end
treatment, implants may be surgically removed by a veterinarian. Implants may be located using
ultrasound.
No adverse reactions other than those described in section 4.6 have been observed following
simultaneous subcutaneous administration of the equivalent of six implants.
Not applicable.
5.
Pharmacotherapeutic group: Gonadotropin-releasing hormones (GnRH), ATCvet code: QH01CA93.
5.1 Pharmacodynamic properties
The GnRH agonist, deslorelin, acts by suppressing the function of the pituitary-gonadal axis when
applied in a low, continuous dose. This suppression results in the failure of treated animals to
synthesise and/or release follicle stimulating hormone (FSH) and luteinising hormone (LH), the
hormones responsible for the maintenance of fertility.
The continuous low dose of deslorelin will reduce the functionality of the male reproductive organs,
libido and spermatogenesis and lower the plasma testosterone levels, from 4 to 6 weeks after
9
implantation. A short transient increase in plasma testosterone may be seen immediately after
implantation. Measurement of plasma concentrations of testosterone has demonstrated the persistent
pharmacological effect of the continuing presence of deslorelin in the circulation for at least
12 months following administration of the veterinary medicinal product.
5.2 Pharmacokinetic particulars
It has been shown that plasma deslorelin levels peak 7 to 35 days following administration of an
implant containing 5 mg radiolabelled deslorelin. The substance can be directly measured in the
plasma up to approximately 2.5 months post implantation. The metabolism of deslorelin is rapid.
6.
6.1 List of excipients
Hydrogenated palm oil
Lecithin
6.2 Incompatibilities
None known.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years
6.4. Specialprecautionsforstorage
Store in a refrigerator (2
°
C – 8
°
C).
Do not freeze.
6.5 Nature and composition of immediate packaging
The implant is supplied in a pre-loaded implanter. Each pre-loaded implanter is packaged in a sealed
foil pouch, which is subsequently sterilised. The final sales presentation consists of a cardboard carton
containing either two or five individually foil wrapped implanters that have been sterilised, together
with an implanting device (actuator) that is not sterilised. The actuator is attached to the implanter
using the Luer Lock connection.
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. The actuator can be re-used.
7.
Virbac S.A.
1ère avenue 2065 m L.I.D.
06516 Carros
France
10
8.
EU/2/07/072/003
EU/2/07/072/004
9.
01/07/2010
01/07/2010
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency
http://www.ema.europa.eu
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
11
ANNEX II
A.
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
12
A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturers responsible for batch release
Virbac S.A.
1ère avenue 2065 m L.I.D.
06516 Carros
France
Brecon Pharmaceuticals Ltd.
Hay-on-Wye HR3 5PG
United Kingdom
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
To be supplied only on veterinary 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 THE SAFE AND EFFECTIVE USE OF THE PRODUCT
Not applicable.
D. STATEMENT OF THE MRLs
Not applicable.
13
ANNEX III
LABELLING AND PACKAGE LEAFLET
14
A. LABELLING
15
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
CARDBOARD CARTON
1.
Suprelorin 4.7 mg implant for dogs
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
4.7 mg deslorelin (as deslorelin acetate)
3.
Implant
4.
PACKAGE SIZE
2 implants preloaded in implanters + 1 actuator
5 implants preloaded in implanters + 1 actuator
5.
Dogs (Male).
6.
For the induction of temporary infertility in healthy male dogs.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Read the package leaflet before use.
Do not use if the foil pouch is broken. Administer one implant only. The implant should be
administered subcutaneously between the shoulder blades of the dog.
8.
Not applicable
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use
16
10. EXPIRY DATE
EXP {month/year}
11. SPECIAL STORAGE CONDITIONS
Store in a refrigerator (2
°
C – 8
°
C).
Do not freeze.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS 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. The actuator can be re-used.
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.
VIRBAC S.A.
1ère avenue 2065 m L.I.D.
06516 Carros
France
EU/2/07/072/001-002
17. MANUFACTURER’S BATCH NUMBER
Batch {number}
17
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
FOIL POUCH
1.
