Suprelorin

Основна информация

  • Търговско наименование:
  • Suprelorin
  • Използвай за:
  • Животни
  • Вид на лекарството:
  • алопатични наркотици

Документи

Локализация

  • Предлага се в:
  • Suprelorin
    Европейски съюз
  • Език:
  • английски

Терапевтична информация

  • Терапевтична група:
  • Dogs, Ferrets
  • Терапевтична област:
  • PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
  • Терапевтични показания:
  • For the induction of temporary infertility in healthy, entire, sexually mature male dogs and ferrets.,
  • Каталог на резюме:
  • Revision: 12

Състояние

  • Източник:
  • EMA - European Medicines Agency
  • Статус Оторизация:
  • Authorised
  • Номер на разрешението:
  • EMEA/V/C/000109
  • Дата Оторизация:
  • 09-07-2007
  • EMEA код:
  • EMEA/V/C/000109
  • Последна актуализация:
  • 23-05-2019

Доклад обществена оценка

7 Westferry Circus

Canary Wharf

London E14 4HB

United Kingdom

Telephone

+44 (0)20 7418 8400

Facsimile

+44 (0)20 7418 8447

E-mail

info@ema.europa.eu

Website

www.ema.europa.eu

An agency of the European Union

© European Medicines Agency, 2012. Reproduction is authorised provided the source is acknowledged.

EMA/295644/2007

EMEA/V/C/000109

EPAR summary for the public

Suprelorin

Deslorelin

This document is a summary of the European Public Assessment Report. Its purpose is to explain

how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on

the basis of the documentation provided, led to the recommendations on the conditions of use.

This document cannot replace a face-to-face discussion with your veterinarian. If you need more

information about your animal’s medical condition or treatment, contact your veterinarian. If you

want more information on the basis of the CVMP recommendations, read the Scientific Discussion

(also part of the EPAR).

What is Suprelorin?

Suprelorin is an implant containing the active substance deslorelin. It is presented in a pre-loaded

applicator.

What is Suprelorin used for?

Suprelorin is used for male dogs and male ferrets to make them temporarily infertile. It is used in

healthy, sexually-mature dogs and ferrets that have not been neutered. The implant is inserted

subcutaneously, under the loose skin on the back between the lower neck and the lumbar area in

dogs and between the shoulder blades in ferrets. Suprelorin starts being effective after about six

weeks in dogs and between 5 to 14 weeks in ferrets. The effect continues for six months in the

case of the 4.7 mg implant for dogs and 12 months in the case of the 9.4 mg implant for dogs (16

months for ferrets) after which the dog and ferret can be re-implanted if necessary.

Suprelorin

EMA/295644/2007

Page 2/3

How does Suprelorin work?

The active substance in Suprelorin, deslorelin, acts like the natural hormone gonadotropin-

releasing hormone (GnRH) which controls the secretion of other hormones involved in fertility.

Suprelorin is given as an implant that slowly releases a continuous low dose of deslorelin. This

suppresses (blocks) the production of follicle stimulating hormone (FSH) and luteinising hormone

(LH). As a result in male dogs and ferrets less testosterone circulates in the blood, the dog and

ferret stop producing sperm and its libido is reduced. If a dog or a ferret under treatment with

Suprelorin were to mate with a female dog (“bitch”) or female ferret (“jill”) on heat, the chance of

the bitch or jill becoming pregnant would be extremely low.

How has Suprelorin been studied?

Suprelorin has been studied under field conditions in dogs weighing between 10 and 25 kg which

were implanted before being followed up for up to a year and in ferrets weighing between 1 and

1.7 kg which were implanted at the beginning of the breeding season before being followed up for

up to 6 months. The studies looked at the effect of Suprelorin on blood testosterone levels and the

size of the testicles for dogs and ferrets and the ability of the dogs to produce semen for collection.

In some of these studies, the dogs and ferrets received Suprelorin more than once and were

observed for up to a year after receiving the final implant. The safety of Suprelorin was studied

after giving dogs more than 10 times and ferrets more than 6 times the recommended dose rate.

What benefit has Suprelorin shown during the studies?

All studies showed a reduction of testosterone levels in the blood, a reduction in the size of the

testicles, decreased libido and decreased spermatogenesis (when fewer sperm are produced by the

testicles). In more than 95% of dogs, these effects started at six weeks after implantation and

between 5 and 14 weeks in treated ferrets after implantation. The majority of dogs regained

normal semen characteristics approximately one year after the last treatment and dogs have been

able to successfully mate with bitches, after treatment with Suprelorin was stopped. The return to

normal fertility after the end of the treatment has not been investigated in ferrets.

What is the risk associated with Suprelorin?

Dogs can have some moderate swelling at the implant site in the two weeks after implantation.

There can also some be some local reaction (e.g. inflammation, hardening) for up to three months

after implantation. Any swelling or local reaction resolves naturally. Ferrets can have transient

moderate swelling, itching and redness at the implant site. Suprelorin is not recommended for use

in dogs and ferrets that have not yet reached puberty, as it has not been investigated in these

animals. The size of the testicles will decrease during treatment.For a full list of all side effects

reported with Suprelorin, see the Package Leaflet.

What are the precautions for the person who gives the medicine or

comes into contact with the animal?

This veterinary medicine has been developed especially for dogs and ferrets and is not for use in

humans. Although skin contact with the product is unlikely, if this occurs the exposed area should

Suprelorin

EMA/295644/2007

Page 3/3

be washed immediately, as these types of substances may be absorbed through the skin. Pregnant

women should not administer the product.

When administering the product, care should be taken to avoid accidental self-injection by ensuring

that animals are suitably restrained and that the application needle is shielded until the moment of

implantation. In case of accidental self-injection, medical advice should be sought immediately and

the Package Leaflet or the label shown to the doctor.

Why has Suprelorin been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of

Suprelorin outweigh its risks for the induction of temporary infertility in healthy, entire, sexually

mature male dogs and ferrets

and recommended that Suprelorin be given a marketing

authorisation. The benefit-risk balance may be found in the scientific discussion module of this

EPAR.

Other information about Suprelorin:

The European Commission granted a marketing authorisation valid throughout the European Union,

for Suprelorin on 10/07/2007. Information on the prescription status of this product may be found

on the label/outer package.

This summary was last updated in March 2012.

Листовка за пациента: състав, показания, Нежелани лекарствени реакции, дозиране, взаимодействия, бременност, кърмене

B. PACKAGE LEAFLET

PACKAGE LEAFLET FOR:

Suprelorin 4.7 mg implant for dogs

1.

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF

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

Manufacturers responsible for batch release

VIRBAC

1ère Avenue – 2065 m – L.I.D.

06516 Carros

France

2.

NAME OF THE VETERINARY MEDICINAL PRODUCT

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.

INDICATION(S)

For the induction of temporary infertility in healthy, non-castrated, sexually mature male dogs.

5.

CONTRAINDICATIONS

None.

6.

ADVERSE REACTIONS

Moderate swelling at the implant site was observed observed for 14 days during safety/efficacy

studies.

During the treatment period, rare clinical effects have been reported: hair coat disorders (e.g. hair loss,

alopecia, hair modification), urinary incontinence, down-regulation associated signs (decrease in

testicle size, reduced activity). In very rare cases, a testicle may be able to ascend the inguinal ring.

In very rare cases there has been transitory increased sexual interest, increased testicle size and

testicular pain immediately after implantation. These signs resolved without treatment.

In very rare cases, a transient behavioural change has been reported with development of aggression

(see “Special warnings”).

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

If you notice any serious effects or other effects not mentioned in this leaflet, please inform your

veterinary surgeon.

7.

TARGET SPECIES

Dogs (male).

8.

DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Administer one implant only, irrespective of the size of the dog (see also “Special warnings”). 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

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.

1. Remove Luer Lock cap from the implanter.

2. Attach the actuator to the implanter using the Luer Lock connection.

3. Lift the loose skin between the shoulder blades. Insert the entire length of the needle

subcutaneously.

4. Fully depress the actuator plunger and, at the same time, slowly withdraw the needle.

5. Press the skin at the insertion site as the needle is withdrawn, and maintain pressure for 30 seconds.

6. 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

Do not freeze

Do not use this veterinary medicinal product after the expiry date which is stated on the carton.

12.

SPECIAL WARNING(S)

Special warnings:

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 6 weeks after initial treatment

One out of 75 dogs treated with the veterinary medicinal 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 6 weeks and 6 months after treatment, appropriate measures

should be taken to rule out the risk of pregnancy.

In rare cases (>0.01 % to < 0.1%), suspected lack of expected efficacy has been reported (in the

majority of cases a lack of reduction of testicle size was reported and/or a bitch was mated). Only

testosterone levels (i.e. an established surrogate marker of fertility) could definitely confirm a lack of

efficacy of the treatment. If lack of treatment efficacy is suspected, then the dog’s implant (e.g.

presence) should be checked.