Suprelorin 4.7 mg implant for dogs
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
4.7 mg deslorelin (as deslorelin acetate)
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
One implant preloaded in one implanter.
4.
ROUTE(S) OF ADMINISTRATION
Subcutaneous use.
5.
6.
BATCH NUMBER
Batch {number}
7.
EXPIRY DATE
EXP {month/year}
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
18
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
CARDBOARD CARTON
1.
Suprelorin 9.4 mg implant for dogs
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
9.4 mg deslorelin (as deslorelin acetate)
3.
Implant
4.
PACKAGE SIZE
2 implants preloaded in implanters + 1 actuator
5 implants preloaded in implanters + 1 actuator
5.
Dogs (male)
6.
For the induction of temporary infertility in healthy, entire, sexually mature male dogs.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Read the package leaflet before use.
Do not use the veterinary medicinal product if the foil pouch is broken. Administer one implant only.
The implant should be administered subcutaneously between the shoulder blades of the dog.
8.
Not applicable.
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
19
10. EXPIRY DATE
EXP {month/year}
11. SPECIAL STORAGE CONDITIONS
Store in a refrigerator (2
°
C – 8
°
C).
Do not freeze.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS 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. The actuator can be re-used.
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.
Virbac S.A.
1ère avenue 2065 m L.I.D.
06516 Carros
France
EU/2/07/072/003
EU/2/07/072/004
17. MANUFACTURER’S BATCH NUMBER
Batch {number}
20
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
FOIL POUCH
1.
Suprelorin 9.4 mg implant for dogs
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
9.4 mg deslorelin (as deslorelin acetate)
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
One implant preloaded in one implanter
4.
ROUTE(S) OF ADMINISTRATION
Subcutaneous route
5.
6.
BATCH NUMBER
Batch {number}
7.
EXPIRY DATE
EXP {month/year}
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
21
B. PACKAGE LEAFLET
22
PACKAGE LEAFLET
Suprelorin 4.7 mg implant for dogs
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder
:
VIRBAC S.A.
1ère avenue 2065 m L.I.D.
06516 Carros
France
Manufacturer for batch release
:
Brecon Pharmaceuticals Ltd.
Hay-on-Wye HR3 5PG
United Kingdom
VIRBAC
1ère Avenue – 2065 m – L..I.D.
06516 Carros
France
2.
Suprelorin 4.7 mg implant for dogs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Suprelorin is a white to pale yellow cylindrical implant containing 4.7 mg deslorelin (as deslorelin
acetate).
4.
For the induction of temporary infertility in healthy, non-castrated, sexually mature male dogs.
5.
None.
6.
Moderate swelling at the implant site may be observed for 14 days.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
7.
Dogs (Male).
23
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Administer one implant only, irrespective of the size of the dog. Repeat treatment every 6 months to
maintain efficacy.
Do not use the product if the foil pouch is broken.
One implant should be administered subcutaneously between the shoulder blades of the dog.
9.
ADVICE ON CORRECT ADMINISTRATION
Remove Luer Lock cap from the implanter. Attach the actuator to the implanter using the Luer Lock
connection.
Disinfection of the implantation site should be undertaken prior to implantation to avoid introduction
of infection.
Select the implant site by locating the area of the back midway between the shoulder blades. Avoid
injection of the implant into fat, as release of the active substance might be impaired in areas of low
vascularisation. If the hair is long, a small area may be clipped, if required. Lift the loose skin between
the shoulder blades. Insert the entire length of the needle subcutaneously. Fully depress the actuator
plunger and, at the same time, slowly withdraw the needle. Press the skin at the insertion site as the
needle is withdrawn, and maintain pressure for 30 seconds. Examine the syringe and needle to
ascertain that the implant has not remained within the syringe or needle, and that the spacer is visible.
It may be possible to palpate the implant
in situ
.
The biocompatible implant does not require removal. However, should it be necessary to end
treatment, implants may be surgically removed by a veterinarian. Implants may be located using
ultrasound.
The actuator can be re-used.
10. WITHDRAWAL PERIOD
Not applicable.