Any mating that occurs more than 6 months after the administration of the veterinary medicinal

product may result in pregnancy. However, it is not necessary to keep bitches away from treated dogs

following subsequent implantations, provided that the veterinary medicinal product is administered

every 6 months.

In certain cases, the implant may be lost from a treated dog. If loss of the first implant is suspected,

then this can be confirmed by observing no reduction in scrotal circumference or plasma testosterone

levels after 6 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 6 months, then 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 the veterinary medicinal 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 6 months, or repeated implantation, are

limited. In very rare cases (< 0.01 %) the temporary infertility may last more than 18 months.

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 veterinary medicinal 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.

Surgical or medical castration might have unexpected consequences (i.e. improvement or worsening)

on aggressive behaviour. Thus, dogs with sociopathic disorders and showing episodes of intra-specific

(dog to dog) and/or inter-specific (dog to another species) aggressions should not be castrated either

surgically or with the implant.

Special precautions for use in animals:

The use of the veterinary medicinal 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

veterinary medicinal product is initiated.

Data demonstrate that treatment with the product will reduce the libido of the dog.

Special precautions to be taken by the person administering the veterinary medicinal product to

animals:

Pregnant women should not administer the veterinary medicinal 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 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, with a view to having the

implant removed. Show the package leaflet or the label to the physician.

Overdose (symptoms, emergency procedures, antidotes):

No clinical adverse reactions other than those described in the section “Adverse reactions” have been

observed following subcutaneous administration of up to 10 times the recommended dose.

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 following

simultaneous subcutaneous administration of up to 10 times the recommended dose.

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

Detailed information on this veterinary medicinal product is available on the website of the European

Medicines Agency http://www.ema.europa.eu

15.

OTHER INFORMATION

The implant is supplied in a pre-loaded implanter. Each pre-loaded implanter is packaged in a sealed

foil pouch, which is subsequently sterilised.

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.

Not all pack sizes may be marketed.

PACKAGE LEAFLET FOR:

Suprelorin 9.4 mg implant for dogs and ferrets

1.

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF

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

Manufacturers responsible for the batch release:

Virbac S.A.

1ère Avenue – 2065 m – L.I.D.

06516 Carros

France

2.

NAME OF THE VETERINARY MEDICINAL PRODUCT

Suprelorin 9.4 mg implant for dogs and ferrets

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.

INDICATION(S)

For the induction of temporary infertility in healthy, entire, sexually mature male dogs and ferrets.

5.

CONTRAINDICATIONS

None.

6.

ADVERSE REACTIONS

In dogs: Moderate swelling at the implant site was commonly observed for 14 days during

safety/efficacy studies.

During the treatment period, rare clinical effects have been reported: hair coat disorders (e.g. hair loss,

alopecia, hair modification), urinary incontinence, down-regulation associated signs (e.g. decrease in

testicle size, reduced activity). In very rare cases, a testicle may be able to ascend the inguinal ring.

In very rare cases there has been transitory increased sexual interest, increased testicle size and

testicular pain immediately after implantation. These signs resolved without treatment.

In very rare cases, a transient behavioural change has been reported with the development of

aggression (see “Special warnings”).

In ferrets: Transient moderate swelling, pruritus and erythema at the implant site were commonly

observed during clinical studies.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals, including isolated reports treated).

If you notice any serious effects or other effects not mentioned in this leaflet, please inform your

veterinary surgeon.

7.

TARGET SPECIES

Dogs (male) and ferrets (male).

8.

DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Dogs:

Administer one implant only, irrespective of the size of the dog (see also “Special warnings”). Repeat

treatment every 12 months to maintain efficacy.

Ferrets:

Administer one implant only, irrespective of the size of the ferret. Repeat treatment every 16 months

to maintain efficacy.

Dogs and ferrets:

The implant should be administered subcutaneously between the shoulder blades of the dog or ferret.

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.

9.

ADVICE ON CORRECT ADMINISTRATION

Dogs:

Subcutaneous use.

The recommended dose is one implant per dog, irrespective of the size of the dog (see also “Special

warnings”).

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.

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.

1. Remove Luer Lock cap from the implanter.

2. Attach the actuator to the implanter using the Luer Lock connection.

3. Lift the loose skin between the shoulder blades. Insert the entire length of the needle

subcutaneously.

4. Fully depress the actuator plunger and, at the same time, slowly withdraw the needle.

5. Press the skin at the insertion site as the needle is withdrawn, and maintain pressure for 30 seconds.

6. 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.