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
Store in a refrigerator (2
°
C – 8
°
C)
Do not freeze
Do not use after the expiry date which is stated on the carton.
12. SPECIAL WARNING(S)
Pregnant women should not administer the product. Another GnRH analogue has been shown to be
foetotoxic in laboratory animals. Specific studies to evaluate the effect of deslorelin when
administered during pregnancy have not been conducted.
24
Although skin contact with the product is unlikely, should this occur, wash the exposed area
immediately, as GnRH analogues may be absorbed through the skin.
When administering the product, take care to avoid accidental self-injection by ensuring that animals
are suitably restrained and the application needle is shielded until the moment of implantation.
In case of accidental self-injection, seek medical advice immediately, with a view to having the
implant removed. Show the package leaflet or the label to the physician.
Infertility is achieved from 6 weeks up to at least 6 months after initial treatment. Treated dogs should
therefore still be kept away from bitches on heat within the first six weeks after initial treatment.
One out of 75 dogs treated with the product during clinical trials mated and tied with a bitch on heat
within six months of implantation, but this did not result in pregnancy. Should a treated dog mate with
a bitch between six weeks and six months after treatment, appropriate measures should be taken to
rule out the risk of pregnancy.
Any mating that occurs more than six months after the administration of the product may result in
pregnancy. However, it is not necessary to keep bitches away from treated dogs following subsequent
implantations, provided that the product is administered every six months.
The ability of dogs to sire offspring following their return to normal plasma testosterone levels, after
the administration of the product, has not been investigated.
With respect to testosterone levels (an established surrogate marker of fertility), during clinical trials
more than 80 % of dogs administered one or more implants, returned to normal plasma testosterone
levels (≥0.4 ng/ml) within 12 months of implantation. Ninety-eight percent of dogs returned to normal
plasma testosterone levels within 18 months of implantation. However, data demonstrating the
complete reversibility of clinical effects (reduced testicular size, reduced ejaculation volume, reduced
sperm count and reduced libido) including fertility after six months, or repeated implantation, are
limited.
During clinical trials, most of the smaller size dogs (<10 kg) maintained suppressed levels of
testosterone for more than 12 months following implantation. For very large dogs (>40 kg), data are
limited but duration of testosterone suppression was comparable to that seen in medium and large
dogs. The use of the product in dogs of less than 10 kg or more than 40 kg bodyweight, therefore,
should be subject to a risk/benefit assessment performed by the veterinarian.
The use of the product in pre-pubertal dogs has not been investigated. It is therefore recommended that
dogs should be allowed to reach puberty before treatment with the product is initiated.
Data demonstrates that treatment with the product will reduce the libido of the dog, but other
behavioural changes (e.g. male-associated aggression) have not been investigated.
No adverse reactions have been observed following simultaneous subcutaneous administration of up to
10 implants.
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. The actuator can be re-used.
25
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
01/07/2010
Detailed information on this product is available on the website of the European Medicines Agency
http://www.ema.europa.eu
15. OTHER INFORMATION
Not all pack sizes may be marketed.
26
PACKAGE LEAFLET FOR:
Suprelorin 9.4 mg implant for dogs
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder and manufacturer for batch release
:
Virbac S.A.
1ère avenue 2065 m L.I.D.
06516 Carros
France
Manufacturer for the batch release
:
Brecon Pharmaceuticals Ltd.
Hay-on-Wye HR3 5PG
United Kingdom
2.
Suprelorin 9.4 mg implant for dogs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Suprelorin is a white to pale yellow cylindrical implant containing 9.4 mg deslorelin (as deslorelin
acetate).
4.
For the induction of temporary infertility in healthy, entire, sexually mature male dogs.
5.
None.
6.
Moderate swelling at the implant site may be observed for 14 days.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
7.
Dogs (male).
27
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Administer one implant only, irrespective of the size of the dog. Repeat treatment every 12 months to
maintain efficacy.
Do not use the veterinary medicinal product if the foil pouch is broken.
The implant should be administered subcutaneously between the shoulder blades of the dog.
9.
ADVICE ON CORRECT ADMINISTRATION
Remove Luer Lock cap from the implanter. Attach the actuator to the implanter using the Luer Lock
connection.
Disinfection of the implantation site should be undertaken prior to implantation to avoid introduction
of infection.
Select the implant site by locating the area of the back midway between the shoulder blades. Avoid
injection of the implant into fat, as release of the active substance might be impaired in areas of low
vascularisation. If the hair is long, a small area may be clipped, if required. Lift the loose skin between
the shoulder blades. Insert the entire length of the needle subcutaneously. Fully depress the actuator
plunger and, at the same time, slowly withdraw the needle. Press the skin at the insertion site as the
needle is withdrawn, and maintain pressure for 30 seconds. Examine the syringe and needle to
ascertain that the implant has not remained within the syringe or needle, and that the spacer is visible.
It may be possible to palpate the implant
in situ
.
The biocompatible implant does not require removal. However, should it be necessary to end
treatment, implants may be surgically removed by a veterinarian. Implants may be located using
ultrasound.
The actuator can be re-used.
10. WITHDRAWAL PERIOD
Not applicable.
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
Store in a refrigerator (2
°
C – 8
°
C)
Do not freeze.
Do not use after the expiry date which is stated on the carton.
12. SPECIAL WARNING(S)
Pregnant women should not administer Suprelorin. Another GnRH analogue has been shown to be
foetotoxic in laboratory animals. Specific studies to evaluate the effect of deslorelin when
administered during pregnancy have not been conducted.
Although skin contact with the veterinary medicinal product is unlikely, should this occur, wash the
exposed area immediately, as GnRH analogues may be absorbed through the skin.
28
When administering the veterinary medicinal product, take care to avoid accidental self-injection by
ensuring that animals are suitably restrained and the application needle is shielded until the moment of
implantation.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or
the label to the physician, with a view to having the implant removed.
Infertility is achieved from 8 weeks up to at least 12 months after initial treatment. Treated dogs
should therefore still be kept away from bitches on heat within the first 8 weeks after initial treatment.
In 2 out of 30 dogs in the clinical trial infertility was not achieved until approximately 12 weeks after
initial treatment, but in most cases these animals are not capable of successfully siring offspring.
Should a treated dog mate with a bitch between 8 and 12 weeks after treatment, appropriate measures
should be taken to rule out the risk of pregnancy.
Any mating that occurs more than 12 months after the administration of the Suprelorin may result in
pregnancy. However, it is not necessary to keep bitches away from treated dogs following subsequent
implantations for the initial 8 week period, provided that the veterinary medicinal product is
administered every 12 months.
In certain cases, the implant may be lost from a treated dog. If loss of the implant is suspected in
connection with the first implantation, this can be confirmed by observing no reduction in scrotal
circumference or plasma testosterone levels after 8 weeks from the suspected date of loss, as both
should reduce under correct implantation. If loss of the implant is suspected following re-implantation
after 12 months, a progressive increase will be seen in scrotal circumference and/or plasma
testosterone levels. In both of these circumstances a replacement implant should be administered.
The ability of dogs to sire offspring following their return to normal plasma testosterone levels, after
the administration of Suprelorin, has not been investigated.
With respect to testosterone levels (an established surrogate marker of fertility), during clinical trials
68 % of dogs administered one implant, returned to fertility within 2 years of implantation. 95 % of
dogs had returned to normal plasma testosterone levels within 2.5 years of implantation. However,
data demonstrating the complete reversibility of clinical effects (reduced testicular size, reduced
ejaculation volume, reduced sperm count and reduced libido) including fertility after 12 months, or
repeated implantation, are limited.
Due to limited data, the use of Suprelorin in dogs of less than 10 kg or more than 40 kg bodyweight
should be subject to a risk/benefit assessment performed by the veterinarian. During clinical trials with
Suprelorin 4.7 mg, the mean duration of testosterone suppression was 1.5 times longer among smaller
size dogs (<10 kg) compared with all larger dogs.
The use of Suprelorin in pre-pubertal dogs has not been investigated. It is therefore recommended that
dogs should be allowed to reach puberty before treatment with the veterinary medicinal product is
initiated.