Ferrets:

Subcutaneous use.

The recommended dose is one implant per ferret, irrespective of the size of the ferret.

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.

It is recommended that the product should be administered under general anaesthesia in ferrets.

The product should be implanted subcutaneously in the loose skin on the back in the intrascapular

space. Avoid injection of the implant into fat, as release of the active substance might be impaired in

areas of low vascularisation.

1. Remove Luer Lock cap from the implanter.

2. Attach the actuator to the implanter using the Luer Lock connection.

3. Lift the loose skin between the shoulder blades. Insert the entire length of the needle

subcutaneously.

4. Fully depress the actuator plunger and, at the same time, slowly withdraw the needle.

5. Press the skin at the insertion site as the needle is withdrawn, and maintain pressure for 30 seconds.

6. 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

Tissue glue can be used to close the site of administration if required.

Subsequent implantations should be based on the increase in testis size and/or increase in plasma

testosterone concentrations as well as return to sexual activity. See also “Special warnings”.

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

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 veterinary medicinal 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 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.

Dogs

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 were 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.

Uncommonly, lack of expected efficacy has been reported in dogs (in the majority of reports a lack of

reduction in testicle size was reported and/or a bitch was mated). Only testosterone levels (i.e. an

established surrogate marker of fertility) could definitely confirm a lack of efficacy of the treatment. If

lack of treatment efficacy is suspected, then the dog’s implant (e.g. presence) should be checked.

Any mating that occurs more than 12 months after the administration of the veterinary medicinal

product 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 first implant is suspected,

then 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, then 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 the veterinary medicinal product, has not been investigated.

With respect to testosterone levels (i.e. 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. In very rare cases the temporary infertility may last more than 18

months.

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.

Surgical or medical castration might have unexpected consequences (i.e. improvement or worsening)

on aggressive behaviour. Thus, dogs with sociopathic disorders and showing episodes of intra-specific

(dog to dog) and/or inter-specific (dog to another species) aggressions should not be castrated either

surgically or with the implant.

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.

Ferrets

Infertility (suppression of spermatogenesis, reduced testis size, levels of testosterone below 0.1 ng/ml,

and suppression of musky odor) is achieved between 5 weeks and 14 weeks after initial treatment

under laboratory conditions. Treated ferrets should therefore still be kept away from jills on heat

within the first weeks after initial treatment.

Levels of testosterone remain below 0.1 ng/ml for at least 16 months. Not all parameters of sexual

activity have been tested specifically (seborrhoea, urine marking and aggressiveness). Any mating that

occurs more than 16 months after the administration of the product may result in pregnancy.

The need for subsequent implantations should be based on the increase in testis size and/or increase in

plasma testosterone concentrations and return to sexual activity.

The reversibility of effects and ability of treated hobs to produce offspring subsequently has not been

investigated. Therefore, the use of Suprelorin should be subject to a benefit/risk assessment performed

by the responsible veterinarian.

In certain cases, the implant may be lost from a treated ferret. If loss of the first implant is suspected,

then this can be confirmed by observing no reduction in testis size or plasma testosterone levels as

both should reduce under correct implantation. If loss of the implant is suspected following re-

implantation, then a progressive increase will be seen in testis size and/or plasma testosterone levels.

In both of these circumstances a replacement implant should be administered.

The use of the veterinary medicinal product in pre-pubertal ferrets has not been investigated. It is

therefore recommended that ferrets should be allowed to reach puberty before treatment with the

veterinary medicinal product is initiated.

Treatment in ferrets should be initiated at the beginning of the breeding season.

The safety after repeated implantations with Suprelorin in ferrets has not been investigated.

The treated hobs may remain infertile up to four years. The veterinary medicinal product should

therefore be used prudently in hobs intended for future reproduction.

Dogs: No adverse reactions other than those described in section “Adverse effects” have been

observed following subcutaneous administration of up to 6 times the recommended dose.

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 following

simultaneous subcutaneous administration of up to 6 times the recommended dose.

Ferrets: There is no information available in ferrets concerning overdose.

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

Detailed information on this veterinary medicinal product is available on the website of the European

Medicines Agency http://www.ema.europa.eu

15.

OTHER INFORMATION

The implant is supplied in a pre-loaded implanter. Each pre-loaded implanter is packaged in a sealed

foil pouch, which is subsequently sterilised.

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.