Data demonstrate that treatment with the veterinary medicinal product will reduce the libido of the
dog, but other behavioural changes (e.g. male-associated aggression) have not been investigated.
No adverse reactions have been observed following simultaneous subcutaneous administration of the
equivalent of six implants.
29
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. The actuator can be re-used.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
01/07/2010
Detailed information on this product is available on the website of the European Medicines Agency
http://www.ema.europa.eu
.
15. OTHER INFORMATION
Not all pack sizes may be marketed.
België/Belgique/Belgien
VIRBAC BELGIUM S.A.
Rue de la station 17
B-1300 WAVRE
Tel: 32 (0) 10 47 06 35
Luxembourg/Luxemburg
VIRBAC BELGIUM S.A.
Rue de la station 17
B-1300 WAVRE
Tel: 32 (0) 10 47 06 35
Република България
VIRBAC S.A.
1
ère
avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Magyarország
VIRBAC S.A.
1
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avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Česká republika
VIRBAC S.A.
1
ère
avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Malta
VIRBAC S.A.
1
ère
avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Danmark
VIRBAC Danmark A/S
Profilvej 1
6000 Kolding
Tel: 45 2219 1733
Nederland
VIRBAC NEDERLAND BV
Hermesweg 15
NL-3771 ND-Barneveld
Tel: 31 (0) 342 427 127
Deutschland
VIRBAC Tierarzneimittel GmbH
West Rögen 20
D-23843 Bad Oldesloe
Tel: 49 (4531) 805 555
Norge
VIRBAC S.A.
1
ère
avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Eesti
OÜ ZOOVETVARU
Pärnasalu 31
ET -76505 Saue/Harjumaa, ESTONIA
Tel: + 372 6 709 006
E-mail: margus@zoovet.ee
Österreich
VIRBAC Österreich GmbH
Hildebrandgasse 27
A-1180 Wien
Tel: 43 (0) 1 21 834 260
30
Ελλάδα
VIRBAC HELLAS A.E.
23 rd Klm National Road Athens-Lamia
145 65 Agios Stefanos
Athens - GREECE
Tel: +30 210 6219520
E-mail: info@virbac.gr
Polska
VIRBAC S.A.
1
ère
avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
España
VIRBAC ESPAÑA S.A.
ES-8950 Esplugues de Llobregat (Barcelona).
Tél. : + 34 93 470 79 40
Portugal
VIRBAC DE Portugal
LABORATÓRIOS LDA
P-2080 Almeirim
Tel: (351) 243 570 500
France
VIRBAC
1
ère
avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
E-mail: dar@virbac.fr
România
VIRBAC S.A.
1
ère
avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Ireland
C&M Vetlink Plc.
IE - Co, Limerick
Tel: 353 61 509 800
Slovenija
VIRBAC S.A.
1
ère
avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Ísland
VIRBAC S.A.
1
ère
avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Slovenská republika
VIRBAC S.A.
1
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avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Italia
VIRBAC SRL
Via Caldera, 21
I-20153 Milano
Tel: +39 02 40 92 47 1
Suomi/Finland
VIRBAC S.A.
1
ère
avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Κύπρος
GEO. PAVLIDES & ARAOUZOS LTD
25-27 Dimostheni Severi, 1080
CY-1080 Nicosia - CYPRUS
Τηλ: + 357 22456117
E-mail: theodosiou.vet@gpa.com.cy
Sverige
VIRBAC S.A.
1
ère
avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Latvija
OÜ ZOOVETVARU
Pärnasalu 31
ET - 76505 Saue/Harjumaa, ESTONIA
Tel: + 372 6 709 006
E-mail: margus@zoovet.ee
United Kingdom
VIRBAC Ltd
UK-Suffolk IP30 9 UP
Tel: 44 (0) 1359 243243
Lietuva
OÜ ZOOVETVARU
Pärnasalu 31
ET - 76505 Saue/Harjumaa, ESTONIA
Tel: + 372 6 709 006
E-mail: margus@zoovet.ee
31
Source: European Medicines Agency
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