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:

België/Belgique/Belgien

VIRBAC BELGIUM NV

Esperantolaan 4

BE-3001 Leuven

Tél/Tel/: +32 (0)16 387 260

Република България

VIRBAC

ère

avenue 2065 m LID

FR-06516 Carros

Prancūzija

Teл: +33-(0)4 92 08 73 00

Lietuva

VIRBAC

ère

avenue 2065 m LID

FR-06516 Carros

Prancūzija

Tel: +33-(0)4 92 08 73 00

Luxembourg/Luxemburg

VIRBAC BELGIUM NV

Esperantolaan 4

BE-3001 Leuven

Belgique/Belgien

Tél/Tel: +32 (0)16 387 260

Česká republika

VIRBAC

ère

avenue 2065 m LID

FR-06516 Carros

Francie

Tel: +33-(0)4 92 08 73 00

Magyarország

VIRBAC HUNGARY KFT

Szent Istvàn krt.11.II/21.

HU-1055 Budapest

Tel: +36703387177

Danmark

VIRBAC Danmark A/S

Profilvej 1

DK-6000 Kolding

Tlf:+ 45 75521244

Malta

VIRBAC.

ère

avenue 2065 m LID

FR-06516 Carros

Tel: +33-(0) 4 92 08 73 00

Deutschland

VIRBAC Tierarzneimittel GmbH

Rögen 20

DE-23843 Bad Oldesloe

Tel: +49-(4531) 805 555

Nederland

VIRBAC NEDERLAND BV

Hermesweg 15

NL-3771 ND-Barneveld

Tel: +31-(0) 342 427 100

Eesti

VIRBAC

ère

avenue 2065 m LID

FR-06516 Carros

Prantsusmaa

Tel: +33-(0)4 92 08 73 00

Norge

VIRBAC Danmark A/S

Profilvej 1

DK-6000 Kolding

Danmark

Tel: +45 75521244

Ελλάδα

VIRBAC HELLAS A.E.

χλμ Ε.Ο. Αθηνών - Λαμίας

EL-14452, Μεταμόρφωση

Tel: +30 2106219520

Österreich

VIRBAC Österreich GmbH

Hildebrandgasse 27

A-1180 Wien

Tel: +43-(0) 1 21 834 260

España

VIRBAC ESPAÑA, SA.

Angel Guimerá 179-181

ES-08950 - Esplugues de Llobregat

(Barcelona)

Tel: + 34-(0) 93 470 79 40

Polska

VIRBAC Sp. z o.o.

ul. Puławska 314

PL 02-819 Warszawa

Tel.:+ 48 22 855 40 46

France

VIRBAC France

rue LID

FR-06517 Carros

Tél: +33 805 05 55 55

Hrvatska

VIRBAC

ère

avenue 2065 m LID

FR-06516 Carros

Tel: +33-(0)4 92 08 73 00

Portugal

VIRBAC de Portugal

Laboratórios LDA

R.do Centro empresarial

Ed13-Piso 1- Esc.3

Quinta da Beloura

PT-2710-693 Sintra

Tel: + 351 219 245 020

România

VIRBAC

ère

avenue 2065 m LID

FR-06516 Carros

Franţa

Tel: +33-(0)4 92 08 73 00

Ireland

VIRBAC

1ère avenue 2065 m LID

FR-06516 Carros

France

Tel: + 33-(0)4 92 08 73 00

Slovenija

VIRBAC S.A.

ère

avenue 2065 m LID

FR-06516 Carros

Francija

Tel: +33-(0) 4 92 08 73 00

Ísland

VIRBAC

Slovenská republika

VIRBAC

ère

avenue 2065 m – LID

FR-06516 Carros

Frakkland

Tel: +33-(0)4 92 08 73 00

ère

avenue 2065 m LID

FR-06516 Carros

Francúzsko

Tel: +33-(0)4 92 08 73 00

Italia

VIRBAC SRL

Via Ettora Bugatti, 15

IT-20142 Milano

Tel: +39 02 40 92 47 1

Suomi/Finland

VIRBAC

ère

avenue 2065 m LID

Puh/FR-06516 Carros

Tel: 33 (0) 4 92 08 73 00

Κύπρος

VIRBAC HELLAS A.E.

χλμ Ε.Ο. Αθηνών - Λαμίας

EL-14452, Μεταμόρφωση

Tel: +30 2106219520

Sverige

VIRBAC Danmark A/S Filial Sverige

SE-171 21 Solna

Tel: 45 7552 1244

Latvija

VIRBAC

ère

avenue 2065 m – LID

FR-06516 Carros

Francjia

Tel: +33-(0)4 92 08 73 00